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

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 16–52weeks,120–150mcg/dose BID–TID), all patients received insulin therapy. In four obesity studies (N = 686,duration of studies 6–24weeks,120–360mcg/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.