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Mortality in two recent reports of clinical trials on patients with congestive heart failure compared with mortality
Insights
Spironolactone reduced excess mortality in congestive heart failure (CHF) patients. Dofetilide did not significantly reduce mortality in patients with atrial fibrillation (AF), with higher excess death rates observed in severe CHF cases.
Area of Science:
- Cardiology
- Pharmacology
- Medical Statistics
Background:
- Previous clinical trials on drug treatment for congestive heart failure (CHF) mortality were reported in the Journal of Insurance Medicine.
- This study presents results from two recent clinical trials and compares them with prior findings.
Purpose of the Study:
- To evaluate the effectiveness of Spironolactone and Dofetilide in reducing mortality in congestive heart failure (CHF) patients.
- To compare the excess death rates (EDRs) between drug treatment groups and placebo groups.
- To analyze the impact of CHF severity on mortality rates.
Main Methods:
- Conducted two international multicenter clinical trials comparing drug treatments (Spironolactone, Dofetilide) against placebo.
- Measured excess mortality using excess death rates (EDRs) per 1000 per year.
- Classified patient severity using the New York Heart Association (NYHA) classification.
Main Results:
- Spironolactone reduced EDR from 195 to 139 per 1000 per year.
- Dofetilide showed no significant reduction in EDR for atrial fibrillation (AF) patients (224 placebo vs. 216 Dofetilide).
- Higher EDRs were observed in both studies due to a greater proportion of severe CHF patients; EDR increased progressively with NYHA class (173 class 2, 237 class 3, 392 class 4).
Conclusions:
- Excess mortality in symptomatic CHF is significant and may exceed individual life insurance limits.
- Findings suggest potential utility for underwriting structured settlement annuities for CHF patients.
- Drug efficacy varies, with Spironolactone showing a mortality benefit while Dofetilide did not significantly impact AF-related mortality in this CHF cohort.
Background:
Several clinical trials of drug treatment of patients with congestive heart failure (CHF) have previously been reported as Mortality Abstracts in the Journal of Insurance Medicine. Results are presented here for two similar clinical trials reported in September 1999 and compared with the previous results.
Results:
In a recent international multicenter clinical trial, excess mortality in terms of excess death rates (EDRs) was reduced from 195 per 1000 per year in the placebo group to 139 in the group treated with Spironolactone. There was no significant reduction in the Danish multicenter study of Dofetilide to convert the atrial fibrillation (AF) to a normal rhythm in the 25% of the CHF patients who had AF (EDR was 224 in the placebo group and 216 in the Dofetilide group). In both of these studies, there were more patients with severe CHF than in the previous studies and the EDR values were higher. Results from the Danish study by severity according to the New York Heart Association (NYHA) classification show a progressive increase in EDR from 173 in class 2 to 237 in class 3 to 392 in class 4.
Conclusion:
Excess mortality in symptomatic CHF is far outside the issue limits for individual life insurance, but these results are of potential utility for the underwriting of such cases for structured settlement annuities.
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