Evid Based Med: first published as 10.1136/ebm.1996.1.179 on 1 October 1996. Downloaded from

Lovastatin was more effective than stepped care in reducing cholesterol

Oster G, Borok GM, Menzin J, et al. ondary hypercholesterolernia; history of the stepped-care approach) for 1 Cholesterol-Reduction Intervention of alcohol or drug abuse; or terminal year for 1 additional patient to achieve Study (CRIS). A randomized trial illness. Follow-up was 90%. the goal LDL cholesterol level, to assess effectiveness and costs in 95% CI 4 to 12; the relative risk clinical practice. Arch Intern Med. Intervention improvement was 40%, CI 24% 1996 Apr 8;156:731-9. Patients were allocated to stepped care to 53%.}* Patients who received (n = 306) or to initial therapy with lovastatin had greater decreases than lovastatin (n = 306). Stepped care in- did patients who received stepped care Objective cluded niacin, 50 mg/d increased over in total cholesterol (16% vs 11 %, P < To compare a stepped-care regimen 2 weeks to 1000 mg twice/d, and con- 0.001) and in LDL cholesterol lev- with initial treatment with lovastatin comitant treatment with aspirin. If the els (22% vs 15%, P < 0.001). The in patients with hypercholesterolernia. goal of an LDL cholesterol level of cost of care with lovastatin was S3 3 3 < 4.14 mmol/L was not attained after 1 higher than stepped care ($786 vs Design month, the dose of niacin could be in- $453, P< 0.001). 1-year randomized controlled trial. creased. The next step included re- placement with or addition of a bile Setting Conclusion acid sequestrant, gemfibrozil, pro- Initial treatment with lovastatin was 3 Kaiser Permanente centers in bucol, or lovastatin, depending on more effective and more costly than southern California. lipid profile. Control group patients a stepped-care regimen in lowering received lovastatin, 20 mg/d, which Patients total and low-density-lipoprotein could be increased to 80 mg/d. 612 patients who were 20 to 70 years cholesterol in patients with hypercholesterolemia. of age (mean age 56 y, 51% men) and Main outcome measures had a low-density lipoprotein (LDL) Source of funding: Merck and Company Attainment of goal LDL cholesterol cholesterol level between 4.14 and 5.95 Incorporated. level and change in lipid levels. rnrnol/L, had a triglyceride level < 4.52 For article reprint: Dr, G. Oster, Policy http://ebm.bmj.com/ mmol/L, had never used cholesterol- Main results Analysis Inc, 4 Davis Court, Brookline, MA 02146, USA. FAX 617-232-1155. lowering medication, and had been Treatment with lovastatin led to more unable to attain adequate cholesterol patients achieving the goal LDL 'Numbers calculated from data in article. levels through diet alone. Exclusion cholesterol level at 1 year than did criteria included recent myocardial stepped care (40% vs 24%, P < 0.001). Abstract and Commentary also published in infarction, bypass surgery, angioplasty, {This absolute risk improvement of AC?Journal Club. 1996;125:37. or hemoglobin A; level > 0.10; un- 16% means that 6 patients would need on September 24, 2021 by guest. Protected copyright. stable angina; hepatic dysfunction; sec- to be treated with lovastatin (instead Commentary Recent trials have shown that cholesterol than were the patients who received stepped comparison of the efficacy of long-term nia- lowering with statin therapy reduces coro- care. Further, altiiough the protocol seemed cin and statin therapy would be valuable, al- nary heart disease risk in both primary and to encourage multi-drug therapy, at the end though expensive; also, because major secondaiy prevention settings. The poten- of the trial only 3% of stepped-care patients pharmaceutical companies have no interest tially high cost of this treatment, however, were receiving > 1 drug. Thus, poor compli- in niacin, it is unlikely to occur. has caused concern (1,2). The lower cost of ance may well be the key to the lower suc- George Davey Smith, MD odier agents, including niacin, makes diem cess rate of stepped care. University of Bristol attractive competitors of statins (3). Niacin The cost of treatment was considerably Bristol, England, UK lowers total and LDL cholesterol levels less higher with lovastatin. It is possible that com- effectively than statins but has the potential pliance with stepped care would be improved References advantage of raising HDL cholesterol levels in a population without such widespread 1. Fey R, Pearson N. Lancet. 1996;347:1389- and lowering triglyceride and lipoprotein (a) third-party drug coverage (90% in this study) 90. levels (4,5). Niacin is not as well tolerated as because the cost of niacin can be less than 2. Davey Smith G, Pekkanen J. Lancet. statins, although some clinicians have noted 5% of that of statin therapy (3). For many 1994;344:1766. good compliance if patients are carefully patients it seems reasonable to start with nia- 3. Schectman G, Hiatt J, Hartz A. Am J managed (4). Cardioi. 1993;71:759-65. cin and, if unsuccessful, therapy can be trans- 4. Alderman JD, Pasternak RC, Sacks FM, In this study by Oster and colleagues, more ferred to a statin. Compliance with this et al. Am J Cardioi. I989;64:725~9. patients who received lovastatin were taking management strategy was not addressed in 5. Carlson LA, Hamsten A, Asplimd A. J cholesterol-lowering medication atstudy end die study by Oster and colleagues. A direct Intern Med.l989;226:271-6.

Evidence-Based Medicine September/October 1996 Therapeutics 179