Monday, March 15, 2010


Last weekend saw the start of the American College of Cardiology annual scientific meeting. As usual, many clinical trial results will be presentated. One in particular interest me as I have been waiting for the rsults for the last 5 years. This is the NAVIGATOR trial. Navigator stands for "Nateglinide and Valsartan in Impaired Glucose Tolerance Outcomes Research". Sponsored by the large Pharma " Novartis " I was briefed on this trial in the early 2004 ( I think ) when the trials was recruiting. Many sales representatives came by to tell me about the new wonder drug of " Starlix" for the treatment of my patients with diabetes, and how it will reduce cardiovascular events. Starlix is a secretogogue, and I told Novartis that I felt that it was too weak to do any good. I was not keen to use it until I had more data. Anyway, with much prompting, I said that I will hold final judgement until the trial results are out. Well, this trial of 9,306 patients, enrolled from 40 countries with followup for 5 years, had their results presented on Sunday at the ACC. It compared the use of valsartan, the blockbuster drug from Novartis for the treatment of hypertension and heart failure, with placebo, on one arm of the trial and compared starlix against placebo, on the other arm of the trial. The cohort were males who either had impaired glucose tolerance, CV risk factors or if they were younger ( >50years ), established CAD. The end point was to see if the use of Stalix or Valsartan will reduce the incidence of diabetes in people with impair glucose tolerance or if we could reduce CV events in patients with impaired glucose tolerance and also cardiovascular disease or risk factor of CV diseae. Basically, the answer came out as a big " NO ". Neither drug, used in this way reduce the major adverse cardiac events and the use of valsartan, marginally rreduced the incidence of diabetes ( by 14% ).
This was very much in line with the result os DREAM where the use of ramipril and rosiglitazone was not associated with a reduce incidence of diabetes.
Well, looks like NAVIGATOR will spll the end of Starlix ( which at the moment is almost dead ). The other issue is that Novartis, strong as they are, have used up alot of funds for this negative trial. I hope that they can re-coup.
More of the ACC trial results as we go down the week.

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