Effects of Pramlintide in Patients with Type 2 Diabetes Mellitus: An Analysis Using Daily Insulin Dose Tertiles |
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| Affiliation: | 1. AstraZeneca, San Diego, California;2. Bristol-Myers Squibb/AstraZeneca, San Diego, California.;1. Departments of Pediatrics, Riyadh, Saudi Arabia;2. Molecular Oncology, Riyadh, Saudi Arabia;3. Medicine, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.;1. Division of Internal Medicine, Mayo Clinic, Rochester, Minnesota;2. Department of Head and Neck, and Endocrine Oncology, Moffitt Cancer Center, Tampa, Florida,;3. Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota.;1. Skaggs School of Pharmacy and Pharmaceutical Sciences;2. Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, Colorado;;3. Department of Pediatrics, University of Colorado School of Medicine, Aurora, Colorado.;1. Departments of Endocrinology, Cairns, Australia.;2. Cardiology, Cairns Hospital, Cairns, Australia. |
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| Abstract: | ObjectiveThe purpose of the analysis was to investigate if the efficacy and tolerability of 6 months of pramlintide therapy in patients with type 2 diabetes mellitus (T2DM) differed with increasing levels of concomitant insulin doses, using data from 3 previously described clinical trials.MethodsIn this post hoc analysis, data from 2 pooled, placebo-controlled pivotal trials and 1 clinical practice trial were evaluated by baseline insulin use tertile in patients with T2DM.ResultsIn the pivotal trials, both glycated hemoglobin (A1C) and body weight decreased similarly across tertiles with pramlintide. A1C decreased slightly and body weight remained relatively unchanged across tertiles with placebo. Similarly, in the clinical practice trial, pramlintide was associated with decreases in A1C, body weight, and total daily insulin use across the tertiles. Overall, the most common adverse events were gastrointestinal in nature, and the rate of severe hypoglycemia was low.ConclusionThese results suggest that pramlintide therapy was associated with improved A1C and decreased body weight, with a low rate of severe hypoglycemia, among patients with T2DM, regardless of baseline insulin use. (Endocr Pract. 2014;20:1070-1075) |
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