Pioglitazone and the risk of bladder cancer: An Indian retrospective cohort study

Abstract

Aim:To determine whether pioglitazone is associated with an increased risk of bladder cancer among Indian type 2 diabetic patients.Methods:A retrospective data analysis of 2222 type 2 diabetic patients was conducted. The study subjects were divided into two equal groups: 1111 pioglitazone users and 1111 pioglitazone non-users. The safety of pioglitazone therapy was analyzed in terms of occurrence of bladder and other types of cancers along with its efficacy in terms of glycemic control. Parameters for assessing safety were duration of disease, duration of usage and total dose of pioglitazone consumed across age groups, glycemic control, obesity and family history of any cancer. Bladder cancer prevalence was analyzed on the basis of urinary cytology, urine routine and microscopy, hematuria, urinary nuclear matrix protein 22 analysis and ultrasonography.Results:Of the 2222 cases analysed, there was no evidence of bladder cancer in any of the studied groups, (p=not significant) which was also evident among 1111 patients on Pioglitazone therapy with a cumulative dose consumption of 2737 mg to 1,31,400 mg. On subgroup analysis, there was no evidence of bladder cancer amongst patients with age >60 years, duration of diabetes > 10 years and uncontrolled diabetics (HbA1c >8%) with cumulative pioglitazone consumption of >28,000 mg. A significant number of patients achieved good glycemic control (HbA1c <7.5%) with pioglitazone therapy.Conclusion:Pioglitazone therapy was not associated with occurrence of bladder cancer among Indian type 2 diabetic patients and demonstrated good glycemic control.

Pioglitazone and the Risk of Bladder Cancer: A Meta-Analysis

“…In order to assess the cumulative effect of pioglitazone use and to determine whether there is an increased risk of urinary bladder cancer in case of prolonged use, we analyzed 12 studies using HR as the relative association measure [ 19 , 23 , 24 , 33 – 41 ]. Ten of them are cohort studies with two prospective cohort studies [ 23 , 33 ] and eight retrospective cohort studies [ 24 , 34 , 35 , 37 – 41 ]. There is one observational study [ 19 ] and one case–control study [ 36 ].…”

“…An Indian retrospective cohort study aimed to determine whether pioglitazone is associated with an increased risk of bladder cancer and analyzed 2222 patients divided into two equal groups. It is interesting to point out that there was no evidence of bladder cancer in any of the studied groups [ 35 ]. The study by Lee et al [ 37 ] investigated the factors that may link pioglitazone to bladder cancer among 34,970 subjects identified from the National Health Insurance Research Database.…”

“…4 a, b, the study by Neumann et al [ 39 ] has the highest weight but results summarized in Table 3 show that it is of arguable quality. When it is excluded from the analysis, together with the works of Gupta et al [ 35 ] and Mackenzie et al [ 38 ], which are also deemed to be of low quality, the summary HR for the rest of the studies becomes 1.07 (0.96–1.18). This result allows us to affirm that there is no link between long-term use of pioglitazone and bladder cancer.…”

Do We Still Need Pioglitazone for The Management of Type 2 Diabetes Mellitus? A Peep In To Risk of Bladder Cancer in Diabetic Population

“…On the other hand, few studies reported no risk of bladder cancer with pioglitazone use [10,11]. For instance, a recent population based cohort study conducted in United Kingdom (UK) generated 689,616 person years of follow-up, during which 622 patients were newly diagnosed as having bladder cancer (crude incidence 90.2 per 100,000 person years).…”

Pioglitazone and risk of bladder cancer in type 2 diabetes mellitus patients: A systematic literature review and meta-analysis of observational studies using real-world data

“…15 Conversely, a recent retrospective cohort study conducted in India documented that pioglitazone was not associated with the bladder cancer in the T2DM patients. 16 Drug Technical Advisory Board (DTAB) of India in 2013 recommended deferment of pioglitazone or manufacture and sale of pioglitazone containing formulation be withdrawn and allowed to be marketed with special caution. 17 Limited real world data regarding safety concern of pioglitazone use and risk of bladder cancer are equivocal and unknown.…”