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      Myopathy in Patients Taking Atorvastatin: A Pilot Study

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          Abstract

          Aim:

          This study aims to investigate the prevalence and risk factors of statin-induced myopathy.

          Subjects and Methods:

          A total of 200 patients aged ≥ 40 years and taking atorvastatin 10 mg/day or more for at least 2 weeks were recruited in the study. A detailed history of participants and anthropometry of study participants was recorded, and features of myopathy were explained. Biochemical investigations along with thyroid stimulating hormone (TSH) and Vitamin D were done in all patients.

          Results:

          Mean age of study population was 54.81 ± 9.10 years. Sixty-five percent (65.5%) of atorvastatin users had coronary heart disease, 62.5% were hypertensive, 38% had diabetes. Thirty-five percent (35.5%) patients were taking 10 mg/day atorvastatin, 45% were taking 20 mg/day, and 19.5% were taking 40 mg/day. The overall frequency of myopathy among statin users was 7.5% which was significantly higher with increasing dose of atorvastatin (1.4% in 10 mg/day group, 10% in 20 mg/day group, and 12.8% in 40 mg/day, P < 0.05). The frequency of atorvastatin-related myopathy was higher in females 8.65% compared to 6.25% in males. Serum TSH levels in patients with myopathy were 4.05 ± 7.76 μIU/ml while in those without myopathy were 3.13 ± 2.88 μIU/ml ( P = 0.649). Serum 25-hydroxy Vitamin D levels were measured in 66 patients randomly. Mean levels in patients with myopathy were 15.98 ± 12.94 ng/ml and without myopathy were 10.20 ± 5.64 ng/ml ( P = 0.285).

          Conclusion:

          The present study demonstrates that a significantly higher number of patients taking atorvastatin develop myopathy in real life clinical condition. The frequency of myopathy increases with increase in atorvastatin dose.

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          Most cited references15

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          High-dose atorvastatin vs usual-dose simvastatin for secondary prevention after myocardial infarction: the IDEAL study: a randomized controlled trial.

          Evidence suggests that more intensive lowering of low-density lipoprotein cholesterol (LDL-C) than is commonly applied clinically will provide further benefit in stable coronary artery disease. To compare the effects of 2 strategies of lipid lowering on the risk of cardiovascular disease among patients with a previous myocardial infarction (MI). The IDEAL study, a prospective, randomized, open-label, blinded end-point evaluation trial conducted at 190 ambulatory cardiology care and specialist practices in northern Europe between March 1999 and March 2005 with a median follow-up of 4.8 years, which enrolled 8888 patients aged 80 years or younger with a history of acute MI. Patients were randomly assigned to receive a high dose of atorvastatin (80 mg/d; n = 4439), or usual-dose simvastatin (20 mg/d; n = 4449). Occurrence of a major coronary event, defined as coronary death, confirmed nonfatal acute MI, or cardiac arrest with resuscitation. During treatment, mean LDL-C levels were 104 (SE, 0.3) mg/dL in the simvastatin group and 81 (SE, 0.3) mg/dL in the atorvastatin group. A major coronary event occurred in 463 simvastatin patients (10.4%) and in 411 atorvastatin patients (9.3%) (hazard ratio [HR], 0.89; 95% CI, 0.78-1.01; P = .07). Nonfatal acute MI occurred in 321 (7.2%) and 267 (6.0%) in the 2 groups (HR, 0.83; 95% CI, 0.71-0.98; P = .02), but no differences were seen in the 2 other components of the primary end point. Major cardiovascular events occurred in 608 and 533 in the 2 groups, respectively (HR, 0.87; 95% CI, 0.77-0.98; P = .02). Occurrence of any coronary event was reported in 1059 simvastatin and 898 atorvastatin patients (HR, 0.84; 95% CI, 0.76-0.91; P<.001). Noncardiovascular death occurred in 156 (3.5%) and 143 (3.2%) in the 2 groups (HR, 0.92; 95% CI, 0.73-1.15; P = .47). Death from any cause occurred in 374 (8.4%) in the simvastatin group and 366 (8.2%) in the atorvastatin group (HR, 0.98; 95% CI, 0.85-1.13; P = .81). Patients in the atorvastatin group had higher rates of drug discontinuation due to nonserious adverse events; transaminase elevation resulted in 43 (1.0%) vs 5 (0.1%) withdrawals (P<.001). Serious myopathy and rhabdomyolysis were rare in both groups. In this study of patients with previous MI, intensive lowering of LDL-C did not result in a significant reduction in the primary outcome of major coronary events, but did reduce the risk of other composite secondary end points and nonfatal acute MI. There were no differences in cardiovascular or all-cause mortality. Patients with MI may benefit from intensive lowering of LDL-C without an increase in noncardiovascular mortality or other serious adverse reactions.Trial Registration ClinicalTrials.gov Identifier: NCT00159835.
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            Statin-associated myopathy.

            Statins (3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors) are associated with skeletal muscle complaints, including clinically important myositis and rhabdomyolysis, mild serum creatine kinase (CK) elevations, myalgia with and without elevated CK levels, muscle weakness, muscle cramps, and persistent myalgia and CK elevations after statin withdrawal. We performed a literature review to provide a clinical summary of statin-associated myopathy and discuss possible mediating mechanisms. We also update the US Food and Drug Administration (FDA) reports on statin-associated rhabdomyolysis. Articles on statin myopathy were identified via a PubMed search through November 2002 and articles on statin clinical trials, case series, and review articles were identified via a PubMed search through January 2003. Adverse event reports of statin-associated rhabdomyolysis were also collected from the FDA MEDWATCH database. The literature review found that reports of muscle problems during statin clinical trials are extremely rare. The FDA MEDWATCH Reporting System lists 3339 cases of statin-associated rhabdomyolysis reported between January 1, 1990, and March 31, 2002. Cerivastatin was the most commonly implicated statin. Few data are available regarding the frequency of less-serious events such as muscle pain and weakness, which may affect 1% to 5% of patients. The risk of rhabdomyolysis and other adverse effects with statin use can be exacerbated by several factors, including compromised hepatic and renal function, hypothyroidism, diabetes, and concomitant medications. Medications such as the fibrate gemfibrozil alter statin metabolism and increase statin plasma concentration. How statins injure skeletal muscle is not clear, although recent evidence suggests that statins reduce the production of small regulatory proteins that are important for myocyte maintenance.
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              The safety of statins in clinical practice.

              Statins are effective cholesterol-lowering drugs that reduce the risk of cardiovascular disease events (heart attacks, strokes, and the need for arterial revascularisation). Adverse effects from some statins on muscle, such as myopathy and rhabdomyolysis, are rare at standard doses, and on the liver, in increasing levels of transaminases, are unusual. Myopathy--muscle pain or weakness with blood creatine kinase levels more than ten times the upper limit of the normal range--typically occurs in fewer than one in 10,000 patients on standard statin doses. However, this risk varies between statins, and increases with use of higher doses and interacting drugs. Rhabdomyolysis is a rarer and more severe form of myopathy, with myoglobin release into the circulation and risk of renal failure. Stopping statin use reverses these side-effects, usually leading to a full recovery. Asymptomatic increases in concentrations of liver transaminases are recorded with all statins, but are not clearly associated with an increased risk of liver disease. For most people, statins are safe and well-tolerated, and their widespread use has the potential to have a major effect on the global burden of cardiovascular disease.
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                Author and article information

                Journal
                Indian J Endocrinol Metab
                Indian J Endocrinol Metab
                IJEM
                Indian Journal of Endocrinology and Metabolism
                Medknow Publications & Media Pvt Ltd (India )
                2230-8210
                2230-9500
                Jul-Aug 2017
                : 21
                : 4
                : 504-509
                Affiliations
                [1]Department of Endocrinology, Centre for Diabetes Endocrinology and Metabolism, University College of Medical Sciences (University of Delhi)and GTB Hospital, New Delhi, India
                Author notes
                Address for correspondence: Dr. S. V. Madhu, Department of Endocrinology, Centre for Diabetes Endocrinology and Metabolism, University College of Medical Sciences (University of Delhi) and GTB Hospital, Dilshad Garden, New Delhi - 110 095, India. E-mail: drsvmadhu@ 123456gmail.com
                Article
                IJEM-21-504
                10.4103/ijem.IJEM_79_17
                5477434
                28670530
                856a1a9b-f830-466a-b106-e51bf2b40d19
                Copyright: © 2017 Indian Journal of Endocrinology and Metabolism

                This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.

                History
                Categories
                Original Article

                Endocrinology & Diabetes
                atorvastatin,myopathy,thyroid stimulating hormone,vitamin d
                Endocrinology & Diabetes
                atorvastatin, myopathy, thyroid stimulating hormone, vitamin d

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