{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T00:37:05Z","timestamp":1792456625325,"version":"4.5.0"},"reference-count":22,"publisher":"American Diabetes Association","issue":"9","content-domain":{"domain":["diabetesjournals.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2008,9,1]]},"abstract":"<jats:p>OBJECTIVE\u2014To assess long-term weight loss efficacy and safety of pramlintide used at different dosing regimens and in conjunction with lifestyle intervention (LSI).<\/jats:p>\n               <jats:p>RESEARCH DESIGN AND METHODS\u2014In a 4-month, double-blind, placebo-controlled, dose-ranging study, 411 obese subjects were randomized to receive pramlintide (six arms: 120, 240, and 360 \u03bcg b.i.d. and t.i.d.) or placebo in conjunction with a structured LSI program geared toward weight loss. Of the 4-month evaluable subjects (n = 270), 77% opted to continue preexisting treatment during an 8-month single-blind extension (LSI geared toward weight maintenance).<\/jats:p>\n               <jats:p>RESULTS\u2014At month 4, mean weight loss from baseline in the pramlintide arms ranged from 3.8 \u00b1 0.7 to 6.1 \u00b1 0.8 kg (2.8 \u00b1 0.8 kg with placebo). By month 12, initial 4-month weight loss was regained in the placebo group but was maintained in all but the 120-\u03bcg b.i.d. group. Placebo-corrected weight loss with 120 \u03bcg t.i.d. and 360 \u03bcg b.i.d. averaged 3.2 \u00b1 1.2 kg (3.1 \u00b1 1.1% body wt) and 3.3 \u00b1 1.1 kg (3.1 \u00b1 1.0% body wt), respectively, at month 4 (both P &amp;lt; 0.01; 4-month evaluable n = 270) and 6.1 \u00b1 2.1 kg (5.6 \u00b1 2.1% body wt) and 7.2 \u00b1 2.3 kg (6.8 \u00b1 2.3% body wt), respectively, at month 12 (both P &amp;lt; 0.01; 12-month evaluable n = 146). At month 12, 40 and 43% of subjects treated with 120 \u03bcg t.i.d. and 360 \u03bcg b.i.d., respectively, achieved \u226510% weight loss (vs. 12% for placebo). Nausea, the most common adverse event with pramlintide in the 4-month study (9\u201329% pramlintide vs. 2% placebo), was generally mild to moderate and occurred in &amp;lt;10% of subjects during the extension.<\/jats:p>\n               <jats:p>CONCLUSIONS\u2014When used over 12 months as an adjunct to LSI, pramlintide treatment, with low-dose three-times-daily or higher-dose two-times-daily regimens, helped obese subjects achieve greater initial weight loss and enhanced long-term maintenance of weight loss.<\/jats:p>","DOI":"10.2337\/dc08-0029","type":"journal-article","created":{"date-parts":[[2008,6,21]],"date-time":"2008-06-21T01:36:46Z","timestamp":1214012206000},"page":"1816-1823","update-policy":"https:\/\/doi.org\/10.2337\/ada-journal-policies","source":"Crossref","is-referenced-by-count":154,"title":["Sustained Weight Loss Following 12-Month Pramlintide Treatment as an Adjunct to Lifestyle Intervention in Obesity"],"prefix":"10.2337","volume":"31","author":[{"given":"Steve R.","family":"Smith","sequence":"first","affiliation":[{"name":"Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, Louisiana"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Louis J.","family":"Aronne","sequence":"additional","affiliation":[{"name":"Weill-Cornell Medical College, New York, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Colleen M.","family":"Burns","sequence":"additional","affiliation":[{"name":"Amylin Pharmaceuticals, San Diego, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicole C.","family":"Kesty","sequence":"additional","affiliation":[{"name":"Amylin Pharmaceuticals, San Diego, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amy E.","family":"Halseth","sequence":"additional","affiliation":[{"name":"Amylin Pharmaceuticals, San Diego, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Weyer","sequence":"additional","affiliation":[{"name":"Amylin Pharmaceuticals, San Diego, California"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1167","reference":[{"key":"2022031218500653800_R1","doi-asserted-by":"crossref","unstructured":"Colman E: Anorectics on trial: a half century of federal regulation of prescription appetite suppressants. 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