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Published in: Cardiovascular Drugs and Therapy 2/2017

Open Access 01-04-2017 | ORIGINAL ARTICLE

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

Authors: 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

Published in: Cardiovascular Drugs and Therapy | Issue 2/2017

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Abstract

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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Literature
1.
go back to reference Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL, et al. European guidelines on cardiovascular disease prevention in clinical practice: the Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice. Atherosclerosis. 2016;252:207–74.CrossRefPubMed Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL, et al. European guidelines on cardiovascular disease prevention in clinical practice: the Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice. Atherosclerosis. 2016;252:207–74.CrossRefPubMed
2.
go back to reference Catapano AL, Graham I, De Backer G, Wiklund O, Chapman MJ, Drexel H, et al. ESC/EAS guidelines for the management of dyslipidaemias: the Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS). Atherosclerosis. 2016;253:281–344.CrossRefPubMed Catapano AL, Graham I, De Backer G, Wiklund O, Chapman MJ, Drexel H, et al. ESC/EAS guidelines for the management of dyslipidaemias: the Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS). Atherosclerosis. 2016;253:281–344.CrossRefPubMed
3.
go back to reference Baigent C, Keech A, Kearney PM, Blackwell L, Buck G, Pollicino C, et al. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet. 2005;366(9493):1267–78.CrossRefPubMed Baigent C, Keech A, Kearney PM, Blackwell L, Buck G, Pollicino C, et al. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet. 2005;366(9493):1267–78.CrossRefPubMed
4.
go back to reference Collins R, Reith C, Emberson J, Armitage J, Baigent C, Blackwell L, et al. Interpretation of the evidence for the efficacy and safety of statin therapy. Lancet. 2016;388(10059):2532–61.CrossRefPubMed Collins R, Reith C, Emberson J, Armitage J, Baigent C, Blackwell L, et al. Interpretation of the evidence for the efficacy and safety of statin therapy. Lancet. 2016;388(10059):2532–61.CrossRefPubMed
5.
go back to reference Zhang H, Plutzky J, Skentzos S, Morrison F, Mar P, Shubina M, et al. Discontinuation of statins in routine care settings: a cohort study. Ann Intern Med. 2013;158(7):526–34.CrossRefPubMedPubMedCentral Zhang H, Plutzky J, Skentzos S, Morrison F, Mar P, Shubina M, et al. Discontinuation of statins in routine care settings: a cohort study. Ann Intern Med. 2013;158(7):526–34.CrossRefPubMedPubMedCentral
6.
go back to reference Rosenbaum D, Dallongeville J, Sabouret P, Bruckert E. Discontinuation of statin therapy due to muscular side effects: a survey in real life. Nutr Metab Cardiovasc Dis. 2013;23(9):871–5.CrossRefPubMed Rosenbaum D, Dallongeville J, Sabouret P, Bruckert E. Discontinuation of statin therapy due to muscular side effects: a survey in real life. Nutr Metab Cardiovasc Dis. 2013;23(9):871–5.CrossRefPubMed
7.
go back to reference Nichols GA, Koro CE. Does statin therapy initiation increase the risk for myopathy? An observational study of 32,225 diabetic and nondiabetic patients. Clin Ther. 2007;29(8):1761–70.CrossRefPubMed Nichols GA, Koro CE. Does statin therapy initiation increase the risk for myopathy? An observational study of 32,225 diabetic and nondiabetic patients. Clin Ther. 2007;29(8):1761–70.CrossRefPubMed
8.
go back to reference Bruckert E, Hayem G, Dejager S, Yau C, Begaud B. Mild to moderate muscular symptoms with high-dosage statin therapy in hyperlipidemic patients—the PRIMO study. Cardiovasc Drugs Ther. 2005;19(6):403–14.CrossRefPubMed Bruckert E, Hayem G, Dejager S, Yau C, Begaud B. Mild to moderate muscular symptoms with high-dosage statin therapy in hyperlipidemic patients—the PRIMO study. Cardiovasc Drugs Ther. 2005;19(6):403–14.CrossRefPubMed
9.
go back to reference Mancini GB, Baker S, Bergeron J, Fitchett D, Frohlich J, Genest J, et al. Diagnosis, prevention, and management of statin adverse effects and intolerance: Canadian Consensus Working Group Update (2016). Can J Cardiol. 2016;32(7 Suppl):S35–65.CrossRefPubMed Mancini GB, Baker S, Bergeron J, Fitchett D, Frohlich J, Genest J, et al. Diagnosis, prevention, and management of statin adverse effects and intolerance: Canadian Consensus Working Group Update (2016). Can J Cardiol. 2016;32(7 Suppl):S35–65.CrossRefPubMed
10.
go back to reference Stroes ES, Thompson PD, Corsini A, Vladutiu GD, Raal FJ, Ray KK, et al. Statin-associated muscle symptoms: impact on statin therapy—European Atherosclerosis Society Consensus Panel statement on assessment. Aetiology and Management Eur Heart J. 2015;36(17):1012–22.CrossRefPubMed Stroes ES, Thompson PD, Corsini A, Vladutiu GD, Raal FJ, Ray KK, et al. Statin-associated muscle symptoms: impact on statin therapy—European Atherosclerosis Society Consensus Panel statement on assessment. Aetiology and Management Eur Heart J. 2015;36(17):1012–22.CrossRefPubMed
11.
go back to reference Rosenson RS, Baker SK, Jacobson TA, Kopecky SL, Parker BA, The National Lipid Association’s Muscle Safety Expert Panel. An assessment by the Statin Muscle Safety Task Force: 2014 update. J Clin Lipidol. 2014;8(3 Suppl):S58–71.CrossRefPubMed Rosenson RS, Baker SK, Jacobson TA, Kopecky SL, Parker BA, The National Lipid Association’s Muscle Safety Expert Panel. An assessment by the Statin Muscle Safety Task Force: 2014 update. J Clin Lipidol. 2014;8(3 Suppl):S58–71.CrossRefPubMed
12.
go back to reference Banach M, Rizzo M, Toth PP, Farnier M, Davidson MH, Al-Rasadi K, et al. Statin intolerance—an attempt at a unified definition. Position paper from an International Lipid Expert Panel. Arch Med Sci. 2015;11(1):1–23.CrossRefPubMedPubMedCentral Banach M, Rizzo M, Toth PP, Farnier M, Davidson MH, Al-Rasadi K, et al. Statin intolerance—an attempt at a unified definition. Position paper from an International Lipid Expert Panel. Arch Med Sci. 2015;11(1):1–23.CrossRefPubMedPubMedCentral
13.
go back to reference De Vera MA, Bhole V, Burns LC, Lacaille D. Impact of statin adherence on cardiovascular disease and mortality outcomes: a systematic review. Br J Clin Pharmacol. 2014;78(4):684–98.CrossRefPubMedPubMedCentral De Vera MA, Bhole V, Burns LC, Lacaille D. Impact of statin adherence on cardiovascular disease and mortality outcomes: a systematic review. Br J Clin Pharmacol. 2014;78(4):684–98.CrossRefPubMedPubMedCentral
14.
go back to reference Serban M-C, Colantonio LD, Manthripragada AD, Monda KL, Bittner VA, Banach M, et al. Statin intolerance and risk of coronary heart events and all-cause mortality following myocardial infarction. J Am Coll Cardiol. 2017;69(11):1386–95.CrossRefPubMed Serban M-C, Colantonio LD, Manthripragada AD, Monda KL, Bittner VA, Banach M, et al. Statin intolerance and risk of coronary heart events and all-cause mortality following myocardial infarction. J Am Coll Cardiol. 2017;69(11):1386–95.CrossRefPubMed
15.
go back to reference Gulizia MM, Colivicchi F, Arca M, Abrignani MG, Perna GP, Mureddu GF, et al. ANMCO position paper: diagnostic and therapeutic pathways in patients with hypercholesterolemia and statin intolerance. G Ital Cardiol (Rome). 2016;17(6):447–55. Gulizia MM, Colivicchi F, Arca M, Abrignani MG, Perna GP, Mureddu GF, et al. ANMCO position paper: diagnostic and therapeutic pathways in patients with hypercholesterolemia and statin intolerance. G Ital Cardiol (Rome). 2016;17(6):447–55.
16.
go back to reference Guyton JR, Bays HE, Grundy SM, Jacobson TA, The National Lipid Association Statin Intolerance Panel. An assessment by the Statin Intolerance Panel: 2014 update. J Clin Lipidol. 2014;8(3 Suppl):S72–81.CrossRefPubMed Guyton JR, Bays HE, Grundy SM, Jacobson TA, The National Lipid Association Statin Intolerance Panel. An assessment by the Statin Intolerance Panel: 2014 update. J Clin Lipidol. 2014;8(3 Suppl):S72–81.CrossRefPubMed
17.
go back to reference Hovingh GK, Gandra SR, McKendrick J, Dent R, Wieffer H, Catapano AL, et al. Identification and management of patients with statin-associated symptoms in clinical practice: a clinician survey. Atherosclerosis. 2016;245:111–7.CrossRefPubMed Hovingh GK, Gandra SR, McKendrick J, Dent R, Wieffer H, Catapano AL, et al. Identification and management of patients with statin-associated symptoms in clinical practice: a clinician survey. Atherosclerosis. 2016;245:111–7.CrossRefPubMed
18.
go back to reference Rosenson RSM K, Bayliss, M., Sanchez, R., Baccara-Dinet, M.T., Chibedi-De-Roche, D, Taylor, B., Khan, I., Manvelian, G., White, M., Jacobson, T.A. The Statin-Associated Muscle Symptom (SAMS) Clinical Index: Revision for clinical use, content validation, and inter-rate reliability. Cardiovasc Drugs Ther. 2017;31. Rosenson RSM K, Bayliss, M., Sanchez, R., Baccara-Dinet, M.T., Chibedi-De-Roche, D, Taylor, B., Khan, I., Manvelian, G., White, M., Jacobson, T.A. The Statin-Associated Muscle Symptom (SAMS) Clinical Index: Revision for clinical use, content validation, and inter-rate reliability. Cardiovasc Drugs Ther. 2017;31.
Metadata
Title
Identification and Management of Statin-Associated Symptoms in Clinical Practice: Extension of a Clinician Survey to 12 Further Countries
Authors
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
Publication date
01-04-2017
Publisher
Springer US
Published in
Cardiovascular Drugs and Therapy / Issue 2/2017
Print ISSN: 0920-3206
Electronic ISSN: 1573-7241
DOI
https://doi.org/10.1007/s10557-017-6727-0

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