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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.
11th August 2022
Early time-restricted eating (eTRE) in combination with a reduction of energy intake is more effective for weight loss in comparison to a similar reduced intake of energy but where feeding occurs over a period of 12 hours or more according to the findings of a randomised trial by US researchers.
Caloric restriction whilst maintaining adequate nutritional intake, can extend both lifespan and delay the onset of age-related disorders in monkeys, indicating that this approach would be of value to human health. Moreover, in a randomised trial in humans, a 6-month period of calorie restriction (roughly 12% over 2 years) concluded that 2 biomarkers of longevity (fasting insulin level and body temperature) are decreased by prolonged calorie restriction in humans. An alternative strategy to calorie restriction is intermittent fasting (IF) and has become popular in recent years as a means of weight loss although the benefits of IF compared to calorie restriction are still uncertain. Evidence from a 50-week randomised trial, suggested that there was no appreciable difference in outcomes between IF and continuous calorie restriction. But what if individuals practiced a form of IF and simultaneously reduced their calorie intake? Might this approach be easier to implement and increase weight loss among obese individuals? This was the objective of the current study in which researchers examined the value of ‘early time-restricted eating’ (between 7 am and 3 pm) in combination with a reduced energy diet. This approach was compared to one in which there was a similar reduced energy intake but where food intake was spread over a 12-hour or longer period. Participants were equally randomised to either eTRE or the control group and which the researchers said was designed to mimic typical US median meal timing habits. In both groups, participants reduced their energy intake by 500 kcal/day below their measured resting energy expenditure, measured by indirect calorimetry. In addition, all participants received counselling from a registered dietitian and were asked to exercise for 75 to 150 minutes per week.
The co-primary outcomes were weight and fat loss, whereas secondary outcomes were fasting cardiometabolic risk factors e.g., blood pressure, fasting glucose, insulin levels.
Early time-restricted eating and weight loss
A total of 90 participants with a mean age of 43 years (80% female) and mean body mass index (BMI) or 39.6, were recruited and equally randomised to eTRE or control arms.
The eTRE group lost a mean of 6.3 kg compared to a mean of 4 kg for the control group and this mean difference of 2.3 kg was statistically significant (p = 0.002). In contrast, there was no significant difference in fat loss (mean difference = -1.4, p = 0.09). Furthermore, there were no differences in trunk or visceral fat or waist circumferences. While eTRE did not significantly reduce systolic blood pressure, the difference in mean diastolic pressure was significant (mean difference = – 4 mmHg, p = 0.04).
The authors concluded that eTRE was more effective as a weight loss strategy in conjunction with energy restriction compared to eating over a 12-hour window.
Citation
Jamshed H et al. Effectiveness of Early Time-Restricted Eating for Weight Loss, Fat Loss, and Cardiometabolic Health in Adults With Obesity: A Randomized Clinical Trial JAMA Intern Med 2022
3rd November 2021
A sustained weight loss over several years, not only delays but reduces the overall incidence of adverse cardiometabolic outcomes including type 2 diabetes, hypertension and hyperlipidaemia. This was the conclusion of a retrospective analysis of nearly 50,0000 patients by researchers from Geisinger Health, Pennsylvania, US. According to the world Health Organisation (WHO), worldwide levels of obesity have tripled since 1975 and in 2016, more than 1.9 billion adults, 18 years and older, were overweight and of these over 650 million were obese. However, obesity is not limited to adults and WHO data also suggests that in 2020, 39 million children under the age of 5 were overweight or obese. In a 2017 article, the World Obesity Federation issued a position statement, arguing that obesity should be perceived as a chronic relapsing disease process in which an abundance of food, coupled with low levels of physical activity, various environmental factors and genetic susceptibilities, all interact to create a positive energy balance. Increased weight and obesity are linked to a higher incidence of cardiovascular diseases, musculoskeletal disorders and some cancers. Nevertheless, even a 5% sustained weight loss improves metabolic function in multiple organs although longer term maintenance of weight loss is challenging, with one meta-analysis of 29 weight loss studies concluding that “weight-loss maintenance 4 or 5 y after a structured weight-loss program averages 3.0 kg or 23% of initial weight loss.”
However, what remains unclear is the impact of sustained weight loss on the development of cardiometabolic diseases and for the present study, researchers turned to in data held the Geisinger Health System, which represents one of the largest healthcare organisations in the US. The team looked at adult patients for whom there were 3 or more electronic health record entries for weight measurements within a 2-year period. Individuals were then categorised as obesity maintainers (OM), i.e., those with a history of obesity and who maintained their weight within 3% of their baseline levels; weight loss rebounders (WLRs) who had lost > 5% body weight but had regained > 20% of their 1-year loss and finally weight loss maintainers (WLMs), who again loss > 5% of their body weight but maintained > 80% of their 1-year weight loss. The outcomes of interest were the development of type 2 diabetes, hypertension and hyperlipidaemia, all of which were extracted from the electronic health records. In their analysis, researchers adjusted for several factors such as age, gender and various co-morbidities.
Findings
The sample contained 49,327 individuals with a mean age of 50.4 years (60.2% female) with the majority classed as OM (the reference group) and the whole sample were followed-up for a mean period of 6.6 years. After 5 years, 11.1% of the OM, 9.1% of the WLR and 6.5% of the WLM had developed type 2 diabetes and those in the sustained weight loss group (WLM) had a 33% lower risk of developing incident type 2 diabetes (adjusted hazard ratio, aHR = 0.68, 95% CI 0.62 – 0.74, p < 0.0001). Similarly, the WLM had a reduced risk of developing hypertension (aHR = 0.72) and hyperlipidaemia (aHR = 0.86).
Based on these findings, the authors concluded that sustained weight loss was associated with a delayed onset of cardiometabolic diseases and that these associations are enhanced in those with the greatest weight loss.
Citation
Bailey-Davis L et al. Impact of Sustained Weight Loss on Cardiometabolic Outcomes. Am J Cardiol 2021
8th June 2021
Weight loss in patients with type 2 diabetes improves metabolic outcomes such as insulin resistance and glycaemic control. This is particularly important in Asian populations where data indicate an increased prevalence of obesity. While traditionally lifestyle interventions have been delivered in face-to-face sessions, potential barriers such as the need for formal appointments, travel and associated costs, together with potential time constraints, can limit the value of these sessions.
In recent years, the development of smartphone technology has enabled the delivery of lifestyle interventions for patients with long-term conditions and which circumvent some of the problems encountered with face-to-face meetings. However, the effectiveness of smartphone-based apps can depend, to some extent, on the cultural appropriateness of the material provided. In an attempt to examine the value of a culturally and contextualised smartphone app, designed to deliver lifestyle interventions, a team from the Department of Dietetics, National University Hospital, Singapore, undertook a randomised, controlled trial to compare a smartphone-based intervention with usual care. Included participants were adults with type 2 diabetes with a body mass index (BMI) of 23 or greater and at the start of the study, all participants received a single advisory session from a dietician concerning weight and physical activity. Intervention participants were then required to use the app for at least 6 months (to track weight and activity levels) and to communicate (via the app) regularly with a dietician. The primary outcome was the change in body weight after six months, whereas secondary outcomes were changes in metabolic profiles (e.g., HbA1c, fasting blood glucose, blood pressure).
Findings
In total, 204 participants were enrolled and randomised to the intervention (99) or control. The mean age of intervention participants was 51.6 years (33.3% female) with an average weight of 84 kg and BMI of 30.3. After six months, participants in the intervention group had a significantly greater mean weight loss (3.6 kg vs 1.2kg, intervention vs control, p < 0.01). In addition, there was a greater change in mean HbA1c levels (-0.7% vs 0.03%, intervention vs control) and in the proportion of participants seeing a reduction in their use of diabetic medications (23.3% vs 5.4%, intervention vs control). There were also favourable changes in fasting glucose levels and diastolic blood pressure. Finally, nearly two-thirds (62%) of intervention participants used the smartphone app at least 75% of the days during the 6-month period.
Commenting on their findings, the authors noted how the intervention group’s weight loss was comparable to the results achieved from face-to-face sessions and, more importantly, this loss was sustained over a six-month period. The authors concluded that the smartphone app led to significant weight loss and metabolic parameters and that future work should focus on the lifestyle factors more likely to achieve successful outcomes.
Citation
Lim SL et al. Effect of a Smartphone App on Weight Change and Metabolic Outcomes in Asian Adults with Type 2 Diabetes. A Randomised Clinical Trial. JAMA Netw Open 2021
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