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.