Among the most commonly cited reasons for failure to initiate comprehensive medical therapy in patients with heart failure are concerns relating to hypotension, kidney dysfunction and hyperkalemia. Here we performed a pooled individual participant-level analysis and developed a prediction model to estimate the short-term (2-12 weeks) treatment effects of combination medical therapy on systolic blood pressure (SBP), diastolic BP, estimated glomerular filtration rate (eGFR) and serum potassium. A total of 38,753 participants (16,877 with heart failure with reduced ejection fraction (HFrEF) and 21,876 with heart failure with mildly reduced or preserved ejection fraction (HFmrEF/HFpEF)) across nine randomized trials were included in the analysis, which tested angiotensin receptor blocker-neprilysin inhibitor (ARNI), steroidal mineralocorticoid receptor antagonist (sMRA), nonsteroidal MRA (nsMRA) and sodium glucose cotransporter-2 inhibitors (SGLT2i). For HFrEF, the estimated mean (95% prediction intervals (PIs)) treatment effect on SBP with combination ARNI + SGLT2i + sMRA therapy was -9.2 (-10.6 to -7.8) mmHg. For HFmrEF/HFpEF, the estimated mean (95% PI) treatment effects on SBP with SGLT2i + sMRA therapy and with SGLT2i + nsMRA therapy were -5.9 (-7.3, -4.6) and -4.8 (-5.7, -4.0) mmHg, respectively. For HFrEF, the estimated treatment effects of ARNI + SGLT2i + sMRA on eGFR and serum potassium were -6.8 (-7.9, -5.4) ml min-1 m-2 and +0.30 (0.25, 0.35) mmol l-1, respectively. For HFmrEF/HFpEF, the treatment effects for combination SGLT2i + sMRA and SGLT2i + nsMRA on eGFR were -7.7 (-8.9, -6.4) and -6.1 (-6.7, -5.5) ml min-1 m-2, respectively and for serum potassium were +0.34 (0.29, 0.38) and +0.21 (0.18, 0.25) mmol l-1, respectively. These analyses provide individualized estimates of the expected treatment effect for any combination of medical therapies in HFrEF and HFmrEF/HFpEF on BP, kidney function and serum potassium.
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