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 Patients with type 2 diabetics and either heart disease or at high
risk for heart problems who received the drug semaglutide in pill
form had a combined rate of heart attack, stroke or heart-related
death of 3.8% compared with 4.8% for placebo, successfully
demonstrating non-inferiority.
Death from any cause occurred in 1.4% of semaglutide patients and
2.8% for placebo, according to data from the 3,183-patient trial
presented at the American Diabetes Association meeting in San
Francisco and published online by the New England Journal of
Medicine.
While the drug led to a lower rate of death and other heart
problems, the trial was not designed to show statistically
significant superiority, only that semaglutide was as safe as, or
non-inferior to, placebo. Similar drugs have also shown an ability
to cut the risk of cardiovascular problems.
"The drug is safe," Dr. Mansoor Husain, director of the Toronto
General Hospital Research Institute who led the study, told Reuters
Health in a phone interview.
"This is the first orally-available GLP-1 (glucagon-like peptide-1)
receptor agonist and that's a pretty big deal," Husain said, noting
the fear many patients have for injections. "Just being able to take
a pill every day makes it much more accessible."
Semaglutide, which stimulates insulin production, is seen as an
important growth driver for Novo Nordisk, which funded the study
known as Pioneer 6.
The Danish drugmaker already sells an injectable once-weekly version
of the drug under the brand name Ozempic at a cost of about $800 per
month, according to the website goodrx.com. The oral version is a
once-a-day tablet.
Novo filed for U.S. approval for oral semaglutide in March. It is
seeking priority review in hopes of getting approval within six
months.
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All trial participants were at high risk of cardiovascular problems
because they were at least 50 years old with established heart
disease or chronic kidney disease, or at least age 60 with
cardiovascular risk factors. They were followed for a median of 15.9
months. The trial was designed to end after a combination of at
least 122 heart attacks, strokes and deaths had accrued.
Individual cardiovascular events in the composite also showed no
significant differences.
The rate of non-fatal heart attack was 2.3% with semaglutide versus
1.9% with placebo, while the rate of non-fatal stroke was 0.8% with
the drug and 1.0% for placebo. The odds of death from any
cardiovascular cause were 0.9% in the semaglutide group and 1.9% in
the placebo group.
"We did see a 50% reduction in cardiovascular death and all-cause
mortality, but these were secondary endpoints," Husain said. The
main goal of the study "was just to demonstrate safety," he said.
He cautioned people should not to read too much into the apparent
reduction in the death risk. "We urge caution because they're small
numbers and it's a relatively short-duration study."
The rate of patients dropping out of the trial was higher for those
who received semaglutide - 11.6% compared with 6.5% for placebo -
with gastrointestinal problems such as nausea and vomiting being the
driving force. Those are common side effects for the GLP-1 class of
diabetes medicines.
(The story corrects paragraph eight to show Ozempic costs about $800
per month, not per week.)
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