Evidence map›Paper›PMID 28702246›Full record

ArticleClinical diabetes and endocrinology2016

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

Kathrin Herrmann, Ming Zhou, Andrew Wang, Tjerk W A de Bruin

Open access · goldAbstract read
In one paragraph

Article in Clinical diabetes and endocrinology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.2field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 18 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
  4. Amylin as a Future Obesity Treatment.Journal of obesity & metabolic syndrome · 2021
    Review
  5. Review
  6. Article
  7. Article
  8. Update on Management of Type 2 Diabetes for Cardiologists.Methodist DeBakey cardiovascular journal
    Review
  9. Cardiovascular outcomes and safety with antidiabetic drugs.International journal of health sciences
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 2 institutions in 1 country.

Kathrin HerrmannBristol-Myers Squibb/AstraZeneca, San Diego, CA USA.
Ming ZhouBristol-Myers Squibb, Hopewell, NJ USA.
Andrew WangBristol-Myers Squibb, Hopewell, NJ USA.
Tjerk W A de BruinAstraZeneca CVMD GMD, One Medimmune Way, Gaithersburg, MD 20878 USA.
AstraZeneca (United States) · USBristol-Myers Squibb (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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,

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.

Indexed as

AmylinCardiovascular safetyInsulinMajor adverse cardiovascular eventsPramlintideType 2 diabetes

Identifiers

PMID28702246
PMCPMC5471856
OpenAlexW2346937144

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.