2009: Year in Review (Continued)
- Lantus cancer connection: Diabetologia came out with a worrying collection of articles suggesting that Lantus (insulin glargine) could increase the risk of cancer. A collection of analyses were published concurrently, with varying results. Some showed no correlation between Lantus use and cancer, some showed a positive correlation with cancer, and some showed a correlation only with certain types of cancer. And importantly, all of the studies are retrospective, meaning that they were performed on data that had already been collected, so they cannot demonstrate a causal relationship. Because of this, we don't see cause for real concern in the use of Lantus, which is still the largest diabetes treatment in the world.
- Liraglutide for obesity: We're seeing more and more how important weight loss is in the management of diabetes, so diabetes treatments that lead to weight loss are considered to be highly advantageous. One relatively new class of drugs, GLP-1 agonists, have been known to cause significant weight loss. Liraglutide, which as been approved in Europe and is pending approval in the US (see above), is a member of this class. In a departure from other studies of diabetes drugs, a study published in the Lancet tested the effects of liraglutide in obese people who did not have diabetes. Patients on the highest dose of liraglutide lost 7.2 kg (15.8 lb), demonstrating its potential use in weight management and/or diabetes prevention. The study suggests that liraglutide, or another GLP-1 agonist, could be used before the onset of diabetes in high-risk individuals.
- VADT: The VADT trial was another study comparing tight versus conventional glycemic control, this time over 5.6 years in 1,791 patients with type 2 diabetes. Unlike ACCORD, this study showed no difference between the rates of heart attacks or mortality between the two groups. The original publication also showed no significant microvascular benefits (decreases in eye, nerve, and kidney complications) in the intensive arm, but this was quietly recanted in a later issue of the New England Journal of Medicine. Where the report originally stated that measures of kidney function were not statistically different between the two groups of the study, the correction indicated that 13.8% of the patients in the standard-therapy group had worsening function as compared to only 9.1% of patients in the intensive-therapy group. We saw this as one of the worst mistakes in diabetes publication history, but unfortunately, NEJM didn't draw attention to its mistake – and unfortunately, many doctors likely still believe that VADT didn't show differences in microvascular complications, a real tragedy in our view.
- DCCT 30 years diabetes duration analysis: A major study was published in the Archives of Internal Medicine in 2010 confirming that intensive therapy should be standard of care for type 1 patients. This study showed how the intensive control of diabetes dramatically reduced development and progression of complications in those with type 1 diabetes for 30 years after the study. While we know this from DCCT, this follow-up data from DCCT/EDIC and the highly respected Dr. Trevor Orchard's group at Pittsburgh provide irrefutable evidence. This, we felt, was the most important of all publications for people with diabetes in 2009. The study showed that, almost 30 years out, fewer than 1% of patients who were intensively managed during the study were blind or had amputations, dialysis, or kidney replacement, compared to 4% in conventionally managed patients. Dr. David Nathan, a highly-respected endocrinologist at Mass General and Harvard Medical School and one of the study chairs for DCCT/EDIC, said: "Now in the modern era, knowing how to use insulin more physiologically has led to really dramatically different outcomes." We believe this report is a major positive for pumps, SMBG, CGM, and centers like Diabetes America and companies like Medco that strive to keep patients in the best possible control by giving them access to the best medical care providers around. Notably, in an audio interview just after the study was released, Dr. Nathan said this research makes it clear that patients should keep their blood glucose levels as close to normal as possible. We are particularly excited about the implications for CGM, which we believe allows patients to have their blood sugars as close to normal as possible, and now there is even more data that could bolster its use. In the interview, Dr. Nathan did specify that these results were for type 1 patients. He said that perhaps some treatments for type 2 may actually cause increased risk - we certainly hear more and more concern from leading clinicians that SFUs cause beta cell burnout in type 2s.
Italian-Style Artichokes Spicy Orange Roughy Fettuccine with Salmon Sauce Herbed Pork & Vegetable Stew Steamed Veal Roll Chayote with Pumpkin Seeds Greens and Orzo in Broth Minestrone Lentil Soup Salsa Roja Mushrooms and Sun Dried Tomatoes with Orzo
As I mentioned in an earlier post, one of the benefits that made it cost-effective for me to go with the real healthcare (HSA) plan rather than the phony (HRA) plan is that my company is now covering "preventative" medicines at $0 copay. The formulary for these, as stated by CVS/Caremark (my pharmacy benefits provider), covers all test strips, lancets, and control solutions. I dutifully get my doctor to write up prescriptions for all of my testing needs, submit...