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Effect of Continued...
Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance in Adults With Overweight or Obesity The STEP 4 Randomized Clinical Trial
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- Rubino, Domenica (author)
- Washington Ctr Weight Management, Arlington, VA USA.
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- Abrahamsson, Niclas, 1976- (author)
- Uppsala universitet,Klinisk diabetologi och metabolism
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- Davies, Melanie (author)
- Univ Leicester, Diabet Res Ctr, Leicester, Leics, England.;Leicester Gen Hosp, NIHR Leicester Biomed Res Ctr, Leicester, Leics, England.
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- Hesse, Dan (author)
- Novo Nordisk AS, Soborg, Denmark.
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- Greenway, Frank L. (author)
- Louisiana State Univ Syst, Pennington Biomed Res Ctr, Baton Rouge, LA USA.
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- Jensen, Camilla (author)
- Novo Nordisk AS, Soborg, Denmark.
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- Lingvay, Ildiko (author)
- Univ Texas Southwestern Med Ctr Dallas, Dept Internal Med, Dallas, TX 75390 USA.;Univ Texas Southwestern Med Ctr Dallas, Dept Endocrinol & Populat & Data Sci, Dallas, TX 75390 USA.
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- Mosenzon, Ofri (author)
- Hebrew Univ Jerusalem, Dept Endocrinol & Metab, Diabet Unit, Hadassah Med Ctr,Fac Med, Jerusalem, Israel.
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- Rosenstock, Julio (author)
- Dallas Diabet Res Ctr Med City, Dallas, TX USA.
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- Rubio, Miguel A. (author)
- Univ Complutense, Hosp Clin Univ San Carlos, Dept Endocrinol & Nutr, Madrid, Spain.;Univ Complutense, Inst Invest Sanitaria Hosp Clin San Carlos IdISSC, Fac Med, Madrid, Spain.
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- Rudofsky, Gottfried (author)
- Kantonsspital Olten, Dept Endocrinol & Metab Dis, Olten, Switzerland.
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- Tadayon, Sayeh (author)
- Novo Nordisk AS, Soborg, Denmark.
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- Wadden, Thomas A. (author)
- Univ Penn, Dept Psychiat, Perelman Sch Med, Philadelphia, PA 19104 USA.
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- Dicker, Dror (author)
- Tel Aviv Univ, Hasharon Hosp, Rabin Med Ctr, Sackler Fac Med,Internal Med Dept, Tel Aviv, Israel.;Tel Aviv Univ, Hasharon Hosp, Rabin Med Ctr, Sackler Fac Med,Obes Clin, Tel Aviv, Israel.
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Washington Ctr Weight Management, Arlington, VA USA Klinisk diabetologi och metabolism (creator_code:org_t)
- American Medical Association (AMA), 2021
- 2021
- English.
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In: Journal of the American Medical Association (JAMA). - : American Medical Association (AMA). - 0098-7484 .- 1538-3598. ; 325:14, s. 1414-1425
- Related links:
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https://jamanetwork....
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
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- IMPORTANCE The effect of continuing vs withdrawing treatment with semaglutide, a glucagon-like peptide 1 receptor agonist, on weight loss maintenance in people with overweight or obesity is unknown. OBJECTIVE To compare continued once-weekly treatment with subcutaneous semaglutide, 2.4 mg, with switch to placebo for weight maintenance (both with lifestyle intervention) in adults with overweight or obesity after a 20-week run-in with subcutaneous semaglutide titrated to 2.4 mg weekly. DESIGN, SETTING, AND PARTICIPANTS Randomized, double-blind, 68-week phase 3a withdrawal study conducted at 73 sites in 10 countries from June 2018 to March 2020 in adults with body mass index of at least 30 (or 7 , -27 with >1 weight-related comorbidity) and without diabetes. INTERVENTIONS A total of 902 participants received once-weekly subcutaneous semaglutide during run-in. After 20 weeks (16 weeks of dose escalation; 4 weeks of maintenance dose), 803 participants (89.0%) who reached the 2.4-mg/wk semaglutide maintenance dose were randomized (2:1) to 48 weeks of continued subcutaneous semaglutide (n = 535) or switched to placebo (n = 268), plus lifestyle intervention in both groups. MAIN OUTCOMES AND MEASURES The primary end point was percent change in body weight from week 20 to week 68; confirmatory secondary end points were changes in waist circumference, systolic blood pressure, and physical functioning (assessed using the Short Form 36 Version 2 Health Survey, Acute Version [SF-36]). RESULTS Among 803 study participants who completed the 20-week run-in period (with a mean weight loss of 10.6%) and were randomized (mean age, 46 [SD, 12] years; 634 [79%] women; mean body weight, 107.2 kg [SD, 22.7 kg]), 787 participants (98.0%) completed the trial and 741(92.3%) completed treatment. With continued semaglutide, mean body weight change from week 20 to week 68 was -7.9% vs +6.9% with the switch to placebo (difference, -14.8 [95% CI, -16.0 to -13.5] percentage points; P < .001). Waist circumference (-9.7 cm [95% CI, -10.9 to -8.5 cm]), systolic blood pressure (-3.9 mm Hg [95% CI, -5.8 to -2.0 mm Hg]), and SF-36 physical functioning score (2.5 [95% CI, 1.6-3,3]) also improved with continued subcutaneous semaglutide vs placebo (all P < .001). Gastrointestinal events were reported in 49.1% of participants who continued subcutaneous semaglutide vs 26.1% with placebo; similar proportions discontinued treatment because of adverse events with continued semaglutide (2.4%) and placebo (2.2%). CONCLUSIONS AND RELEVANCE Among adults with overweight or obesity who completed a 20-week run-in period with subcutaneous semaglutide, 2.4 mg once weekly, maintaining treatment with semaglutide compared with switching to placebo resulted in continued weight loss over the following 48 weeks.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Endokrinologi och diabetes (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Endocrinology and Diabetes (hsv//eng)
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Rubino, Domenica
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Abrahamsson, Nic ...
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Davies, Melanie
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Hesse, Dan
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Greenway, Frank ...
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Jensen, Camilla
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Lingvay, Ildiko
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Mosenzon, Ofri
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Rosenstock, Juli ...
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Rubio, Miguel A.
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Rudofsky, Gottfr ...
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Tadayon, Sayeh
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Wadden, Thomas A ...
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Dicker, Dror
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Endocrinology an ...
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Uppsala University