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Aldo Lorenzetti M.D, Internal Medicine & Hepatology, Milano - SIMEDET Delegate
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#Semaglutide and #Cardiovascular Outcomes in Patients with Type 2 Diabetes

http://www.nejm.org/doi/full/10.1056/NEJMoa1607141#t=article

CONCLUSIONS
In patients with type 2 diabetes who were at high cardiovascular risk, the rate of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke was significantly lower among patients receiving semaglutide than among those receiving placebo, an outcome that confirmed the noninferiority of semaglutide
#Semaglutide #weight loss in phase 2 trial

https://globenewswire.com/news-release/2017/06/23/1028468/0/en/Novo-Nordisk-reports-up-to-13-8-weight-loss-in-people-with-obesity-receiving-semaglutide-in-phase-2-trial.html

In the trial, 957 people with obesity were randomised to treatment with doses of semaglutide between 0.05 to 0.4 mg/day or placebo. Liraglutide 3.0 mg/day was included for comparison. Approximately 100 people were included in each active treatment arm in combination with diet and exercise. All people in the trial were treated for 52 weeks followed by a 7-week follow-up period.

From a mean baseline weight of around 111 kg and a body mass index of approximately 39 kg/m2, a weight loss up to 17.8 kg was observed after 52 weeks of treatment with semaglutide. This corresponded to an estimated 13.8% weight loss compared to the weight loss of 2.3% achieved by diet, exercise and placebo alone, with all treatment arms adjusted for people discontinuing treatment in the study. The results from the liraglutide 3.0 mg treatment arm were broadly in line with previously reported data.

Once-daily semaglutide had a well-tolerated safety profile, with the most common adverse events being gastrointestinal side effects.
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#Semaglutide once weekly as add-on to #SGLT-2 inhibitor therapy in type 2 diabetes (SUSTAIN 9): a randomised, placebo-controlled trial

https://www.thelancet.com/journals/landia/article/PIIS2213-8587(19)30066-X/fulltext

Patients given semaglutide had greater reductions in HbA 1c (estimated treatment difference −1·42% and bodyweight (−3·81 kg versus those randomised to placebo (both p<0·0001). 356 adverse events were reported by 104 (69·3%) patients in the semaglutide group, and 247 adverse events were reported by 91 (60·3%) patients in the placebo group. Gastrointestinal adverse events were most common and were reported in 56 (37·3%) patients in the semaglutide group and 20 (13·2%) in the placebo group. Serious adverse events occurred in seven (4·7%) patients in the semaglutide group and six (4·0%) in the placebo group. Severe or blood glucose-confirmed hypoglycaemic events were reported in four patients on semaglutide (2·7%). 16 patients stopped treatment early because of an adverse event, 13 of whom were in the semaglutide group. no deaths during the trial.

Interpretation
Adding semaglutide to SGLT-2 inhibitor therapy significantly improves glycaemic control and reduces bodyweight in patients with inadequately controlled type 2 diabetes, and is generally well tolerated.
A Placebo-Controlled Trial of Subcutaneous #Semaglutide in Nonalcoholic #Steatohepatitis
https://2medical.news/2020/11/18/a-placebo-controlled-trial-of-subcutaneous-semaglutide-in-nonalcoholic-steatohepatitis/

Nonalcoholic steatohepatitis (NASH) is a common disease that is associated with increased morbidity and mortality, but treatment options are limited. The efficacy and safety of the glucagon-like peptide-1 receptor agonist semaglutide in patients with NASH is not known.. ..In total, 320 patients (of whom 230 had stage F2 or F3 fibrosis) were randomly assigned to receive semaglutide at a dose of 0.1 mg (80 patients), …
Effects of oral #semaglutide on energy intake, #food preference, #appetite, control of eating and body #weight in subjects with type 2 #diabetes
https://2medical.news/2020/11/26/effects-of-oral-semaglutide-on-energy-intake-food-preference-appetite-control-of-eating-and-body-weight-in-subjects-with-type-2-diabetes/

Aims To evaluate the effect of oral semaglutide on energy intake and appetite in subjects with type 2 diabetes (T2D). Materials and methods In this randomised, double‐blind, placebo‐controlled, two‐period cross‐over trial, 15 subjects with T2D received 12 weeks’ treatment with once‐daily oral semaglutide (4‐week dose‐escalation from 3 to 7 to 14 mg) followed by placebo, or vice versa. Energy intake was measured during an ad …
Once-Weekly #Semaglutide in Adults with Overweight or #Obesity
https://2medical.news/2021/02/13/once-weekly-semaglutide-in-adults-with-overweight-or-obesity/

Obesity is a global health challenge with few pharmacologic options. Whether adults with obesity can achieve weight loss with once-weekly semaglutide at a dose of 2.4 mg as an adjunct to lifestyle intervention has not been confirmed. METHODS In this double-blind trial, we enrolled 1961 adults with a body-mass index (the weight in kilograms divided by the square of the height in meters) of 30 …
#Semaglutide 2·4 mg once a week in adults with #overweight or #obesity, and type 2 diabetes (STEP 2): a randomised, double-blind, double-dummy, placebo-controlled, phase 3 trial
https://2medical.news/2021/03/24/semaglutide-2%C2%B74-mg-once-a-week-in-adults-with-overweight-or-obesity-and-type-2-diabetes-step-2-a-randomised-double-blind-double-dummy-placebo-controlled-phase-3-trial/

Background This trial assessed the efficacy and safety of the GLP-1 analogue once a week subcutaneous semaglutide 2·4 mg versus semaglutide 1·0 mg (the dose approved for diabetes treatment) and placebo for weight management in adults with overweight or obesity, and type 2 diabetes. Methods This double-blind, double-dummy, phase 3, superiority study enrolled adults with a body-mass index of at least 27 kg/m2 and glycated …