cholesterol,

Merck avoids a ‘torcetrapib’ moment

So far, at least. The drugmaker is reporting that its experimental cholesterol med, which is in the same class as Pfizer’s fabulous flop, had dramatic results in a small clinical trial, and didn’t exhibit the sort of safety problems that killed torcetrapib. Merck’s CETP inhibotor raised HDL by 139 percent and cut LDL levels by 40 percent during an 8-week trial, in 589 patients, according to data presented at the Drugs Affecting Lipid Metabolism meeting in New York. By contrast, the current best-selling drugs to boost HDL - whose active ingredient is niacin - typically raise good cholesterol by only 20 to 30 percent, Reuters reminds us. Just as significant, the Merck drug - code-named MK-859 - didn’t cause a rise in blood pressure, which was a big issue with Pfizer’s torcetrapib and may have caused an increased number of deaths that ultimately ended further development. “As hard as we looked, we couldn’t find any increase in blood pressure,” Daniel Bloomfield, a senior Merck research told Reuters. “The data really point out you can inhibit CETP with MK-859, and substantially reduce LDL and increase HDL, and importantly not raise blood pressure…The data suggest any does would be safe to go forward with.” Four doses - 10 mg, 40 mg, 150 mg and 300 mg, were tested against placebo. The incidence of side effects among patients taking the Merck drug, at whatever dose, was similar to those seen among patients given placebos. But Bloomfield cautioned that the safety won’t really be known until the drug goes through much larger studies, which typically take 4 to 7 years and focus on the risk of heart attacks and death. And despite the effects on LDL and HDL cholesterol, he believes the FDA is unlikely to approve MK-859 until such studies are completed. (more…) Share / E-mail (Source: Pharmalot)

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