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Comparative long‐term efficacy and tolerability of pitavastatin 4 mg and atorvastatin 20–40 mg in patients with type 2 diabetes mellitus and combined (mixed) dyslipidaemia
Author(s) -
Gumprecht J.,
Gosho M.,
Budinski D.,
Hounslow N.
Publication year - 2011
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/j.1463-1326.2011.01477.x
Subject(s) - pitavastatin , atorvastatin , medicine , tolerability , apolipoprotein b , statin , type 2 diabetes , post hoc analysis , endocrinology , type 2 diabetes mellitus , dyslipidemia , cholesterol , gastroenterology , diabetes mellitus , adverse effect
Aim: To compare the long‐term efficacy and safety of pitavastatin with atorvastatin in patients with type 2 diabetes and combined (mixed) dyslipidaemia. Methods: Randomised, double‐blind, active‐controlled, multinational non‐inferiority study. Patients were randomised 2 : 1 to pitavastatin 4 mg (n = 279) or atorvastatin 20 mg (n = 139) daily for 12 weeks. Patients completing the core study could continue on pitavastatin 4 mg (n = 141) or atorvastatin 20 mg (n = 64) [40 mg (n = 7) if lipid targets not reached by week 8] for a further 44 weeks (extension study). The primary efficacy variable was the change in low‐density lipoprotein cholesterol (LDL‐C). Results: Reductions in LDL‐C were not significantly different at week 12 between the pitavastatin (−41%) and atorvastatin (−43%) groups. Attainment of National Cholesterol Education Program and European Atherosclerosis Society targets for LDL‐C and non‐high‐density lipoprotein cholesterol (non‐HDL‐C) was similarly high for both treatment groups. Changes in secondary lipid variables (e.g. HDL‐C, apolipoprotein B and triglycerides) were similar between treatments. Post hoc analysis showed that adjusted mean treatment differences for pitavastatin vs. atorvastatin were within the non‐inferiority margin at weeks 16 (+0.11%; 95% confidence interval (CI), −5.23 to 5.44) and 44 (−0.02%; 95% CI, −5.46 to 5.41) of the extension study. Both treatments were well tolerated; atorvastatin increased fasting blood glucose from baseline (+7.2%; p < 0.05), whereas pitavastatin had no significant effect (+2.1%). Conclusions: Reductions in LDL‐C and changes in other lipids were not significantly different in patients treated with pitavastatin 4 mg or atorvastatin 20 or 40 mg. Pitavastatin may, however, have a more favourable effect on the glycaemic status.