Toprol XL

Clinical Pharmacology

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Clinical Pharmacology

Toprol XL

The trial was terminated early for a statistically significant reduction in all-cause mortality (34%, nominal p= 0.00009). The risk of all-cause mortality plus all-cause hospitalization was reduced by 19% (p= 0.00012). The trial also showed improvements in heart failure-related mortality and heart failure-related hospitalizations, and NYHA functional class.

The table below shows the principal results for the overall study population. The figure below illustrates principal results for a wide variety of subgroup comparisons, including US vs. non-US populations (the latter of which was not pre-specified). The combined endpoints of all-cause mortality plus all-cause hospitalization and of mortality plus heart failure hospitalization showed consistent effects in the overall study population and the subgroups, including women and the US population. However, in the US subgroup (n=1071) and women (n=898), overall mortality and cardiovascular mortality appeared less affected. Analyses of female and US patients were carried out because they each represented about 25% of the overall population. Nonetheless, subgroup analyses can be difficult to interpret and it is not known whether these represent true differences or chance effects.

Clinical Endpoints in the MERIT-HF Study

Clinical Endpoint	Number of Patients			Risk Reduction With TOPROL-XL	Nominal P-value
Clinical Endpoint	Placebo N=2001	TOPROL-XL N=1990	Relative Risk (95% CI)	Risk Reduction With TOPROL-XL	Nominal P-value
All-cause mortality plus all-cause hospitalization†	767	641	0.81 (0.73-0.90)	19%	0.00012
All-cause mortality	217	145	0.66 (0.53-0.81)	34%	0.00009
All-cause mortality plus heart failure hospitalization†	439	311	0.69 (0.60-0.80)	31%	0.0000008
Cardiovascular mortality	203	128	0.62 (0.50-0.78)	38%	0.000022
Sudden death	132	79	0.59 (0.45-0.78)	41%	0.0002
Death due to worsening heart failure	58	30	0.51 (0.33-0.79)	49%	0.0023
Hospitalizations due to worsening heart failure ‡	451	317	N/A	N/A	0.0000076
† Time to first event ‡ Comparison of treatment groups examines the number of hospitalizations (Wilcoxon test); relative risk and risk reduction are not applicable.

Results for Subgroups in MERIT-HF

Brand Name: Toprol XL
Generic Name: Metoprolol Succinate

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