Pramlintide in obesity and overweight in adults — evidence extract
The Institute's graded assessment of Pramlintide for obesity and overweight in adults, with the contributing trials and the domain-by-domain certainty reasoning.
§1Evidence extract: Obesity and overweight in adults
§1.1Question and anchor outcome
- Population
- Excess adiposity sufficient to impair health, operationalised in the pivotal incretin programmes as a body-mass index of 30 kg/m² or above, or 27 kg/m² or above with at least one weight-related comorbidity.
- Intervention
- Pramlintide, subcutaneous immediately before major meals
- Comparator
- As used in each contributing trial; reported per trial rather than pooled across comparator types
- Anchor outcome
- Percentage change in body weight from baseline
Additional outcomes the Institute extracts for this indication: Proportion achieving ≥5 %, ≥10 %, ≥15 % and ≥20 % weight reduction; Change in waist circumference; Change in systolic blood pressure; Change in high-sensitivity C-reactive protein.
§1.2Contributing trials
Table 1. Trials contributing to the assessment of Pramlintide in obesity and overweight in adults.
| Trial | Phase | Design | Randomised | Duration | Year |
|---|---|---|---|---|---|
| PRAM-OBESITY-PH2 | 2 | Randomised, double-blind, placebo-controlled | 411 | 16 weeks | 2007 |
§1.3Certainty assessment
Table 2. Reasoning recorded against each certainty domain.
| Domain | Rating | Reasoning |
|---|---|---|
| Risk of bias | Serious | Differential attrition exceeded the pre-specified threshold in one arm. |
| Inconsistency | Serious | Estimates vary in magnitude across contributing trials beyond what chance would produce. |
| Indirectness | No concern | No serious concern identified in this domain. |
| Imprecision | No concern | No serious concern identified in this domain. |
| Publication bias | No concern | No serious concern identified in this domain. |
| Overall rating: Low certainty. Confidence in the effect estimate is limited. The true effect may be substantially different from the estimate. | ||
§1.4What this extract does not establish
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- Hollander PA, Levy P, Fineman MS, Maggs DG, Shen LZ, Strobel SA, Weyer C, Kolterman OG. Pramlintide as an adjunct to insulin therapy improves long-term glycemic and weight control in patients with type 2 diabetes: a 1-year randomized controlled trial. Diabetes Care 2003;26(3):784–790. doi:10.2337/diacare.26.3.784 · PMID 12610038
- Lau DCW, Erichsen L, Francisco AM, Satylganova A, le Roux CW, McGowan B, Pedersen SD, Pietiläinen KH, Rubino DM, Batterham RL. Once-weekly cagrilintide for weight management in people with overweight and obesity: a multicentre, randomised, double-blind, placebo-controlled and active-controlled, dose-finding phase 2 trial. The Lancet 2021;398(10317):2160–2172. doi:10.1016/S0140-6736(21)01751-7 · PMID 34798060
- D’Hondt M, Bracke N, Taevernier L, Gevaert B, Verbeke F, Wynendaele E, De Spiegeleer B. Related impurities in peptide medicines. Journal of Pharmaceutical and Biomedical Analysis 2014;101:2–30. doi:10.1016/j.jpba.2014.06.012 · PMID 25044089
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.