INTRAVENOUS
NESIRITIDE VS NITROGLYCERIN FOR TREATMENT OF DECOMPENSATED CONGESTIVE HEART
FAILURE: A RANDOMIZED CONTROLLED TRIAL.
Publication
Committee for the VMAC Investigators (Vasodilatation in the Management of Acute
CHF). JAMA 2002 Mar 27;287(12):1531-40.
CONTEXT:
Decompensated congestive heart failure (CHF) is the leading hospital discharge
diagnosis in patients older than 65 years. OBJECTIVE: To compare the efficacy
and safety of intravenous nesiritide, intravenous nitroglycerin, and placebo.
DESIGN,
SETTING, AND PATIENTS: Randomized, double-blind trial of 489 inpatients with
dyspnea at rest from decompensated CHF, including 246 who received pulmonary
artery catheterization, that was conducted at 55 community and academic
hospitals between October 1999 and July 2000.
INTERVENTIONS:
Intravenous nesiritide (n = 204), intravenous nitroglycerin (n = 143), or
placebo (n = 142) added to standard medications for 3 hours, followed by
nesiritide (n = 278) or nitroglycerin (n = 216) added to standard medication
for 24 hours.
MAIN
OUTCOME MEASURES: Change in pulmonary capillary wedge pressure (PCWP) among
catheterized patients and patient self-evaluation of dyspnea at 3 hours after
initiation of study drug among all patients. Secondary outcomes included
comparisons of hemodynamic and clinical effects between nesiritide and
nitroglycerin at 24 hours.
RESULTS:
At 3 hours, the mean (SD) decrease in PCWP from baseline was -5.8 (6.5) mm Hg
for nesiritide (vs placebo, P<.001; vs nitroglycerin, P =.03), -3.8 (5.3) mm
Hg for nitroglycerin (vs placebo, P =.09), and -2 (4.2) mm Hg for placebo. At 3
hours, nesiritide resulted in improvement in dyspnea compared with placebo (P
=.03), but there was no significant difference in dyspnea or global clinical
status with nesiritide compared with nitroglycerin. At 24 hours, the reduction
in PCWP was greater in the nesiritide group (-8.2 mm Hg) than the nitroglycerin
group (-6.3 mm Hg), but patients reported no significant differences in dyspnea
and only modest improvement in global clinical status.
CONCLUSION:
When added to standard care in patients hospitalized with acutely decompensated
CHF, nesiritide improves hemodynamic function and some self-reported symptoms
more effectively than intravenous nitroglycerin or placebo.
COMMENT:
This was a poor comparison as the average dose of NTG was only 30-40 mcg/min, a
suboptimal dose compared to the 400 mcg routinely given sublingually.
Furthermore, the "improvement" yielded was only 2mm Hg, hardly a
clinical significance. Also, there was no significant difference in dyspnea or
global clinical status. Furthermore, by day 7, there were 4 deaths in the nesiritide
group compared to only 1 in the NTG group.