Lilly, Boehringer diabetes drug cuts heart attack, stroke risk in trial

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[August 21, 2015] By Ransdell Pierson

(Reuters) - A new diabetes pill from Eli Lilly and Co and Boehringer Ingelheim cut risk of heart attack, stroke and death in a closely watched study, the first glucose-lowering drug to show such protective results in a large cardiovascular trial, the drugmakers said on Thursday.

Besides burnishing the image of the year-old drug, Jardiance, the results could raise the profile of rival new drugs in the same class of medicines called SGLT2 inhibitors, such as Johnson & Johnson's Invokana and AstraZeneca Plc's Farxiga.

Lilly shares rose 2.8 percent in morning trading, amid a decline of 0.7 percent for the Arca Pharmaceutical Index of large drugmakers.

Jardiance (empagliflozin) was approved by U.S. regulators last August. By blocking the protein SGLT2, it inhibits reabsorption of glucose in the kidney, thereby lowering overall blood sugar.

Lilly and privately held German drugmaker Boehringer said the favorable results for Jardiance were seen in a 7,000-patient study of patients with type 2 diabetes considered at high risk of heart attacks and stroke. That is the most common form of diabetes, which is closely linked to obesity.

Significantly fewer cardiac deaths, non-fatal heart attacks or non-fatal strokes were seen in patients who took Jaridance in combination with standard treatments, compared with patients who took standard treatments alone, meeting the trial's primary goal.

Standard treatments included statins and blood pressure drugs. Patients were followed an average of 3.1 years.

Lilly and Boehringer said about half of deaths in people with type 2 diabetes are caused by cardiovascular disease, and that reducing cardiovascular risk is therefore an essential component of diabetes care.

"This is a positive, and a first for the field of diabetes," Sanford Bernstein analyst Tim Anderson said in a research note. "(This) could give the drug - and the broader SGLT2 class in which it competes - a competitive leg up."

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Anderson noted that besides lowering blood sugar levels, SGLT2 inhibitors also modestly lower body weight and blood pressure, and that those effects could have helped Jardiance in the cardiovascular "outcomes" trial.

The drugmakers said they plan to release full results of the trial on Sept. 17 at the annual meeting of the European Association for the Study of Diabetes in Stockholm.

Safety of Jardiance was consistent with results of previous trials. Its side effects have included dehydration, dizziness and low brood sugar.

(Reporting by Ransdell Pierson Editing by W Simon)

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