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      Management of statin intolerance

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          Abstract

          Statins are the revolutionary drugs in the cardiovascular pharmacotherapy. But they also possess several adverse effects like myopathy with elevation of hepatic transaminases (>3 times the upper limit of normal) or creatine kinase (>10 times the upper limit of normal) and some rare side-effects, including peripheral neuropathy, memory loss, sleep disturbances, and erectile dysfunction. Due to these adverse effects, patients abruptly withdrew statins without consulting physicians. This abrupt discontinuation of statins is termed as statin intolerance. Statin-induced myopathy constitutes two third of all side-effects from statins and is the primary reason for statin intolerance. Though statin intolerance has considerably impacted cardiovascular outcomes in the high-risk patients, it has been well effectively managed by prescribing statins either as alternate-day or once weekly dosage regimen, as combination therapy with a non-statin therapy or and by dietary intervention. The present article reviews the causes, clinical implications of statin withdrawal and management of statin intolerance.

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          The safety of statins in clinical practice.

          Jane Armitage (2007)
          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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            Safety of statins: focus on clinical pharmacokinetics and drug interactions.

            Stefano Bellosta, Rodolfo Paoletti, Alberto Corsini (2004)
            Statin monotherapy is generally well tolerated, with a low frequency of adverse events. The most important adverse effects associated with statins are myopathy and an asymptomatic increase in hepatic transaminases, both of which occur infrequently. Because statins are prescribed on a long-term basis, however, possible interactions with other drugs deserve particular attention, as many patients will typically receive pharmacological therapy for concomitant conditions during the course of statin treatment. This review summarizes the pharmacokinetic properties of statins and emphasizes their clinically relevant drug interactions.
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              Effects of a dietary portfolio of cholesterol-lowering foods vs lovastatin on serum lipids and C-reactive protein.

              David Jenkins (2003)
              To enhance the effectiveness of diet in lowering cholesterol, recommendations of the Adult Treatment Panel III of the National Cholesterol Education Program emphasize diets low in saturated fat together with plant sterols and viscous fibers, and the American Heart Association supports the use of soy protein and nuts. To determine whether a diet containing all of these recommended food components leads to cholesterol reduction comparable with that of 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins). Randomized controlled trial conducted between October and December 2002. Forty-six healthy, hyperlipidemic adults (25 men and 21 postmenopausal women) with a mean (SE) age of 59 (1) years and body mass index of 27.6 (0.5), recruited from a Canadian hospital-affiliated nutrition research center and the community. Participants were randomly assigned to undergo 1 of 3 interventions on an outpatient basis for 1 month: a diet very low in saturated fat, based on milled whole-wheat cereals and low-fat dairy foods (n = 16; control); the same diet plus lovastatin, 20 mg/d (n = 14); or a diet high in plant sterols (1.0 g/1000 kcal), soy protein (21.4 g/1000 kcal), viscous fibers (9.8 g/1000 kcal), and almonds (14 g/1000 kcal) (n = 16; dietary portfolio). Lipid and C-reactive protein levels, obtained from fasting blood samples; blood pressure; and body weight; measured at weeks 0, 2, and 4 and compared among the 3 treatment groups. The control, statin, and dietary portfolio groups had mean (SE) decreases in low-density lipoprotein cholesterol of 8.0% (2.1%) (P =.002), 30.9% (3.6%) (P<.001), and 28.6% (3.2%) (P<.001), respectively. Respective reductions in C-reactive protein were 10.0% (8.6%) (P =.27), 33.3% (8.3%) (P =.002), and 28.2% (10.8%) (P =.02). The significant reductions in the statin and dietary portfolio groups were all significantly different from changes in the control group. There were no significant differences in efficacy between the statin and dietary portfolio treatments. In this study, diversifying cholesterol-lowering components in the same dietary portfolio increased the effectiveness of diet as a treatment of hypercholesterolemia.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Indian J Endocrinol Metab
                Journal ID (iso-abbrev): Indian J Endocrinol Metab
                Journal ID (publisher-id): IJEM
                Title: Indian Journal of Endocrinology and Metabolism
                Publisher: Medknow Publications & Media Pvt Ltd (India )
                ISSN (Print): 2230-8210
                ISSN (Electronic): 2230-9500
                Publication date (Print): Nov-Dec 2013
                Volume: 17
                Issue: 6
                Pages: 977-982
                Affiliations
                [1] Care Hospital, The Institute of Medical Sciences, Hyderabad, India
                [1 ] Department of Cardiology, St John's Medical College and Hospital, Bangalore, India
                [2 ] Medical Affairs, AstraZeneca India, Bangalore, India
                Author notes
                Corresponding Author: Dr. Madhu K, Medical affairs, AstraZeneca, India. E-mail: madhu.k@ 123456astrazeneca.com
                Article
                Publisher ID: IJEM-17-977
                DOI: 10.4103/2230-8210.122602
                PMC ID: 3872714
                PubMed ID: 24381870
                SO-VID: 345d58c9-e870-4e0d-b731-549c680b4dac
                Copyright © Copyright: © Indian Journal of Endocrinology and Metabolism
                License:

                This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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                Categories
                Subject: Review Article

                ScienceOpen disciplines: Endocrinology & Diabetes
                Keywords: adverse effects of stains,myopathy,rhabdomyolysis,statins,statin intolerance
                Data availability:
                ScienceOpen disciplines: Endocrinology & Diabetes
                Keywords: adverse effects of stains, myopathy, rhabdomyolysis, statins, statin intolerance

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