New Delhi: Blockbuster diabetes drug semaglutide, frequently prescribed for weight loss in the United States, can significantly lower the risk of cardiovascular events and related deaths, a new trial has found.
In a statement issued last week, Danish drugmaker Novo Nordisk — which manufactures and distributes various versions of semaglutide — declared that results from its ‘SELECT’ cardiovascular outcomes trial have shown that a 2.4 mg dose of the drug can reduce major heart-related events by up to 20 percent.
The company told ThePrint via email that it has only announced its main findings for now. “The full study will be published in a peer-reviewed journal before year-end,” it said.
In the US, 2.4 mg strength of semaglutide — a weekly injection — is sold by Novo Nordisk under the brand name Wegovy and is prescribed for obesity and weight loss even to people without diabetes.
The drug is prescribed in a lower dose to treat diabetes.
Semaglutide belongs to a class of medicine that works by attaching itself to receptors of gut hormones and leads to delayed gastric emptying — the slowing or stopping of the movement of food from the stomach to the small intestine. The drug has shown to cause improved insulin secretion while reducing appetite — a key reason why it is prescribed for obesity.
Although not available in India, semaglutide in the injectible form can be imported and costs between Rs 12,000 and 20,000 a month.
In India, a version of the drug is marketed under the brand name Rybelsus. This is, however, a lower dosage and is available in the form of pills.
Buoyed by its new findings, Novo Nordisk has said it now expects to file for regulatory approvals of a indication expansion for Wegovy — that is, expanding the drug’s use in applications other than the one it was originally intended for — in the US and the European Union this year.
A controversy broke out over the use of semaglutide just last month. In its report on 25 July, CNN quoted some women in the US as claiming to have developed gastroparesis or stomach paralysis — a disorder that affects the normal movement of the stomach muscles — after having used the drug for diabetes and weight loss for several years.
According to doctors ThePrint spoke to, the Novo Nordisk trial shows promise for a country like India, which has a high burden of cardiovascular diseases. A study conducted by researchers associated with the Madras Diabetes Research Foundation and the Indian Council of Medical Research (ICMR), published in The Lancet this year, showed that a whopping 35.5 percent Indians have hypertension and 24 percent suffer from hypercholesterolaemia — a condition in which fat collects in arteries and puts individuals at greater risk of heart attack and stroke.
‘Encouraging results’
According to the Novo Nordisk press statement, “SELECT was a randomised, double-blind, parallel-group, placebo-controlled trial designed to evaluate the efficacy of semaglutide 2.4 mg versus placebo” among people who were overweight or obese and had established cardiovascular disease with no prior history of diabetes.
The trial had enrolled 17,604 such adults aged 45 years or older. The patients were assessed for a period of five years, beginning 2018, the statement said.
“People living with obesity have an increased risk of cardiovascular disease but to date, there are no approved weight management medications proven to deliver effective weight management while also reducing the risk of heart attack, stroke or cardiovascular death,” the statement quoting Martin Holst Lange, executive vice-president for development at Novo Nordisk, read, calling it a “landmark” trial.
Diabetologists and medical experts in India say this is encouraging, although some have advised caution. Doctors told ThePrint that nausea, bloating, vomiting and diarrhoea are known side-effects of semaglutide, but added they had not yet seen stomach paralysis like the cases reported by CNN.
“Semaglutide, a runaway success, is an established powerful agent for controlling diabetes and obesity (in higher strength) and has been a runaway success,” Dr V. Mohan, a diabetologist from Chennai, told ThePrint. Dr Mohan is one of the founders of Madras Diabetes Research Foundation, which conducted the study published in The Lancet last month.
The additional benefit of reducing cardiovascular disease (CVD) risk is welcome “but not entirely unexpected since the drug limits insulin resistance and controls obesity”, Dr Mohan added. “The fact that this is now being proven in a randomised clinical trial that is well-powered adds to the growing body of evidence supporting the use of once-weekly Semaglutide.”
A “well-powered” study is a well-designed study with robust intervention and control arms and strong results.
According to Dr Mohan, the additional benefit of reducing CVD risk would make the drug “highly advantageous to Indians who are more prone to these diseases”, adding that the drug is eagerly awaited here.
However, Dr Ashish Govil, a senior consultant in the department of interventional cardiology at Noida’s Jaypee Hospital, was more cautious about the trial results, saying that the drug should be used strictly under a physician’s supervision.
“It’s worth noting that while semaglutide shows promise, it’s not a one-size-fits-all solution,” he said.
(Edited by Uttara Ramaswamy)
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