In her editorial, Ingelfinger also pointed out that olmesartan was approved by the FDA in 2002 for treating high blood pressure, so it's likely that if the drug were responsible for an increased cardiovascular risk, such a risk would be evident by now.
The latest research came from a randomized, double-blind controlled trial called Roadmap, which was sponsored by the drug's maker, Daiichi Sankyo. It included 4,447 people with type 2 diabetes at 262 centers in 19 European countries. The study volunteers were between the ages of 18 and 75, with an average age of 58 years. Forty six percent were male. Just under 25 percent had a history of heart disease. On average, the volunteers had been diagnosed with type 2 diabetes for six years, and had slightly elevated systolic (the top number) blood pressure levels.
Half the group was randomly assigned to receive 40 milligrams of olmesartan once a day, or a daily placebo pill for an average of 3.2 years.
Target blood pressure levels (less than 130/80 mm Hg) were achieved in nearly 80 percent of those on olmesartan, and 71 percent of those on placebo. Microalbuminuria developed in 8.2 percent of those on olmesartan and 9.8 percent in the placebo group.
The time to onset of microalbuminuria was extended for people taking olmesartan by 23 percent compared to those on placebo.
Nonfatal heart problems occurred in 81 of the people taking olmesartan versus 91 of those on placebo. However, fatal cardiovascular events were more common in people taking olmesartan compared to those on placebo: 15 to 3.
"The small number of events in a large study can be a statistical fluke," explained Dr. Joel Zonszein, director of the clinical diabetes center at the Montefiore Medical Center in New York City. Or, he said, in providing medication to those who already h
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