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Effects on the incidence of cardiovascular events of the addition of pioglitazone versus sulfonylureas in patients with type 2 diabetes inadequately controlled with metformin (TOSCA.IT): a randomised, multicentre trial
This study is registered with ClinicalTrials.gov, number NCT00700856. Findings Between Sept 18, 2008, and Jan 15, 2014, 3028 patients were randomly assigned and included in the analyses. 1535 were assigned to pioglitazone and 1493 to sulfonylureas (glibenclamide 24 [2%], glimepiride 723 [48%], gliclazide 745 [50%]). At baseline, 335 (11%) participants had a previous cardiovascular event. The study was stopped early on the basis of a futility analysis after a median follow-up of 57·3 months. The primary outcome occurred in 105 patients (1·5 per 100 person-years) who were given pioglitazone and 108 (1·5 per 100 person-yea...
Source: The Lancet Diabetes and Endocrinology - September 14, 2017 Category: Endocrinology Source Type: research

Ten‐year observational follow‐up of PROactive: a randomized cardiovascular outcomes trial evaluating pioglitazone in type 2 diabetes
ConclusionsThe 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.
Source: Diabetes, Obesity and Metabolism - January 8, 2016 Category: Endocrinology Authors: E. Erdmann, S. Harding, H. Lam, A. Perez Tags: ORIGINAL ARTICLE Source Type: research

10‐Year Observational Follow‐Up of PROactive: a randomized cardiovascular outcomes trial evaluating pioglitazone in type 2 diabetes
ConclusionsThe 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 due to limitations of the observational study design.
Source: Diabetes, Obesity and Metabolism - November 23, 2015 Category: Endocrinology Authors: Erland Erdmann, Sarah Harding, Hung Lam, Alfonso Perez Tags: ORIGINAL ARTICLE Source Type: research

Observational follow‐up of the PROactive study: a 6‐year update†
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.
Source: Diabetes, Obesity and Metabolism - August 19, 2013 Category: Endocrinology Authors: E. Erdmann, E. Song, R. Spanheimer, A.‐R. van Troostenburg de Bruyn, A. Perez Tags: ORIGINAL ARTICLE Source Type: research

Observational follow‐up of the PROactive Study: a 6‐year update
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.
Source: Diabetes, Obesity and Metabolism - July 22, 2013 Category: Endocrinology Authors: Erland Erdmann, Eric Song, Robert Spanheimer, Anne‐Ruth van Troostenburg de Bruyn, Alfonso Perez Tags: Original Paper Source Type: research