Enhanced weight loss following coadministration of pramlintide with sibutramine or phentermine in a multicenter trial
| Autor: | Stephan Miller, Colleen Burns, Louis J. Aronne, Larry Z. Shen, Amy Halseth |
|---|---|
| Rok vydání: | 2010 |
| Předmět: |
Adult
Male medicine.medical_specialty Phentermine Adolescent Endocrinology Diabetes and Metabolism Medicine (miscellaneous) Blood Pressure Placebo Young Adult Endocrinology Weight loss Heart Rate Multicenter trial Internal medicine Heart rate Appetite Depressants Weight Loss medicine Humans Hypoglycemic Agents Single-Blind Method Obesity Nutrition and Dietetics business.industry Middle Aged Pramlintide Islet Amyloid Polypeptide Blood pressure Drug Therapy Combination Female medicine.symptom business Cyclobutanes Sibutramine medicine.drug |
| Zdroj: | Obesity (Silver Spring, Md.). 18(9) |
| ISSN: | 1930-739X |
| Popis: | Preclinical evidence suggests that pharmacotherapy for obesity using combinations of agents targeted at distinct regulatory pathways may produce robust additive or synergistic effects on weight loss. This randomized placebo-controlled trial examined the safety and efficacy of the amylin analogue pramlintide alone or in combination with either phentermine or sibutramine. All patients also received lifestyle intervention. Following a 1-week placebo lead-in, 244 obese or overweight, nondiabetic subjects (88% female; 41 +/- 11 years; BMI 37.7 +/- 5.4 kg/m(2); weight 103 +/- 19 kg; mean +/- s.d.) received placebo subcutaneously (sc) t.i.d., pramlintide sc (120 microg t.i.d.), pramlintide sc (120 microg t.i.d.) + oral sibutramine (10 mg q.a.m.), or pramlintide sc (120 microg t.i.d.) + oral phentermine (37.5 mg q.a.m.) for 24 weeks. Treatment was single-blind for subjects receiving subcutaneous medication only and open-label for subjects in the combination arms. Weight loss achieved at week 24 with either combination treatment was greater than with pramlintide alone or placebo (P < 0.001; 11.1 +/- 1.1% with pramlintide + sibutramine, 11.3 +/- 0.9% with pramlintide + phentermine, -3.7 +/- 0.7% with pramlintide; -2.2 +/- 0.7% with placebo; mean +/- s.e.). Elevations from baseline in heart rate and diastolic blood pressure were demonstrated with both pramlintide + sibutramine (3.1 +/- 1.2 beats/min, P < 0.05; 2.7 +/- 0.9 mm Hg, P < 0.01) and pramlintide + phentermine (4.5 +/- 1.3 beats/min, P < 0.01; 3.5 +/- 1.2 mm Hg, P < 0.001) using 24-h ambulatory monitoring. However, the majority of subjects receiving these treatments remained within normal blood pressure ranges. These results support the potential of pramlintide-containing combination treatments for obesity. |
| Databáze: | OpenAIRE |
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