Effect of Subcutaneous Semaglutide vs Placebo as an Adjunct to Intensive Behavioral Therapy on Body Weight in Adults With Overweight or Obesity

Wadden, Thomas A.; Bailey, Timothy S.; Billings, Liana K.; Davies, Melanie J.; Frías, Juan P.; Koroleva, Anna; Lingvay, Ildiko; O’Neil, Patrick M.; Rubino, Domenica; Skovgaard, Dorthe; Wallenstein, Signe Olrik Rytter; Garvey, W. Timothy; Investigators, Step

doi:10.1001/jama.2021.1831

Cited by 564 publications

(735 citation statements)

References 31 publications

Supporting

Mentioning

605

Contrasting

Unclassified

Order By: Relevance

“…The mean reduction in body weight from baseline to week 68 was 9.6%-16.0% in the semaglutide group versus 2.4%-5.7% with placebo, across the STEP 1-3 trials [90,91,93]. Although direct cross-study comparisons of liraglutide and semaglutide should be interpreted with caution, compared with liraglutide (6%-8%), semaglutide appears to have greater weight-reducing potential.…”

Section: Use Of Other Glp-1 Ra Therapy In Obesitymentioning

confidence: 87%

“…The safety and efficacy of once-weekly-administered semaglutide 2.4 mg for obesity have been assessed and published in four phase 3, 68-week trials (STEP clinical program) [90][91][92][93]. The STEP 1 trial focused on the use of semaglutide 2.4 mg as an adjunct to lifestyle intervention [90].…”

Section: Use Of Other Glp-1 Ra Therapy In Obesitymentioning

confidence: 99%

“…STEP 2 compared semaglutide 2.4 mg versus 1.0 mg versus placebo [93]. STEP 3 explored the efficacy of semaglutide 2.4 mg versus placebo, both combined with IBT [91]. STEP 4 compared continued treatment with semaglutide 2.4 mg versus switch to placebo [92].…”

Section: Use Of Other Glp-1 Ra Therapy In Obesitymentioning

confidence: 99%

See 2 more Smart Citations

Patient initiation and maintenance of GLP-1 RAs for treatment of obesity

Patel

Smith

2021

Expert Review of Clinical Pharmacology

View full text Add to dashboard Cite

Introduction: Healthcare providers (HCPs) see many patients with obesity-related complications and are therefore well placed to help treat obesity itself. However, limited collated information exists to help HCPs with the practical use of anti-obesity medications (AOMs). We focus on the initiation and maintenance of a glucagon-like peptide-1 receptor agonist (GLP-1 RA) for weight management, liraglutide 3.0 mg. Literature search was conducted between 25-28 November 2019 on PubMed and ClinicalTrials.gov. Areas covered: Clinical trial and real-world data describing weight-loss efficacy, cardiometabolic risk factors, incidence of adverse events (AEs), and persistence are presented to assist HCPs with patient discussions. Practical considerations to overcome barriers to optimal use are provided, equipping HCPs with the information required to aid with adherence to and persistence with AOMs. The use of other GLP-1-RA therapies in obesity is discussed in light of the recent US Food and Drug Administration approval of semaglutide 2.4 mg for weight management. Expert opinion: Liraglutide 3.0 mg provides benefits regarding weight loss and improvements in cardiometabolic risk factors. Promising areas of future research in the field of obesity include dual receptor agonists and the combination of glucagon-like peptide-1 receptor agonists with other molecules.

show abstract

Section: Use Of Other Glp-1 Ra Therapy In Obesitymentioning

confidence: 87%

Section: Use Of Other Glp-1 Ra Therapy In Obesitymentioning

confidence: 99%

See 1 more Smart Citation

Patient initiation and maintenance of GLP-1 RAs for treatment of obesity

Patel

Smith

2021

Expert Review of Clinical Pharmacology

View full text Add to dashboard Cite

show abstract

“…At week 68, 86-89% of patients without T2D achieved ≥5% body weight loss (STEP 1, 3 and 4), with 69% of patients with T2D achieving this threshold (STEP 2). Across all studies, semaglutide 2.4 mg also demonstrated benefits beyond weight loss on cardiometabolic parameters and patient-reported outcomes (81)(82)(83)(84).…”

Section: Semaglutide In Obesitymentioning

confidence: 90%

Clinical Perspectives on the Use of Subcutaneous and Oral Formulations of Semaglutide

Gallwitz

Giorgino

2021

Front. Endocrinol.

View full text Add to dashboard Cite

Early and effective glycemic control can prevent or delay the complications associated with type 2 diabetes (T2D). The benefits of glucagon-like peptide-1 receptor agonists (GLP-1RAs) are becoming increasingly recognized and they now feature prominently in international T2D treatment recommendations and guidelines across the disease continuum. However, despite providing effective glycemic control, weight loss, and a low risk of hypoglycemia, GLP-1RAs are currently underutilized in clinical practice. The long-acting GLP-1RA, semaglutide, is available for once-weekly injection and in a new once-daily oral formulation. Semaglutide is an advantageous choice for the treatment of T2D since it has greater efficacy in reducing glycated hemoglobin and body weight compared with other GLP-1RAs, has demonstrated benefits in reducing major adverse cardiovascular events, and has a favorable profile in special populations (e.g., patients with hepatic impairment or renal impairment). The oral formulation represents a useful option to help improve acceptance and adherence compared with injectable formulations for patients with a preference for oral therapy, and may lead to earlier and broader use of GLP-1RAs in the T2D treatment trajectory. Oral semaglutide should be taken on an empty stomach, which may influence the choice of formulation. As with most GLP-1RAs, initial dose escalation of semaglutide is required for both formulations to mitigate gastrointestinal adverse events. There are also specific dose instructions to follow with oral semaglutide to ensure sufficient gastric absorption. The evidence base surrounding the clinical use of semaglutide is being further expanded with trials investigating effects on diabetic retinopathy, cardiovascular outcomes, and on the common T2D comorbidities of obesity, chronic kidney disease, and non-alcoholic steatohepatitis. These will provide further information about whether the benefits of semaglutide extend to these other indications.

show abstract

“…The most durable method of weight loss is currently being explored in a randomized control trial 30 comparing diet with bariatric surgery because of concern over recurrence secondary to weight gain 31 . The recent STEP‐3 randomized control trial investigating semaglutide, 32 a glucagon‐like peptide 1 receptor (GLP‐1R) agonist, found semaglutide to be superior in weight loss when used as an adjunct to behavioral therapy and initial low‐calorie diet compared with placebo. This noninvasive weight management therapy will likely be of direct clinical relevance to those with IIH; exendin‐4, a GLP‐1R agonist, has been found in an animal model to modulate CSF secretion at the choroid plexus and subsequently reduce ICP 33 …”

Section: Methodsmentioning

confidence: 99%

Headache attributed to idiopathic intracranial hypertension and persistent post‐idiopathic intracranial hypertension headache: A narrative review

Mollan

Grech

2021

Headache

View full text Add to dashboard Cite

Objective Headache is a near‐universal sequela of idiopathic intracranial hypertension (IIH). The aim of this paper is to report current knowledge of headache in IIH and to identify therapeutic options. Background Disability in IIH is predominantly driven by headache; thus, headache management is an urgent and unmet clinical need. At present, there is currently no scientific evidence for the directed use of abortive or preventative headache therapy. Methods A detailed search of the scientific literature and narrative review was performed. Results Headache in IIH is driven by raised intracranial pressure (ICP) and reduction of ICP has been reported in some studies to reduce headache. Despite resolution of papilledema and normalization of raised ICP, a majority suffer persistent post‐IIH headache. The lack of evidence‐based management approaches leaves many untreated. Where clinicians attempt to manage IIH headache, they use off‐label therapies to target the prevailing headache phenotype. A recent prospective open‐label study demonstrated the effective use of a calcitonin gene‐related peptide monoclonal antibody therapy in IIH for persistent post‐IIH headache. Conclusions There is overwhelming evidence of the headache burden in IIH. Studies are required to investigate the biological foundations of headache related to ICP and to develop treatments specifically directed to manage headache in IIH.

show abstract

Effect of Subcutaneous Semaglutide vs Placebo as an Adjunct to Intensive Behavioral Therapy on Body Weight in Adults With Overweight or Obesity

Cited by 564 publications

References 31 publications

Patient initiation and maintenance of GLP-1 RAs for treatment of obesity

Patient initiation and maintenance of GLP-1 RAs for treatment of obesity

Clinical Perspectives on the Use of Subcutaneous and Oral Formulations of Semaglutide

Headache attributed to idiopathic intracranial hypertension and persistent post‐idiopathic intracranial hypertension headache: A narrative review

Contact Info

Product

Resources

About