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
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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)