On the 26 August 2018, the New England Journal of Medicine (NEJM) published the results of a study that confirmed the, “Cardiovascular safety of Locarserin in overweight or obese patients.” Although a genuine scientific study, many international press organisations grasped at it and headlines talking of a “miracle pill” were common.

Obesity is a complex and multi-faceted problem and at Delano we were concerned. Is offering a so-called miracle actually helpful to anyone suffering from obesity? Might it even be counter-productive? In the first of two articles on this subject, we talked to the Luxembourg’s National Health Directorate to find out if it has any intentions of offering such a medication in Luxembourg. 

Margaret Ferns: Is the Luxembourg health ministry aware of the NEJM study?

Health Directorate: The New England Journal of Medicine (NEJM) published the results of a large clinical trial including more than 12,000 patients and showing that Locarserin, a drug known to favour weight loss, has no significant cardiovascular side effects. This is important information, as obese patients are prone to cardiovascular diseases, and any drug to be used in this group of patients must therefore demonstrate that it does not increase the risk of serious heart disease. 

MF: The press around the world have grasped at this report, some of them talking of a new miracle drug for obese patients. What is your view on this?

HD: Locarserin is most certainly not a miracle drug. In the NEJM study, the average weight loss after one year of treatment was a modest 4.2 kg, compared to a loss of 1.4 kg in the control group (where patients received a placebo and not the active medication). Therefore, the net loss was only 2.8 kg, not really the miracle many people dream of.

However, the Federal Drug Agency (FDA) in the US approved Locarserin for the treatment of obesity in 2012. In Europe, the European Medicines Agency (EMA) evaluated Locarserin in 2013 for possible market authorisation and expressed concerns that the rather modest weight loss seen in the studies was offset by several potential safety issues, such as the long term risk of tumours, psychiatric side effects (depression) and the risk of valvulopathies (problems with the valves of the heart). The current study brings some reassuring information, at least for the last item (heart valves). In 2013, the EMA requested more information on safety from the producing pharmaceutical company. Instead of replying to that request, the company preferred to withdraw its application for market authorisation in May 2013.  Therefore, Locarserin is not commercially available--at least not legally--in the European Union. 

MF: Is Luxembourg currently looking into this medication for use with obese patients here?

HD: No, as explained, the authorisation process in Europe is centralised at the EMA, but the process has been on hold since 2013. Based on the safety data from the NEJM, the pharmaceutical company would of course have the option to re-introduce a new request for authorisation but has not done so far.

MF: In general, what support is available for obese and overweight patients in Luxembourg?

MD: In terms of medical care, dietary advice from a doctor or dietician is recommended for weight loss. In addition to medical or dietary consultations, some hospitals also offer comprehensive care in "obesity clinics". Bariatric surgery (obesity surgery) is a last-resort medical option for long-term obesity.

The department of health also promotes preventative measures and organises activities to inform the general public and educate them on the importance of healthy eating and regular physical activity.

These activities form part of the inter-ministerial programme called "Gesond iessen, Mei bewegen" (eat well, move more), developed by the ministries of health, sports, national education, youth and childhood and family. The main objective is to combat the growing problem of obesity and sedentary lifestyles in the general population, and especially among children and adolescents.

Delano would like to thank the National Health Directorate for its help in preparing this article: Olivier Moes, pharmacist; Anne Marx, master in public health and Dr Bechara Ziadé, physician.