Pramlintide — safety
Adverse events as reported, contraindications, warnings, and an explicit statement of what the safety evidence does not establish.
§4Safety
§4.1Adverse events reported in controlled trials
Table 4. Adverse events for Pramlintide as reported in the trial safety tables the Institute holds. Percentages are of randomised participants in the stated trial and arm.
| Event | Active, % | Comparator, % | Difference, pp | Source |
|---|---|---|---|---|
| Nausea | 48.0 | 16.0 | +32.0 | Type 1 diabetes pivotal |
| Anorexia | 17.0 | 2.0 | +15.0 | Pivotal pooled |
| Vomiting | 11.0 | 4.0 | +7.0 | Pivotal pooled |
| Severe hypoglycaemia | — | — | — | Boxed warning; incidence highest in the first four weeks and requires a prospective insulin dose reduction of 50 % at initiation |
| Injection-site reaction | — | — | — | Reported |
| Discontinuation for adverse events | 29.0 | — | — | Pivotal pooled — high |
| A difference column is computed by the Institute from the two reported percentages and is not itself a published figure. Confidence intervals for adverse-event differences are not reported in the contributing trials and are not constructed here. | ||||
§4.2Contraindications
- Confirmed gastroparesis
- Hypoglycaemia unawareness
- Known hypersensitivity to pramlintide or metacresol
§4.3Warnings and precautions
- Boxed warning: severe hypoglycaemia when used with insulin, typically within three hours of injection. Prandial insulin must be reduced by 50 % at initiation
- Not to be mixed in the same syringe as insulin — the formulation pH differs
- Nausea is dose-limiting for a large minority
§4.4What this section does not establish
Related assessments: tolerability of incretin receptor agonists · acute pancreatitis · the rodent thyroid C-cell signal.[1,2]
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
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