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Göteborgs universitets publikationer

Efficacy of sacubitril/valsartan vs. enalapril at lower than target doses in heart failure with reduced ejection fraction: the PARADIGM-HF trial

Författare och institution:
O. Vardeny (-); B. Claggett (-); M. Packer (-); M. R. Zile (-); J. Rouleau (-); Karl Swedberg (Institutionen för medicin, avdelningen för molekylär och klinisk medicin); J. R. Teerlink (-); A. S. Desai (-); M. Lefkowitz (-); V. Shi (-); J. J. McMurray (-); S. D. Solomon (-)
Publicerad i:
European journal of heart failure, Epub ahead of print
1879-0844 (Electronic) 1388-9842 (Linking)
Artikel, refereegranskad vetenskaplig
Sammanfattning (abstract):
AIMS: In this analysis, we utilized data from PARADIGM-HF to test the hypothesis that participants who exhibited any dose reduction during the trial would have similar benefits from lower doses of sacubitril/valsartan relative to lower doses of enalapril. METHODS AND RESULTS: In a post-hoc analysis from PARADIGM-HF, we characterized patients by whether they received the maximal dose (200 mg sacubitril/valsartan or 10 mg enalapril twice daily) throughout the trial or had any dose reduction to lower doses (100/50/0 mg sacubitril/valsartan or 5/2.5/0 mg enalapril twice daily). The treatment effect for the primary outcome was estimated, stratified by dose level using time-updated Cox regression models. In the two treatment arms, participants with a dose reduction (43% of those randomized to enalapril and 42% of those randomized to sacubitril/valsartan) had similar baseline characteristics and similar baseline predictors of the need for dose reduction. In a time-updated analysis, any dose reduction was associated with a higher subsequent risk of the primary event [hazard ratio (HR) 2.5, 95% confidence interval (CI) 2.2-2.7]. However, the treatment benefit of sacubitril/valsartan over enalapril following a dose reduction was similar (HR 0.80, 95% CI 0.70-0.93, P < 0.001) to that observed in patients who had not experienced any dose reduction (HR 0.79, 95% CI 0.71-0.88, P < 0.001). CONCLUSIONS: In PARADIGM-HF, study medication dose reduction identified patients at higher risk of a major cardiovascular event. The magnitude of benefit for patients on lower doses of sacubitril/valsartan relative to those on lower doses of enalapril was similar to that of patients who remained on target doses of both drugs.
Ämne (baseras på Högskoleverkets indelning av forskningsämnen):
Klinisk medicin
Postens nummer:
Posten skapad:
2016-08-05 11:22
Posten ändrad:
2016-08-17 16:08

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