Last Updated: 2008-09-10 14:24:21 -0400 (Reuters Health)
NEW YORK (Reuters Health) - Obese men and women may enhance a weight-loss program of lifestyle changes by adding a drug to lower blood sugar levels, researchers report.
Pramlintide is currently approved by the FDA for diabetes to take in combination with insulin to control their blood sugar levels. Previous research also linked pramlintide to weight loss, report Dr. Christian Weye of Amylin Pharmaceuticals in San Diego, Calif., and colleagues.
To further evaluate the drug's potential for affecting weight loss, Weyer's group assessed different pramlintide dosing regimens among nondiabetic obese subjects (about 70 percent female) involved in a lifestyle altering weight-loss program.
In addition to changing diet, physical activity and behavior, the 411 mostly middle-aged and otherwise healthy participants were assigned to inject 120, 240 or 360 micrograms pramlintide two or three times daily or to inject a placebo.
After four months, 240 participants remained in the study. Those taking pramlintide had lost from 3.8 to 6.1 kilograms (about 8.4 to 13.4 pounds), the investigators report in the journal Diabetes Care. By contrast, the placebo group lost 2.8 kg (about 6.2 pounds) on average.
The investigators offered these 240 participants the opportunity to continue their respective treatment through 12 months. Of the 146 who completed the extended treatment, those taking pramlintide generally maintained or continued to lose weight, while the placebo group largely regained their weight.
The most common pramlintide side effect was nausea, reported by up to 29 percent of participants during the initial four-month study period. However, this generally subsided over time and less than 10 percent of pramlintide users reported nausea during extended use.
These findings support the potential of pramlintide in treating obesity, the investigators note. However, larger, longer-term studies must confirm the safety and efficacy of pramlintide as a weight loss medication.
SOURCE: Diabetes Care, September 2008
Dr. Sears comments:
The problem with pramlintide (a synthetic version of the natural hormone amylin) besides increased nausea is that it has to be injected. Simply by following the Zone Diet, one would be expected to lose about two pounds per week. Studies from the Joslin Diabetes Research Center at Harvard Medical School indicate that a diet virtually identical to the Zone Diet gives an average 25-pound weight loss in obese diabetic patients over three months. Given this data, it makes more sense to follow the Zone Diet than to take daily injections.