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BLOG: March 2010

 Diabetes vs. drugs, 3:0

If there were any doubts about the final score of the government's decade long "landmark study" aspiring to defeat diabetes by throwing best of drugs - and lots of them - at it, there's none left. Last month, the remaining two pieces fell in, and the quick summary is: can't do it.

Of course, we are talking about the ACCORD study, which attempted to fight diabetes at all three major fronts at once: by lowering blood glucose, pressure and cholesterol in diabetes II patients at high risk for heart attacks and strokes, by subjecting them to

super-high doses of multiple prescription drugs.

The study started accepting participants back in 2001. By 2008, when sufficient data accumulated, the intense arm of the study - the core of the whole experiment - was cancelled due to significantly higher death rates in treatment groups - particularly the all-intense (i.e. for blood sugar, cholesterol and pressure treatment) groups - vs. placebo. This is covered in more details by HealthKnot ACCORD articles at the time.

Participants from the cancelled arm - half of the total - were merged with the standard treatment arm, till study's planned ending. The final results were published in March 14th New England Journal of Medicine.

The Combination Lipid Therapy arm of the study (Ginsburg et al), which used combination of statin (simvastatin, sold as Lipitor and Zocor) and fibrate (fenofibrate TriCor)for the treatment group, vs. statin alone in the control group, had average follow-up of 4.7 years per participant. The rate of "primary outcome" - fatal and non-fatal heart attack or stroke - was nearly identical in the two groups (annual rate 2.2% vs. 2.4%, respectively), and so was the "death of all causes" rate (1.5% vs. 1.6%).

Gender-wise, study results indicate that the treatment may have possible beneficial effect for men, but harmful for women.

In all, the authors conclude that the combined statin/fibrate therapy for reducing cardiovascular risk in diabetes II patients does not seem to be a viable alternative for routine use.

The other half of the crippled study had the goal of establishing if lowering systolic blood pressure with (unspecified) medications below 120 mm Hg will be beneficial in lowering cardiovascular risk in diabetes II patients vs. standard therapy, targeting systolic pressure below 140 mm Hg. The results, for the same outcomes, were 1.87% vs. 2.09%, and 1.19% vs. 1.07% (annual rates) for the overall death rate with intense vs. standard treatment, respectively.

The conclusion: driving systolic blood pressure below 120 mm Hg with intense drug treatment did not reduce the rate of heart attacks and strokes compared to lowering it below 140 mm Hg with the standard drug treatment.

But it sure has caused more adverse effects. The rate of serious adverse effects "attributed to antihypertensive treatment" was

more than two and a half times higher
in the intense treatment group.

Unexpected? Not really; where the expectations failed was treatment benefit. Has it played out as planned, the whole package would have been wrapped up in the old, proven-to-work cliché of "benefits outweighing the risk" and sold to the public.

The real question is, why not a single alternative non-drug treatment for diabetes was included in the study? We can understand that drug companies don't do it in their studies; why should a business promote its deadly competition? But why not the government? What makes medicating diabetes more of a priority to the government than striking at its very causes and promoting a number of proven, safe drug-free alternatives, both preventive and therapeutic?

Of course, we all know that the National Cancer Institute, formally sponsoring the study, is far from being independent of the pharmaceutical industry and its influence. It is easy for a big game to find ways to protect and promote its interests. The question is, who represents the rabbits?