title: Sustained weight loss following 12-month pramlintide treatment as an adjunct to lifestyle intervention in obesity.
abstract: OBJECTIVE
  To assess long-term weight loss efficacy and safety of pramlintide used at different dosing regimens and in conjunction with lifestyle intervention (LSI).
  
  
  METHODS
  In a 4-month, double-blind, placebo-controlled, dose-ranging study, 411 obese subjects were randomized to receive pramlintide (six arms: 120, 240, and 360 microg 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).
  
  
  RESULTS
  At month 4, mean weight loss from baseline in the pramlintide arms ranged from 3.8 +/- 0.7 to 6.1 +/- 0.8 kg (2.8 +/- 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-microg b.i.d. group. Placebo-corrected weight loss with 120 microg t.i.d. and 360 microg b.i.d. averaged 3.2 +/- 1.2 kg (3.1 +/- 1.1% body wt) and 3.3 +/- 1.1 kg (3.1 +/- 1.0% body wt), respectively, at month 4 (both P < 0.01; 4-month evaluable n = 270) and 6.1 +/- 2.1 kg (5.6 +/- 2.1% body wt) and 7.2 +/- 2.3 kg (6.8 +/- 2.3% body wt), respectively, at month 12 (both P < 0.01; 12-month evaluable n = 146). At month 12, 40 and 43% of subjects treated with 120 microg t.i.d. and 360 microg b.i.d., respectively, achieved >or=10% weight loss (vs. 12% for placebo). Nausea, the most common adverse event with pramlintide in the 4-month study (9-29% pramlintide vs. 2% placebo), was generally mild to moderate and occurred in <10% of subjects during the extension.
  
  
  CONCLUSIONS
  When 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.
authors.affiliation: Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, Louisiana, USA.
authors.forename: Steve R
authors.initials: SR
authors.lastname: Smith
authors.forename: Louis J
authors.initials: LJ
authors.lastname: Aronne
authors.forename: Colleen M
authors.initials: CM
authors.lastname: Burns
authors.forename: Nicole C
authors.initials: NC
authors.lastname: Kesty
authors.forename: Amy E
authors.initials: AE
authors.lastname: Halseth
authors.forename: Christian
authors.initials: C
authors.lastname: Weyer