Format

Send to

Choose Destination
See comment in PubMed Commons below
Diabetologia. 2012 Jul;55(7):1953-62. doi: 10.1007/s00125-012-2538-9. Epub 2012 Mar 31.

Pioglitazone and risk of bladder cancer among diabetic patients in France: a population-based cohort study.

Author information

1
Caisse Nationale de l'Assurance Maladie, 50 Avenue du Pr André Lemierre, 75986 Paris Cedex 20, France.

Abstract

AIMS/HYPOTHESIS:

Previous studies have suggested an increased risk of bladder cancer with pioglitazone exposure. We aimed to investigate the association between pioglitazone exposure and bladder cancer in France.

METHODS:

This cohort study involved use of data from the French national health insurance information system (Système National d'Information Inter-régimes de l'Assurance Maladie; SNIIRAM) linked with the French hospital discharge database (Programme de Médicalisation des Systèmes d'Information; PMSI). The cohort included patients aged 40 to 79 years who filled a prescription for a glucose-lowering drug in 2006. The cohort was followed for up to 42 months. Pioglitazone exposure was modelled as a time-dependent variable and defined by having filled at least two prescriptions over a 6-month period. Incident cases of bladder cancer were identified by a discharge diagnosis of bladder cancer combined with specific aggressive treatment. Statistical analyses involved a multivariate Cox model adjusted for age, sex and exposure to other glucose-lowering drugs.

RESULTS:

The cohort included 1,491,060 diabetic patients, 155,535 of whom were exposed to pioglitazone. We found 175 cases of bladder cancer among exposed patients and 1,841 among non-exposed patients. Incidence rates were 49.4 and 42.8 per 100,000 person-years, respectively. Pioglitazone exposure was significantly associated with bladder cancer incidence (adjusted HR 1.22 [95% CI 1.05, 1.43]). We observed a dose-effect relationship, with a significantly increased risk for high cumulative doses (≥ 28,000 mg, adjusted HR 1.75 [95% CI 1.22, 2.50]) and long duration of exposure (≥ 24 months, adjusted HR 1.36 [1.04, 1.79]).

CONCLUSIONS/INTERPRETATION:

In this cohort of diabetic patients from France, pioglitazone exposure was significantly associated with increased risk of bladder cancer.

PMID:
22460763
PMCID:
PMC3369136
DOI:
10.1007/s00125-012-2538-9
[Indexed for MEDLINE]
Free PMC Article
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Springer Icon for PubMed Central
    Loading ...
    Support Center