June 4th, 2013
With One Big Exception FDA Reviewers Back More Benign View of Avandia Trial
Larry Husten, PHD
The FDA has released a 538-page briefing document for an advisory panel meeting on Wednesday and Thursday that will reassess a key clinical trial and reconsider the fate of the now-tarnished former blockbuster diabetes drug rosiglitazone (Avandia, GlaxoSmithKline). (Click here for the FDA documents.) As reported last week, the re-adjudication of the RECORD safety trial performed by […]
June 4th, 2013
Day Two At the NLA: Interviewed On The Radio
Reva Balakrishnan, MD, MPH
June 2– The early part of my second day at the NLA conference started out in an exciting way. As a third place winner of the Young Investigators abstract competition I was invited to talk about my research on “Lipid Luminations,”XM radio’s Reach MD station hosted by Dr. Alan Brown. My research, titled “Prevalence of […]
May 29th, 2013
Report on the RECORD Trial Released
Larry Husten, PHD
An independent re-adjudication of the RECORD trial has confirmed the trial’s original finding that rosiglitazone does not increase cardiovascular risk. But critics of the trial and the drug are unlikely to be appeased by the new result. The re-adjudication of RECORD will be the subject of an extraordinary 2-day FDA advisory committee meeting next week on […]
April 11th, 2013
Cuban History Offers Important Lessons For Global Health Today
Larry Husten, PHD
A large new study from Cuba shows the impressive benefits that can be achieved with weight loss and increased exercise. Much more ominously, the same study shows the dangers associated with weight gain and less exercise. In the study, published in BMJ, researchers took advantage of a “natural” experiment that occurred in Cuba as a result of a major […]
March 29th, 2013
FDA Approves First SGLT2 Inhibitor for Diabetes
Larry Husten, PHD
The FDA said today that it had approved canaglifozin (Invokana, Johnson & Johnson), the first of a new class of diabetes drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. Canaglifozin is indicated, in conjunction with diet and exercise, to improve glycemic control in adults with type 2 diabetes. The drug has been studied as monotherapy and in combination with […]
February 15th, 2013
Amid Rising Tide of Diabetes More Patients Reach Treatment Goals
Larry Husten, PHD
There’s a glimmer of good news amidst all the recent bad news about diabetes. Although the prevalence of diabetes has doubled over the last generation, more people today are reaching their treatment goals than in the past. New data from the National Health and Nutrition Examination Surveys (NHANES), published online today in Diabetes Care, show that efforts to control hemoglobin […]
February 11th, 2013
FDA Wants Cardiovascular Safety Data Before Approving Insulin Degludec
Larry Husten, PHD
The FDA informed Novo Nordisk on Friday that it would not approve the company’s highly anticipated long-acting insulin degludec products (Tresiba and Ryzodeg) until it receives data from a cardiovascular outcomes trial. Approval of the drugs had been widely anticipated for this year, following a positive recommendation from an FDA advisory committee last fall. But the committee […]
January 2nd, 2013
CABG Highly Cost-Effective in Diabetics with Multivessel Disease
Larry Husten, PHD
In November the main results of the FREEDOM trial showed that diabetics with multivessel disease do better with CABG than PCI. Now the findings of the trial’s cost-effectiveness study, published online in Circulation, demonstrate that CABG is also highly cost-effective when compared with PCI. Elizabeth Magnuson and colleagues found that although CABG initially cost nearly $9000 more than PCI ($34,467 […]
December 27th, 2012
Selections from Richard Lehman’s Literature Review: December 27th
Richard Lehman, BM, BCh, MRCGP
This week’s topics include an intensive lifestyle intervention and its association with type-2 diabetes remission, strategies for multivessel revascularization in patients with diabetes, and more.
December 13th, 2012
Diabetics with Multivessel Disease: FREEDOM with CABG?
Valentin Fuster, MD
Dr. Valentin Fuster answers questions about the FREEDOM trial, which shows that diabetics with multivessel disease had lower rates of death and MI with CABG than with PCI.