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 language | English (US) |
|---|---|
| Pages (from-to) | 884-889 |
| Number of pages | 6 |
| Journal | The American journal of cardiology |
| Volume | 74 |
| Issue number | 9 |
| DOIs | |
| State | Published - Nov 1 1994 |
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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 journal › Article
}
TY - JOUR
T1 - Intravenous diltiazem for the treatment of patients with atrial fibrillation or flutter and moderate to severe congestive heart failure
AU - Goldenberg, Irvin F.
AU - Lewis, William R
AU - Dias, Virgil C.
AU - Heywood, J. Thomas
AU - Pedersen, Wes R.
PY - 1994/11/1
Y1 - 1994/11/1
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.
AB - 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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U2 - 10.1016/0002-9149(94)90580-0
DO - 10.1016/0002-9149(94)90580-0
M3 - Article
VL - 74
SP - 884
EP - 889
JO - American Journal of Cardiology
JF - American Journal of Cardiology
SN - 0002-9149
IS - 9
ER -