Sometimes it pays to know what doesn’t work
Today has been one of those days when there was a host of news and all of it fairly significant. The day started with two FDA complete response letters- Amylin (NASDAQ:AMLN) got good news, while MannKind (NASDAQ:MNKD) received bad news. Perhaps lost in all this news where the studies published in the recent issue of the New England Journal of Medicine. While there were three published article two were related to one study, The NAVIGATOR (Nateglinide and Valsartan in Impaired Glucose Tolerance Outcomes Research) Study. The other study was an extension of ACCORD (Action to Control Cardiovascular Risk in Diabetes) actually called ACCORD Lipid.
Here are the conclusions from all three studies:
“In conclusion, we found that combination therapy with the use of fenofibrate and simvastatin (at a daily dose of 40 mg or less) did not reduce rates of cardiovascular disease, as compared with simvastatin alone. Our findings do not support the use of combination fibrate–statin therapy, rather than statin therapy alone, to reduce cardiovascular risk in the majority of patients with type 2 diabetes who are at high risk for cardiovascular disease. In conclusion, we found that combination therapy with the use of fenofibrate and simvastatin (at a daily dose of 40 mg or less) did not reduce rates of cardiovascular disease, as compared with simvastatin alone. Our findings do not support the use of combination fibrate–statin therapy, rather than statin therapy alone, to reduce cardiovascular risk in the majority of patients with type 2 diabetes who are at high risk for cardiovascular disease.”
“The results of the NAVIGATOR trial show that among persons with impaired glucose tolerance and cardiovascular disease or cardiovascular risk factors, assignment to nateglinide, at a dose of 60 mg three times daily, as compared with placebo, in addition to a lifestyle modification program, did not reduce the incidence of diabetes or cardiovascular outcomes.”
“In conclusion, when added to a lifestyle intervention, valsartan at a daily dose of 160 mg reduced the risk of diabetes but did not affect cardiovascular outcomes in patients with impaired glucose tolerance. No safety concerns were identified.”
At first glance it may seem a bit crazy to state that studies that show a drug or drug combination that does not work as anticipated is good news, but the truth is this is actually very good news. It’s just as important to know what doesn’t work as it is to know what does work. This is particularly important for patients with diabetes who besides taking multiple medications to control their diabetes are also taking even more medications to control other conditions. It is not an exaggeration to state that a diabetes patient can take upwards of 4 to 6 pills PER DAY, and that does not include the growing number of patients who also inject insulin once or more times each day.
Open the medicine cabinet of a patient with diabetes and you’ll likely to find not just their diabetes medications but a host of pills for cholesterol, high blood pressure, hypertension and a few other sorted maladies. Is it any wonder that therapy non-compliance is a major factor as to why the majority of patients are not properly controlling their diabetes? With so many pills to take it’s a wonder these patients have any time left in their day to perform such mundane tasks as working, eating or exercising.
For once it’s nice to see a series of studies that actually tell a physician it’s ok NOT to add another medication to the patient’s plethora of existing medications. While the results of these studies we’re probably not what everyone hoped for, they actually could have a greater impact than the many studies that only add to the confusion as to what drugs should or should not be used. The reality of the situation is that it’s just as important to know what NOT to do. This may not seem like progress but given the way things have been going Diabetic Investor applauds these authors for bring some clarity into the murky waters of diabetes and how it should be treated.