한국인 환자의 아토르바스타틴에 의한 근육통 발병률에 대한 단일 병원 전향연구: 스타틴근육통 임상지수의 적용
A Prospective Single-Center Study of Incidence of Atorvastatin-Induced Myalgia in Korean Patients: Application of the Statin Myalgia Clinical Index
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Background: Statin-induced myalgia is a common cause of discontinuation and a barrier that interferes with long-term treatment. The incidence of myalgia reported by previous atorvastatin trials in Korea ranged from 0.8% to 3.4%. This study assessed the incidence of myalgia after atorvastatin was administered to Korean patients with dyslipidemia. In addition, the Statin Myalgia Clinical Index (SMCI) was used to assess the likelihood that a patient’s myalgia was caused by atorvastatin. Methods: Dyslipidemic patients were eligible to participate if they were statin-naïve or treated with statins other than atorvastatin. Muscle complaints were assessed at the baseline, the 10-weeks visit and the final follow-up visit (16 weeks or later). The SMCI score was calculated if a patient developed myalgia, which was rated as probable, possible or unlikely related to the statin. Results: A total of 89 patients were analyzed. The atorvastatin doses ranged from 10 to 80 mg. Six (7%) patients reported new and unexplained muscle pain. Information on the timing of myalgia relative to stopping was unavailable in two patients. After excluding these two patients, three (3.4%) out of 87 patients were classified by the SMCI as having possible or probable atorvastatin-associated myalgia. Conclusions: In this study, the incidence of myalgia was higher than the incidences reported by the previous trials in Korea. However, the incidence of statin-associated myalgia assessed using SMCI was comparable to those of the trials. The SMCI may help diagnosis of statin-associated myalgia in clinical practice and optimize treatment for patients with myalgia.
Abstract
Background: Statin-induced myalgia is a common cause of discontinuation and a barrier that interferes with long-term treatment. The incidence of myalgia reported by previous atorvastatin trials in Korea ranged from 0.8% to 3.4%. This study assessed the incidence of myalgia after atorvastatin was administered to Korean patients with dyslipidemia. In addition, the Statin Myalgia Clinical Index (SMCI) was used to assess the likelihood that a patient’s myalgia was caused by atorvastatin. Methods: Dyslipidemic patients were eligible to participate if they were statin-naïve or treated with statins other than atorvastatin. Muscle complaints were assessed at the baseline, the 10-weeks visit and the final follow-up visit (16 weeks or later). The SMCI score was calculated if a patient developed myalgia, which was rated as probable, possible or unlikely related to the statin. Results: A total of 89 patients were analyzed. The atorvastatin doses ranged from 10 to 80 mg. Six (7%) patients reported new and unexplained muscle pain. Information on the timing of myalgia relative to stopping was unavailable in two patients. After excluding these two patients, three (3.4%) out of 87 patients were classified by the SMCI as having possible or probable atorvastatin-associated myalgia. Conclusions: In this study, the incidence of myalgia was higher than the incidences reported by the previous trials in Korea. However, the incidence of statin-associated myalgia assessed using SMCI was comparable to those of the trials. The SMCI may help diagnosis of statin-associated myalgia in clinical practice and optimize treatment for patients with myalgia.
참고문헌 (16)
- 김상현, "이상지질혈증의 약물치료", 대한의사협회지, 59(5), pp.366~373 (2016), 대한의사협회[DOI]
- "Dyslipidemia fact sheets in Korea" (2020)[URL]
- Backes JM, "Statin-associated muscle symptoms-Managing the highly intolerant", J Clin Lipidol, 11, pp.24~33 (2017)
- Chan JC, "Safety of atorvastatin in Asian patients within clinical trials", Cardiovasc Ther, 34, pp.431~440 (2016)
- Chien SC, "2019 Taiwan Society of Lipids and Atherosclerosis expert consensus statement on statin intolerance", J Formos Med Assoc, 118, pp.1385~1392 (2019)
- Collins R, "Interpretation of the evidence for the efficacy and safety of statin therapy", Lancet, 388, pp.2532~2561 (2016)
- Mancini GB, "Diagnosis, prevention, and management of statin adverse effects and intolerance : Canadian consensus working group update(2016)", Can J Cardiol, 32, pp.S35~S65 (2016)
- Tomlinson B, "Statin intolerance-an Asian perspective", J Atheroscler Thromb, 27, pp.485~488 (2020)
- Rosenson RS, "An assessment by the statin muscle safety task force : 2014 update", J Clin Lipidol, 8, pp.S58~ (2014)
- Joy TR, "N-of-1(single-patient)trials for statin-related myalgia", Ann Intern Med, 160, pp.301~310 (2014)
- Newman CB, "statin safety and associated adverse events : a scientific statement from the American heart association", Arterioscler Thromb Vasc Biol, 39, pp.e38~e81 (2019)
- Catapano AL, "2016 ESC", EAS guidelines for the management of dyslipidaemias, 2016, pp.37, 2999~3058
- 이은정, "2018 Guidelines for the Management of Dyslipidemia in Korea", 지질·동맥경화학회지, 8(2), pp.78~131 (2019), 한국지질동맥경화학회[DOI]
- Kim SH, "Efficacy and tolerability of a generic and a branded formulation of atorvastatin 20 mg", d in hypercholesterolemic Korean adults at high risk for cardiovascular disease : a multicenter, prospective, randomized, double-blind, double-dummy clinical trial, 2010, pp.32, 1896~1905
- Kim SH, "Assessment of the efficacy and tolerability of 2 formulations of atorvastatin in Korean adults with hypercholesterolemia : a multicenter, prospective, open-label, randomized trial", Clin Ther, 35, pp.77~86 (2013)
- Kim JB, "A randomized, open-label, parallel, multi-center Phase IV study to compare the efficacy and safety of atorvastatin 10 and 20 mg in high-risk Asian patients with hypercholesterolemia", PLoS One, 16, pp.e0245481~ (2021)