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LIBRIS Formathandbok  (Information om MARC21)
FältnamnIndikatorerMetadata
00006107naa a2200445 4500
001oai:DiVA.org:uu-445466
003SwePub
008210615s2021 | |||||||||||000 ||eng|
0247 a https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-4454662 URI
0247 a https://doi.org/10.1001/jama.2021.32242 DOI
040 a (SwePub)uu
041 a engb eng
042 9 SwePub
072 7a ref2 swepub-contenttype
072 7a art2 swepub-publicationtype
1001 a Rubino, Domenicau Washington Ctr Weight Management, Arlington, VA USA.4 aut
2451 0a Effect of Continued Weekly Subcutaneous Semaglutide vs Placebo on Weight Loss Maintenance in Adults With Overweight or Obesity The STEP 4 Randomized Clinical Trial
264 1b American Medical Association (AMA),c 2021
338 a print2 rdacarrier
520 a 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.
650 7a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Endokrinologi och diabetes0 (SwePub)302052 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Endocrinology and Diabetes0 (SwePub)302052 hsv//eng
7001 a Abrahamsson, Niclas,d 1976-u Uppsala universitet,Klinisk diabetologi och metabolism4 aut0 (Swepub:uu)nicab972
7001 a Davies, Melanieu Univ Leicester, Diabet Res Ctr, Leicester, Leics, England.;Leicester Gen Hosp, NIHR Leicester Biomed Res Ctr, Leicester, Leics, England.4 aut
7001 a Hesse, Danu Novo Nordisk AS, Soborg, Denmark.4 aut
7001 a Greenway, Frank L.u Louisiana State Univ Syst, Pennington Biomed Res Ctr, Baton Rouge, LA USA.4 aut
7001 a Jensen, Camillau Novo Nordisk AS, Soborg, Denmark.4 aut
7001 a Lingvay, Ildikou 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.4 aut
7001 a Mosenzon, Ofriu Hebrew Univ Jerusalem, Dept Endocrinol & Metab, Diabet Unit, Hadassah Med Ctr,Fac Med, Jerusalem, Israel.4 aut
7001 a Rosenstock, Juliou Dallas Diabet Res Ctr Med City, Dallas, TX USA.4 aut
7001 a Rubio, Miguel A.u 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.4 aut
7001 a Rudofsky, Gottfriedu Kantonsspital Olten, Dept Endocrinol & Metab Dis, Olten, Switzerland.4 aut
7001 a Tadayon, Sayehu Novo Nordisk AS, Soborg, Denmark.4 aut
7001 a Wadden, Thomas A.u Univ Penn, Dept Psychiat, Perelman Sch Med, Philadelphia, PA 19104 USA.4 aut
7001 a Dicker, Droru 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.4 aut
7102 a Washington Ctr Weight Management, Arlington, VA USA.b Klinisk diabetologi och metabolism4 org
7730 t Journal of the American Medical Association (JAMA)d : American Medical Association (AMA)g 325:14, s. 1414-1425q 325:14<1414-1425x 0098-7484x 1538-3598
8564 u https://jamanetwork.com/journals/jama/articlepdf/2777886/jama_rubino_2021_oi_210023_1618250221.55359.pdf
8564 8u https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-445466
8564 8u https://doi.org/10.1001/jama.2021.3224

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