Com­mon drugs for di­a­betes ap­pear safe for the heart: stud­ies


Some widely used di­a­betes medicines help con­trol blood sugar with­out the heart risks sug­gested by ear­lier re­search, new stud­ies find.

Although re­as­sur­ing on safety, the re­sults dis­ap­pointed some doc­tors who had hoped the drugs would do bet­ter and help pre­vent heart prob­lems, the top cause of death for peo­ple with di­a­betes.

The medicines are called GLP-1 drugs. At least seven brands are sold in the U.S. and more in Europe, in­clud­ing Merck’s block­buster Janu­via and As­traZeneca’s Byetta and By­dureon.

The new stud­ies were dis­cussed Mon­day at an Amer­i­can Di­a­betes As­so­ci­a­tion con­fer­ence in Bos­ton, and one on Janu­via was pub­lished on­line by the New Eng­land Jour­nal of Medicine.

More than 25 mil­lion Amer­i­cans and 33 mil­lion peo­ple in Europe have Type 2 di­a­betes, which im­pairs pro­duc­tion or use of in­sulin to break down food into en­ergy. That causes blood sugar to rise, which can lead to prob­lems not just with the heart, but also eyes, blood ves­sels, kid­neys and many other things.

GLP-1 drugs help spur in­sulin pro­duc­tion af­ter meals and are of­ten pre­scribed for peo­ple who can’t con­trol their blood sugar well with first-step medicines and good diet and weight con­trol.

Sev­eral years ago, stud­ies hinted that GLP-1 drugs might raise the risk of heart fail­ure, and the new stud­ies were aimed at look­ing broadly at heart risks.

In one, more than 14,600 pa­tients were given Janu­via or dummy pills to add to their other di­a­betes medicines. Af­ter about three years, roughly 11 per­cent of both groups had suf­fered a heart attack, stroke or heart-re­lated death. Heart fail­ure hos­pi­tal­iza­tion rates also were sim­i­lar.

The study “very defini­tively” shows Janu­via is safe, said one study leader, Dr. Eric Peter­son, direc­tor of the Duke Clin­i­cal Re­search In­sti­tute. He has con­sulted for drug com­pa­nies in­clud­ing Merck, the study’s spon­sor.

The sec­ond study tested Sanofi’s lixise­n­atide, sold as Lyx­u­mia in Europe. The com­pany sought ap­proval to sell the drug in the U.S. sev­eral years ago, then de­layed the process un­til the heart safety study was fin­ished, and now plans to restart it later this year.

The study in­volved 6,000 pa­tients who had suf­fered a heart prob­lem in the pre­vi­ous six months — a higher risk group than in the Merck study. Af­ter about two years, rates of heart prob­lems were sim­i­lar for those on the drug ver­sus a placebo, about 13 per­cent of each group.

Di­a­betes spe­cial­ists are happy the drug proved a safe way to help con­trol blood sugar, but “I’m kind of dis­ap­pointed” the re­sults were not bet­ter for hearts, said that study’s leader, Dr. Marc Pf­ef­fer of Brigham and Women’s Hos­pi­tal in Bos­ton.

“We were look­ing to prove safety but we were hop­ing for ef­fec­tive­ness,” he said.

Pf­ef­fer’s study was funded by Sanofi, and Pf­ef­fer has con­sulted for sev­eral di­a­betes drug mak­ers. The re­sults of this study have not been pub­lished yet, so they are con­sid­ered pre­lim­i­nary.

“It is dis­ap­point­ing that th­ese drugs do not ap­pear to have a car­dio­vas­cu­lar ben­e­fit,” said one in­de­pen­dent ex­pert, Dr. Steven Nis­sen, heart chief at the Cleve­land Clinic. The drugs cost US$5 a day or more, he said.

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