Comparative efficacy and safety of generic rosuvastatin (K-zuva®) versus proprietary rosuvastatin (Crestor®) in patients with hypercholesterolemia: An open-label, 6-week randomized controlled trial
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Keywords
statin, rosuvastatin, generic drug, hypercholesterolemia
Abstract
Background: A recent study from Thailand reported that simvastatin is more frequently used than rosuvastatin and that the rate of attaining an optimal low-density lipoprotein-cholesterol (LDL-C) level is low. The rosuvastatin pioneer brand, Crestor®, is costly for many patients in developing countries. Some generic rosuvastatins have become available but there has no evidence from randomized control trials to support the efficacy and safety of generic rosuvastatin formula in Thailand. Objectives: To determine whether a generic rosuvastatin (K-zuva®) has a comparative efficacy and safety to branded rosuvastatin (Crestor®). Methods: A phase 4, multicenter, randomized, open, active-controlled, parallel-arm study of patients with hypercholesterolemia was conducted to compare the generic rosuvastatin (K-zuva®) to the branded rosuvastatin (Crestor®). The study included a 2-week run-in period and a 6-week treatment period. The primary efficacy endpoint was the mean difference in direct LDL-C levels from baseline to week 6. Safety issues, including treatment-emergent adverse events and clinical laboratory safety parameters, were also studied. Differences between before and after treatment in each group were evaluated using a paired t-test. For comparison between two groups, a two-sample t-test was used. Results: Of 107 participants screened, 92 were randomized (46 each in the brand group and generic group). In the brand group, the mean difference in LDL-C was −64.2 mg/dL [95%CI: −77.8 to −50.5], and the mean percent change in LDL-C level was −38.7% [95%CI: −46.0 to −31.3] from baseline to week 6. In the generic group, the mean difference in LDL-C was −69.0 mg/dL [95%CI: −80.0 to −57.9], and the mean percent change in LDL-C was −42.8% [95%CI: −48.5 to −37.0] from baseline to week 6. There was no significant difference in the mean difference (p=0.58) or percentage reduction between the two groups (p=0.37). Incidence of adverse events was similar between the groups. Conclusions: K-zuva®, the generic rosuvastatin, had the same efficacy in LDL-C reduction as the branded rosuvastatin, with a similar incidence of adverse effects. Physicians may be reassured to prescribe effective and safe generic rosuvastatin with greater confidence. Our results may promote the use of the less expensive generic rosuvastatin as a substitute for branded rosuvastatin.
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