Abstract | CONTEXT: OBJECTIVE: DESIGN/SETTING: We performed a randomized, double-blind, placebo-controlled, multicenter study. PATIENTS: A total of 204 obese subjects [80/20% female/male, age 48 +/- 10 yr, and body mass index 37.8 +/- 5.6 kg/m(2) (mean +/- SD)] participated in the study. INTERVENTION: For 16 wk, without concomitant lifestyle intervention, subjects self-administered pramlintide (nonforced dose escalation < or = 240 microg) or placebo via sc injection three times a day before meals. MAIN OUTCOME MEASURES: Weight, waist circumference, tolerability, and safety were the main outcome measures. RESULTS:
Pramlintide was generally well tolerated, with 88% of subjects able to escalate to the maximum dose of 240 microg. Withdrawal rates were similar between placebo (25%) and pramlintide-treated subjects (29%). Subjects completing 16 wk of pramlintide treatment experienced placebo-corrected reductions in body weight of 3.7 +/- 0.5% (3.6 +/- 0.6 kg; P < 0.001) and waist circumference (3.6 +/- 1.1 cm; P < 0.01). Approximately 31% of pramlintide-treated subjects achieved > or =5% weight loss (vs. 2% placebo; P < 0.001). More pramlintide than placebo-treated subjects reported improvements in appetite control (72% vs. 31%), weight control (63% vs. 24%), and overall well-being (52% vs. 17%). No unexpected safety signals were observed. The most common adverse event reported was mild, transient nausea. Pramlintide-treated subjects not reporting nausea experienced weight loss similar to those who did (3.6 +/- 0.5% and 3.9 +/- 0.5%, respectively). CONCLUSION: These results support continued evaluation of pramlintide as a potential treatment for obesity.
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Authors | Louis Aronne, Ken Fujioka, Vanita Aroda, Kim Chen, Amy Halseth, Nicole C Kesty, Colleen Burns, Cameron W Lush, Christian Weyer |
Journal | The Journal of clinical endocrinology and metabolism
(J Clin Endocrinol Metab)
Vol. 92
Issue 8
Pg. 2977-83
(Aug 2007)
ISSN: 0021-972X [Print] United States |
PMID | 17504894
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Amyloid
- Anti-Obesity Agents
- Glycated Hemoglobin A
- Hypoglycemic Agents
- Islet Amyloid Polypeptide
- pramlintide
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Topics |
- Adult
- Amyloid
(adverse effects, therapeutic use)
- Anthropometry
- Anti-Obesity Agents
(adverse effects, therapeutic use)
- Body Weight
(drug effects)
- Dose-Response Relationship, Drug
- Double-Blind Method
- Female
- Glycated Hemoglobin
(metabolism)
- Humans
- Hypoglycemic Agents
(adverse effects, therapeutic use)
- Islet Amyloid Polypeptide
- Male
- Middle Aged
- Obesity
(drug therapy)
- Surveys and Questionnaires
- Treatment Outcome
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