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© 2008  Harvey Whitney Books Company. 6. ACC/AHA/NHLBI clinical advisory on the use and safety of statins. Toxicol Lett. Bruckert et al used pravastatin as a reference and demonstrated that atorvastatin and simvastatin were associated with higher incidences of myopathy, whereas fluvastatin XL was associated with a lower incidence.4 The FDA has recently advised against the use of simvastatin 80 mg (the highest FDA-approved dose) because of its association with myopathy.5 The rates of myopathy are higher in the clinical practice setting when compared to clinical trials; however, the incidence of myopathy remains a rare adverse event. Guijarro C, Blanco-Colio L, Ortego M, et al. All doses used demonstrated significant LDL-C reductions; … You will receive email when new content is published. Click the topic below to receive emails when new articles are available. Majority of Generic Drug Ingredients Produced in Asia -study, Critical Drugs for Critical Care: Protecting the US Pharmaceutical Supply in a Time of Crisis, SAMSON Answers the Statin Side Effect Question. bIncludes ≥2 risk factors, 10-y CHD risk 10-20%. Chatzizisis Y, Koskinas K, Misirli G, et al. Methods: An 8 week, randomized, open-label, parallel trial was conducted at the outpatient department of Phramongkutklao Hospital in Bangkok, Thailand. [5] Moreover, the National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP-III) Update emphasized LDL-C reductions of at least 30-40% and the option of more aggressive LDL-C goals for patients considered at high-risk for a cardiovascular event. Drug Saf. fIncludes 0-1 risk factors. [16] The study reported here examined the effect and tolerance of EOD rosuvastatin therapy in a considerably larger cohort. Dosing a statin (rosuvastatin) every other day (EOD) may provide significant lipoprotein changes while avoiding common adverse effects in this statin-intolerant population. deployedfiles/imshealth/ hIncludes plant stanol/sterols, policosanol, flaxseed oil. Once patients are initiated on statin therapy, pharmacists have the opportunity to monitor patient adherence, treatment response, and medication safety, in addition to providing ongoing patient education on statin therapy and its adverse effects. If you log out, you will be required to enter your username and password the next time you visit. Marcoff L, Thompson PD. Statin-related myalgias and hepatotoxicity are dose-related and so reducing systemic drug concentration may lower the incidence of ADRs and potentially increase adherence to the regimen. 1. J Cardiovasc Pharmacol Ther. East Hanover, NJ: Novartis Pharmaceuticals Corporation; July 2011. Will Biased Ligands Be the Opioids of the Future? Am J Cardiol. An alternative option is the use of nonstatin lipid-lowering agents in place of statin therapy. [1] Nonspecific muscle complaints or joint pain without elevated creatine kinase levels have been reported in approximately 5% of clinical trial participants;[2] however, the range is wide (0.3-33%). Updated April 2011. www.imshealth.com/ Final conclusions and recommendations of the National Lipid Association Statin Safety Assessment Task Force. Zocor (simvastatin) package insert. A number of trials have demonstrated efficacy with alternate-day statin dosing,[11,12,13,14,15] including rosuvastatin;[15] however, the study populations included patients without previous intolerance to statins. 2008;101:490-496. Results: Myalgias (76.5%) and increased transaminase levels (19.5%) were the most common causes of prior statin intolerance, but 72.5% (37/51) of patients were able to tolerate the EOD therapy (mean dose 5.6 mg) regimen for 4 ± 2.9 (mean ± SD) months. The Prediction of Muscular Risk in Observational Conditions (PRIMO) study reported a myopathy rate of 10.5% of patients (832 out of 7,924) who were receiving high-dose statin therapy (fluvastatin 80 mg; atorvastatin 40 or 80 mg; pravastatin 40 mg; or simvastatin 40 or 80 mg) with a median onset of 1 month. Stein EA, Ballantyne CM, Windler E, et al. Mevacor (lovastatin) package insert. Mean LDL-C decreased 34.5% (p < 0.001) in the patients who tolerated the regimen, enabling approximately 50% to achieve their LDL-C goal. BMJ. Whitehouse Station, NJ: Merck & Co., Inc; October 2011. dIncludes ≥2 risk factors, 10-y CHD risk 10-20%. Knowledge of the currently available statins and their properties will enable pharmacists to provide appropriate recommendations for individualized treatment regimens. Rosuvastatin 5 and 10 mg/d: a pilot study of the effects in hypercholesterolemic adults unable to tolerate other statins and reach LDL cholesterol goals with non-statin lipid-lowering therapies. While many patients may self-treat their symptoms with analgesics or pain relievers, any sudden unexplained muscle weakness or other symptoms should be conveyed to their physician. Ann Pharmacother. 2007;100:1400-1403. The myalgias and elevation in hepatic enzymes caused by statin therapy are considered to be dose-dependent adverse effects. Joy TR, Hegele RA. IHII_UseOfMed_report.pdf. 1998;83:490-500. We theorized that by using low doses of a statin (rosuvastatin) every other day (EOD), a significant LDL-C reduction may still be achieved while also avoiding the dose-dependent … Educating the patient on the warning signs and risks of myopathy can prevent serious complications. Mild to moderate muscular symptoms with high-dosage statin therapy in hyperlipidemic patients—the PRIMO study. Abd TT, Jacobson TA. Reproduction in whole or in part without permission is prohibited. 2009;150:858-868. The precise mechanisms underlying statin-associated myopathy are not well understood; however, theories do exist. Conclusions: Treating patients intolerant to statins with rosuvastatin EOD was tolerated by the majority of patients and reduced LDL-C in our study. 30. 22. James M Backes, PharmD,1,2 Carmelo V Venero, MD,3 Cheryl A Gibson, PhD,4 Janelle F Ruisinger, PharmD,5 Patricia A Howard, PharmD FCCP BCPS,5 Paul D Thompson, MD,6,7 Patrick M Moriarty, MD 8 1Department of Pharmacy Practice, Schools of Pharmacy and Medicine, University of Kansas, Kansas City, KS 2Lipid, Atherosclerosis, Metabolic and LDL-Apheresis Center, University of Kansas Medical Center, Kansas City, KS 3Hartford Hospital, Hartford, CT 4Department of Internal Medicine, University of Kansas Medical Center, Kansas City, KS 5Department of Pharmacy Practice, Schools of Pharmacy and Medicine, University of Kansas, Kansas City, KS 6The Henry Low Heart Center, Hartford Hospital, Hartford, CT 7University of Connecticut, Farmington, CT 8Department of Internal Medicine; Lipid, Atherosclerosis, Metabolic and LDL-Apheresis Center, University of Kansas Medical Center, Kansas City, KS. Monitoring is important at the time of initiation, as baseline elevations in CK levels are not uncommon and the knowledge of this prior to starting statin therapy may be helpful should a patient develop muscle symptoms while on statin therapy.28 Alternatively, the NLA does not recommend baseline monitoring of CK levels for all patients, as they report that this is not cost-effective. Wilmington, DE: AstraZeneca Pharmaceuticals; June 2011. 2004;116:408-416. A second proposed mechanism involves depletion of isoprenoids that control myofiber apoptosis, and a third mechanism suggests that a depletion of ubiquinone or coenzyme Q10 (CoQ10) may account for the potential myotoxicity of statins.2,3,6,7, Reduced Sarcolemmal Cholesterol: It is proposed that because cholesterol plays a key role in cell membrane fluidity, lowering cholesterol with a statin may possibly disturb the integrity of the myocyte and lead to membrane destabilization.3,8,9 This theory is unlikely to be valid because it has been demonstrated in experimental models that nonstatin lipid-lowering agents, including fibrates, have induced myopathy through different pathways.2 Additionally, a second finding demonstrates that inherited disorders of the distal cholesterol synthetic pathway result in reduced cholesterol levels without occurrence of associated myopathy.9, Isoprenoid Depletion: Isoprenoids are lipids that are by-products of the HMG-CoA reductase pathway and play a key role in the control of myofiber apoptosis or cell death.2,3,6,9 Isoprenoids are linked to proteins by a process called farnesylation or geranyl generation. Upsides. You've successfully added to your alerts. The incidence of myopathy was highest for rosuvastatin and lowest for fluvastatin.2. 2006;97(suppl):27C-31C. Laaksonen R, Jokelainen K, Sahi T, et al. Young J, Florkowski C, Molyneux S, et al. 33. If a patient develops rhabdomyolysis, defined as a CK level >10 × ULN or >10,000 IU/L with an elevation in serum creatinine or a requirement for IV hydration therapy, statin therapy should be discontinued immediately.29, Both the ACC/AHA/NHLBI and the NLA emphasize the importance of counseling patients who are beginning statin therapy to report muscle discomfort and/or weakness to a health care professional immediately, as well as the need to rule out other causes of myopathy should muscle symptoms occur while on statin therapy.28,29, For most patients, myopathy symptoms induced by statin therapy resolve relatively quickly; however, the results of the PRIMO study showed that it may take up to 2 months for resolution of symptoms.4 There is limited evidence regarding the treatment of statin-associated myopathy. 14. [5] We theorized that by using low doses of a statin (rosuvastatin) every other day (EOD), a significant LDL-C reduction may still be achieved while also avoiding the dose-dependent adverse effects. Incidence of hospitalized rhabdomyolysis in patients treated with lipid-lowering drugs. All patients who were considered to be intolerant to rosuvastatin EOD therapy (27.5%; 14/51) reexperienced the symptoms of their prior statin intolerance. Jennifer Shannon, PharmD cIncludes ≥2 risk factors, 10-y CHD risk <10%. IHII_UseOfMed_report.pdf. Please see our, 2001http://www.medscape.com/features/year-in-medicine/public/2014. Crestor (rosuvastatin) package insert. 20Institute/Static%20File/ 34. Thus, additional options are essential for patients unable to tolerate typical statin dosing in order to achieve the desired LDL-C goal. Stroke. 10. 2002;128:159-168. Pasternak RC, Smith SC, Bairey-Merz CN, et al. 29. 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