Landmark trial reveals ‘holy grail’ diet pill that boosts weight loss without harming heart

The “holy grail” of weight-loss pills – one that has been shown to work effectively without raising the risk of heart problems – has been welcomed by experts who said it could provide a major boost for efforts to curb the global obesity epidemic.

Sold as Belviq in the US since 2013, lorcaserin is the first weight-loss medicine to successfully pass a long-term safety study now required by regulators to stay on the market.

Researchers hope that passing this milestone will encourage more widespread use and pave the way for approval in the UK.

“Patients and their doctors have been nervous about using drugs to treat obesity, and for good reason,” said study leader Dr Erin Bohula of Brigham and Women’s Hospital in Boston. “There’s a history of these drugs having serious complications.”

Taken twice a day, the drug is an appetite suppressant that works by stimulating brain chemicals to induce a feeling of fullness.

The US study saw 12,000 people who were either obese or overweight given the pills or a placebo – with those who took the drug shedding an average of 9lb (4kg) in 40 months, twice as much as those on dummy pills.

While Belviq did not raise heart risks, it did not seem to lower them either, as some had predicted it would.

The results were announced at a European Society of Cardiology meeting in Munich over the weekend and published by the New England Journal of Medicine. Belviq’s maker, Eisai Inc, sponsored the study and many of the researchers consult or work for the company.

“I think it is the thing everybody has been looking for,” said Tam Fry from the UK’s National Obesity Forum. “I think there will be several holy grails, but this is a holy grail and one that has been certainly at the back of the mind of a lot of specialists for a long time. But all of the other things apply – lifestyle change has got to be root and branch part of this.”

As it stands there are no appetite suppressants available on the NHS and experts say there is a need for treatments that plug the gap between lifestyle modification and surgery.

If the drug is approved by the UK’s National Institute of Health and Care Excellence (Nice) as it has been by the US Food and Drug Administration, it is likely to be widely prescribed.

Across the Atlantic Belviq costs between $220 and $290 (£155-£225) a month.

Several popular diet medicines have previously been withdrawn from sale after they were found to raise the risk for heart valve damage, suicidal thoughts or other problems, prompting the new requirement for heart safety studies.

Tests for heart valve damage were done on 3,270 participants, but no significant differences in rates were identified.

Suicidal thoughts or behaviour were reported in 21 people taking lorcaserin compared with 11 people given placebo, however those taking the weight-loss drug had a history of depression.

In a commentary released to accompany the publication of the new study, journal editors Drs Julie Inglefinger and Clifford Rosen said for the time being Belviq “may be best used on a cautious basis, according to the needs of individual patients”.

They said there were other treatments in the pipeline that could be alternatives to this new medication.

One drug used to treat diabetes, liraglutide, also needs to be tested for its cardiac safety using the new tests, but it too has been shown to cause weight loss.

Additional reporting by agencies