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9th March 2023
A technology appraisal guidance document from NICE has recommended the use of semaglutide for the management of overweight and obesity.
Obesity is a global health problem and the World Obesity Atlas 2023 report has estimated based on current trends, that overweight and obesity will affect over 4 billion people by 2035, reflecting an increase from 38% of the global population in 2020 to more than 50% in 2035. Semaglutide (brand name Wegovy) has a current marketing authorisation ‘as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of ≥30 kg/m2 (obesity), or ≥27 kg/m2 to <30 kg/m2 (overweight) in the presence of at least one weight-related comorbidity.’
In its guidance, NICE has recommended use of the drug based on the licensed use, only if it is used ‘for a maximum of 2 years, and within a specialist weight management service providing multidisciplinary management of overweight or obesity.’ Adding that semaglutide should be stopped if an individual fails to achieve less than 5% of the initial weight after 6 months of treatment.
Semaglutide clinical efficacy
In an associated press release from NICE, it was stated that evidence for the effectiveness of the drug in weight loss was derived from the STEP 1 trial. This randomised, double-blind, placebo-controlled trial included nearly 2,000 adults with a body mass index (BMI) of 30 or more and individuals with a BMI of 27 but with ≥1 weight-related coexisting condition and who were not diabetic. Participants received once weekly semaglutide 2.4 mg or placebo. After 68 weeks of treatment, participants receiving semaglutide saw 14.9% mean decrease in their body weight compared to baseline compared to only 2.4% among placebo participants and this difference was statistically significant (p < 0.001).
In the press release, Helen Knight, Director of Medicines Evaluation at NICE, said that ‘it (semaglutide) won’t be available to everyone. Our committee has made specific recommendations to ensure it remains value for money for the taxpayer, and it can only be used for a maximum of two years.’
The release also cites data from a 2019 Health Survey for England, which estimated that 28% of adults in England were obese and a further 36% were overweight and that the government estimated that the current NHS costs of obesity in the UK were £6.1 billion and £27 billion to wider society.
28th September 2022
Semaglutide 2.4 mg given as a weekly subcutaneous injection to patients with obesity but without type 2 diabetes in combination with diet and exercise, led to a significant reduction in their 10-year risk of developing type 2 diabetes compared to placebo according to the findings of a study by US researchers presented at the 58th European Association for the Study of Diabetes (EASD) 2022.
Obesity is a major public health challenge and several lines of evidence from both observational and clinical studies over the past 30 years have clearly demonstrated a strong link between visceral and ectopic fat and the development of a clinical syndrome characterised by atherogenic dyslipidaemia, hyper-insulinaemia/glucose intolerance, hypertension, atherosclerosis and adverse cardiac remodelling and heart failure. Although diet and exercise are recommended as a first step to reduce obesity, some evidence shows that among obese individuals who have lost weight, multiple compensatory mechanisms encouraging weight gain, can persist for at least 12 months after weight loss. Semaglutide is a glucagon-like peptide-1 (GLP-1) analogue that is approved as an adjunct to diet and exercise in adults with insufficiently controlled type 2 diabetes mellitus. However, the STEP 1 trial showed that semaglutide at a dose of 2.4 mg weekly in combination with a lifestyle intervention could also result in sustained, clinically relevant reductions in body weight among patients with a body mass index (BMI) > 30. Moreover, in a further trial (STEP 4), researchers examined the effect of continuing vs withdrawing treatment with semaglutide on weight loss maintenance and showed that after a 20-week run-in period, maintaining treatment with semaglutide 2.4 mg once weekly, compared with switching to placebo resulted in continued weight loss over the following 48 weeks.
With clear evidence that semaglutide could lead to weight loss, whether this also reduced an individual’s risk of developing type 2 diabetes was unclear and was the objective of the study presented at the EASD meeting. Researchers used data from both STEP 1 and 4, to assess an individual’s 10-year risk of developing type 2 diabetes. The team used the cardiometabolic disease staging tool which uses three unmodifiable factors (age, sex, and race) and five modifiable factors (BMI, blood pressure, glucose level, high-density lipoprotein (HDL) cholesterol, and triglycerides) to predict an individual’s percentage risk of developing the disease over the next 10 years.
Semaglutide and 10-year diabetes risk
For the STEP 1 trial, the 10-year risk scores of developing T2D after 68 weeks of treatment decreased from 18.2% to 7.1% with semaglutide 2.4 mg, and 17.8% to 15.6% with placebo (p < 0.01). In STEP 4, most of the risk score reduction with semaglutide 2.4 mg occurred during weeks 0-20, from 20.6% to 11.4% but the risk score decreased further to 7.7% with continued semaglutide 2.4 mg during weeks 20-68 but increased to 15.4% after a switch to placebo (p < 0.01). In addition, data from STEP 4 showed that weight loss was 11% for weeks 0 – 20 and a further 9% with continued semaglutide 2.4 mg vs a 6%
regain with switch to placebo for weeks 20 – 68.
The authors concluded that treatment with semaglutide 2.4 mg reduces the 10-year risk of T2D by
~60% adding that sustained treatment was required to maintain this benefit but suggested that semaglutide 2.4 mg could help prevent type 2 diabetes in people with obesity.
Garvey TW et al. Semaglutide 2.4 mg reduces the 10-year type 2 diabetes risk in people with overweight or obesity Abstract 562. EASD 2022