Glitazone study shows CV risk may be higher for elderly
A 60% increase in heart failure, a 40% increase in risk of myocardial infarction (MI), and a 30% increase in death? These are the findings for patients enrolled in a Canadian study to evaluate the risk of the glitazone drugs [pioglitazone (Actos, Takeda) and rosiglitazone (Avandia, GSK)] used to treat type 2 diabetes. The new study, "Thiazolidinediones and Cardiovascular Outcomes in Older Patients with Diabetes," published in the December 12 issue of JAMA, looked at all Ontario residents aged 65 years or older who were treated with at least one oral diabetes medication between 2002 and 2006. Results showed the risk was predominantly among patients taking rosiglitazone. However, a smaller number of people received pioglitazone, limiting the investigators? ability to be certain about adverse events in that group. GSK called the findings of the Canadian study misleading regarding acute MI and death, and inconsistent with larger, long-term studies including ADOPT and RECORD. The new study results were released by the Institute for Clinical Evaluative Sciences (ICES) and, according to ICES? lead researcher, it is not known whether these findings in the elderly would be similar in a younger population.
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FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.