Rosiglitazone’s efficacy to provide long term sustained glycaemic control re-endorsed by new studies: Dr Harold Lebovitz
Internationally acclaimed endocrinologist Dr. Harold Lebovitz, Professor of Medicine, Division of Endocrinology and Metabolism/Diabetes at the State University of New York, Brooklyn provided doctors in Pakistan with an insight to the latest ACCORD, ADVANCE and VADT clinical trials during a real-time video conference held simultaneously in Karachi, Lahore and Islamabad.
The video conference – organized by Pakistan Endocrine Society and GlaxoSmithKline Pakistan – was chaired by Professor Khurram Shahid, President, Pakistan Endocrine Society (PES), Professor Zafarullah Khan, Vice Chancellor, Kind Edward Medical University, Lahore, Professor Najmul Islam, Director, Diabetes, Endocrinology & Metabolism Fellowship Programme, AKU Hospital, Karachi, and Dr Amjad Naseem, Associate Professor of Medicine, Fauji Foundation Hospital, Islamabad. A large number of diabetologists from the three cities attended the symposia.
Dr. Lebovitz in his presentation focused on the findings of ACCORD (Action to Control Cardiovascular Risk in Diabetes) Trial – a large clinical study of adults with established type 2 diabetes who are at especially high risk of cardiovascular disease (CVD). He also discussed two other major clinical trials: Action in Diabetes and Vascular Disease (ADVANCE) and Veteran Affairs Diabetes Trial (VADT).
Dr. Lebovitz informed the participants that ACCORD researchers have extensively analyzed the available data and have not been able to identify any specific cause for the higher death rate among the intensive blood sugar treatment group. Based on analyses done to date, there was no evidence that any medication or combination of medications was responsible for the higher risk. In addition, although the number of severe hypoglycemic events was greater in the intensive blood sugar strategy group, this does not appear to account for the difference.
Because of the recent concerns with rosiglitazone, one of several medications used in ACCORD, researchers specifically reviewed data to determine whether there was any link between this particular medication and the increased deaths. To date, no link has been found, he informed.
According to ADOPT findings rosiglitazone was proven to provide long term sustained glycaemic control to metformin and sulphonylurea, he further added.
He said that findings from VADT—a large, long-term and independent study into heart attack problems in high-risk diabetes patients showed that while rosiglitazone was used in a majority of patients in the study, it was not associated with increased deaths.
Dr. Lebovitz presentation was followed by an interactive session on the ADVANCE study which confirmed a previously identified benefit of the lower blood-sugar strategy for type 2 diabetes patients. He said that diabetes patients can benefit from the combination of metformin and/or SU and rosiglitazone as compared to up-titrations of these traditional OAD to provide sustained glycaemic control to the patients.
To a question about the black box warning and the precautions and contraindications of rosiglitazone, Dr Lebovitz remarked that these were exactly the same as of pioglitazone and it can not be assumed that the latter was safer.
It may be mentioned that the ACCORD, ADVANCE and VADT studies not only contradict the NEJM meta-analysis published last year but clearly explain why the newly-presented outcomes research was more significant.