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Diabetes 2 drugs

Posted by medconsumers on March 22, 2010

Whenever I read that a common medical practice has just been proven to be either useless or outright dangerous, I always wonder how the prescribing physicians inform their patients. Do they call each one immediately? Or do they just wait until the patient comes in for a follow-up visit? I got to ponder these questions all over again recently when I read about two new studies that explored aggressive drug treatment of people with diabetes 2. Both studies took off from the fact that such people are at high risk for heart attack, stroke, and premature death. Both tested the common medical assumption that extreme reductions in heart-related risk factors—high blood pressure and high cholesterol—would result in equivalent reductions in heart attack, stroke, etc. Both studies showed that using drugs to make extreme reductions in blood pressure and cholesterol provided zero benefit to people with diabetes 2. And in the case of blood pressure reduction, the result was a higher incidence of serious harm.

Both studies were published recently in the online version of The New England Journal of Medicine (See Lipid-lowering study and the blood pressure lowering study.) In the one that looked at blood pressure reduction, all participants had diabetes 2, but only 34% also had heart disease. Half of the 4,733 study participants were randomly assigned to bring their systolic blood pressure to 120 mm Hg or below; and the rest aimed for 140 mm Hg or below. No new drugs were under review in this study. All the participants were taking the standard range of anti-hypertension drugs that have been in use for years. After nearly five years of follow-up, there was no difference between the two groups in the number of heart attacks, deaths, or strokes. The more intensive reduction in blood pressure, however, came with more serious adverse events (SAEs), including death and disability (3% vs. 1%). The greater proportion of SAEs in the aggressively treated group was attributed to the fact that they were taking one or two more anti-hypertension drugs than the other participants. Known risks of drug-induced extreme reductions in blood pressure include dangerously low blood pressure and heart rate.

The second study involved the extreme reduction of two fatty acids in the blood—triglycerides LDL cholesterol. It, too, found no benefit to such extreme measures, but at least this treatment did not kill more study participants than the less-aggressive reductions…at least in the 4 ½ years it lasted. In this study, half the participants took the cholesterol-lowering statin drug called simvastatin (brand name: Zocor) and the rest took a two-drug combination: simvastatin plus a fibrate drug (brand name: TriCor).

Both studies are part of a landmark study called the Accord, which explored three aggressive treatments for diabetes 2 and came up empty. Sponsored by the U.S. National Heart, Lung, and Blood Institute, Accord made headlines two years ago when the first of its studies had to be stopped ahead of schedule because there were more deaths among the participants given drugs to reduce their blood sugar (glucose) levels well below normal levels.

The same online issue of the New England Journal of Medicine featured two additional studies from The Navigator Study Group. Both used drug therapy to prevent people with impaired glucose tolerance from developing diabetes 2. Both overturned the medical wisdom that people with rapid increases in blood sugar following a meal were headed for heart disease. The 9,300 people in this study either had heart disease and impaired glucose tolerance or were at very high risk for heart disease. At five years, a drug (nateglinide, brand name: Starlix) that increases insulin secretion tested in this trial proved to be no better than a placebo in reducing the chance of developing diabetes 2 or heart problems. And lastly, the other trial from The Navigator Study Group tested the anti-hypertensive drug (valsartan, brand name: Diovan) in a similar group of patients and produced nearly similar disappointing results at five years. The Navigator Study Group is supported by Novartis Pharma, maker of both drugs in these two studies.

For more information

●This article was about drug therapy for extreme reductions in blood sugar levels. To learn more about drugs for less aggressive reductions, read “Diabetes drugs–risks without benefits.”

●If you want to know more about the three Accord studies, click here.

●The Accord results indicate that lowering systolic blood pressure below 135 does not benefit people with diabetes 2. Hypertension expert, Jim Wright, MD, found that studies have failed to prove that reducing blood pressure below 140/90 benefits anyone. See this 2009 interview with Dr. Wright: “No benefit to reducing blood pressure below 140/90.”

●Type 2 diabetes is largely due to lack of exercise and poor eating habits. The recommended exercise regimen need only be at least one half-hour of brisk walking five times a week. See “You can be fat and fit:” an interview with researcher Dr. Steve Blair. And to learn how to eat well and lower your risk of type 2 diabetes and other chronic conditions, read Michael Pollen’s new book entitled, Food Rules.

Maryann Napoli, Center for Medical Consumers(c)

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