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, 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 Weyer, of Amylin Pharmaceuticals in San Diego, California, 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 2- or 3-times daily or to inject a placebo.

After 4 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 4-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