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A widely anticipated study found that Novo Nordisk’s top-selling diabetes drug Victoza lowered the risk of a heart attack, stroke and death by 13 percent. The results, which were released Monday at the American Diabetes Association annual meeting, mark only the second time that a diabetes drug has demonstrated such a benefit.

The study, which involved 9,340 adults with type 2 diabetes and a high risk of a cardiovascular disease, also showed that participants given Victoza had a 22 percent lower chance of cardiovascular death. This was statistically significant. As an added bonus, those given Victoza lost about 5 pounds more than those who were on a placebo.

Despite the promising results, reactions have been mixed. In fact, Novo Nordisk stock fell in response.

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To be sure, the outcome is encouraging. But the Novo findings were similar to the 14 percent risk reduction reported last year for Jardiance, a different type of diabetes drug that is jointly marketed by Eli Lilly and Boehringer Ingelheim. Victoza, which is an injectable medication, by the way, belongs to a class of drugs known as GLP-1, while Jardiance is in the SGLT-2 class.

Several months ago, when Novo telegraphed the results, the company described the lowered cardiovascular risk as “significant,” and Wall Street took that to mean the results would be stronger. Consequently, investors are now less enthusiastic about the extent to which the Novo medicine will change the treatment paradigm. One analyst believes it’s too soon.

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“The argument for broader use is simple. Diabetics have elevated risk for cardiovascular disease, and, given GLP1s … address this risk, it should be used in all diabetic patients,” even those who can control diabetes with other meds, wrote Sanford Bernstein analyst Ronny Gal. “The pushback is that there is lack of evidence to make this case convincing and the data actually did not contribute much to the case.”

But one physician expressed some optimism.

“I tried to find something wrong with the trial — something to temper the positive results — but I could not, other than the cost of treatment and the potentially higher rate of pancreatic cancer,” said Dr. Walid Gellad, an associate professor of medicine and cohead of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh. “In those with high cardiovascular risk, a strong case can be made that one of these two drugs should be used.”

A key test will now be whether other clinical trials will demonstrate that there is a so-called class effect at work. In other words, Victoza may not be the only GLP-1 drug that lowers cardiovascular risks, and perhaps the same is true that Jardiance is not the only SGLT-2 that does the same thing.

“Most physicians believe all SGLT-2s will produce cardiovascular benefits and, therefore, there is no reason to change prescribing patterns,” wrote David Kliff of Diabetic Investor in a note to clients. “Should this same belief take hold in the crowded GLP-1 category, Victoza could run into the same problem as Jardiance — great data but no jump in (market) share.”

  • Based on the fact that LEADER was a large prospective placebo controlled with positive end points for primary prevention of adverse CV events, Novo should be in the process of filing a supplemental NDA for a new indication. They will then be the first to secure the claim for primary prevention, and as the marketing folks remind us claims are everything. The fact that efficacy was proven in a non-inferiority trial, where the statistical burden is higher makes the statistical differences more compelling, even if not numerically large.

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