Identification and Management of Statin-Associated Symptoms in Clinical Practice: Extension of a Clinician Survey to 12 Further Countries

Cardiovascular Drugs and Therapy, Apr 2017

Purpose Statins are the first-choice pharmacological treatment for patients with hypercholesterolemia and at risk for cardiovascular disease; however, a minority of patients experience statin-associated symptoms (SAS) and are considered to have reduced statin tolerance. The objective of this study was to establish how patients with SAS are identified and managed in clinical practice in Austria, Belgium, Colombia, Croatia, the Czech Republic, Denmark, Portugal, Switzerland, Russia, Saudi Arabia, Turkey, and the United Arab Emirates. Methods A cross-sectional survey was conducted (2015–2016) among clinicians (n = 60 per country; Croatia: n = 30) who are specialized/experienced in the treatment of hypercholesterolemia. Participants were asked about their experience of patients presenting with potential SAS and how such patients were identified and treated. Results Muscle-related symptoms were the most common presentation of potential SAS (average: 51%; range across countries [RAC] 17–74%); other signs/symptoms included persistent elevation in transaminases. To establish whether symptoms are due to statins, clinicians required rechallenge after discontinuation of statin treatment (average: 77%; RAC 40–90%); other requirements included trying at least one alternative statin. Clinicians reported that half of high-risk patients with confirmed SAS receive a lower-dose statin (average: 53%; RAC 43–72%), and that most receive another non-statin lipid-lowering therapy with or without a concomitant statin (average: 65%; RAC 52–83%). Conclusions The specialists and GPs surveyed use stringent criteria to establish causality between statin use and signs or symptoms, and persevere with statin treatment where possible.

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Identification and Management of Statin-Associated Symptoms in Clinical Practice: Extension of a Clinician Survey to 12 Further Countries

Identification and Management of Statin-Associated Symptoms in Clinical Practice: Extension of a Clinician Survey to 12 Further Countries Robert S. Rosenson 0 1 2 3 4 5 6 Shravanthi R. Gandra 0 1 2 3 4 5 6 Jan McKendrick 0 1 2 3 4 5 6 Ricardo Dent 0 1 2 3 4 5 6 Heather Wieffer 0 1 2 3 4 5 6 Lung-I Cheng 0 1 2 3 4 5 6 Alberico L. Catapano 0 1 2 3 4 5 6 Paul Oh 0 1 2 3 4 5 6 G. Kees Hovingh 0 1 2 3 4 5 6 Erik S. Stroes 0 1 2 3 4 5 6 Shravanthi R. Gandra 0 1 2 3 4 5 6 0 Academic Medical Center , Amsterdam , the Netherlands 1 Toronto Rehabilitation Institute , Toronto, ON , Canada 2 University of Milano and IRCCS Multimedica , Milan , Italy 3 PRMA Consulting , Fleet, Hampshire , UK 4 Amgen Inc. , Thousand Oaks, CA , USA 5 Icahn School of Medicine at Mount Sinai , 1425 Madison Ave, MC1 Level, New York, NY 10029 , USA 6 Alberico L. Catapano Purpose Statins are the first-choice pharmacological treatment for patients with hypercholesterolemia and at risk for cardiovascular disease; however, a minority of patients experience statin-associated symptoms (SAS) and are considered to have reduced statin tolerance. The objective of this study was to establish how patients with SAS are identified and managed in clinical practice in Austria, Belgium, Colombia, Croatia, the Czech Republic, Denmark, Portugal, Switzerland, Russia, Saudi Arabia, Turkey, and the United Arab Emirates. Methods A cross-sectional survey was conducted (20152016) among clinicians (n = 60 per country; Croatia: n = 30) who are specialized/experienced in the treatment of hypercholesterolemia. Participants were asked about their experience of Paul Oh G. Kees Hovingh - patients presenting with potential SAS and how such patients were identified and treated. Results Muscle-related symptoms were the most common presentation of potential SAS (average: 51%; range across countries [RAC] 17–74%); other signs/symptoms included persistent elevation in transaminases. To establish whether symptoms are due to statins, clinicians required rechallenge after discontinuation of statin treatment (average: 77%; RAC 40–90%); other requirements included trying at least one alternative statin. Clinicians reported that half of high-risk patients with confirmed SAS receive a lower-dose statin (average: 53%; RAC 43–72%), and that most receive another nonstatin lipid-lowering therapy with or without a concomitant statin (average: 65%; RAC 52–83%). Conclusions The specialists and GPs surveyed use stringent criteria to establish causality between statin use and signs or symptoms, and persevere with statin treatment where possible. Statins are the first-choice pharmacological treatment to reduce circulating levels of low-density lipoprotein cholesterol (LDL-C), an important and modifiable risk factor for cardiovascular disease [1, 2]. The incidence of reported adverse events attributed to statins is low in clinical trials [3, 4]; however, in observational studies, approximately 10% of patients experience side effects (statin-associated symptoms [SAS]) [5–8]. The most commonly reported SAS are statinassociated muscle symptoms (SAMS), such as muscle discomfort or weakness [9–11]; other less common presentations that may be attributed to SAS include hepatic, gastrointestinal, or central nervous system (CNS) effects [12]. Patients with SAS may require a decrease in dose or complete discontinuation of statin therapy [12]. This limits effective treatment, putting patients at increased risk of cardiovascular morbidity and mortality [13, 14]. National and international clinical guidelines have been developed in recent years to help clinicians evaluate and manage patients with SAS in clinical practice [2, 9–12, 15, 16]. Such guidelines provide pragmatic definitions of SAMS, and SAS in general, which include new approaches using the terminology Bgoalinhibiting statin intolerance^ that emphasize the effect of such symptoms on the ability to achieve lipid-lowering goals through adequate therapy or optimally reduce cardiovascular risk [9]. Even with the publication of guidelines, it remains unclear how clinicians manage patients presenting with SAS in clinical practice. In 2014, we conducted a survey of clinicians in 13 countries to establish how patients with SAS are identified and managed in clinical practice [17]. In 2015–2016, this work was extended to include a further 12 countries, to gain a broader understanding of treatment practice across additional countries and regions. Material and Methods This cross-sectional survey was conducted among clinicians who specialize in the treatment of patients with hypercholesterolemia in Austria, Belgium, Colombia, Croatia, the Czech Republic, Denmark, Portugal, Switzerland, Russia, Saudi Arabia, Turkey, and the United Arab Emirates (UAE). The survey was conducted between December 2015 and August 2016. Questionnaire Development and Administration The questionnaire was based on the one used in 2014 for the initial 13 countries [17]. T (...truncated)


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Robert S. Rosenson, Shravanthi R. Gandra, Jan McKendrick, Ricardo Dent, Heather Wieffer, Lung-I Cheng, Alberico L. Catapano, Paul Oh, G. Kees Hovingh, Erik S. Stroes. Identification and Management of Statin-Associated Symptoms in Clinical Practice: Extension of a Clinician Survey to 12 Further Countries, Cardiovascular Drugs and Therapy, 2017, pp. 187-195, Volume 31, Issue 2, DOI: 10.1007/s10557-017-6727-0