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28th July 2023
Patients should no longer have to attempt weight loss by non-surgical interventions before referral to bariatric surgery, under new NICE guidance.
They also no longer have to be ‘generally fit for anaesthesia and surgery’ before referral to a specialist weight management service, which will instead undertake this assessment.
A new update to the clinical guideline for obesity identification, assessment and management removes a number of barriers for GPs to refer patients to be assessed for weight-loss surgery.
The previous guidance, first published nine years ago, had stipulated that referral for bariatric surgery should only be considered once ‘all appropriate non-surgical measures have been tried but the person has not achieved or maintained adequate, clinically beneficial weight loss’.
But this has now been removed, alongside a requirement for the person to have gone through intensive weight management treatment in a Tier 3 service.
The new guideline instead uses the term ‘specialist weight management centre‘ – which requires the necessary expertise to assess patients but does not necessarily need to be tier 3.
Professor Alex Miras, professor of endocrinology at Ulster University, who participated in developing the new guidance, said: ‘If the team decide that the patient needs optimisation, this can take place before surgery is undertaken. If the team decide that there is no need for optimisation, then the patient can proceed to surgery much faster.’
The guidance also highlights that ‘drug treatments may be used to maintain or reduce weight before surgery for people who have been recommended surgery’.
And it further aims to clarify in which patents bariatric surgery interventions may be most beneficial.
Professor Miras said: ‘We have made it a bit more clear as to which obesity complications have a high level of evidence in terms of response to surgery (e.g. diabetes and fatty liver disease), while clarifying that the list is not exhaustive. In the previous guidance, the language used was more vague.’
GP referral criteria will also be subject to local commissioners, which may limit opportunities for bariatric surgery.
‘What we have done is make the patient’s journey towards bariatric surgery less cumbersome and removed some of the obstacles,’ said Professor Miras.
‘These changes may not necessarily increase the number of operations funded by the ICBs, but it will make the journey of the individual patient much more efficient.’
According to NICE, removing these barriers to referral will reduce variation in practice and increase uptake in previously overlooked groups.
‘This however does not mean more people will have bariatric surgery, because they may decide it is not right for them or they are not judged to be clinically suitable for surgery,’ a NICE spokesperson said.
Professor Azeem Majeed, a GP professor of primary care and public health at Imperial College London, said the new guideline ‘potentially has significant implications for general practices in England’.
He argued it will bring ‘additional work in discussing weight management with patients’ and that ‘suitable referral pathways would need to be in place with sufficient capacity to deal with an increase in patient numbers’.
This article was originally published by our sister publication Pulse.
28th June 2023
Retatrutide gave rise to substantial reductions in body weight in adults with obesity, according to a recent phase 2, randomised placebo-controlled trial.
Retatrutide (formerly LY3437943) is an agonist for the glucagon-like peptide 1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP) and glucagon (GCG) receptors. In a phase 1b trial, the drug was shown to produce robust reductions in glucose and bodyweight. In addition to drugs such as semaglutide, it is being explored as a treatment for weight loss.
Continuing to explore the value of the drug, in a recent phase 2 trial published in the New England Journal of Medicine, researchers undertook a double-blind, randomised, placebo-controlled trial in adults with a body mass index (BMI) of 30 or more, or those with a BMI of 27 but with at least one weight-related condition.
The trial randomised participants to subcutaneous retatrutide at doses of 1 mg, 4 mg, 8 mg and 12 mg or placebo, administered once weekly for a total of 48 weeks. The primary endpoint was the percentage change in body weight from baseline to week 24, and researchers also assessed the safety of the drug.
In addition to treatment, all the participants received a lifestyle intervention, including regular counselling sessions delivered by a dietitian or qualified healthcare professional.
A total of 338 participants with a mean age of 48.2 years (48% female) were enrolled and randomised to the different doses or placebo.
After 24 weeks of treatment, weight loss ranged from -7.2% in the 1 mg group through to -17.5% in the 12 mg group, compared to -1.6% in the placebo group. However, at week 48, weight loss increased to -24.2% in the 12 mg group compared to -2.1% in the placebo arm. In addition, at week 48, among those receiving 12 mg of retatrutide, 26% of participants had a body-weight reduction of 30% or more.
Treatment with retatrutide also improved cardiometabolic measures including systolic and diastolic blood pressure, glycated haemoglobin, fasting glucose, insulin and lipids – except for high-density lipoprotein. Furthermore, improvements in blood pressure within the 48-week treatment period resulted in discontinuation of at least one antihypertensive medication in 30% of the participants in the 12 mg group.
Adverse events were reported in 70% of the placebo participants and in 73-94% of retatrutide patients. They were highest in the 8 and 12 mg groups. Serious adverse events occurred in 4% of the retatrutide placebo groups.
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 practised 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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