Cerivastatin versus branded pravastatin in the treatment of primary hypercholesterolemia in primary care practice in Canada: A one-year, open-label, randomized, comparative study of efficacy, safety, and cost-effectiveness

Background. Potential cost differences between statins are driven primarily by drug costs, differential lowering effects on low-density lipoprotein cholesterol (LDL-C) levels, and adverse drug interactions and reactions. Objective: The purpose of this study was to compare the efficacy, safety, and direct treatment costs of cerivastatin and branded pravastatin in adult patients with primary hypercholesterolemia over a 1-year period. Methods: This was a multicenter (48 sites), randomized, open-label, parallel-group, optional dose-titration study conducted in Canada. Patients aged 18 to 75 years with documented primary hypercholesterolemia (mean LDL-C greater than or equal to 160 mg/dL [greater than or equal to4.5 mmol/L] and at least 1 fasting triglyceride measurement less than or equal to 400 mg/dL [less than or equal to4.5 mmol/L]) that did not respond adequately to dietary intervention were enrolled. Patients who were on a diet at study entry were instructed to continue that diet for the duration of the study. Patients not following a diet were also entered into the study provided they had received previous dietary counseling and were unwilling or unable to comply with this dietary advice. Before randomization, treating physicians were required to record a target lipid level for each patient and then instructed to randomize patients to treatment with any dose and any titration schedule of cerivastatin or branded pravastatin according to their normal practice. Physicians were not required to titrate the study drug dose if the patient did not achieve the predefined target goal. Lipid analyses were conducted at baseline/randomization and at months 3, 6, 9, and 12. All samples drawn for lipid analyses were collected after a fast of greater than or equal to 10 hours. A cost-minimization approach was used to compare the direct treatment costs between cerivastatin and branded pravastatin. Since the analysis was from the perspective of the third-party payer (Ministries of Health), only costs attributed to the third-party payer were included. Results: A total of 417 patients were randomized to once-daily treatment with cerivastatin 0.1 mg to 0.4 mg (n=209) or branded pravastatin 10 mg to 40 mg (n=208); 39 (9.4%) of patients discontinued prematurely, 19 (4.6%) because of an adverse event. The incidence of adverse events was similar for cerivastatin (73.6%) and branded pravastatin (74.9%). The majority of adverse events were mild or moderate and included headache, nausea, pain, and dizziness. Both cerivastatin and pravastatin were effective in lowering LDL-C to target levels (mean reduction 29.8% and 27.5%, respectively, P=0.35). An LDL-C decrease of greater than or equal to 20% from baseline to end point was achieved in 74.2% of cerivastatin patients and 74.0% of pravastatin patients. The annualized direct hyperlipidemia treatment cost was 19% higher in the branded pravastatin group compared with the cerivastatin group. A sensitivity analysis designed to examine the impact of generic pricing on the cost-minimization analysis indicated that the cost difference between cerivastatin and generic pravastatin was not significant. Conclusions: Both cerivastatin and branded pravastatin were well tolerated and effective in lowering LDL-C by greater than or equal to 20% versus baseline. A cost savings in favor of cerivastatin was a reflection of the lower drug acquisition cost of cerivastatin compared with branded pravastatin.