Table 3 Selected adverse events

From: Lifetime benefits of comprehensive medical therapy in heart failure with mildly reduced or preserved ejection fraction

Safety event

DELIVER

FINEARTS-HF

PARAGON-HF

Dapagliflozin

Placebo

Finerenone

Placebo

Sacubitril/valsartan

Valsartan

Any serious adverse event

1,361/3,126 (43.5)

1,423/3,127 (45.5)

1,157/2,993 (38.7)

1,213/2,993 (40.5)

1,424/2,419 (58.9)

1,416/2,402 (59.0)

Renal impairment

10/3,126 (0.3)

7/3,127 (0.2)

57/2,897 (2.0)

34/2,888 (1.2)

38/2,407 (1.6)

40/2,389 (1.7)

Hypotension

6/3,126 (0.2)

1/3,127 (0.0)

538/2,911 (18.5)

361/2,904 (12.4)

380/2,407 (15.8)

257/2,389 (10.8)

Elevated serum potassium >5.5 mmol l−1

–

–

413/2,898 (14.3)

199/2,889 (6.9)

316/2,386 (13.2)

361/2,367 (15.3)

  1. Adverse events were defined differently across trials and were collected in the safety analytic sets. Renal impairment was defined as events leading to permanent study drug discontinuation (in DELIVER) and as serum creatinine levels ≥3.0 mg dl−1 (in FINEARTS-HF and PARAGON-HF). Hypotension was defined as events leading to permanent study drug discontinuation (in DELIVER), any visit systolic blood pressure <100 mm Hg (in FINEARTS-HF) and investigator-reported hypotension with systolic blood pressure <100 mm Hg (in PARAGON-HF). Serum potassium levels after randomization were not collected in the DELIVER trial.
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