Preventive cardiologyOnce-a-Week Rosuvastatin (2.5 to 20 mg) in Patients With a Previous Statin Intolerance
The purpose of this study was to determine the efficacy of rosuvastatin dosed once a week in patients with a previous statin adverse event. Rosuvastatin once a week was tolerated by 37 (74%) of the 50 study participants, with doses ranging from 2.5 mg to 20 mg a week (mean 10 ± 4 mg). Patients tolerating the once-a-week regimen experienced a 17% reduction in total cholesterol, 23% reduction in low-density lipoprotein cholesterol, 12% reduction in triglycerides, and a 5% increase in high-density lipoprotein cholesterol (all p <0.001), during a mean follow-up of 4 months ± 2. Although this alternative dosing regimen has not been proven to reduce cardiovascular events, it may provide a therapeutic option for patients who may otherwise go without the proven benefits of statin therapy. In conclusion, this dosing strategy was well tolerated in patients with a history of an adverse event to 1 or more statins and led to significant lipoprotein changes.
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Cited by (58)
Statin-associated muscle symptoms: Myth or reality?
2022, Revista Clinica EspanolaLa sintomatología muscular asociada con estatinas es una entidad que engloba una constelación de diversas manifestaciones clínicas de distinta gravedad. Desde la introducción de las primeras estatinas se han publicado numerosos estudios acerca de su incidencia, fisiopatología, diagnóstico y tratamiento; sin embargo, a día de hoy estos aspectos siguen generando controversia. Con el aumento progresivo del uso de estatinas en la población general se han multiplicado las notificaciones de reacciones adversas relacionadas con su uso, particularmente las relacionadas con la toxicidad muscular. No obstante, las diferencias existentes entre los estudios publicados tanto en metodología como en resultados obtenidos hacen de esta relación un tema complejo y de gran interés para el clínico y los pacientes. La integración de la evidencia de la que disponemos actualmente puede ayudarnos a comprender mejor esta entidad y facilitar su manejo en la práctica clínica.
Statin-associated muscle symptoms is an entity that encompasses a constellation of various clinical manifestations of variyng severity. Since the introduction of the first statins, numerous studies have been published regarding its incidence, pathophysiology, diagnosis and treatment; however, to this day these aspects are still controversial. With the progressive increase in the use of statins in the general population, notifications of adverse reactions related to its use have multiplied, particularly those related to muscular toxicity. Nevertheless, the differences between the published studies, both in methodology and in the results obtained, make this relationship a complex issue of great interest for clinicians and patients. The integration of the evidence that we currently have can help us understand better this entity and facilitate its management in clinical practice.
Hypercholesterolemia, from screening to treatment: Who, why and how to manage
2021, Revue de Medecine InterneLe terme d’hypercholestérolémie désigne les dyslipidémies avec augmentation du taux de cholestérol circulant. Il s’agit de la dyslipidémie la plus fréquente et qui est associée à une augmentation du risque de survenue d’une maladie cardio-vasculaire athéromateuse. Un des enjeux majeur en prévention primaire est de définir le seuil d’intervention thérapeutique permettant à la fois d’obtenir un bénéfice clinique significatif sans exposer inutilement le patient aux potentiels effets secondaires des traitements hypolipémiants. Il s’agit également de ne pas méconnaître une hypercholestérolémie familiale hétérozygote, une maladie génétique du métabolisme lipidique fréquente, responsable de complications coronaires particulièrement graves et précoces. Dans cet article, seront abordées les questions du dépistage de l’hypercholestérolémie, de la définition des objectifs thérapeutiques et bénéfices attendus ainsi que des modalités de prise en charge thérapeutique en abordant la problématique de l’intolérance aux statines.
Hypercholesterolemia refers to dyslipidemia with an increased circulating cholesterol levels. This is the most common dyslipidemia and is associated with an increased risk of developing atheromatous cardiovascular diseases. One of the major challenges in primary prevention is to define the threshold for therapeutic intervention that allow to obtain a significant clinical benefit without unnecessarily expose the patient to potential side effects of lipid-lowering treatments. It is also important to recall to screen patient for heterozygous familial hypercholesterolemia, a common genetic disease of lipid metabolism responsible for particularly severe and early coronary disease. In this article, the issues of hypercholesterolemia screening, the definition of therapeutic targets and expected benefits as well as the modalities of therapeutic management (by also addressing the problem of statin intolerance) will be addressed.
Tolerability and effectiveness of every-other-day atorvastatin compared to daily atorvastatin in patients with muscle symptoms: A randomized controlled clinical trial
2020, Contemporary Clinical Trials CommunicationsDespite limited evidence, non-daily dosing of statins is recommended for managing muscle symptoms associated with statin therapy. We assessed the tolerability and effectiveness of every-other-day atorvastatin compared to daily atorvastatin in patients having muscle symptoms associated with atorvastatin therapy. A parallel-group, outcome-assessment-blinded, randomized controlled clinical trial was conducted at Colombo South Teaching Hospital, Sri Lanka. Patients with muscle pain, tenderness or cramps alone or in combination for ≥2 weeks while on daily atorvastatin for ≥1 month, with no alternative cause, were recruited. Patient's regular atorvastatin dose was given every-other-day to those in intervention group (IG) and daily to those in control group (CG). Primary outcomes were assessed at 24 weeks and included composite of myalgia and myositis, LDL-cholesterol level and percentage reduction of LDL-cholesterol from baseline. Number recruited was 49 to IG (women:79.6%; mean-age:60.6 ± 8.7years) and 52 to CG (women:73.1%; mean-age:61.7 ± 9.8years). Mean atorvastatin dose per day was 8.6 mg (SD = 4 mg) and 17.6 mg (SD = 8.4 mg) in IG and CG, respectively. Composite of myalgia and myositis at 24 weeks was 79.6% in IG and 69.2% in CG (OR = 1.7, 95% CI 0.7–4.3; p = 0.234). IG failed to show noninferiority for mean LDL-cholesterol (difference:0.31 mmol/L; upper limit 97.5% CI:0.61 mmol/L; p for noninferiority = 0.989) and for mean percentage reduction of LDL-cholesterol from baseline (difference:3.13%; upper limit 97.5% CI:15.5%; p for noninferiority = 0.718). At 24 weeks, mean creatine kinase and discomfort due to muscle symptoms (assessed with Visual Analogue Scale) were not different between the two groups. Findings of this study do not favor every-other-day atorvastatin as an option for managing patients with muscle symptoms associated with atorvastatin therapy.
Coronary Artery Disease
2018, Integrative Medicine: Fourth EditionPractical aspects in the management of statin-associated muscle symptoms (SAMS)
2017, Atherosclerosis SupplementsStatin-associated muscle symptoms (SAMS) frequently cause statin non-adherence, switching and discontinuation, contributing to adverse cardiovascular (CV) outcomes. Therefore, the management of SAMS is key in the effective treatment of patients with cardiovascular disease (CVD), through achievement of maximum-tolerated statin dosing and other practical aspects. The aim of this article is to provide practical, focused advice for healthcare professionals on the management of patients with SAMS.
An expert working group combined current evidence, published guidelines and experiences surrounding a number of topics concerning SAMS to provide recommendations on how to best assess and manage this condition and reach the highest tolerated dose of statin for each individual patient.
The group collaborated to provide guidance on definitions in the SAMS field, psychological issues, re-challenging and switching treatments, as well as interpretation of current guidelines and optimal treatment of SAMS in different patient populations. An algorithm was developed to guide the management of patients with SAMS. In addition, the expert working group considered some of the more complex scenarios in a series of frequently asked questions and suggested answers.
The expert working group gave recommendations for healthcare professionals on the management of SAMS but highlighted the importance of tailoring the treatment approach to each individual patient. Evidence supporting the role of nutraceuticals and complementary therapies, such as vitamin D, was lacking, however the majority of the group favoured combination therapy with ezetimibe and the addition of PCSK9 inhibitors in high-risk patients.
Statin-associated muscle symptoms—Managing the highly intolerant
2017, Journal of Clinical LipidologyMusculoskeletal symptoms are the most commonly reported adverse effects associated with statin therapy. Yet, certain data indicate that these symptoms often present in populations with underlying musculoskeletal complaints and are not likely statin related. Switching statins or using lower doses resolves muscle complaints in most patients. However, there is a growing population of individuals who experience intolerable musculoskeletal symptoms with multiple statins, regardless of the individual agent or prescribed dose. Recent randomized, placebo-controlled trials enrolling highly intolerant subjects provide significant insight regarding statin-associated muscle symptoms (SAMS). Notable findings include the inconsistency with reproducing muscle complaints, as approximately 40% of subjects report SAMS when taking a statin but not while receiving placebo, but a substantial cohort reports intolerable muscle symptoms with placebo but none when on a statin. These data validate SAMS for those likely experiencing true intolerance, but for others, suggest a psychosomatic component or misattribution of the source of pain and highlights the importance of differentiating from the musculoskeletal symptoms caused by concomitant factors. Managing the highly intolerant requires candid patient counseling, shared decision-making, eliminating contributing factors, careful clinical assessment and the use of a myalgia index score, and isolating potential muscle-related adverse events by gradually reintroducing drug therapy with the utilization of intermittent dosing of lipid-altering agents. We provide a review of recent data and therapeutic guidance involving a focused step-by-step approach for managing SAMS among the highly intolerant. Such strategies usually allow for clinically meaningful reductions in low-density lipoprotein cholesterol and an overall lowering of cardiovascular risk.