PMID- 21199269 OWN - NLM STAT- MEDLINE DCOM- 20110516 LR - 20181201 IS - 1463-1326 (Electronic) IS - 1462-8902 (Linking) VI - 13 IP - 2 DP - 2011 Feb TI - The effect of pramlintide acetate on glycemic control and weight in patients with type 2 diabetes mellitus and in obese patients without diabetes: a systematic review and meta-analysis. PG - 169-80 LID - 10.1111/j.1463-1326.2010.01337.x [doi] AB - AIM: the objective of this systematic review and meta-analysis was to assess the effect of pramlintide on glycemic control, weight and incidence of nausea and hypoglycaemia in patients with type 2 diabetes mellitus (T2DM) and in obese patients without diabetes (OBP). METHODS: eight randomized, clinical trials were identified from multiple databases. Qualitative assessments and quantitative analyses were performed. RESULTS: in four T2DM studies (N = 930,duration of studies 16-52 weeks,120-150 mcg/dose BID-TID), all patients received insulin therapy. In four obesity studies (N = 686,duration of studies 6-24 weeks,120-360 mcg/dose BID-TID), equivalent volumes of placebo were administered before major meals. Pramlintide significantly reduced haemoglobin A1c (HbA1c) (-0.33% [95% CI -0.51, -0.14], p = 0.004) and weight (-2.57 kg, [95% CI -3.44, -1.70], p < 0.00001) versus the control group. More patients in the control group reported hypoglycaemia of any severity versus the pramlintide group (risk ratio 0.84 [95% CI 0.69, 10.3], p = 0.09). In OBP, pramlintide caused a reduction in weight (-2.27 kg [95% CI -2.88, -1.66], p < 0.00001). When event data from both populations were combined, patients randomized to pramlintide were 1.8 times more likely to report nausea of any severity versus control (p = 0.0005). CONCLUSIONS: pramlintide was associated with a small reduction in HbA1c, and a modest reduction in weight in patients with T2DM or OBP. There was increased incidence of nausea but not hypoglycaemia at any time during therapy. Studies about the long-term effect of pramlintide on diabetes- and cardiovascular-related complications and cost-effectiveness analyses are needed. FAU - Singh-Franco, D AU - Singh-Franco D AD - College of Pharmacy, Nova Southeastern University, Fort Lauderdale, FL 33324, USA. singh@nova.edu FAU - Perez, A AU - Perez A FAU - Harrington, C AU - Harrington C LA - eng PT - Journal Article PT - Meta-Analysis PT - Review PT - Systematic Review PL - England TA - Diabetes Obes Metab JT - Diabetes, obesity & metabolism JID - 100883645 RN - 0 (Islet Amyloid Polypeptide) RN - D3FM8FA78T (pramlintide) SB - IM MH - Body Weight/*drug effects MH - Diabetes Mellitus, Type 2/*drug therapy MH - Female MH - Humans MH - Hypoglycemia/chemically induced/*drug therapy MH - Incidence MH - Islet Amyloid Polypeptide/*administration & dosage/adverse effects MH - Male MH - Obesity/complications/*drug therapy MH - Randomized Controlled Trials as Topic MH - Treatment Outcome EDAT- 2011/01/05 06:00 MHDA- 2011/05/17 06:00 CRDT- 2011/01/05 06:00 PHST- 2011/01/05 06:00 [entrez] PHST- 2011/01/05 06:00 [pubmed] PHST- 2011/05/17 06:00 [medline] AID - 10.1111/j.1463-1326.2010.01337.x [doi] PST - ppublish SO - Diabetes Obes Metab. 2011 Feb;13(2):169-80. doi: 10.1111/j.1463-1326.2010.01337.x.