A double-blind, randomised trial of tesaglitazar versus pioglitazone in patients with type 2 diabetes mellitus

  • Harold Bays
    Louisville Metabolic and Atherosclerosis Research Center Inc. (L-MARC), 3288 Illinois Avenue, Louisville, KY, 40213, US.
  • Jennifer McElhattan
    AstraZeneca, 1800 Concord Pike, Wilmington, DE, US.
  • Brian S Bryzinski
    AstraZeneca, 1800 Concord Pike, Wilmington, DE, US.

書誌事項

公開日
2007-09
権利情報
  • https://journals.sagepub.com/page/policies/text-and-data-mining-license
DOI
  • 10.3132/dvdr.2007.039
公開者
SAGE Publications

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説明

<jats:p> The efficacy and safety of tesaglitazar (0.5 and 1 mg) and pioglitazone (15, 30 and 45 mg) were compared in a 24-week, randomised, double-blind study in 1, 707 patients with type 2 diabetes mellitus. </jats:p><jats:p> Tesaglitazar 1 mg was non-inferior to pioglitazone 45 mg for change from baseline in glycosylated haemoglobin (HbA<jats:sub>1C</jats:sub>) at 24 weeks (difference: −0.056 [95% confidence intervals −0.161, 0.049], p<jats:sub>NI</jats:sub><0.001 for non-inferiority hypothesis). Tesaglitazar 1 mg improved triglyceride (TG), high-density lipoprotein cholesterol (HDL-C) and non-HDL-C levels compared with all pioglitazone doses at 24 weeks (p<0.001). Low-density lipoprotein cholesterol (LDL-C) was lower with tesaglitazar for all pioglitazone comparisons (p<0.05), except for tesaglitazar 0.5 mg versus pioglitazone 15 mg. Tesaglitazar 1 mg decreased LDL particle number, when compared with all pioglitazone doses (p<0.01). Both agents increased body weight and peripheral oedema in a dose-dependent manner, but only tesaglitazar increased serum creatinine. </jats:p><jats:p> In summary, tesaglitazar provided similar glycaemic control to pioglitazone, was associated with significant improvement in lipid and lipoprotein variables, and increased serum creatinine in a dose-dependent manner. </jats:p>

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