As a physician I have to ponder how to treat diabetes when it seems like all the news about medications is bad these days? It’s not as clear cut today as it seemed a year or so ago. It seems like we are back to the basics of diet, weight loss and exercise. When we choose medications to help, it gets more complicated. Of course as with all conditions we try to choose medications which have the best risk-benefit ratio. Still the rules seem to be changing literally by the day.
The news of the last few weeks about the risks associated with medications we use in managing the risk factors in our patients with type 2 diabetes makes physicians feel like we are walking a mine field. Take a look at the headline type of news that has come out recently regarding the meds we use to address the four major risk factors for cardiovascular disease in Type 2 diabetes. It is felt to be very important in patients with diabetes to not focus only on blood sugar control, but to aggressively manage blood pressure, LDL cholesterol levels, and find a way to help diabetics who smoke to stop smoking.
Blood Sugar Control: Suboptimal blood sugar control has been a understood as a major risk for most of the major vascular, neurologic, and ophthalmologic complications of diabetes for years. Physicians are encouraged to try to keep the Hemoglobin A1C levels near or below 6.5% in our type 2 diabetes patients. To do this often requires the use of multiple hypoglycemic drugs. Recently drugs in to of the major classes used to manage blood sugars, the GLP-1 analogues including Liraglutide (Victoza) and the class of medications called the thiazolidinediones (TZDs) which included in the U.S. rosiglitazone and pioglitazone. Pioglitazone, or Actos was the 10th highest gross sales medication in the U.S. in 2008 with sales of about $2.4 billion.
- Rosiglitazone (Avandia): Removed from the market over increased risks of congestive heart failure and other heart disease concerns.
- Pioglitazone (Actos): Possibly related to increased risk of bladder cancer in a FDA news release just this month. Removed from much of the European market, now with increased warnings in the U.S. market.
- Liraglutide (Victoza): Possibly related to increased risks of thyroid cancer and pancreatitis in a FDA news release in June 2011. Although to date the other drug in this class, marketed as Byetta has not seemed to be associated with thyroid cancer risks, the course of the Avandia first, and Actos next seems ominous to me.
- Glargine insulin (Lantus): The good news is that the 2009 concerns raised about a possible cancer risk with glargine insulin were declared unfounded by the FDA this year.
Lipid Control: Ideal LDL cholesterol levels in our diabetic patients are less than 70 mg/dl, and to achieve this level most patients require treatment with a statin, often use of a high dose of simvastatin or one of the more expensive branded statins. See my prior post Simvastatin vs. Lipitor.
- Simvastatin 80 mg, the highest dose of the most effective current generic statin had recent FDA restrictions imposed. Now the question is what to do for our diabetic patients with recommended low goal LDL levels. Simvastatin vs. Lipitor or Crestor is the question. Pay more or accept possible risks. Lousy choices. Fortunately Lipitor is going to be available as a generic as soon as Nov. 30, 2011.
- The recent NIH decision to stop the study of niacin combined with a statin for treatment of hypercholesterolemia raises more questions than ever about how to best address suboptimal lipid profiles in our patients, especially our diabetic patients. This is a topic for another post to fully address the subject, so stay tuned.
Smoking Cessation: Our diabetic patients who continue to smoke have much higher risks of heart disease, stroke, and it is imperative that we do what we can to help them quit smoking. Now one of the more effective tools we have has come under increased scrutiny.
- Chantix (varenicline) has been very helpful in some patients who have been unable to quit smoking otherwise. Its side effects including vivid dreams, GI symptoms, and depression have been ongoing concerns, but now the FDA reports just this week that the risk of MI may be slightly increased in patients with known coronary disease. This is really unfortunate, as those are exactly the patients who need to quit smoking the most. I look forward to more clarification of this issue, but for now may be more cautious in use of Chantix in my patients who need to quit smoking the most.
Hypertension control: Control of hypertension may be the single most important aspect of reduction of morbidity and mortality in our diabetic patients. So far this remains relatively free of breaking news. Actually some good news recently is more evidence that the fears of increased cancer risk in patients using ARBs are likely unfounded. This is good, because with one generic arb now available, and more on the way, this class of medication is likely to be used with increasing frequency.
Stay tuned as how to treat diabetes hopefully becomes less controversial and we get more answers about the risk/benefit decisions on medication management. Certainly diet, exercise, weight loss and medications are all going to have their place. It will be interesting to see where bariatric surgery ends up in our recommendations in the future.