Monday, February 13, 2012

Despite the hype, some new drugs aren’t effective for patients - Healthy Living

Despite the hype, some new drugs aren’t effective for patients - Healthy Living:

For years, I frustrated the Tekturna representative who came to my office. I refused to write even one prescription. Our conversations each week were identical. I would argue that there are generic high blood pressure medicines that are cheaper and just as effective, but much more importantly, I would argue that Tekturna did not have any proof that it was truly beneficial.

To this claim, the representative was astounded that I did not agree with the glossy graphs that showed how much blood pressures were lowered for people on the drug. For me and my patients, though, lowering blood pressure is not nearly enough; we need to know that the drug protects against the problems, such as strokes, that are linked to high blood pressure.

Despite showing that Tekturna lowered blood pressures, no research trial ever documented that it reduces the risk of heart disease, stroke and death.

We treat high blood pressure to reduce the risk for heart attacks and strokes. Period. Lowering the numbers we see on the blood pressure cuff is nice, but stopping a stroke is what counts.

Dozens of generic blood pressure medicines reduce the risk of stroke, heart attack and death, but Tekturna had no such research evidence.

A FULLER PICTURE

In the past, there have been many instances of drugs that move numbers (like blood pressure), but that can worsen clinical outcomes. Alpha-blockers, for example, were shown decades ago to cause increased numbers of deaths in heart failure patients despite powerfully lowering blood pressures.

Last month, a clinical trial of Tekturna (the ALTITUDE trial) was stopped before it was completed. In trying to measure if Tekturna reduced the risk for heart attack and stroke, researchers discovered that Tekturna significantly increased the risk of stroke, kidney complications and problems with blood potassium levels.

The drug actually caused patients harm in comparison with generic alternatives, so the manufacturer recently stopped marketing it.


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