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

Pharmacy Practice

  • Thanitha Sirirak1Department of Family and Preventive Medicine, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkla, 90110, Thailand.
  • Sarawut Siwamogsatham2The Maha Chakri Sirindhorn Clinical Research Center (Chula CRC), Faculty of Medicine, Chulalongkorn University, Bangkok, 10330, Thailand.
  • Supawan Buranapin3Endocrinology Unit, Department of Internal Medicine, Chiang Mai University Clinical Research Center, Faculty of Medicine, Chiang Mai University, Chiang Mai, 50200, Thailand.
  • Piti Inthaphan4Chiang Mai University Clinical Research Center, Faculty of Medicine, Chiang Mai University, Chiang Mai, 50200, Thailand.
  • Worapaka Manosroi
  • Thongchai Pratipanawatr6Academic Clinical Research Office (ACRO), Faculty of Medicine, Khon Kaen University, Khon Kaen, 40002, Thailand.
  • Sittichai Khamsai6Academic Clinical Research Office (ACRO), Faculty of Medicine, Khon Kaen University, Khon Kaen, 40002, Thailand.
  • Pasuree Sangsupawanich7Department of Clinical Research and Medical Data Science, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkla, 90110, Thailand.
  • Saranyou Suwanugsorn8Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkla, 90110, Thailand.

Volume 24 Issue 1 Pages 1-7

DOI: 10.18549/PharmPract.2026.1.3277

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.

Keywords

  • statin
  • rosuvastatin
  • generic drug
  • hypercholesterolemia
Pharmacy Practice

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