Cardiovascular safety assessment of pramlintide in type 2 diabetes: results from a pooled analysis of five clinical trials.

Herrmann K, Zhou M, Wang A, de Bruin TWA

Clinical diabetes and endocrinology11 May 2016Cited by 15 (Europe PMC)

PMID28702246PMCIDPMC5471856DOI10.1186/s40842-016-0030-zPepBankPUB-28702246

Summary

BackgroundThis report evaluated the cardiovascular safety of the amylin analog pramlintide-an existing diabetes injectable treatment-by comparing relevant cardiovascular adverse events (AEs) reported in previous phase 3 and 4 clinical trials among patients receiving pramlintide and those receiving control treatments.MethodsCardiovascular safety of pramlintide was assessed using accepted regulatory medical definitions of AEs reported in five randomized, controlled phase 3 and 4 trials of 16-52 weeks' duration in adults with type 2 diabetes. The original trials compared pramlintide (90-120 mcg twice daily or 30-150 mcg three times daily) with placebo (four studies) or a mealtime rapid-acting insulin analog (one study). Background therapies included insulin alone or in combination with oral glucose-lowering agents. AE data obtained from clinical study reports were combined into one database and analyzed for the intention-to-treat population of 2016 patients (pramlintide, n = 1434; pooled comparator, n = 582). The primary analysis compared reported major adverse cardiovascular events (MACE) between pramlintide and control.ResultsThe incidence of reported MACE was similar between pramlintide (4.7 %) and pooled comparators (4.5 %). Secondary analyses included MACE relative risk and hazard ratio point estimates, which ranged from 0.86 to 0.93 for pramlintide relative to comparator treatment; the upper limit of the two-sided 95 % confidence interval did not exceed the threshold of 1.8.ConclusionsBoth the point estimate of the reported MACE frequency and estimated risk ratios showed that mealtime pramlintide as an adjunct to insulin conferred no increased risk of cardiovascular AEs in patients with type 2 diabetes using insulin.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study2

2 results from studies that gave the peptide. 2 results from people.

01HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, MACE incidence was similar with pramlintide and pooled comparators.
In plain wordsIn adults with type 2 diabetes, major cardiovascular event rates were similar with pramlintide and pooled comparators.
Peptide
Pramlintide (Symlin)
Outcome
No significant changeMACE incidence
Study
n = 2,016
Comparator
pooled placebo and mealtime rapid-acting insulin analog comparators
Analysis
Primary
Outcome group
Cardiovascular events · Cardiovascular
Studied dose
90-120 mcg twice daily or 30-150 mcg three times daily · 16-52 weeksAs given in this study (human).
Measurements
MACE incidence
4.7%
pramlintide
MACE incidence
4.5%
pooled comparators
Source sentences
Summary
The incidence of reported MACE was similar between pramlintide (4.7 %) and pooled comparators (4.5 %).
3 context sentences(design, population, supporting numbers)
Summary · context
Cardiovascular safety of pramlintide was assessed using accepted regulatory medical definitions of AEs reported in five randomized, controlled phase 3 and 4 trials of 16-52 weeks' duration in adults with type 2 diabetes.
Summary · context
The original trials compared pramlintide (90-120 mcg twice daily or 30-150 mcg three times daily) with placebo (four studies) or a mealtime rapid-acting insulin analog (one study).
Summary · context
AE data obtained from clinical study reports were combined into one database and analyzed for the intention-to-treat population of 2016 patients (pramlintide, n = 1434; pooled comparator, n = 582).
Show in the study text Report a problemFND-2870224601
02HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, pramlintide MACE risk estimates were 0.86-0.93 versus pooled comparators, with upper 95% confidence limits no greater than 1.8.
In plain wordsIn adults with type 2 diabetes, pramlintide's estimated major cardiovascular risk ratios were 0.86–0.93 versus pooled comparators. The upper confidence limit did not exceed 1.8.
Peptide
Pramlintide (Symlin)
Outcome
Not applicableMACE risk estimates
Study
n = 2,016
Comparator
pooled placebo and mealtime rapid-acting insulin analog comparators
Analysis
Secondary
Outcome group
Cardiovascular events · Cardiovascular
Studied dose
90-120 mcg twice daily or 30-150 mcg three times daily · 16-52 weeksAs given in this study (human).
Measurements
relative risk and hazard ratio point estimates
0.86 to 0.93 ratio
pramlintide versus comparator treatment
Source sentences
Summary
Secondary analyses included MACE relative risk and hazard ratio point estimates, which ranged from 0.86 to 0.93 for pramlintide relative to comparator treatment; the upper limit of the two-sided 95 % confidence interval did not exceed the threshold of 1.8.
3 context sentences(design, population, supporting numbers)
Summary · context
Cardiovascular safety of pramlintide was assessed using accepted regulatory medical definitions of AEs reported in five randomized, controlled phase 3 and 4 trials of 16-52 weeks' duration in adults with type 2 diabetes.
Summary · context
The original trials compared pramlintide (90-120 mcg twice daily or 30-150 mcg three times daily) with placebo (four studies) or a mealtime rapid-acting insulin analog (one study).
Summary · context
AE data obtained from clinical study reports were combined into one database and analyzed for the intention-to-treat population of 2016 patients (pramlintide, n = 1434; pooled comparator, n = 582).
Show in the study text Report a problemFND-2870224602

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Version 2Current
22 Oct 2026, 02:26 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

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