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- Irwin Hoffman, MD, FACCa
Macdonald et al. (1)have reported favorably on the use of carvedilol in patients with New York Heart Association functional class IV heart failure. However, no mortality figures were stated. Table 3, “Nonfatal Adverse Events,” indicates that 27 of 63 patients in functional class IV experienced adverse events, most commonly worsening heart failure. But no information on the number of deaths in the 63 patients is reported. On page 933, “Actuarial Survival,” the statement is made that “the 1-year mortality of 16 ± 5% in this patient group treated with carvedilol compares favorably with the mortality reported for similar patient groups in other studies.” However, patients in functional class IV heart failure with certain unfavorable characteristics were excluded. The following were the exclusion criteria: cardiogenic shock, intractable pulmonary or systemic edema, heart failure requiring intravenous inotropic or mechanical support, bradycardia with heart rate <50 beats/min, systemic hypotension with blood pressure <80/50 mm Hg or chronic air flow limitation with evidence of ≥20% reversibility in airway obstruction in response to inhaled salbutamol. It would seem reasonable to expect that with these very sick patients excluded from the treatment group, the mortality figures in the remainder receiving carvedilol would be clearly favorable in comparison to any control group, if carvedilol were indeed beneficial.
Because adverse events with carvedilol therapy usually occur early in the treatment course, it would be important to know not only how many of the treated patients in functional class IV died, but also the duration of their treatment before death. One would anticipate that the deaths occurred early.
Additional data on the survival of patients in functional class IV heart failure treated with carvedilol are clearly needed.
- American College of Cardiology