Table 3.

Safety outcomes

OutcomeACE Inhibitor, n=413, n (%)ARB, n=414, n (%)ACE Inhibitor + ARB, n=416, n (%)ACE Versus ARB P ValueaACE Versus Combination P ValueaARB Versus Combination P Valuea
Serious adverse event41 (9.9)41 (9.1)48 (11.5)>0.990.500.50
Permanent discontinuation of therapy65 (15.7)26 (6.3)75 (18.3)<0.0010.40<0.001
Hyperkalemia6 (1.4)7 (1.6)9 (2.1)>0.990.600.80
Hypotension3 (0.7)2 (0.5)2 (0.5)0.690.69>0.99
Cough22 (5.6)1 (0.3)8 (1.9)<0.0010.010.04
  • Serious adverse events were defined as any unfavorable sign, symptom, or medical event, regardless of whether due to study intervention, that resulted in death, life-threatening illness, hospitalization or prolongation of hospitalization, persistent or significant disability, or a serious medical event in the opinion of the responsible investigator. The reasons for discontinuation of medication were adverse event (29.5%), BP not at target (10.2%), cough (2.4%), hospitalization (4.8%), end of study (3.0%), end point (4.2%), hyperkalemia (0.6%), patient decision (0.6%), physician decision in primary care (13.9%), physician decision in cardiology (11.5%), physician decision in nephrology (1.8%), unknown (6.0%), and worsening kidney function (2.4%). ACE, angiotensin-converting enzyme; ARB, angiotensin receptor blocker.

  • a Number of participants experiencing events was compared using the two-sided Fisher exact test.