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

Table 3 Comparative incidence of investigator-reported CV events in five pooled clinical trials with pramlintide as adjunct to insulin

Event definition, n (%)	Pramlintide (n = 1434)	Pooled comparator (n = 582)	Risk ratio (95 % CI)
Primary MACE^a
Incidence, n (%)	67 (4.7)	26 (4.5)
Event rate per 1000 patient-years	95.12	91.98	1.034 (0.694–1.540)
Subset MACE^b
Incidence, n (%)	32 (2.2)	12 (2.1)
Event rate per 1000 patient-years	37.63	36.23	1.039 (0.551–1.958)
SMQ MACE^c
Incidence, n (%)	49 (3.4)	15 (2.6)
Event rate per 1000 patient-years	60.63	50.17	1.208 (0.712–2.051)
Broad CV^d
Incidence, n (%)	127 (8.9)	43 (7.4)
Event rate per 1000 patient-years	190.24	189.53	1.004 (0.760–1.326)

Overall incidence in the pooled population was 4.6 % for primary MACE, 2.2 % for subset MACE, 3.2 % for SMQ MACE, and 8.4 % for broad CV
CI confidence interval, CV cardiovascular, MACE major adverse cardiovascular events, SMQ MACE standardized Medical Dictionary for Regulatory Activities query for MACE
^aPrimary MACE included CV mortality, myocardial infarction, stroke, hospitalization for acute coronary syndrome, and urgent revascularization procedures
^bSubset MACE included CV mortality, myocardial infarction, and stroke only
^cSMQ MACE included myocardial infarction, central nervous system hemorrhages, and cerebrovascular accidents
^dBroad CV included CV mortality, myocardial infarction, stroke, hospitalization for acute coronary syndrome, urgent revascularization procedures, arrhythmia, heart failure, or mechanical-related events

ISSN: 2055-8260