Intravenous diltiazem for the treatment of patients with atrial fibrillation or flutter and moderate to severe congestive heart failure

Irvin F. Goldenberg, William R Lewis, Virgil C. Dias, J. Thomas Heywood, Wes R. Pedersen

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Abstract

The objective of this multicenter, randomized, double-blind, placebo-controlled study was to determine the safety and efficacy of intravenous diltiazem in the treatment of 37 patients with rapid (ventricular rate, mean ± SD 142 ± 17 beats/min) atrial fibrillation or flutter and moderate to severe congestive heart failure (ejection fraction, mean ± SD 36 ± 14%; New York Heart Association class III [23 patients], class IV [14 patients]). During the double-blind portion of the study, patients received either intravenous diltiazem, 0.25 mg/kg over 2 minutes, or placebo followed 15 minutes later by diltiazem or placebo, 0.35 mg/kg over 2 minutes, if the first dose was tolerated but ineffective. Placebo nonresponders were given open-label intravenous diltiazem in a similar fashion as in the double-blind portion of the study. In the double-blind part of the study, 21 (18 with 0.25 mg/kg, 3 with an additional 0.35 mg/kg) of the 22 patients (95%) responded to diltiazem, and 0 of 15 patients (0%) responded to placebo (p < 0.001). All 15 patients (13 with 0.25 mg/kg and 2 with an additional 0.35 mg/kg) who received placebo during the double-blind period had a therapeutic response to diltiazem during open-label therapy. Overall, 36 of 37 patients (97%) had a therapeutic response to intravenous diltiazem. Heart rate response to diltiazem after the 2-minute bolus infusions consisted of a ≥20% decrease in heart rate from baseline in 36 patients; in addition, 17 patients also had heart rates decreased to <100 beats/min, whereas no patient had conversion to sinus rhythm. The median time to response from the beginning of the 2-minute bolus dose of diltiazem was about 5 minutes. Hypotension was the most common adverse event occurring in 4 of the 37 patients (11%). No patient had an exacerbation of congestive heart failure due to diltiazem. In conclusion, intravenous diltiazem is rapid, safe, and effective in acutely lowering a rapid ventricular rate in patients with atrial fibrillation or flutter and moderate to severe congestive heart failure.

Original languageEnglish (US)
Pages (from-to)884-889
Number of pages6
JournalThe American journal of cardiology
Volume74
Issue number9
DOIs
StatePublished - Nov 1 1994

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Atrial Flutter
Diltiazem
Atrial Fibrillation
Heart Failure
Placebos
Therapeutics
Double-Blind Method
Heart Rate
Hypotension

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Intravenous diltiazem for the treatment of patients with atrial fibrillation or flutter and moderate to severe congestive heart failure. / Goldenberg, Irvin F.; Lewis, William R; Dias, Virgil C.; Heywood, J. Thomas; Pedersen, Wes R.

In: The American journal of cardiology, Vol. 74, No. 9, 01.11.1994, p. 884-889.

Research output: Contribution to journalArticle

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abstract = "The objective of this multicenter, randomized, double-blind, placebo-controlled study was to determine the safety and efficacy of intravenous diltiazem in the treatment of 37 patients with rapid (ventricular rate, mean ± SD 142 ± 17 beats/min) atrial fibrillation or flutter and moderate to severe congestive heart failure (ejection fraction, mean ± SD 36 ± 14{\%}; New York Heart Association class III [23 patients], class IV [14 patients]). During the double-blind portion of the study, patients received either intravenous diltiazem, 0.25 mg/kg over 2 minutes, or placebo followed 15 minutes later by diltiazem or placebo, 0.35 mg/kg over 2 minutes, if the first dose was tolerated but ineffective. Placebo nonresponders were given open-label intravenous diltiazem in a similar fashion as in the double-blind portion of the study. In the double-blind part of the study, 21 (18 with 0.25 mg/kg, 3 with an additional 0.35 mg/kg) of the 22 patients (95{\%}) responded to diltiazem, and 0 of 15 patients (0{\%}) responded to placebo (p < 0.001). All 15 patients (13 with 0.25 mg/kg and 2 with an additional 0.35 mg/kg) who received placebo during the double-blind period had a therapeutic response to diltiazem during open-label therapy. Overall, 36 of 37 patients (97{\%}) had a therapeutic response to intravenous diltiazem. Heart rate response to diltiazem after the 2-minute bolus infusions consisted of a ≥20{\%} decrease in heart rate from baseline in 36 patients; in addition, 17 patients also had heart rates decreased to <100 beats/min, whereas no patient had conversion to sinus rhythm. The median time to response from the beginning of the 2-minute bolus dose of diltiazem was about 5 minutes. Hypotension was the most common adverse event occurring in 4 of the 37 patients (11{\%}). No patient had an exacerbation of congestive heart failure due to diltiazem. In conclusion, intravenous diltiazem is rapid, safe, and effective in acutely lowering a rapid ventricular rate in patients with atrial fibrillation or flutter and moderate to severe congestive heart failure.",
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AU - Pedersen, Wes R.

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N2 - The objective of this multicenter, randomized, double-blind, placebo-controlled study was to determine the safety and efficacy of intravenous diltiazem in the treatment of 37 patients with rapid (ventricular rate, mean ± SD 142 ± 17 beats/min) atrial fibrillation or flutter and moderate to severe congestive heart failure (ejection fraction, mean ± SD 36 ± 14%; New York Heart Association class III [23 patients], class IV [14 patients]). During the double-blind portion of the study, patients received either intravenous diltiazem, 0.25 mg/kg over 2 minutes, or placebo followed 15 minutes later by diltiazem or placebo, 0.35 mg/kg over 2 minutes, if the first dose was tolerated but ineffective. Placebo nonresponders were given open-label intravenous diltiazem in a similar fashion as in the double-blind portion of the study. In the double-blind part of the study, 21 (18 with 0.25 mg/kg, 3 with an additional 0.35 mg/kg) of the 22 patients (95%) responded to diltiazem, and 0 of 15 patients (0%) responded to placebo (p < 0.001). All 15 patients (13 with 0.25 mg/kg and 2 with an additional 0.35 mg/kg) who received placebo during the double-blind period had a therapeutic response to diltiazem during open-label therapy. Overall, 36 of 37 patients (97%) had a therapeutic response to intravenous diltiazem. Heart rate response to diltiazem after the 2-minute bolus infusions consisted of a ≥20% decrease in heart rate from baseline in 36 patients; in addition, 17 patients also had heart rates decreased to <100 beats/min, whereas no patient had conversion to sinus rhythm. The median time to response from the beginning of the 2-minute bolus dose of diltiazem was about 5 minutes. Hypotension was the most common adverse event occurring in 4 of the 37 patients (11%). No patient had an exacerbation of congestive heart failure due to diltiazem. In conclusion, intravenous diltiazem is rapid, safe, and effective in acutely lowering a rapid ventricular rate in patients with atrial fibrillation or flutter and moderate to severe congestive heart failure.

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