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Is One Statin Pill a Week Enough?
Abstract & commentary
By Harold L. Karpman, MD, FACC, FACP, Clinical Professor of Medicine, UCLA School of Medicine. Dr. Karpman reports no financial relationship to this field of study.
Synopsis: Once-a-week rosuvastatin therapy was well tolerated in patients with a history of adverse events to one or more statins and led to significantly improved lipoprotein changes.
Source: Ruisinger JF, et al. Once-a-week rosuvastatin (2.5 to 20 mg) in patients with a previous statin intolerance. Am J Cardiol 2009;103:393-394.
Published data have demonstrated that instead of administering rosuvastatin on a daily basis, alternative dosing schedules (every other day, three times a week, and twice a week) for patients with previous adverse events, presumably secondary to statin therapy, have improved patient tolerability and at the same time are capable of significantly lowering total serum cholesterol and low-density lipoprotein cholesterol (LDL-C).1-3 These results were probably possible because of rosuvastatin's long half-life (approximately 19 hours)4 and, because the LDL-C reduction was significant5 in these studies, it has been suggested that rosuvastatin might be an attractive statin agent for a weekly dosing schedule.
Ruisinger and her colleagues mounted a study in an attempt to test the efficacy of once-a-week rosuvastatin on the lipid profile in patients with previous adverse events presumably secondary to a statin drug. The once-a-week schedule was tolerated by 74% of the patients with doses ranging from 2.5 to 20 mg once weekly. Nearly all patients (92%) were also taking other lipid-altering agents such as ezetimide, nicotinic acid, fibrates, bile acid sequestrants, and/or omega-3 fatty acids. Patients tolerating the once-a-week dosing regimen experienced a 17% reduction in total cholesterol, a 23% reduction in LDL-C, a 12% reduction in triglycerides, and a 5% increase in high-density lipoprotein cholesterol (all significant, P < 0.001) during a mean follow-up period of 4 months.
It is important to recognize that the retrospective observational study reported by Ruisinger was performed in a very small group of patients (n = 50) and was not placebo-controlled. The lipid-lowering effects of once-a-week rosuvastatin proved to be statistically significant; however, no attempt was made to determine whether this alternative dosing regimen was capable of reducing cardiovascular events over the course of this relatively short-term study. Patients with lipid levels measured 1-3 days and 4-7 days after receiving their last rosuvastatin dose had similar mean LDL-C reductions. The are several explanations as to why rosuvastatin was so well tolerated in the study including: Lower plasma concentrations from infrequent drug dosing are less likely to cause adverse effects, simply switching to a different statin quite possibly could have helped some patients tolerate the medication, and/or the psychological effects of taking the medication only once a week may have contributed to the improved drug tolerance in this small group of patients who otherwise might have experienced an adverse effect if treated with a daily statin drug.
Obviously, long-term studies are needed to assess the tolerability and efficacy of once-a-week rosuvastatin administration and to determine whether this regimen is capable of reducing cardiovascular events as has been demonstrated in many of the reported daily-dosage statin trials. The once-a-week dosing schedule was well tolerated in this small group of patients with a history of adverse events to 1 or more statin drugs and led to significantly improved lipoprotein levels, but large randomized trials are needed to confirm these findings and determine whether the once-a-week alternative dosing schedule is more desirable than no statin therapy at all for statin-intolerant patients with abnormally elevated serum lipids.
1. Backes JM, et al. Effectiveness and tolerability of every-other-day rosuvastatin dosing in patients with prior statin intolerance. Ann Pharmacother 2008; 42:341-346.
2. Mackie BD, et al. Monday, Wednesday, and Friday dosing of rosuvastatin in patients previously intolerant to statin therapy. Am J Cardiol 2007;99:291.
3. Gadarla M, et al. Efficacy of rosuvastatin (5 mg and 10 mg) twice a week in patients intolerant to daily statins. Am J Cardiol 2008;101:1747-1748.
4. Lopez LM. Rosuvastatin: A high potency HMG-CoA reductase inhibitor. J Am Pharm Assoc 2005;45: 503-513.
5. Jones PH, et al; STELLAR Study Group. Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR* trial). Am J Cardiol 2003;92:152-160.