PMID- 28702246
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20201001
IS  - 2055-8260 (Print)
IS  - 2055-8260 (Electronic)
IS  - 2055-8260 (Linking)
VI  - 2
DP  - 2016
TI  - Cardiovascular safety assessment of pramlintide in type 2 diabetes: results from 
      a pooled analysis of five clinical trials.
PG  - 12
LID - 10.1186/s40842-016-0030-z [doi]
LID - 12
AB  - BACKGROUND: This 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. METHODS: 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. 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. RESULTS: The 
      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. CONCLUSIONS: Both 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.
FAU - Herrmann, Kathrin
AU  - Herrmann K
AD  - Bristol-Myers Squibb/AstraZeneca, San Diego, CA USA.
FAU - Zhou, Ming
AU  - Zhou M
AD  - Bristol-Myers Squibb, Hopewell, NJ USA. GRID: grid.419971.3
FAU - Wang, Andrew
AU  - Wang A
AD  - Bristol-Myers Squibb, Hopewell, NJ USA. GRID: grid.419971.3
FAU - de Bruin, Tjerk W A
AU  - de Bruin TWA
AD  - AstraZeneca CVMD GMD, One Medimmune Way, Gaithersburg, MD 20878 USA.
LA  - eng
PT  - Journal Article
DEP - 20160511
PL  - England
TA  - Clin Diabetes Endocrinol
JT  - Clinical diabetes and endocrinology
JID - 101669619
PMC - PMC5471856
OTO - NOTNLM
OT  - Amylin
OT  - Cardiovascular safety
OT  - Insulin
OT  - Major adverse cardiovascular events
OT  - Pramlintide
OT  - Type 2 diabetes
EDAT- 2016/05/11 00:00
MHDA- 2016/05/11 00:01
PMCR- 2016/05/11
CRDT- 2017/07/14 06:00
PHST- 2015/12/31 00:00 [received]
PHST- 2016/04/19 00:00 [accepted]
PHST- 2017/07/14 06:00 [entrez]
PHST- 2016/05/11 00:00 [pubmed]
PHST- 2016/05/11 00:01 [medline]
PHST- 2016/05/11 00:00 [pmc-release]
AID - 30 [pii]
AID - 10.1186/s40842-016-0030-z [doi]
PST - epublish
SO  - Clin Diabetes Endocrinol. 2016 May 11;2:12. doi: 10.1186/s40842-016-0030-z. 
      eCollection 2016.