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 ch olesterol (LDL-C) levels, and adverse drug interactions and reactions. Objective: The purpose of this study was to compare the efficacy, safety, a nd 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, paralle l-group, optional dose-titration study conducted in Canada. Patients aged 1 8 to 75 years with documented primary hypercholesterolemia (mean LDL-C grea ter 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 [l ess 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 wer e 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 rec eived previous dietary counseling and were unwilling or unable to comply wi th this dietary advice. Before randomization, treating physicians were requ ired to record a target lipid level for each patient and then instructed to randomize patients to treatment with any dose and any titration schedule o f cerivastatin or branded pravastatin according to their normal practice. P hysicians were not required to titrate the study drug dose if the patient d id not achieve the predefined target goal. Lipid analyses were conducted at baseline/randomization and at months 3, 6, 9, and 12. All samples drawn fo r 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 treatme nt costs between cerivastatin and branded pravastatin. Since the analysis w as from the perspective of the third-party payer (Ministries of Health), on ly costs attributed to the third-party payer were included. Results: A total of 417 patients were randomized to once-daily treatment wi th 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%) beca use of an adverse event. The incidence of adverse events was similar for ce rivastatin (73.6%) and branded pravastatin (74.9%). The majority of adverse events were mild or moderate and included headache, nausea, pain, and dizz iness. Both cerivastatin and pravastatin were effective in lowering LDL-C t o 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 w as achieved in 74.2% of cerivastatin patients and 74.0% of pravastatin pati ents. The annualized direct hyperlipidemia treatment cost was 19% higher in the branded pravastatin group compared with the cerivastatin group. A sens itivity analysis designed to examine the impact of generic pricing on the c ost-minimization analysis indicated that the cost difference between ceriva statin 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 base line. A cost savings in favor of cerivastatin was a reflection of the lower drug acquisition cost of cerivastatin compared with branded pravastatin.