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Review: pioglitazone does not reduce risk of mortality or cardiovascular events in type 2 diabetes -- 12 (2): 53 -- Evidence-Based Medicine Q In patients with type 2 diabetes, does pioglitazone reduce cardiovascular events, other adverse events, and mortality or improve health related quality of life?The duration of follow up was 6�12 months in all but 1 RCT. Mortality and major morbidity events were reported by only 1 RCT that compared pioglitazone plus other glucose lowering drugs with placebo plus other glucose lowering drugs with a mean follow up of 35 months; groups did not differ for any individual outcome (table). Greater increase in weight or body mass index with pioglitazone was reported in 19 of the 22 RCTs. Greater decrease in haemoglobin concentrations with pioglitazone was reported in all of the 6 RCTs that evaluated this outcome, including a dose related decrease in 1 trial that evaluated several doses. Oedema occurred more frequently with pioglitazone (table). No RCT reported on costs or health related quality of life. Pioglitazone treatment resulted in similar reductions in glycosylated haemoglobin AUpdated Drug Label Approved for Pioglitazone after Safety Review - The ASCO PostThe FDA recently approved updated drug labels for pioglitazone (Actos) and other pioglitazone-containing medicines (in combination with metformin, Actoplus Met and Actoplus Met XR; and with glimepiride, Duetact) to include safety information that the use of pioglitazone for more than 1�year may be associated with an increased risk of bladder cancer.The updated drug labels recommend that health-care professionals should not use pioglitazone in patients with active bladder cancer, and use pioglitazone with caution in patients with a prior history of bladder cancer. The new labels also recommend that patients should contact their health-care professional if they experience any sign of blood (or a red color) in the urine or other symptoms such as new or worsening urinary urgency or pain on urination since starting pioglitazone, as these may be due to bladder cancer. Actos (pioglitazone): Ongoing Safety Review - Potential Increased Risk of Bladder Cancer Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links [UPDATED 08/04/2011] The U.S. Food and Drug Administration (FDA) is informing the public that the Agency has approved updated drug labels for the pioglitazone-containing medicines to include safety information that the use of pioglitazone for more than one year may be associated with an increased risk of bladder cancer.NPC Rapid Review Pioglitazone� and the occurrence of bladder cancer Rapid reviews | Podcasts | Shared practice examples | Events | Publications and resources | FAQs | Email alerts | Newsroom | Contact us | A to Z While the review is ongoing the CHMP is not recommending any changes to the use of pioglitazone-containing medicines. However, prescribers should be aware of this safety concern about bladder cancer, in addition to several other safety concerns with this drug (see below). Pioglitazone remains a black triangle drug and any suspected adverse reactions should be reported through the Yellow Card system.The risk of bladder cancer in association with pioglitazone has been under close review by the CHMP since 2000, and the manufacturer is conducting several cohort studies to investigate this concern.
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