Symlin (pramlintide) (120 mcg three times per day) caused weight loss of 13.4 lbs in one year

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Thursday, September 11, 2008 11:49 am Email this article
Symlin (pramlintide) at a dose of 120 mcg three times per day caused diabetics to lose an average of 7 pounds more than those given a placebo in four months which was 3.1 percent of body weight, and 13.4 pounds more than placebo after one year which was 5.6 percent of body weight according to a new study. Symlin (pramlintide) Approved for Diabetics on Insulin

Symlin (pramlintide) approved in the U.S. for diabetics on insulin

Symlin (pramlintide) is approved in the U.S. for use by type 1 and type 2 diabetics who use insulin.

However, people in this study were not diabetic and not taking insulin.

 

Symlin (pramlintide) Injected

Symlin (pramlintide) is injected under the skin

Pramlintide is a synthetic analog of amylin, a hormone that is released along with insulin in response to meals. It allows the use of less insulin.

The drug is injected subcutaneously (under the skin).

 

Dose Increased Gradually

Dose increased 120 mcg every two weeks

The starting dose was started at 120 mcg per day and then increased by 120 mcg per day every two weeks until the target dose was reached.

 

Side Effects

Side effects: Nausea in 9.3% of patients

Mild to moderate nausea was the most common side effect reported by 9.3 percent of patients given the drug versus 2 percent of patients give the placebo.

 

Subjects

Subjects: 270 people

The study was performed in 24 centers in the U.S. and started with 411 obese people (BMI of 30 or more) without diabetes who were 18- to 70-years-old.

After four months there were 270 people still in the study.

Approximately three-fourths of subjects were female.

Subjects were randomized to received one of six drug treatments—120 mcg, 240 mcg or 360 mcg either two or three times per day—or a placebo.

Out of these, 208 chose to continue the study for an additional eight months.

 

Lifestyle Program Taught

All patients taught lifestyle changes

“All subjects participated in an individualized [lifestyle intervention] program based on LEARN” the paper notes.

“LEARN is a commercially available program for weight management that encompasses diet, physical activity, and behavioral modifications and has been extensively used in pharmacological and nonpharmacological weight loss intervention studies.”

Subjects were encouraged to reduce their calorie intake by 500 calories per day and to walk 10,000 steps per day.

The subjects were also given a pedometer to measure steps.

 

Conclusion

Conclusion

“When used over 12 months as an adjunct to [lifestyle intervention], 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,” the researchers concluded.

REFERENCE

Smith S, Aronne L, Burns C, Kesty N, Halseth A, Weyer C. Sustained weight loss following 12-month pramlintide treatment as an adjunct to lifestyle intervention in obesity. Diabetes Care. 2008 Sep, 31(9):1816-23.

AUTHOR’S CONTACT INFORMATION

Christian Weyer, MD
Amylin Pharmaceuticals
San Diego, California USA
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Steve R. Smith, MD
Pennington Biomedical Research Center
Louisiana State University
Baton Rouge, Louisiana USA
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• Diabetes

• Symlin (pramlintide)