Table 3 Tabular summary of retained studies providing estimates of the cumulative incidence of ACEI-AE
Reference | Mancia & Schumacher | Makani et al. | Burkhart et al. | Toh et al. |
|---|---|---|---|---|
Region | Global | Global | USA | USA |
Time period | 1994–2007 | 1980–2011 | 1986–1992 | 2001–2010 |
Design | Pooled analysis of 12 randomized controlled trials of ACEI vs. ARB from Boehringer Ingelheim database | Syst. review of 26 randomized trials indexed in PubMed, CENTRAL or EMBASE, comparing ACEI vs. placebo or other antihypertensives | Retrospective inception cohort study, Michigan, Ohio and Tennessee Medicaid records, age 15+ | Retrospective inception cohort study, age 18+, 17 US health plans in Mini-Sentinel program |
Reference population | 4708 patients with hypertension, of which 2144 on ACEI | 74,857 patients on ACEI, 232,532 patient-years of follow-up | 155,258 patients on ACEI, 155,437 patient-years of exposure | 65,006,161 health plan members >18y, of which 1,845,138 ACEI initiators |
Angioedema Cases | 4 on ACEI vs. 0 on ARB | 394 on ACEI | 285 on ACEI | 3301 on ACEI |
Diagn. criteria | MedDRA v. 8.1 Adv. event coding | As reported in original trials | ICD 995.1 | ICD 995.1 |
Calculated prevalence | 0.2% or 2 per 1000 person-years | 0.3% or 3 per 1000 person-years (95% CI: 0.28% to 0.32%) | 1.2 per 1000 person-years (adjusted) 1.8 per 1000 (unadjusted) | 1.8 per 1000 person-years (0.18%) |