New data on metabolic & cardiovascular safety and efficacy

Worldwide, the incidence of obesity is increasing dramatically having almost tripled in the last 40 years [1]. In 2016, 39% of adults aged 18 years and older were overweight - 13% were obese. Because obesity is associated with an array of metabolic pathologies, including cardiovascular disease, type 2 diabetes, musculoskeletal disorders, and even some cancers, identifying effective strategies for sustained weight loss are imperative.

A substantial amount of studies in the last decade have determined the detrimental effects of overweight and obesity on the risk of myocardial infarction, stroke, cancer, and overall mortality. Nonetheless, there is also evidence in favour of the so-called “obesity-paradox” which states that overweight - or even obesity - exerts a protective role or has no impact on the incidence of cardiovascular disease (CVD) and overall mortality, because of increased cardiovascular mortality in the lowest BMI strata (J-curve).

In March 2018, a study was published by researchers from the University of Glasgow, challenging the obesity-paradox and heating up the debate of this much-discussed topic [1].

Glucagon-like peptide receptor (GLP-1R) agonists are an established treatment option for type 2 diabetes. In addition to their blood glucose lowering effect (with a low risk of hypoglycaemia) they also promote weight loss. With the approval of liraglutide 3.0 mg/wk last year, a GLP-1R agonist is now also available for the treatment of obesity.

SUSTAIN 7 was an open-label, parallel-group, phase 3b trial at 194 sites in 16 countries investigating GLP-1R agonists semaglutide and dulaglutide [1]. Participants were 18 years and older and had type 2 diabetes with an HbA_1c of 7.0-10.5% on metformin therapy (n=1201). Patients were assigned to either semaglutide 0.5 mg, dulaglutide 0.75 mg, semaglutide 1.0 mg or dulaglutide 1.5 mg. The study medication was injected once weekly for 40 weeks. Primary endpoint was change from baseline in HbA1c; the confirmatory secondary endpoint was change in bodyweight, both after 40 weeks of treatment. 

Moving to Amsterdam

EMA is moving on in its relocation to Amsterdam; since the  5^th of March a new tool gives transparent overview of main milestones and work stream deliverables.

Moving to Amsterdam is planned before 29^th of March 2019; however the relocation has to be done in two steps: for 15^th of November 2019 a completely new, tailor-made building has been outlined by the Dutch Authorities in the Zuidas business district. The interim period (April to mid November 2019) will be covered by temporary premises in the Sloterdijk area of Amsterdam.

Is alternate-day fasting regimes the new trend?

Alternate-day fasting regimens have gained particular popularity in the last decade. The strategy of alternate-day fasting is to implement a fasting day, where individuals consume only 25% of their calories (approximately 500 kcal). The fasting day alternates with a “feast” day (every other day) where foods and liquids can be consumed ad libitum.

The idea behind is to eat the way our ancestors did – who had a life expectancy of 35 years without obesity and heart attacks – and the hope to lose weight with a diet which is said to be easier to stick to than traditional, everyday calorie restriction diets.