Name of some important mycotoxin-producing fungi, susceptible foods, and mycotoxin effects on humans and animals [19].
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More than half of the publishers listed alongside IntechOpen (18 out of 30) are Social Science and Humanities publishers. IntechOpen is an exception to this as a leader in not only Open Access content but Open Access content across all scientific disciplines, including Physical Sciences, Engineering and Technology, Health Sciences, Life Science, and Social Sciences and Humanities.
\\n\\nOur breakdown of titles published demonstrates this with 47% PET, 31% HS, 18% LS, and 4% SSH books published.
\\n\\n“Even though ItechOpen has shown the potential of sci-tech books using an OA approach,” other publishers “have shown little interest in OA books.”
\\n\\nAdditionally, each book published by IntechOpen contains original content and research findings.
\\n\\nWe are honored to be among such prestigious publishers and we hope to continue to spearhead that growth in our quest to promote Open Access as a true pioneer in OA book publishing.
\\n\\n\\n\\n
\\n"}]',published:!0,mainMedia:null},components:[{type:"htmlEditorComponent",content:'
Simba Information has released its Open Access Book Publishing 2020 - 2024 report and has again identified IntechOpen as the world’s largest Open Access book publisher by title count.
\n\nSimba Information is a leading provider for market intelligence and forecasts in the media and publishing industry. The report, published every year, provides an overview and financial outlook for the global professional e-book publishing market.
\n\nIntechOpen, De Gruyter, and Frontiers are the largest OA book publishers by title count, with IntechOpen coming in at first place with 5,101 OA books published, a good 1,782 titles ahead of the nearest competitor.
\n\nSince the first Open Access Book Publishing report published in 2016, IntechOpen has held the top stop each year.
\n\n\n\nMore than half of the publishers listed alongside IntechOpen (18 out of 30) are Social Science and Humanities publishers. IntechOpen is an exception to this as a leader in not only Open Access content but Open Access content across all scientific disciplines, including Physical Sciences, Engineering and Technology, Health Sciences, Life Science, and Social Sciences and Humanities.
\n\nOur breakdown of titles published demonstrates this with 47% PET, 31% HS, 18% LS, and 4% SSH books published.
\n\n“Even though ItechOpen has shown the potential of sci-tech books using an OA approach,” other publishers “have shown little interest in OA books.”
\n\nAdditionally, each book published by IntechOpen contains original content and research findings.
\n\nWe are honored to be among such prestigious publishers and we hope to continue to spearhead that growth in our quest to promote Open Access as a true pioneer in OA book publishing.
\n\n\n\n
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We hope that chapters of this book will provide useful information within crisis management issue for a wide audience.",isbn:"978-1-78923-235-6",printIsbn:"978-1-78923-234-9",pdfIsbn:"978-1-83881-595-0",doi:"10.5772/intechopen.71641",price:119,priceEur:129,priceUsd:155,slug:"crisis-management-theory-and-practice",numberOfPages:268,isOpenForSubmission:!1,hash:"f3b12d109006096ab14d339a50fa1860",bookSignature:"Katarina Holla, Michal Titko and Jozef Ristvej",publishedDate:"June 27th 2018",coverURL:"https://cdn.intechopen.com/books/images_new/6620.jpg",keywords:null,numberOfDownloads:11328,numberOfWosCitations:2,numberOfCrossrefCitations:10,numberOfDimensionsCitations:16,numberOfTotalCitations:28,isAvailableForWebshopOrdering:!0,dateEndFirstStepPublish:"October 19th 2017",dateEndSecondStepPublish:"November 9th 2017",dateEndThirdStepPublish:"January 8th 2018",dateEndFourthStepPublish:"March 29th 2018",dateEndFifthStepPublish:"May 28th 2018",remainingDaysToSecondStep:"3 years",secondStepPassed:!0,currentStepOfPublishingProcess:5,editedByType:"Edited by",kuFlag:!1,biosketch:null,coeditorOneBiosketch:null,coeditorTwoBiosketch:null,coeditorThreeBiosketch:null,coeditorFourBiosketch:null,coeditorFiveBiosketch:null,editors:[{id:"184727",title:"Dr.",name:"Katarina",middleName:null,surname:"Holla",slug:"katarina-holla",fullName:"Katarina Holla",profilePictureURL:"https://mts.intechopen.com/storage/users/184727/images/6172_n.jpg",biography:"Dr. Katarina Holla gained her PhD. with the thesis Risk Assessment of Industrial Process at Faculty of Security Engineering, University of Zilina in Zilina. Since 2014 she has been appointed Vice – dean for International Relations and Marketing on Faculty of Security Engineering. Her research is mainly focused on the area of Major Industrial Accidents Prevention (Risk Assessment and Treatment) and Crisis Management cycle phases where she has already implemented semi – quantitative and quantitative methods for risks assessment developed within R&D projects. This Complex model for risk assessment is now being used by several companies in Slovak Republic by creation of documentation on safety. She has published more than 82 research papers and 7 books in Slovak and English language. She has delivered special invite presentation on Northumbria University in Newcastle, University of Cardiff and University of Economics in Prague. She obtained specialized skills in the area of Major Industrial Accidents Prevention (Seveso III directive - specialist), Transport of Dangerous Goods (safety advisor) and Health and Safety at Work issues (safety advisor for companies). She has participated in 7FP projects (e.g.COBACORE) and attended several scientific conferences (in Tokyo, USA, Korea and other EU member states).",institutionString:null,position:null,outsideEditionCount:0,totalCites:0,totalAuthoredChapters:"1",totalChapterViews:"0",totalEditedBooks:"1",institution:null}],coeditorOne:{id:"224458",title:"Dr.",name:"Jozef",middleName:null,surname:"Ristvej",slug:"jozef-ristvej",fullName:"Jozef Ristvej",profilePictureURL:"https://mts.intechopen.com/storage/users/224458/images/6174_n.jpg",biography:"Dr. Jozef Ristvej gained his PhD. in 2007 at the University of Zilina, Slovakia – the EU, in Crisis Management. Since that time he received postdoctoral position as the Assistant Professor and in 2014 after successful habilitation he has received position as Associate Professor at the Department of Crisis Management, Faculty of Security Engineering, University of Zilina. Since October 2014 is on the position of Vice-Rector for International Relations and Marketing at the university. In 2007 he participated in ISCRAM Crisis Management Summer School for PhD. students. In 2010 received the visiting scholar grant of Ruth Crawford Mitchell to the Center for Disaster Management at the Graduate School of Public and International Affairs, University of Pittsburgh. In his work he is focusing on supporting the information systems in the area of the decision making process in crisis management. For the year of 2012 was selected by the European Commission as Erasmus Staff Ambassador - 25th anniversary of the Erasmus Programme. He is a member of editorial board of the Infotechnology journal in Lithuania, in 2012 was member of ISCRAM 2012 Conference organizing committee. He is an author of several papers in Europe and abroad. He is a member of several scientific project teams as well as of the ISCRAM Association in Brussels (Information Systems for Crisis Response and Management) and the Society for Science and the Public, in Washington D.C.",institutionString:null,position:null,outsideEditionCount:0,totalCites:0,totalAuthoredChapters:"0",totalChapterViews:"0",totalEditedBooks:"0",institution:null},coeditorTwo:{id:"224472",title:"Dr.",name:"Michal",middleName:null,surname:"Titko",slug:"michal-titko",fullName:"Michal Titko",profilePictureURL:"https://mts.intechopen.com/storage/users/224472/images/6173_n.jpg",biography:"Dr. Michal Titko graduated from the Faculty of Security Engineering, University of Zilina, where he also completed his PhD study in the field of Crisis Management. Currently, he is a professor assistant at Department of Crisis Management at the Faculty of Security Engineering. His research is focused on crisis planning, assessment of the critical infrastructure elements vulnerability and assessment of the societal resilience and vulnerability to the impacts of disasters. Vulnerability and resilience assessment of the society was his main task within the FP7 project (RAIN – Risk Analysis of Network Infrastructure in response to Extreme Weather). In addition, he was a co-investigator of another FP7 project (COBACORE – Community Based Comprehensive Recovery) and a co-investigator of several national projects. 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Cardiovascular disease (CVD), which includes coronary heart disease (CHD) and strokes, is considered as a number one cause of morbidity and mortality worldwide. Together with hypertension, dyslipidemia is among the most prevalent risk factors leading to CVD. Thus, treatment of dyslipidemia is crucial in reducing CVD events and the morbidity and mortality associated with them. Studies in the last decade have confirmed a causal relationship between low-density lipoprotein cholesterol (LDL-C) and the risk of atherosclerotic cardiovascular diseases (ASCVD) [1]. LDL-C can be lowered by diet restriction and lifestyle changes or by various lipid-lowering therapies, among which statins (3-hydroxy-3-methylglutaryl-coenzyme A [HMG-CoA] reductase inhibitors) are currently considered the cornerstone medication. Based on the 2018 guidelines published by the American College of Cardiology (ACC) and the American Heart Association (AHA), multiple recommendations have been made for patients with or at risk of developing cardiovascular disease [2].
Under certain circumstances, non-statin medications like ezetimibe and PCSK9 inhibitors are found to be useful particularly in combination with statin therapy. Clinical trials pertaining to these novel therapies have shown great benefits with significant LDL-C-lowering potential and decrease in cardiovascular risk. These agents are generally well tolerated, but long-term safety and cost remain to be proven.
PCSK9 gene was initially discovered as part of a search for members of the protein convertase family of serine proteases [3]. It was initially named as neural apoptosis-regulated convertase-1 (NARC1) due to its upregulation in apoptosis of primary cultures of cerebellar neurons. Subsequent studies classified it as a member of the proteinase K family of subtilases, and it was renamed as (proprotein convertase subtilisin/kexin type 9 (PCSK9)). The gene mapped to chromosome 1p32 comprises 12 exons, and it is translated into a protein of 692 amino acids (NM-174936.3) and is mainly expressed in the liver [3]. Interestingly, the gene coding for PCSK9 coincides with a region linked to dominant inheritance of hypercholesterolemia in American and French families who had no mutations in either LDL-R or APOB genes [4, 5]. Loss-of-function mutations in the later are the two main culprits that comprise 99% of cases with familial hypercholesterolemia (FH). Further genetic analysis of these index families identified a few rare heterozygous missense mutations in PCSK9 gene, all coinciding with hypercholesterolemia [6]. Thus, PCSK9 is now recognized as the third gene causing FH and currently accounts for <1% of FH cases [7].
A crucial step in further understanding the role of this gene in cholesterol metabolism was achieved by Maxwell and Breslow, who showed that transgenic overexpression of PCSK9 in mice caused a FH-like phenotype due to increased intracellular degradation of the LDL-receptor (LDL-R) [8, 9]. This observation shed light into the physiological implication of PCSK9 gene in the lipid metabolism and dyslipidemia. It became clear that gain-of-function rather than loss-of-function mutations in PCSK9 lead to hypercholesterolemia. In the last decade, many disease-causing mutations, occurring in various domains of the protein and leading to either increased transcription or impaired autocatalysis, have confirmed the above findings [10, 11, 12, 13].
It was not until 2005 when studies in individuals with extremely low LDL-C levels revealed some PCSK9 coding variants that were not seen in individuals with high levels of LDL-C. Some of these variants encoded truncated version of the protein that was clearly predicted to cause loss-of-function of PCSK9 [14, 15]. Mendelian randomization experiments clearly revealed that individuals with PCSK9 loss-of-function variants had lifelong depressed LDL-C levels as well as reduced ASCVD risk [16]. In these initial studies, of 3363 blacks, 2.6% carried heterozygous PCSK9 nonsense variants and were associated with 28 and 88% reductions in LDL-C and ASCVD risk, respectively. Of the 9524 white subjects examined, 3.2% had a PCSK9 mutation and were associated with 15 and 47% reductions in LDL-C and ASCVD risk, respectively. The above results were then confirmed in subsequent larger cohort studies [17, 18].
Taken together, the findings in either gain-of-function or loss-of-function mutations in PCSK9 gene have provided very strong evidence for the potential pharmacological use of targeted reduction of PCSK9 protein. Additionally, studies of complete human knockouts of PCSK9 (biallelic loss-of-function mutations) revealed only isolated decreased LDL-C levels with no deleterious health complications [19, 20]. This supports the potential safety of pharmacologically targeting PCSK9. However, it is worth mentioning that carriers of PCSK9 loss-of-function mutations showed an increased risk of developing type 2 diabetes mellitus (T2DM) [21, 22]. This finding would suggest that a similar side effect may be encountered in potential pharmacological inhibitors of PCSK9 (an increase of T2DM has been reported in statin drugs) [23]. However, no such association was found in clinical trials with human monoclonal anti-PCSK9 [24]. An increased risk of T2DM was also observed in a phenome-wide association study performed in >337,000 individuals with PCSK9 p.R46L mutation [25]. The same mutation was found to have a protective effect on hyperlipidemia, coronary heart disease (CHD), ischemic stroke, and cerebral infarction. No association with cataracts, heart failure, atrial fibrillation, or cognitive dysfunction was reported.
PCSK9 is a serine protease involved in cholesterol metabolism. In the liver, it binds to the LDL-receptor (LDL-R), inducing intracellular degradation, thus reducing serum LDL clearance. Generally, PCSK9 molecule is absent allowing repeated recycling of the LDL-R receptor. One study also suggests that intracellular PCSK9 may be recycled so that a single molecule might contribute multiple times to receptor degradation [26]. Under physiological conditions, PCSK9 expression is very low compared to LDL-R, thus allowing continuous recycling of the receptor (Figure 1A). In the case of low intracellular levels of cholesterol, both LDL-R and PCSK9 are transcribed (Figure 1B). Once secreted in the plasma, PCSK9 serves as one of the many potential ligands for LDL-R. After endocytosis, LDL-R, LDL particle, and PCSK9 enter the lysosome. Once inside the lysosome, the LDL particle is degraded, whereas the LDL-R attached to PCSK9 fails to exit the lysosome, where it gets degraded and can no longer be recycled (Figure 1B) [10, 27, 28]. Using this intricate mechanism, PCSK9 would prevent overexpression of LDL-R and thus increase the intracellular cholesterol levels. On the other hand, in patients with elevated cholesterol levels, administering PCSK9 monoclonal antibodies would neutralize the PCSK9 molecules floating in the plasma, thus increasing LDL-R recycling and surface LDL-R (Figure 1C).
Under physiological conditions, PCSK9 expression is very low compared to LDL-R, thus allowing continuous recycling of the receptor (a). In the case of low intracellular levels of cholesterol, both LDL-R and PCSK9 are transcribed (b). In patients with elevated cholesterol levels, administering PCSK9 monoclonal antibodies would neutralize the PCSK9 molecules floating in the plasma, thus increasing LDL-R recycling and surface LDL-R (c).
To better understand the action of PCSK9 inhibitors, we can correlate it with the pharmacological action of HMG-CoA reductase inhibitors (statins). Cholesterol is mainly synthetized in the liver via the mevalonate pathway, with HMG-CoA reductase being the rate-limiting enzyme in the process. The decrease in the intracellular cholesterol in the liver is sensed by sterol regulatory element-binding protein 2 (SREBP2) which then increases the production of HMG-CoA reductase to promote the intracellular synthesis of cholesterol as well as increase LDL-R and PCSK9 levels. As a result, statins will (1) decrease intracellular cholesterol production, (2) increase LDL-R expression on the hepatocytes, and (3) increase PCSK9 levels. This can explain why addition of anti-PCSK9 monoclonal antibodies can accentuate the lipid-lowering effect of statins.
Currently, statins are the first-choice agents to reduce high blood cholesterol which is considered one of the main risk factors for cardiovascular disease (CVD). Cholesterol Treatment Trialists’ (CTT) Collaboration as well as other clinical trials showed that primary prevention with statins reduced all-cause mortality, reduced combined fatal and nonfatal stroke, reduced revascularization rate, and improved patient quality of life [29, 30]. Statin prescription is not associated with serious harm and is considered to be cost-effective [31]. That said, in the last decade, many patients have reported more and more severe side effects particularly with high-intensity statin therapy [32]. Additionally, certain patient populations (familial hypercholesterolemia) are at particular high risk for cardiovascular events. The risk can be attributed to the complexity of the underlying disease, and sole treatment with statins may be insufficient.
Multiple studies were performed to investigate the cardiovascular effect of the anti-PCSK9 monoclonal antibodies. The Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk (FOURIER) trial, a randomized, double-blinded, placebo-controlled trial published in 2017, is currently considered one of the landmark studies in the efficacy of anti-PCSK9 monoclonal antibodies [36]. The aim of the study was to understand whether evolocumab (anti-PCSK9 monoclonal antibody) which lowers LDL-C levels by 69% can prevent cardiovascular events. This trial included 27,564 patients with atherosclerotic cardiovascular disease and LDL-C levels of ≥70 mg/dl while on maximally tolerated statin therapy. Patients were then randomly assigned to either evolocumab (140 mg every 2 weeks or 429 mg monthly) or placebo. The primary end point of the study was the composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. The secondary end point was the composite of cardiovascular death, myocardial infarction, or stroke. The median duration of follow-up was 2.2 years. Inhibition of PCSK9 with evolocumab on a background of statin therapy lowered LDL-C levels to a median of 30 mg/dl. Addition of evolocumab to statin therapy significantly reduces the risk of cardiovascular events, with a 15% reduction risk of primary composite and a 20% reduction risk of the secondary composite outcomes. Based on this study, PCSK9 inhibitor therapy should be considered for ASCVD risk reduction in patients with stable ASCVD, particularly in those with additional risk factors, on maximally tolerated statin therapy, with on-treatment LDL-C ≥70 mg/dl or non-HDL-C ≥100 mg/dl. In the same FOURIER trial, similar recommendations but with a lower level of evidence can also be applicable to patients with progressive ASCVD (additional diagnosis of MI or nonhemorrhagic stroke).
There is currently no universally accepted definition for statin intolerance. Previous studies have confirmed statin-related muscle side effects; however more needs to be done to accurately address the issue. That said, statin intolerance in individuals with a history of CVD is a challenge to a clinician. According to the latest National Lipid Association (NLA) recommendations, PCSK9 inhibitors may be considered to reduce LDL-C in selected very-high-risk patients who are classified as statin-intolerant, in the presence of additional LDL-C-lowering therapies [37]. The quality of evidence for such a recommendation is low.
Severe hypercholesterolemia is defined as LDL-C ≥190 mg/dl. The majority of these patients have polygenic hypercholesterolemia attributed to multiple, undefined genetic factors. Familial hypercholesterolemia (both heterozygous and homozygous) is due to defined mutations yet less commonly encountered. Regardless of the etiology, long-term risk for cardiovascular diseases in all these patients is very high. However, studies have shown that particularly patients with clinically defined FH have a greater risk for cardiovascular events despite being on maximum dose of statins. Studies in patients with heterozygous familial hypercholesterolemia who received PCSK9 inhibitors (either alirocumab or evolocumab) revealed significant additional LDL-C reduction.
Based on the current data, the National Lipid Association is recommending addition of PCSK9 inhibitors in patients with LDL-C ≥190 mg/dl with additional risk factors or genetic confirmation of FH on maximally tolerated statin ± ezetimibe.
In order to determine the effects of PCSK9 inhibitors (evolocumab) on progression of coronary atherosclerosis in statin-treated patients, the Global Assessment of Plaque Regression with a PCSK9 Antibody as Measured by Intravascular Ultrasound (GLAGOV) multicenter, double-blind, placebo-controlled, randomized clinical trial was conducted [38]. In this trial 968 patients with angiographic coronary disease were studied. These patients were randomized to receive monthly 420 mg evolocumab or placebo via subcutaneous injection for 76 weeks, in addition to moderate- or high-intensity statins. In this trial, the primary efficacy was the change in percent atheroma volume from baseline to week 78, measured by serial intravascular ultrasonography (IVUS) imaging. Secondary efficacy was measured in normalized total atheroma volume and patients demonstrating plaque regression. Interestingly, IVUS showed atherosclerosis regression during 18 months of therapy in patients treated with the combination of evolocumab and statins and absence of regression in patients treated with statin alone. Additionally, the evolocumab group showed a significant reduction in percent atheroma volume as well as total atheroma volume (−0.95%,
The most recent study to evaluate the effects of alirocumab on the occurrence of cardiovascular events in patients who have experienced an acute coronary syndrome (ODYSSEY OUTCOMES) suggested a reduction in mortality with alirocumab in patients after acute coronary syndrome [39].Based on the results from multiple trials, alirocumab reduced the risk of all-cause mortality: 6 fewer deaths per 1000 patients treated (RR, 0.82; 95% CI 0.72–0.95). No reduction in cardiovascular mortality was observed (RR, 0.87; 95% CI, 0.73–1.02) [40]. On the other hand, trials of evolocumab did not show a reduction in either all-cause or cardiovascular mortality (RR, 0.91; 95% CI, 0.57–1.44 and RR, 1.04; 95% CI, 0.88–1.24, respectively). Taken together, PCSK9 inhibitors did not reduce the risk of all-cause or cardiovascular mortality.
Both alirocumab and evolocumab reduced the risk of myocardial infarction, stroke, and coronary revascularization. Alirocumab, but not evolocumab, reduced stable angina hospitalization, and neither drug reduced heart failure.
Regarding the safety of anti-PCSK9 monoclonal antibodies (alirocumab and evolocumab), all phase 2 and 3 studies have demonstrated excellent safety profile [41]. The most commonly reported adverse effect has been injection site reaction [42]. As part of the safety analysis, fat-soluble vitamin concentrations (A, D, E, K) were measured. Compared to placebo, no change in the levels of any of these vitamins was reported. Additionally, no increase in neurocognitive events, new-onset or worsening diabetes, muscle-related events, or myalgia has been noted [43].
Bococizumab has been excluded from most of these studies as the drug is no longer available after the cessation of development by the manufacturer due to high rates of neutralizing antibody formation and subsequent loss of therapeutic efficacy (SPIRE trial) [44].
Since the early 1990s when statins were initially introduced, several large clinical trials have highlighted the benefits of their use with beneficial effects above and beyond lipid lowering [45]. Statins are currently the cornerstone of hyperlipidemia treatment. However, due to safety concerning high-dose therapy as well as residual risk of CVD especially in high-risk patients, additional lipid-modifying therapies have emerged in the last decades.
Ezetimibe reduces absorption of cholesterol from the brush border of the small intestine by targeting the Niemann-Pick C1-like 1 (NPC1L1) protein (Figure 2) [46, 47]. Genetic studies have shown that polymorphisms affecting NPC1L1 are associated with lower levels of LDL cholesterol and a lower risk of cardiovascular diseases [48]. A decrease in cholesterol absorption results in a decrease of total cholesterol, triglycerides, and LDL cholesterol and an increase in HDL cholesterol.
Ezetimibe reduces absorption of cholesterol from the brush border of the small intestine by targeting the Niemann-Pick C1-like 1 (NPC1L1) protein. In the liver, HMG-CoA reductase (statins) promotes the intracellular synthesis of cholesterol as well as increases LDL-R and PCKS9 levels. PCSK9 monoclonal antibodies would neutralize the PCSK9 molecules floating in the plasma, thus increasing LDL-R recycling and surface LDL-R in the liver.
It was FDA-approved in 2002 as an agent to treat people with hyperlipidemia. Ezetimibe given as monotherapy leads to an LDL reduction of approximately 20%. When added to statins, ezetimibe reduces LDL cholesterol levels by an additional 23–24% on average [49, 50]. The Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT) was then conducted to understand if further lowering of the LDL-C levels by statin-ezetimibe dual therapy leads to clinical benefit [51]. In this trial they studied the effect of ezetimibe combined with simvastatin, as compared with that of simvastatin alone, in stable patients who had an acute coronary syndrome and whose LDL cholesterol values were within the guideline recommendations. The primary end points were death from cardiovascular disease, a major coronary event, or nonfatal stroke, assessed from the time of randomization until the first occurrence of one of the events. The combination of simvastatin and ezetimibe resulted in additional lowering of LDL-C levels as well as lower risk of cardiovascular event. A reduction of cholesterol levels of 12.8 mg per deciliter correlated with a proportionally 7.2% lower rate of major vascular events, providing further evidence for a relationship between lower lipid and improved outcomes.
Multiple statin trials including the CTT collaboration have shown clinical benefits when LDL cholesterol was lowered to progressively lower levels. It was on the basis of these trials that a LDL-C of <70 mg per deciliter has been recommended for patients with acute coronary syndrome. Data from the IMPROVE-IT trial support the previous finding and show a direct evidence between further lipid lowering and improved outcomes [51]. Additionally, this trial provides evidence, for the first time, that a non-statin lipid-lowering agent can reduce cardiovascular risk by lowering LDL-C and that statins are not the only beneficiary drugs in hyperlipidemia. The American College of Cardiology recommends consideration of ezetimibe therapy in addition to maximally tolerated statin therapy for both primary and secondary prevention in patients who have not achieved target reduction in their LDL-C by maximally tolerated statin therapy alone.
Ezetimibe is currently marketed as a monotherapy under the trade name of Zetia, as well as in combination with a statin such as Vytorin and Liptruzet. It has a half-life of 22 hours, and it can be administered at 10 mg daily. It can be taken at the same time as fenofibrates or statins, but it is recommended to take it at least 2 hours before or 4 hours after taking bile acid sequestrants.
Based on current studies, very few side effects to ezetimibe have been reported, most common being headache, runny nose, and sore throat [52]. Rhabdomyolysis has been reported only in combination with statin therapy and rarely with monotherapy. Due to its daily dosing and limited side effects, ezetimibe is considered a safer drug with no compliance issues. Contraindications to its use include hypersensitivity to possible ingredients of the formulation. It is not recommended in patients with moderate to severe hepatic impairment but can be administered in patients with renal impairment without any need for dose adjustment. Liver function tests need to be performed only if it is administered with a statin. It is worth mentioning that patients taking ezetimibe with cyclosporine are at an increased risk of ezetimibe toxicity as it can result in 2.3–12-fold increase in exposure [53]. In these cases, cyclosporine concentrations should be closely monitored.
When results from trials of ezetimibe (IMPROVE-IT) and PCSK9 inhibitors (FOURIER RCT) are compared in regard to secondary prevention of cardiovascular events in patients with ASCVD and type 2 diabetes, evolocumab (PCSK9 inhibitor) seems to be more effective [54]. Interestingly, as of December 2018, the annual cost of evolocumab is $6540 and $88 for ezetimibe. From a healthcare cost standpoint, ezetimibe has a significantly lower cost and may be considered a preferred add-on therapy for these patients. The difference in avoiding cardiovascular events between the two therapies is negligible compared with the significant difference in the drug costs. However, a randomized controlled trial (RCT) comparing evolocumab and ezetimibe would be necessary to evaluate and compare the effectiveness of these two drugs. Additionally, long-term effects of these novel drugs in reducing the cardiovascular events in patients with ASCVD and type 2 diabetes will be needed.
Dyslipidemia is a major risk factor for both fatal and nonfatal CVD. Lowering cholesterol levels particularly LDL-C, through lifestyle modifications as well as pharmacological interventions, is crucial for CVD risk reduction. Currently, statins are the cornerstone medication for treatment and primary prevention of hypercholesterolemia. Studies have shown that benefits from statins outweigh any possible adverse effects. However, as the intensity of statin therapy increases, intolerance to their use becomes more prominent. Additionally, high-risk patients on maximally tolerated statins may benefit from novel LDL-C-lowering therapies. Clinical trials have provided evidence that these novel drugs such as PCSK9 inhibitors or ezetimibe can successfully lower LDL-C in levels and contribute in lowering cardiovascular events in high-risk patients with elevated LDL-C on maximally tolerated statins. Both ezetimibe and PCSK9 inhibitors have demonstrated a modest absolute ASCVD risk reduction and good safety profiles. However, given cost considerations particularly for PCSK9 inhibitors, healthcare providers will need to carefully consider the subgroup of patients benefiting the most from their use.
The author declares no conflict of interest.
Mycotoxins are secondary toxic metabolites with a wide variety of chemical structures synthesized by fungi (mold) [1]. Mycotoxins are thought to be a kind of “chemical defense system” to protect mold from insects, microorganisms, nematodes, grazing animals, and humans [2]. Molds reproduce by means of spores, and their small molecular weight spores are easily disseminated to environment by wind. They cannot be affected by the adverse environmental conditions and can be present in the latent state for long periods. Moreover, when the environmental conditions are appropriate, spores return to vegetative form and can form into new mold colonies. Agricultural products can be contaminated with mold in pre-harvest via insect and bird damage and harsh weather condition damage such as hail damage. In addition, selected harvesting method is one of the most important reasons in contamination of the mold to the products. Improper storage, transport, and marketing can also cause the mold growth and synthesis of mycotoxins [3].
Mycotoxin can occur in food and agricultural products via many contamination pathways, at any stage of production, processing, transport, and storage (Figure 1) [4]. Factors that affect mold growth and mycotoxin production are temperature, relative humidity, fungicides and/or fertilizers, interaction between the colonizing toxigenic fungal species, type of subtract and nutritional factors, geographical location, genetic requirements, and insect infestation [5, 6].
Factors affecting mycotoxin occurrence in the food and feed chain [
Approximately 400 fungal secondary metabolites are known to be toxic, and one quarter of agricultural products have been reported to be contaminated with mycotoxins in the world [5, 6, 7, 8, 9]. While a type of mold may form more than one mycotoxin, a mycotoxin can be synthesized by many molds. The most common types of mold which are known to produce mycotoxins are
According to the result of many studies in poultry and mammals, mycotoxins can be carcinogenic, mutagenic, teratogenic, hepatotoxic, nephrotoxic, immunosuppressive, and embryotoxic [11]. The phenomenon of toxicity is called mycotoxicosis occurring after consumption of mycotoxin-contaminated product by human and animal [12].
Especially cereals, grains, nuts, oilseeds, fruits, dried fruits, vegetables, cocoa and coffee beans, wine, beer, herbs, and spices are major mycotoxin vectors since they are consumed by a large mass of people and animals [4]. Mycotoxins cause different degrees of toxicity according to exposure time, mycotoxin amount, physiological state, and sensitivity of the organism in humans and animals.
In addition to risk of public health, mycotoxins generate high level of economical loses for food industry due to reduced crop yields, lost trade revenues (local and international), and livestock illnesses [13, 14]. Elimination of mycotoxin is quite though due to resistant to physical, chemical, and biological methods; however, some of the measures described in the following sections may help to prevent mycotoxin. The methods used for mycotoxin determination are chromatography such as high-performance liquid chromatography (HPLC), thin-layer chromatography (TLC), gas chromatography-mass spectrometry (GC-MS), and also enzyme-linked immunosorbent assay (ELISA) technique and biosensor-based screening methods [15]. Detection is complicated due to limitations in analytical methodology [16]. Therefore, prevention of mold contamination and mycotoxin synthesis is essential for food safety in food industry.
According to the Food and Agricultural Organization (FAO), 77 countries have established guidance and regulations on mycotoxin in food and feed to control the level of mycotoxin. On the other hand, 13 countries including African countries still do not have specific regulation for food safety [4].
Ergotism is one of the oldest determined mycotoxicoses (disease) in human and results from consumption of the ergot body in rye or other grains infected by a parasitic fungus of the genus
Mycotoxins can occur in the food in several ways (Figure 1), but technically divided into two groups; first is mold growth as a pathogen plant in field, another one is grow on stored. After plant materials are contaminated with mold spores from soil and air, they easily contaminate other food source, production area, laboratory, and even kitchen of our homes. Certain species of mold are capable of mycotoxin synthesis; therefore, each food contaminated with mold always may not contain mycotoxins. Nevertheless, moldy products are considered to be risky products in terms of mycotoxin.
Mycotoxins appear in almost all kinds of animal feed and products such as wheat bran, noug cake, pea hulls, maize grain, milk and meat, and also human food such as cereal, fruit and vegetables, spice, etc. [5]. Consuming these foods creates serious health risks in human and all animal species. Mycotoxin intake by feed or food causes chronic intoxication rather than acute symptoms. Acute toxicity is observed in high-dose mycotoxin exposure, and symptoms show a rapid effect such as borborygmy, abdominal pain, diarrhea, etc. On the other hand, low-level mycotoxin exposure in long period causes serious impairments in the liver, kidney, and immune system organs and tissues. Therefore, mycotoxin plays a significant role in cancer in these organs [2]. Some important mycotoxin health effects are shown in Figure 2. Toxic effects on humans and animals of important mycotoxins are shown in Table 1 [19].
Aflatoxin (AFL), ochratoxin A (OTA), patulin (PAT), fumonisin (FUM), trichothecenes (TCT), and zearalenone (ZEA) mycotoxin health effects [
Mycotoxins | Genus/species | Major food | Toxic effects and diseases |
---|---|---|---|
Aflatoxin | Cereals, feeds, oilseeds and pulp, coconut | Carcinogenic, hepatotoxicity, teratogenicity, decreasing immune systems, affecting the structure of DNA, hepatitis, bleeding, kidney lesions | |
Fumonisin | Cereals, corn | Encephalomalacia, pulmonary edema, carcinogenic, neurotoxicity, liver damage, heart failure, esophageal cancer in humans | |
Ochratoxin OTA | Cereals, herbs, oil seeds, figs, beef jerky, fruits, and wine | Kidney and liver damage, loss of appetite, nausea, vomiting, suppression of immune system, carcinogenic | |
Patulin | Silage, wheat, feeds, apples, grapes, peaches, pears, apricots, olives, cereals | Neural syndromes, brain hemorrhage, skin lesions, skin cancer, lung, mutagenicity, antibacterial effect | |
Trichothecenes (T2, DON, DAS, HT2) | Cereals, feeds, silage, legumes, fruits, and vegetables | Immune suppression, cytotoxic, skin necrosis, hemorrhage, anemia, granulocytopenia, oral epithelial lesions, GIS lesions, hematopoietic, alimentary toxic aleukia (ATA), hypotension, coagulopathy | |
Zearalenone | Cereals, corn, silage, timothy grass, fodder | Carcinogenic, hormonal imbalance estrogenic effect, reproductive problems, teratogenic |
Name of some important mycotoxin-producing fungi, susceptible foods, and mycotoxin effects on humans and animals [19].
Mycotoxins have caused many serious outbreaks worldwide. There was an outbreak that occurred in 1967, and 26 people were poisoned because of the consumption of moldy rice for up to 3 weeks in Taiwan [21]. An outbreak of aflatoxicosis affecting humans, reported in India, led to the death of 100 people in 1974 [22]. Another outbreak was reported in India in 1995, affecting 1424 people due to sorghum and maize contaminated with fumonisin [23]. During January–June 2004, an aflatoxicosis outbreak in eastern Kenya resulted in 317 cases and 125 deaths [24].
Mycotoxin contamination in foods and fodder has been becoming a global concern day by day. According to Food and Agricultural Organization (FAO) reports, it is estimated that mycotoxin affects nearly 25% of the world’s crop each year and is causing huge agricultural product and industrial losses in billions of dollars [25]. For example, estimated annual loss in the United States is approximately $ 0.5–1.5 billion [19]. The main effects of mycotoxins on national economies can be thought in five ways:
Product yield losses due to toxigenic mold diseases
Decrease in commercial value because of contaminated food and feed
Human and animal health losses due to harmful impacts associated with mycotoxin-contaminated food and fodder consumption
Cost of analysis of mycotoxin
Strategies to control mycotoxin contamination
Economic impacts are felt by agricultural chain such as manufacturer of plant and animal, especially cereal industry, consumers, and briefly all farm-to-fork steps.
Aflatoxins are a group of toxic secondary metabolites of filamentous fungi,
Ochratoxin A (OTA) is a natural mycotoxin produced mainly by fungal type of
Fumonisins are generated by various fungal species such as
The International Agency for Research on Cancer (IARC) identified FB1 as possibly carcinogenic to humans (group 2B). Recent studies reported that FB1 causes an increased prevalence of esophageal and liver cancer in humans [59]. Furthermore, this mycotoxin has been found to have toxic effects against several organs (nervous and cardiovascular systems, liver, lung, kidney) in animals [60]. Fumonisins are largely found in corn and corn-based foods and also FB1 in rice, beer, sorghum, cowpea seeds, triticale, beans, asparagus, and soybeans [61].
Zearalenone (ZEA), known as an estrogenic mycotoxin, is a secondary metabolite produced by
Several in vivo studies found that ZEA disrupts hormonal balance due to its similarity to naturally occurring estrogens [64]. The mycotoxin has high affinity for estrogen receptors, causing reproduction and fertility disorders in mammals [65]. In addition, it is known that progressive exposure to endocrine-modulatory compound has been linked with carcinogenesis in human [64]. According to the European Food Safety Authority (EFSA) report in 2014, the bioavailability of toxin is up to 80% in human and animals such as rats, rabbits, and pigs [66]. Moreover, recent works report ZEA is metabolized in the liver and has shown hepatotoxic, immunotoxic, carcinogenic, and nephrotoxic effect in animal tests [67, 68, 69]. As this mycotoxin possesses such consumer health risks, the European Union (EU) has prescribed the limits of ZEA (20–350 μg/kg) for various processed and unprocessed cereals [66].
Trichothecenes are a large group of mycotoxins produced predominantly by
The mechanism of action of trichothecenes is based on the inhibition of protein synthesis in eukaryotes. This mycotoxin affects peptidyl transferase enzyme binding the 60S ribosomal subunit, thus causing the inhibition of protein translation and ribotoxic stress [75]. Also, Pestka reported these groups of mycotoxins cause immunosuppression or immune stimulation by affecting the leucocytes [76].
The family of trichothecenes has a significant impact on cereal and grain production due to health risk for human consumption, livestock feed, or malting purposes [77, 78]. According to report from the FDA, economic losses associated with mycotoxin ranges from USD 0.5 million to over USD 1.5 billion from aflatoxin (corn and peanuts), fumonisin (corn), and deoxynivalenol (wheat) in the United States. [72]. Hence, control of these mycotoxins is essential for human and animal health and economic reasons.
Deoxynivalenol (DON), known as vomitoxin, is the most commonly detected trichothecenes in grains such as wheat, barley, oats, rye, and corn and less often in rice, sorghum, and triticale [79]. Even though NIV presence of cereals appears generally to be lower than DON [80], it has been reported that the occurrence of NIV in of wheat and barley is as prevalent as that of deoxynivalenol (DON) in Japan [81]. According to animal toxicity studies, NIV shows higher toxicity than DON. The LD50 values for DON and NIV in tests in mice were 78 and 39 mg/kg, respectively, and DON and NIV, similarly to other trichothecenes, show inhibitor effect on cell metabolism such as protein, DNA, and RNA synthesis [82]. In addition, these mycotoxins affect cell division and mitochondrial functions [83, 84, 70]. Both mycotoxins exhibit major symptoms such as abdominal discomfort, diarrhea, vomiting, and inflammation of the throat, weight loss, and anorexia [85].
The World Health Organization (WHO) reported that trichothecenes shows fatal and chronic intoxications on human and livestock and also DON shows teratogenic, neurotoxigenic, and immunosuppressant effects [86].
According to the conducted BIOMIN World Mycotoxin Survey, DON appeared in 81% of livestock feed from 81 countries worldwide followed by fumonisins that were detected in 71% of samples. Therefore, DON is reported as the most common mycotoxin worldwide (https://www.biomin.net/en/biomin-mycotoxin-survey/).
Food safety is a key component in public health issue, and a mycotoxin is a huge food safety risk in developing countries. Prevention is the most important and effective way in reducing fungal growth and mycotoxin production to ensure food safety. The following steps that explain prevention and control of mycotoxin occurrence include good agricultural practices (GAP) in field, control practices of harvesting and storage, physical methods (cleaning, milling, etc.), implementation of biotechnological application, biological control through the use of controlled atmosphere during storage, detoxification/degradation, and fermentation techniques.
Pre-harvesting is considered first and one of the most important stages to prevent mold growth and mycotoxin synthesis. Several strategies are available for the produce of healthy products and reduce the mold formation at pre-harvesting, including selection of plants according to the soil structure and production capacity, use of plant which is resistant to fungi and insects, irrigation time, make fertilization, use of insecticides to prevent insect damage [87].
Harvesting at the appropriate time periods (low moisture and full maturity) is essential for reducing the risk of a mycotoxin contamination since overmaturity creates sensitivity to mold growth. Additionally, suitable harvesting equipment and procedures should be used, and crops should be dried after maturity to both reduce grain moisture to safe levels [88].
The latest technological advances provided new paths in mycotoxin control strategies that include the use of a controlled atmosphere with inhibitory or a protective effect and use of naturally occurring compounds under different conditions and essential oils with antioxidant properties to decrease fungal growth and mycotoxin production in grains during storage [89]. Moreover, these strategies also include using regularly cleaned transport vehicles to prevent cross contamination of products; monitoring of temperature, humidity, aeration and pest infestation periodic during storage [90]; using mold inhibitors (propionic acid) to contaminated food and feed; and application of disinfectant such as sodium hypochlorite to storage area [91].
Some studies have shown that using physical methods (dehulling, washing, sorting, and cleaning of visible moldy seed) reduces different mycotoxin species in foods regardless of grain genre [70]. Scudamore and Pascale et al. [92] and Patel [93] observed a reduction of T-2 (62%) and HT-2 (53%) and DON (50%) in wheat seeds after cleaning. Scudamore and Patel also reported a 32% reduction in fumonisin levels in corn in an industrial enterprise [94]. Moreover, milling is an important effect in the reduction of
One of the best applicable strategies for the prevention of mycotoxin formation is the cultivation of fungal infestation-resistant plants and improvement of the genetic composition to suppress mycotoxin production [96]. The benefits of biotechnological applications were observed with Aflasafe. Aflasafe is a biocontrol product that includes a blend of four fungal species covered over grains which reduce aflatoxigenic fungi that produce AFs in maize and groundnuts (https://aflasafe.com/).
Mycotoxins are resistant to heat and cannot be completely destroyed under normal cooking process. On the other hand, mycotoxin reduction has been determined after heating, and this may be the result of reactions changing the chemical structure [70]. Ryu et al. reported heat treatment (at temperature 120–160°C) causes a reduction between 66 and 83% of ZEN [97]. Scott and Lawrence also reported a reduction of 60–100% of fumonisins with a heat treatment at 190°C (60 min) and 220°C (25 min).
Biological control of mycotoxins via detoxification/degradation offers a promising alternative method [98]. Recently the effectiveness of fermentation for the reduction and elimination of mycotoxins has also been proven. Studies documented in the literature generally show that mycotoxins are reduced by conversion, detoxification, binding, degradation, and decontamination after food fermentation [99]. Modification of the chemical structure of the mycotoxin molecule, removal or detoxification/inactivation, and adhesion to bacterial cell walls provide a reduced toxicity during fermentation [99]. Implementation of these preventive methods cannot solve the problem alone; also it must be an integral part of an integrated food safety management system based on the hazard analysis and critical control point (HACCP).
HACCP is a food management system where food safety is addressed through the analysis, control, and monitoring of physical, chemical, and biological hazards from raw material manufacturing, supply, and handling to production, distribution, and consumption of the finished product [100]. The National Advisory Committee on Microbiological Criteria for Foods (NACMCF) published a guideline about HACCP containing seven basic principles, decision tree, and all plans in 1992 [101]. Implementation of HACCP is an effective strategy for prevention, control, and periodic monitoring of mycotoxin in all stages from field to the consumer. There are 12 successive steps recommended to implementation of HACCP system. Previous HACCP studies can be researched to set up tasks from 1 to 5 that specify each food process, and tasks required for mycotoxin control begin at 6 (Principle 1).
Establish the HACCP team.
Describe the product.
Identify the product’s intended use.
Draw up the commodity flow diagram.
Confirm the flow diagram on-site.
Identify and analyze hazard(s) (Principle 1).
Determine the critical control points (CCPs) (Principle 2).
Establish critical limits for each (CCP) (Principle 3).
Establish a monitoring procedure (Principle 4).
Establish corrective action (Principle 5).
Verify the HACCP plan (Principle 6).
Keep record (Principle 7).
Crops and tolerated levels of mycotoxins (μgkg−1) | |||||
---|---|---|---|---|---|
Country | Mycotoxins | Rice | Maize | Spices | Fruit juices |
Brazil | AFB1/AFG1 | 30 | 30 | 30 | 30 |
China | AFB1 | 10 | 20 | — | — |
France | FB1 | 1000 | 1000 | — | — |
Hungary | Total AF OTA | 50 5 | 50 5 | - - | - - |
Japan | AFB1 Patulin | 10 | 10 | 10 | — |
The United States | Total AF Patulin | 20 - | 20 - | 20 - | - 50 |
Turkey | AFB1 Patulin | 2 - | 2 - | 5 - | - - |
Global regulation of mycotoxin contamination in agricultural products [103].
Microbiological and/or chemical tests can be used to confirm which product is meeting CCP.
Asking questions especially to CCP employees.
Internal or external audit by independent person to check whether HACCP system is being implemented.
Step/CCP | Hazard analysis | Monitoring | Corrective action | |||
---|---|---|---|---|---|---|
Hazard | Control | Critical limit | Monitoring | Frequency | ||
Pre-harvest/ growing | Low soil moisture leading to plant stress during kernel development | Irrigate | Lower limit of critical water activity (aw) (check with your agronomist/extension staff for an exact value) | Measure soil moisture and record | Weekly on Monday morning | Additional irrigation; record amounts |
Insufficient soil nutrients leading to plant stress during kernel development | Fertilize | N, P, and K applications as recommended for hybrid by local agronomists (insert the values) | Fertilizer applied (appropriate for soil type and hybrid); amounts and type recorded | As recommended for hybrid | Additional fertilizer; record amounts added | |
Insect attack leading to damaged kernels | Integrated pest management (IPM) plan | Insect population within acceptable limits as determined by control program | Visual inspection and sample, with results recorded | Weekly | Apply pesticide in accordance with IPM plan | |
Harvest | Damage to kernels from harvester | Harvest when kernels are dry | Moisture content ≤14% | Measure and record grain moisture | Prior to harvest | Delay harvest till kernels are dried enough |
Storage | Excessive moisture content of kernels | Do not store until kernels are dry | Moisture content ≤14% | Measure and record grain moisture | Immediately prior to storage | Dry mechanically |
Insect attack, allowing fungi to penetrate kernels | IPM plan | No evidence of insect or rodent infestation using inspection protocols specified in IPM plan | Visual inspection with results recorded | Weekly | Apply pest control methods in accordance with IPM plan | |
High ambient humidity and temperature | Aerate grain to control temperature and humidity | Temperature and humidity within limits recommended in industry literature | Measure and record humidity, ambient temperature, and airflow | Daily during storage | Adjust aeration time of day or airflow to achieve desired temperature and humidity |
HACCP plan of maize [102].
Mycotoxin is a well-known food safety risk, which is a threat to human and livestock health, and has high economic significance in food industry. Recently, the food industry has become aware of the new term modified mycotoxins introduced by Rychlik et al. (masked mycotoxin) [104]. Food safety risk has risen since masked mycotoxins which pose many difficulties including the unknown occurrence/co-occurrence of these compounds and their toxicological properties. In addition, Lorenz et al. reported that the European Food Safety Authority (EFSA) has taken into account efforts to address this emerging issue in food safety by developing strategies on how to evaluate potential added health risk due to the occurrence of modified mycotoxins [104].
Mycotoxigenic molds are difficult to prevent and control due to their widespread presence in nature. Prevention of mycotoxin synthesis in all stages of food processing is an essential point for public health and economic reasons. Many practices used for prevention of mycotoxin include good agricultural practices (GAP) in field, control practices of harvesting and storage, physical methods (cleaning, milling, etc.), implementation of biotechnological application, biological control through the use of controlled atmosphere during storage, detoxification/degradation, and fermentation techniques.
Meanwhile a number of techniques for mycotoxin control and management prove to be quite costly and/or unenforceable in some cases. On the other hand, using fermentation process for appropriate process has been recommended for mycotoxin reduction by Adebiyi et al. [99]. In the future, more emphasis should be given to nanotechnology and genetic engineering practices in the development of durable product types to ensure food safety.
In addition to these applications, food safety management systems such as HACCP, GAP, and good manufacturing practices (GMP) should be integrated at all stages of production, transport, and storage, in order to minimize contamination in food industry. Also fairly new food safety system including threat assessment critical control points (TACCP), vulnerability critical control points (VACCP), and hazard analysis and risk-based preventive controls (HARPC) should be investigated and implemented to ensure an effective control system.
"Open access contributes to scientific excellence and integrity. It opens up research results to wider analysis. It allows research results to be reused for new discoveries. And it enables the multi-disciplinary research that is needed to solve global 21st century problems. Open access connects science with society. It allows the public to engage with research. To go behind the headlines. And look at the scientific evidence. And it enables policy makers to draw on innovative solutions to societal challenges".
\n\nCarlos Moedas, the European Commissioner for Research Science and Innovation at the STM Annual Frankfurt Conference, October 2016.
",metaTitle:"About Open Access",metaDescription:"Open access contributes to scientific excellence and integrity. It opens up research results to wider analysis. It allows research results to be reused for new discoveries. And it enables the multi-disciplinary research that is needed to solve global 21st century problems. Open access connects science with society. It allows the public to engage with research. To go behind the headlines. And look at the scientific evidence. And it enables policy makers to draw on innovative solutions to societal challenges.\n\nCarlos Moedas, the European Commissioner for Research Science and Innovation at the STM Annual Frankfurt Conference, October 2016.",metaKeywords:null,canonicalURL:"about-open-access",contentRaw:'[{"type":"htmlEditorComponent","content":"The Open Access publishing movement started in the early 2000s when academic leaders from around the world participated in the formation of the Budapest Initiative. They developed recommendations for an Open Access publishing process, “which has worked for the past decade to provide the public with unrestricted, free access to scholarly research—much of which is publicly funded. Making the research publicly available to everyone—free of charge and without most copyright and licensing restrictions—will accelerate scientific research efforts and allow authors to reach a larger number of readers” (reference: http://www.budapestopenaccessinitiative.org)
\\n\\nIntechOpen’s co-founders, both scientists themselves, created the company while undertaking research in robotics at Vienna University. Their goal was to spread research freely “for scientists, by scientists’ to the rest of the world via the Open Access publishing model. The company soon became a signatory of the Budapest Initiative, which currently has more than 1000 supporting organizations worldwide, ranging from universities to funders.
\\n\\nAt IntechOpen today, we are still as committed to working with organizations and people who care about scientific discovery, to putting the academic needs of the scientific community first, and to providing an Open Access environment where scientists can maximize their contribution to scientific advancement. By opening up access to the world’s scientific research articles and book chapters, we aim to facilitate greater opportunity for collaboration, scientific discovery and progress. We subscribe wholeheartedly to the Open Access definition:
\\n\\n“By “open access” to [peer-reviewed research literature], we mean its free availability on the public internet, permitting any users to read, download, copy, distribute, print, search, or link to the full texts of these articles, crawl them for indexing, pass them as data to software, or use them for any other lawful purpose, without financial, legal, or technical barriers other than those inseparable from gaining access to the internet itself. The only constraint on reproduction and distribution, and the only role for copyright in this domain, should be to give authors control over the integrity of their work and the right to be properly acknowledged and cited” (reference: http://www.budapestopenaccessinitiative.org)
\\n\\nOAI-PMH
\\n\\nAs a firm believer in the wider dissemination of knowledge, IntechOpen supports the Open Access Initiative Protocol for Metadata Harvesting (OAI-PMH Version 2.0). Read more
\\n\\nLicense
\\n\\nBook chapters published in edited volumes are distributed under the Creative Commons Attribution 3.0 Unported License (CC BY 3.0). IntechOpen upholds a very flexible Copyright Policy. There is no copyright transfer to the publisher and Authors retain exclusive copyright to their work. All Monographs/Compacts are distributed under the Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). Read more
\\n\\nPeer Review Policies
\\n\\nAll scientific works are Peer Reviewed prior to publishing. Read more
\\n\\nOA Publishing Fees
\\n\\nThe Open Access publishing model employed by IntechOpen eliminates subscription charges and pay-per-view fees, enabling readers to access research at no cost. In order to sustain operations and keep our publications freely accessible we levy an Open Access Publishing Fee for manuscripts, which helps us cover the costs of editorial work and the production of books. Read more
\\n\\nDigital Archiving Policy
\\n\\nIntechOpen is committed to ensuring the long-term preservation and the availability of all scholarly research we publish. We employ a variety of means to enable us to deliver on our commitments to the scientific community. Apart from preservation by the Croatian National Library (for publications prior to April 18, 2018) and the British Library (for publications after April 18, 2018), our entire catalogue is preserved in the CLOCKSS archive.
\\n"}]'},components:[{type:"htmlEditorComponent",content:'The Open Access publishing movement started in the early 2000s when academic leaders from around the world participated in the formation of the Budapest Initiative. They developed recommendations for an Open Access publishing process, “which has worked for the past decade to provide the public with unrestricted, free access to scholarly research—much of which is publicly funded. Making the research publicly available to everyone—free of charge and without most copyright and licensing restrictions—will accelerate scientific research efforts and allow authors to reach a larger number of readers” (reference: http://www.budapestopenaccessinitiative.org)
\n\nIntechOpen’s co-founders, both scientists themselves, created the company while undertaking research in robotics at Vienna University. Their goal was to spread research freely “for scientists, by scientists’ to the rest of the world via the Open Access publishing model. The company soon became a signatory of the Budapest Initiative, which currently has more than 1000 supporting organizations worldwide, ranging from universities to funders.
\n\nAt IntechOpen today, we are still as committed to working with organizations and people who care about scientific discovery, to putting the academic needs of the scientific community first, and to providing an Open Access environment where scientists can maximize their contribution to scientific advancement. By opening up access to the world’s scientific research articles and book chapters, we aim to facilitate greater opportunity for collaboration, scientific discovery and progress. We subscribe wholeheartedly to the Open Access definition:
\n\n“By “open access” to [peer-reviewed research literature], we mean its free availability on the public internet, permitting any users to read, download, copy, distribute, print, search, or link to the full texts of these articles, crawl them for indexing, pass them as data to software, or use them for any other lawful purpose, without financial, legal, or technical barriers other than those inseparable from gaining access to the internet itself. The only constraint on reproduction and distribution, and the only role for copyright in this domain, should be to give authors control over the integrity of their work and the right to be properly acknowledged and cited” (reference: http://www.budapestopenaccessinitiative.org)
\n\nOAI-PMH
\n\nAs a firm believer in the wider dissemination of knowledge, IntechOpen supports the Open Access Initiative Protocol for Metadata Harvesting (OAI-PMH Version 2.0). Read more
\n\nLicense
\n\nBook chapters published in edited volumes are distributed under the Creative Commons Attribution 3.0 Unported License (CC BY 3.0). IntechOpen upholds a very flexible Copyright Policy. There is no copyright transfer to the publisher and Authors retain exclusive copyright to their work. All Monographs/Compacts are distributed under the Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). Read more
\n\nPeer Review Policies
\n\nAll scientific works are Peer Reviewed prior to publishing. Read more
\n\nOA Publishing Fees
\n\nThe Open Access publishing model employed by IntechOpen eliminates subscription charges and pay-per-view fees, enabling readers to access research at no cost. In order to sustain operations and keep our publications freely accessible we levy an Open Access Publishing Fee for manuscripts, which helps us cover the costs of editorial work and the production of books. Read more
\n\nDigital Archiving Policy
\n\nIntechOpen is committed to ensuring the long-term preservation and the availability of all scholarly research we publish. We employ a variety of means to enable us to deliver on our commitments to the scientific community. Apart from preservation by the Croatian National Library (for publications prior to April 18, 2018) and the British Library (for publications after April 18, 2018), our entire catalogue is preserved in the CLOCKSS archive.
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