Universität zu Köln

Erdmann, E., Harding, S., Lam, H. and Perez, A. (2016). Ten-year observational follow-up of PROactive: a randomized cardiovascular outcomes trial evaluating pioglitazone in type 2 diabetes. Diabetes Obes. Metab., 18 (3). S. 266 - 274. HOBOKEN: WILEY. ISSN 1463-1326

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Abstract

Aims: To conduct a 10-year, observational follow-up of patients completing PROactive to investigate whether trends of cardiovascular benefit with pioglitazone and imbalances in specific malignancies persisted over time. Methods: Macrovascular endpoints and malignancies were compared based on original randomization to pioglitazone or placebo and 'any' versus 'no' pioglitazone use for bladder and prostate cancer. Results: Of 4873 patients completing the PROactive trial, 74% entered the follow-up. During follow-up (mean 7.8 years), there were no statistically significant differences in the primary [all-cause mortality, myocardial infarction (MI), cardiac intervention, stroke, major leg amputation, leg revascularization] or main secondary (death, MI, stroke) endpoints for subjects originally randomized to pioglitazone and placebo, except for leg amputations during follow-up [4.1% pioglitazone, 5.6% placebo; hazard ratio 0.74, 95% confidence interval (CI) 0.55-0.99; p = 0.046]. During follow-up, the incidence of total malignancies was similar between groups; bladder cancer was reported in 0.8% of patients (n = 14) in the pioglitazone versus 1.2% (n = 21) in the placebo group [relative risk (RR) 0.65, 95% CI 0.33-1.28], and prostate cancer was reported in 44 men (3.7%) in the pioglitazone versus 29 men (2.5%) in the placebo group (RR 1.47, 95% CI 0.93-2.34). Conclusions: The trends of macrovascular benefits of pioglitazone compared with placebo during PROactive did not persist in the absence of continued pioglitazone during this 10-year follow-up. Trends of decreased bladder cancer and increased prostate cancer were observed in the pioglitazone group during follow-up; however, these imbalances should be interpreted with caution because of the limitations of the observational study design.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Erdmann, E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Harding, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Lam, H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Perez, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-283458
DOI:	10.1111/dom.12608
Journal or Publication Title:	Diabetes Obes. Metab.
Volume:	18
Number:	3
Page Range:	S. 266 - 274
Date:	2016
Publisher:	WILEY
Place of Publication:	HOBOKEN
ISSN:	1463-1326
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language BLADDER-CANCER; CLINICAL-TRIAL; MACROVASCULAR EVENTS; GLUCOSE CONTROL; RISK; COHORT; THIAZOLIDINEDIONES; AGENTS Multiple languages Endocrinology & Metabolism Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/28345