Abstract | PURPOSE: This study was designed to compare the efficacy and tolerability of the generic formulation (Atorva®) and the reference formulation (Lipitor®) of atorvastatin, both at a dosage of 20 mg once daily. METHODS: RESULTS: Three hundred and seventy-six patients were randomized, and 346 patients (176 in the generic group and 170 in the reference group) completed the study. After the 8 weeks of treatment, LDL cholesterol level was significantly decreased in both the groups, and the decrement was comparable between the two groups (-43.9%±15.3% in the generic group, -43.3%±17.0% in the reference group, P=0.705). The percent changes of total cholesterol, HDL cholesterol, TG, ApoB, ApoA1, ApoB/ApoA1 ratio, total cholesterol/HDL cholesterol ratio, and hsCRP showed insignificant difference between the two groups. However, LDL cholesterol goal achievement rate was significantly higher in the generic group compared to the reference group (90.6% vs 83.0%, P=0.039) in per-protocol analysis. Adverse event rate was comparable between the two groups (12.0% vs 13.7%, P=0.804). CONCLUSION:
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Authors | Ju-Hee Lee, Sang-Hyun Kim, Dong-Ju Choi, Seung-Jea Tahk, Jung-Han Yoon, Si Wan Choi, Taek-Jong Hong, Hyo-Soo Kim |
Journal | Drug design, development and therapy
(Drug Des Devel Ther)
Vol. 11
Pg. 2277-2285
( 2017)
ISSN: 1177-8881 [Electronic] New Zealand |
PMID | 28814835
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
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Topics |
- Atorvastatin
(administration & dosage, chemistry, therapeutic use)
- Drug Administration Schedule
- Drug Compounding
- Drug Tolerance
- Female
- Humans
- Hypercholesterolemia
(drug therapy)
- Male
- Middle Aged
- Molecular Conformation
- Prospective Studies
- Republic of Korea
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