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).

RESEARCH DESIGN AND 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: Steve R Smith, Louis J Aronne, Colleen M Burns, Nicole C Kesty, Amy E Halseth, Christian Weyer
• Journal: Diabetes care (Diabetes Care) Vol. 31 Issue 9 Pg. 1816-23 (Sep 2008) ISSN: 1935-5548 [Electronic] United States
• PMID: 18753666 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Amyloid
• Hypoglycemic Agents
• Islet Amyloid Polypeptide
• Placebos
• pramlintide

Topics

• Adult
• Amyloid (therapeutic use)
• Body Mass Index
• Body Size
• Double-Blind Method
• Female
• Follow-Up Studies
• Humans
• Hypoglycemic Agents (therapeutic use)
• Islet Amyloid Polypeptide
• Life Style
• Male
• Middle Aged
• Placebos
• Single-Blind Method
• Time Factors
• Weight Loss (drug effects)