Excess Mortality in CHF Patients Treated with SR Moxonidine Leads to Study Termination: Results of the SR Moxonidine For Congestive Heart Failure Trial - MOXCON

Description:

The goal of the trial was to compare the effects of SR moxonidine to placebo in patients with CHF.

Hypothesis:

To compare the effects of SR moxonidine to placebo in patients with CHF.

Study Design

Study Design:

Patients Enrolled: 1993
NYHA Class: II-IV
Mean Follow Up: minimum 1 year

Patient Populations:

Patients with NYHA class II-IV heart failure

Primary Endpoints:

Combined endpoint: all-cause mortality and hospitalization for worsening heart failure

Drug/Procedures Used:

SR moxonidine titrated from a dose of 0.25 mg. b.i.d., to 1.5 mg. b.i.d. or the highest tolerated dose

Principal Findings:

The group treated with SR moxonidine had an excess mortality rate (5.4% vs. 3.1%; P = 0.05). This finding prompted study termination. The SR moxonidine group had a higher incidence of hospitalizations due to worsening heart failure and acute myocardial infarctions. Excess deaths in SR moxonidine group occurred at all dosage levels. Plasma norepinephrine levels fell in patients treated with SR moxonidine.

Interpretation:

The results in this study are difficult to explain. Norepinephrine levels were substantially decreased in patients on SR moxonidine who died during the study. Thus, the excess mortality rate was not attributed to the failure of the drug to inhibit the excess activity of the sympathetic nervous system that commonly occurs in heart failure. Instead, these findings suggest that the excess mortality in the SR moxonidine group may be related to the inhibition of the sympathetic nervous system, although study investigators cannot confirm this hypothesis nor explain the possible mechanisms behind it.

References:

ESC 1999, Clinical Trials, presented by Jay N. Cohn, University of Minnesota Medical School, Minnesota, United States

Clinical Topics: Heart Failure and Cardiomyopathies, Acute Heart Failure

Keywords: Myocardial Infarction, Imidazoles, Sympathetic Nervous System, Heart Failure, Norepinephrine


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