Safety and tolerability of serial home infusions of nesiritide for advanced heart failure.
Although the therapeutic strategy of serial 6-hour intravenous infusions of nesiritide for advanced chronic heart failure (HF) is currently under investigation, frequent hospital or clinic visits may present logistical challenges for many patients with HF. Therefore, a pilot study was conducted to evaluate the safety and tolerability of serial nesiritide infusions administered at home in this patient population. Twenty patients with advanced HF were enrolled into a protocol for the administration of 12 weekly intravenous infusions of nesiritide (2 microg/kg bolus, 0.01 microg/kg/min for 6 hours) at home. Blood samples and weights were obtained weekly, and clinical assessments were made at 4 and 12 weeks. During the 12-week study period, there were 3 deaths unrelated to nesiritide therapy. Six patients required >or=1 hospitalization for HF. Two of 204 infusions resulted in symptomatic hypotension, and there were no adverse renal events. Mean body weight decreased at week 4 but returned to baseline by week 12. Antibodies to nesiritide were not detected in any patient. In conclusion, serial home infusions of nesiritide in patients with advanced HF appear to be safe and well tolerated, but the efficacy of this therapeutic strategy requires definition in a larger, randomized trial.
Chung
Eugene S
ES
The Lindner Clinical Trial Center, The Christ Hospital, Cincinnati, Ohio, USA. chunge@ohioheart.org
Menon
Santosh G
SG
Daly
Kathleen A
KA
Atkinson
Jennifer
J
Peterson
Tina
T
Robertson
Roxanne
R
Ibanez
Karen
K
Kereiakes
Dean J
DJ
D000368:Aged; D001794:Blood Pressure / Q000187:drug effects; D001835:Body Weight / Q000187:drug effects; D003404:Creatinine / Q000032:analysis; D006333:Heart Failure / Q000188:drug therapy*; D006801:Humans; D007262:Infusions, Intravenous; D045283:Natriuretic Agents / Q000627:therapeutic use*; D020097:Natriuretic Peptide, Brain / Q000097:blood / Q000627:therapeutic use*; D010865:Pilot Projects; D012646:Self Administration; D016896:Treatment Outcome
D045283:Natriuretic Agents; D020097:Natriuretic Peptide, Brain; D003404:Creatinine