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

Neumann A, Weill A, Ricordeau P, Fagot JP, Alla F, Allemand H - Diabetologia (2012)

Bottom Line: We found 175 cases of bladder cancer among exposed patients and 1,841 among non-exposed patients.Pioglitazone exposure was significantly associated with bladder cancer incidence (adjusted HR 1.22 [95% CI 1.05, 1.43]).In this cohort of diabetic patients from France, pioglitazone exposure was significantly associated with increased risk of bladder cancer.

View Article: PubMed Central - PubMed

Affiliation: 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.

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Related in: MedlinePlus

Flow chart of the pioglitazone and risk of bladder cancer study population
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Related In: Results  -  Collection


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Fig1: Flow chart of the pioglitazone and risk of bladder cancer study population

Mentions: The study included 1,491,060 diabetic patients, 155,535 (10.4%) of whom were exposed to pioglitazone during the study period. Figure 1 shows a flow chart describing the study population.Fig. 1


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

Neumann A, Weill A, Ricordeau P, Fagot JP, Alla F, Allemand H - Diabetologia (2012)

Flow chart of the pioglitazone and risk of bladder cancer study population
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3369136&req=5

Fig1: Flow chart of the pioglitazone and risk of bladder cancer study population
Mentions: The study included 1,491,060 diabetic patients, 155,535 (10.4%) of whom were exposed to pioglitazone during the study period. Figure 1 shows a flow chart describing the study population.Fig. 1

Bottom Line: We found 175 cases of bladder cancer among exposed patients and 1,841 among non-exposed patients.Pioglitazone exposure was significantly associated with bladder cancer incidence (adjusted HR 1.22 [95% CI 1.05, 1.43]).In this cohort of diabetic patients from France, pioglitazone exposure was significantly associated with increased risk of bladder cancer.

View Article: PubMed Central - PubMed

Affiliation: 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.

Show MeSH
Related in: MedlinePlus