Novo Nordisk A/S’s diabetes drug Victoza reduced the risk of heart attacks, strokes and deaths from cardiovascular causes by 13 percent, a significant benefit for the 1 million patients taking the medicine.
The study found that patients given Victoza injections were 22 percent less likely to die from heart disease and had a lower overall death rate from any cause than those who were given a placebo. Known as Leader, it tracked 9,340 patients for a mean of 3.8 years.
The study is the second to show a heart benefit from a medicine that’s used to lower blood sugar in diabetics -- a critical finding since heart disease is by far the group’s leading cause of death. While good news for patients, Novo’s data didn’t satisfy investors. The stock fell as much as 3.8 percent in Copenhagen trading, the biggest drop in more than two months.
The drugmaker announced in March, without giving details, that the study beat its initial goal by reducing the risk of heart attacks, strokes and deaths from cardiovascular disease among diabetics. Some analysts were expecting a benefit of 15 percent or more, beyond the 13 percent reduction in cardiovascular events seen in the study.
The “data were solid, but the 13 percent risk reduction was not enough to meet expectations,” Jeffrey Holford, an analyst at Jefferies in London wrote in a note to clients. “We believe that investors were looking for a mid- to high-teens percent reduction.”
Novo dropped 3.6 percent to 350 kroner at 9:14 a.m. in Copenhagen. The study was published in the New England Journal of Medicine and presented at the American Diabetes Association’s annual meeting in New Orleans on Monday.
Last year, Eli Lilly & Co. and Boehringer Ingelheim GmbH said their pill Jardiance reduced the risk of heart attacks, strokes and death from heart disease by 14 percent, with a 38 percent reduction in cardiovascular deaths.
The Novo study was originally conducted to rule out an increase in heart complications with the medicine, also known as liraglutide, which generated $2.68 billion for Bagsvaerd, Denmark-based Novo last year. The studies are required by U.S. regulators for all diabetes treatments after suggestions of risk were seen with GlaxoSmithKline Plc’s Avandia.
“Our results should give patients and providers comfort that liraglutide can safely improve outcomes beyond the core treatment of type 2 diabetes,” said lead author John Buse, from the University of North Carolina School of Medicine. “In addition, liraglutide reduced the risk of the most serious complications associated with type 2 diabetes, including the risk of death.”
One striking finding was the breadth and consistency of the benefit across different cardiac events, suggesting that the drug may modify the progression of heart disease, the researchers said. Other medicines across various treatment classes have a similar improvements in blood sugar control, without a related drop in heart disease risk, the researchers said, pointing specifically to a direct rival in the GLP-1 class, Sanofi’s lixisenatide.
More patients taking Victoza quit taking the medicine because of side effects, though rates of pancreatitis were numerically lower. Gallstones were more common in patients getting the injection. Cancers originating in the pancreas were also more slightly more common, though the difference wasn’t statistically significant and the study wasn’t designed to look at cancer risk, the researchers said.
Novo Chief Scientific Officer Mads Krogsgaard Thomsen said the company didn’t anticipate getting such a strong result. It was particularly striking how quickly the benefit appeared, he said. The findings should boost the number of patients taking Victoza and lead doctors to start prescribing it earlier, he said.
“It’s the profile of a true cardiovascular drug, by which I mean all the things you are looking at -- heart attack, stroke, death -- everything points to intervening in the process that leads to cardiovascular disease,” Thomsen said. “This is something that should be used as early as possible because then you can reap the benefits longer.”
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