The Role of Nutraceuticals in Statin Intolerant Patients

Banach, Maciej; Patti, Angelo Maria; Giglio, Rosaria Vincenza; Cicero, Arrigo Francesco Giuseppe; Atanasov, Atanas G.; Bajraktari, Gani; Bruckert, Éric; Descamps, Olivier; Djuric, Dragan; Ezhov, M.; Fras, Zlatko; Haehling, Stephan von; Katsiki, Niki; Langlois, Michel; Latkovskis, Gustavs; Mancini, G.B. John; Mikhailidis, Dimitri P.; Mitchenko, O.; Moriarty, Patrick M.; Muntner, Paul; Nikolić, Dragana; Panagiotakos, Demosthenes B.; Paragh, György; Paulweber, Bernhard; Pella, Daniel; Pitsavos, Christos; Reiner, Željko; Rosano, Giuseppe M.C.; Rosenson, Robert S.; Rysz, Jacek; Sahebkar, Amirhossein; Șerban, Maria-Corina; Vinereanu, Dragoş; Vráblík, Michal; Watts, Gerald F.; Wong, Nathan D.; Rizzo, Manfredi

doi:10.1016/j.jacc.2018.04.040

Cited by 223 publications

(147 citation statements)

References 158 publications

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“…Among the nutraceuticals that may gain a place in cardiovascular risk reduction (Sahebkar et al, 2016), odourless garlic seems to be a future option. There is a great demand for such options in statin intolerant patients (Banach et al, 2018).…”

Section: Discussionmentioning

confidence: 99%

Preliminary evidence of the clinical effectiveness of odourless garlic

Vlachojannis

Schoenenberger

Erné

et al. 2019

Phytotherapy Research

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This study attempts a systematic evaluation of the clinical evidence for the use of odourless garlic prepared by ageing or fermentation. By PubMed, CENTRAL, and handsearching, 59 clinical studies were identified for potential extraction, of which 24 fulfilled the inclusion criteria. The quality of the studies and evidence of effectiveness were assessed by an established set of conventional criteria. Even the 12 best clinical trials (50%) had fundamental flaws that prevented to grade them as confirmatory. On the basis of a subsample of 19 exploratory studies (79%), an impressive reduction of cardiovascular risk was found for odourless garlic (evidence of effectiveness, “moderate” and for other indications, “poor”). Evidence of effectiveness is further limited by the fact that most studies used aged garlic produced by one pharmaceutical company and that products differed in composition and dose of the marker substance S‐allyl‐cysteine. In case odourless garlic is potentially an effective remedy in particular for cardiovascular diseases, we discern an urgent need for long‐term confirmatory studies. The ultimate cardiovascular endpoint for definitive studies would be mortality, but reductions in blood pressure or demonstrable decreases in atherosclerotic plaques or blood markers of cardiovascular risk would be useful surrogates. Sample sizes for various assumptions are provided.

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Section: Discussionmentioning

confidence: 99%

Preliminary evidence of the clinical effectiveness of odourless garlic

Vlachojannis

Schoenenberger

Erné

et al. 2019

Phytotherapy Research

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“…При этом нутрицевтики, включая препараты на основе КДР, не могут заменить медикаментозную терапию, если к ней имеются показания. Кроме того, у некоторых пациентов с гиперхолестеринемией может иметься непереносимость статинов, что снижает приверженность терапии, ограничивает эффективность лечения и повышает риск ССЗ [21][22][23]. Для пациентов, не желающих принимать статины и другие липидсни-жающие препараты даже при наличии четких показаний и рекомендации врачей, препарат на основе КДР может быть средством выбора ввиду его существенного гипохолестринемического эффекта и безопасности.…”

Section: нутрицевтики в современных рекомендациях и реальной клиничесunclassified

“…Реальная непереносимость статинов имеется только у 3-5% пациентов, и лишь у очень немногих (<1%) возникают серьезные нежелательные явления, такие как миопатия, миозит или рабдомиолиз (1,6 на 100000 человеко-лет) [21]. У большинства пациентов, у которых возникли связанные со статинами мышечные симптомы, сохраняется возможность использовать статины с изменением дозы и типа статина, или с режимом приема статина через день, или же может быть рассмотрено применение нестатиновых препаратов либо определенных нутрицевтиков с липидснижающими свойствами [23]. Было показано, что у пациентов с мышечными симптомами применение препарата на основе КДР снижает уровень ХС ЛНП на 20-30% (на 40% в сочетании с эзетимибом) и сопровождается низкой частотой отмены вследствие рецидива миопатии (2-7%) [24].…”

Section: нутрицевтики в современных рекомендациях и реальной клиничесunclassified

“…Нутрицевтики, включая препараты на основе КДР, не могут заменить статины, но могут использоваться в качестве дополнения к нестатиновым гиполипидемическим средствам, таким как эзетимиб, для The Red Yeast Rice Based Preparations for Dyslipidemia Препараты на основе красного дрожжевого риса при дислипидемии достижения терапевтических целей. В особых случаях это может быть важным вариантом лечения для пациентов, не желающих принимать статины [23].…”

Section: нутрицевтики в современных рекомендациях и реальной клиничесunclassified

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The Role of Red Yeast Rice Based Preparations for Non-Pharmacological Correction of Dyslipidemia in Patients with Low and Moderate Cardiovascular Risk (Expert Opinion)

Ezhov

Catapano

Escobar

et al. 2020

Racionalʹnaâ farmakoterapiâ v kardiologii

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The Russian Federation is among countries with high cardiovascular risk. Hypercholesterolemia is a leading risk factor for the development of atherosclerotic cardiovascular diseases. To achieve low-density lipoprotein cholesterol (LDL-C) targets, such approaches as lifestyle changes and pharmacological correction, based on the use of statins, are applied. At the same time, a significant proportion of the population has moderate hypercholesterolemia and is characterized by low or moderate cardiovascular risk. Although first-line recommendations should be followed, a healthy lifestyle alone is not enough to achieve target levels of LDL-C, which means that even people with low to moderate risk may end up with the prospect of lifelong therapy with lipid-lowering drugs. These individuals do not have an indication for lipid-lowering therapy, and they are usually recommended a change in diet and supplementation. Innovative nutritional strategies have been developed to manage dyslipidemia. They were based either on changing some “risky” food components or on encouraging the consumption of “healthy” functional foods and/or nutraceuticals. Nutraceuticals (registered as food supplements in Russia) is an innovative way to help control LDL-C at low and moderate risk individuals without lipid-lowering drugs and as nutritive support for the cholesterol-lowering diet. Red yeast rice (RYR) based preparations have been already developed and available at the moment. RYR based preparations can be considered in patients with low and moderate cardiovascular risk, who have not reached the target level of LDL-C and have no indications for statin therapy or have statin intolerance. RYR based preparations contains a statin-like substance monacolin K in a dose of 3 mg. In randomized clinical trials, it was proved that the use of high-quality RYR nutraceutical leads to a decrease in LDL-C by an average of 20% without increasing the risk of side effects like for statins. Evaluation of dietary supplements and functional foods should necessarily include not only evidence of beneficial effects with respect to effects on the lipid profile and atherosclerosis, but also proven good tolerability. The manufacturing standard for these products is also important, guaranteeing component standardization and quality. RYR analogues should guarantee the absence of mycotoxin in their composition. In Russia, programs are needed for the primary prevention of atherosclerotic cardiovascular diseases with effects on hypercholesterolemia at the population level.

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“…To this end, there are alternate treatment options, including neutraceuticals such as berberine, which can also inhibit PCSK9 and reduce LDL‐c, although to much lesser degree than PCSK9 monoclonal antibodies. Further discussion of nutraceuticals is outside the scope of this review, but we and others have previously reviewed their use in a range of patient populations . Furthermore, limited safety and tolerability data is available on the use of PCSK9 inhibitors in several populations.…”

Section: Safety and Tolerability Of Pcsk9 Monoclonal Antibodiesmentioning

confidence: 99%

Clinical guidance on the contemporary use of proprotein convertase subtilisin/kexin type 9 monoclonal antibodies

Ward

Page

Watts

2019

Diabetes Obesity Metabolism

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There is now significant evidence for the benefits of lowering low‐density lipoprotein cholesterol (LDL‐c) to reduce the risk of atherosclerotic cardiovascular disease (ASCVD). Although statins are the most widely prescribed lipid‐lowering therapy that effectively lower LDL‐c, especially in combination with ezetimibe, some patients require adjunctive therapy to further lower LDL‐c and mitigate attendant risk of ASCVD. The gap can be filled by proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies whose use is currently supported by two recent cardiovascular outcome studies and new treatment guidelines. We provide an overview of extant studies investigating PCSK9 monoclonal antibodies in various patient populations, an update of the guidelines regarding their use and a case‐based discussion.

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The Role of Nutraceuticals in Statin Intolerant Patients

Cited by 223 publications

References 158 publications

Preliminary evidence of the clinical effectiveness of odourless garlic

Preliminary evidence of the clinical effectiveness of odourless garlic

The Role of Red Yeast Rice Based Preparations for Non-Pharmacological Correction of Dyslipidemia in Patients with Low and Moderate Cardiovascular Risk (Expert Opinion)

Clinical guidance on the contemporary use of proprotein convertase subtilisin/kexin type 9 monoclonal antibodies

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