Universität zu Köln

Erdmann, E., Song, E., Spanheimer, R., de Bruyn, A. -R. van Troostenburg and Perez, A. (2014). Observational follow-up of the PROactive study: a 6-year update. Diabetes Obes. Metab., 16 (1). S. 63 - 75. HOBOKEN: WILEY. ISSN 1463-1326

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Abstract

AimsThe PROactive study investigated pioglitazone for secondary prevention of macrovascular events in type 2 diabetes mellitus. Pioglitazone showed a 10% (non-significant) relative risk (RR) reduction for the primary composite endpoint and a significant 16% reduction for the main secondary endpoint (death, myocardial infarction, stroke) after a mean 34.5months. There was no difference in cumulative malignancy incidence, but an imbalance in bladder malignancies (pioglitazone 14, placebo 5). We present a pre-specified 6-year interim analysis of a 10-year observational follow-up. MethodsAny patient completing PROactive was eligible. No study treatments were provided. A Cox proportional hazard model compared non-adjudicated macrovascular events (same endpoints as PROactive excluding acute coronary syndrome) based on original randomization. Malignancies were compared using conventional RR ratios. ResultsOf 5238 randomized patients, 3599 (74%) entered the follow-up. For the follow-up (mean 5.8years) or combined double-blind and follow-up periods (9.5years, mean 8.7), there were no statistically significant differences in primary or main secondary endpoints. For the combined period, a similar percentage of patients had any diagnosed malignancy (RR=1.05, 95% CI [0.89, 1.24]) or bladder malignancy (RR=1.06, 95% CI [0.59, 1.89]) in the pioglitazone and placebo groups. There were fewer cases of bladder malignancy with pioglitazone (15 [0.6%] vs. 19 [0.7%] for placebo) for the combined period when events diagnosed in the first 365days were excluded, and fewer cases for the follow-up period alone (10 [0.5%] vs. 17 [1.0%] for placebo). Further analyses of pioglitazone use (including use during follow-up) found no significant difference in bladder malignancies between any and no pioglitazone use for the combined period. ConclusionsThese data suggest that improved macrovascular outcomes seen with pioglitazone subside without continued pioglitazone treatment. The double-blind period bladder cancer imbalance did not persist in follow-up.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Erdmann, E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Song, E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Spanheimer, R. UNSPECIFIED UNSPECIFIED UNSPECIFIED de Bruyn, A. -R. van Troostenburg UNSPECIFIED UNSPECIFIED UNSPECIFIED Perez, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-452013
DOI:	10.1111/dom.12180
Journal or Publication Title:	Diabetes Obes. Metab.
Volume:	16
Number:	1
Page Range:	S. 63 - 75
Date:	2014
Publisher:	WILEY
Place of Publication:	HOBOKEN
ISSN:	1463-1326
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language PIOGLITAZONE CLINICAL-TRIAL; DENSITY-LIPOPROTEIN-CHOLESTEROL; INTIMA-MEDIA THICKNESS; HIGH-RISK PATIENTS; BLADDER-CANCER; DIABETES-MELLITUS; PROSTATE-CANCER; CARDIOVASCULAR EVENTS; THIAZOLIDINEDIONE THERAPY; CORONARY ATHEROSCLEROSIS Multiple languages Endocrinology & Metabolism Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/45201