PATHWAY-2

PATHWAY-2

Is spironolactone superior to add-on bisoprolol in patients with drug-resistant HTN?

Study design

Population

• 335 patients (105 female, 230 male)
• Inclusion criteria: patients aged 18-79 years with seated clinic systolic BP ≥ 140 mmHg and home systolic BP ≥ 130 mmH, despite treatment with maximally tolerated doses of 3 antihypertensive drugs for at least 3 months
• Key exclusion criteria: secondary/accelerated HT; T1DM; eGFR < 45 mL/min; sustained AF; non-adherence to antihypertensive treatment

Interventions

• N=285 spironolactone (at a dose of 25 mg/day through week 6, forced uptitration to 50 mg/day through week 12)
• N=285 bisoprolol (at a dose of 5 mg/day through week 6, forced uptitration to 10 mg/day through week 12)

Primary outcome

Significant increase in reduction in home systolic BP through week 6 to week 12 (12.8 mmHg vs. 8.3 mmHg; AD 4.48 mmHg, 95% CI 3.46 to 5.5)

Secondary outcomes

• Significant increase in reduction in home systolic BP at week 12 (14.4 mmHg vs. 8.4 mmHg; AD 5.98 mmHg, 95% Cl 4.51 to 7.45)
• Significant increase in reduction in seated clinic systolic BP through week 6 to week 12 (20.7 mmH vs. 16.3 mmHg; AD 4.45 mmHg, 95% CI 3.11 to 5.8)

Safety outcomes

No significant difference in adverse and serious adverse events.

Conclusion

In patients aged 18-79 years with seated clinic systolic BP ≥ 140 mmHg and home systolic BP ≥ 130 mmH, despite treatment with maximally tolerated doses of 3 antihypertensive drugs for at least 3 months, spironolactone was superior to bisoprolol with respect to reduction in home systolic BP through week 6 to week 12.