Real-world effectiveness and safety of torsemide and spironolactone fixed dose combination in Indian heart failure patients (RESTORE-HF study): a prospective, multicenter, observational study.

Torsemide-spironolactone fixed-dose combination significantly reduced mean body weight over 3 weeks in Indian heart failure patients.

• Mean body weight decreased from 75.54 kg at baseline to 73.13 kg at week 3
• Mean difference of 2.41 kg reduction (p < 0.0001)
• 1752 patients were enrolled across 101 sites in India
• 1520 patients completed the study
• Patients were followed over 3 weeks from baseline

Improvement in NYHA functional class was observed over 3 weeks from baseline following torsemide-spironolactone FDC treatment.

• Change in NYHA functional class was a secondary endpoint
• Improvement was observed over the 3-week follow-up period
• Study enrolled patients with HF with reduced ejection fraction and signs of congestion
• Participants were aged 18-75 years

Edema improved over the 3-week study period, with 22.11% of patients achieving no-edema stage.

• Change in edema was a secondary endpoint
• Overall, 22.11% of patients achieved no-edema stage by week 3
• Edema improvement was assessed from baseline to week 3
• All enrolled patients had signs of congestion at baseline

The torsemide-spironolactone FDC demonstrated a favorable safety profile with very few adverse events reported.

• Only three mild adverse events related to loose stools were reported
• No serious adverse events occurred during the study
• No deaths occurred during the study period
• Occurrence of adverse events was a secondary endpoint

Over 98% of both physicians and patients rated the torsemide-spironolactone FDC therapy favorably in terms of efficacy and tolerability.

• Physician and patient assessments of efficacy and tolerability were secondary endpoints
• More than 98% of physicians rated the therapy favorably
• More than 98% of patients rated the therapy favorably
• Assessments were conducted over the 3-week observation period

The study enrolled a predominantly male, middle-aged Indian heart failure population across 101 sites.

• Of 1841 patients screened, 1752 were enrolled and 1520 completed the study
• Mean (SD) age of participants was 58.61 (9.45) years
• 61.05% of participants were male
• Study was conducted across 101 sites in India
• Eligible patients were aged 18-75 years with HF with reduced ejection fraction and signs of congestion