Effect of dofetilide in patients with recent myocardial infarction and left-ventricular dysfunction: a randomised trial

L Køber; P E Bloch Thomsen; M Møller; C Torp-Pedersen; J Carlsen; E Sandøe; K Egstrup; E Agner; J Videbaek; B Marchant; A J Camm; Danish Investigations of Arrhythmia and Mortality on Dofetilide (DIAMOND) Study Group

Effect of dofetilide in patients with recent myocardial infarction and left-ventricular dysfunction: a randomised trial

L Køber, P E Bloch Thomsen, M Møller, C Torp-Pedersen, J Carlsen, E Sandøe, K Egstrup, E Agner, J Videbaek, B Marchant, A J Camm, Danish Investigations of Arrhythmia and Mortality on Dofetilide (DIAMOND) Study Group

260 Citations (Scopus)

Abstract

BACKGROUND: Arrhythmias cause much morbidity and mortality after myocardial infarction, but in previous trials, antiarrhythmic drug therapy has not been convincingly effective. Dofetilide, a new class III agent, was investigated for effects on all-cause mortality and morbidity in patients with left-ventricular dysfunction after myocardial infarction. METHODS: In 37 Danish coronary-care units, 1510 patients with severe left-ventricular dysfunction (wall motion index < or = 1.2, corresponding to ejection fraction < or = 0.35) were enrolled in a randomised, double-blind study comparing dofetilide (n=749) with placebo (n=761). The primary endpoint was all-cause mortality. Secondary endpoints included cardiac and arrhythmic mortality and total arrhythmic deaths. Analyses were by intention to treat. FINDINGS: No significant differences were found between the dofetilide and placebo groups in all-cause mortality (230 [31%] vs 243 [32%]), cardiac mortality (191 [26%] vs 212 [28%]), or total arrhythmic deaths (129 [17%] vs 140 [18%]). Atrial fibrillation or flutter was present in 8% of the patients at study entry. In these patients, dofetilide was significantly better than placebo at restoring sinus rhythm (25 of 59 vs seven of 56; p=0.002). There were seven cases of torsade de pointes ventricular tachycardia, all in the dofetilide group. INTERPRETATION: In patients with severe left-ventricular dysfunction and recent myocardial infarction, treatment with dofetilide did not affect all-cause mortality, cardiac mortality, or total arrhythmic deaths. Dofetilide was effective in treating atrial fibrillation or flutter in this population.

Original language	English
Journal	Lancet
Volume	356
Issue number	9247
Pages (from-to)	2052-8
Number of pages	6
ISSN	0140-6736
Publication status	Published - 2000

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Køber, L., Bloch Thomsen, P. E., Møller, M., Torp-Pedersen, C., Carlsen, J., Sandøe, E., Egstrup, K., Agner, E., Videbaek, J., Marchant, B., Camm, A. J., & Danish Investigations of Arrhythmia and Mortality on Dofetilide (DIAMOND) Study Group (2000). Effect of dofetilide in patients with recent myocardial infarction and left-ventricular dysfunction: a randomised trial. Lancet, 356(9247), 2052-8.

Køber, L, Bloch Thomsen, PE, Møller, M, Torp-Pedersen, C , Carlsen, J, Sandøe, E, Egstrup, K, Agner, E, Videbaek, J, Marchant, B, Camm, AJ & Danish Investigations of Arrhythmia and Mortality on Dofetilide (DIAMOND) Study Group 2000, 'Effect of dofetilide in patients with recent myocardial infarction and left-ventricular dysfunction: a randomised trial', Lancet, vol. 356, no. 9247, pp. 2052-8.

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title = "Effect of dofetilide in patients with recent myocardial infarction and left-ventricular dysfunction: a randomised trial",

abstract = "BACKGROUND: Arrhythmias cause much morbidity and mortality after myocardial infarction, but in previous trials, antiarrhythmic drug therapy has not been convincingly effective. Dofetilide, a new class III agent, was investigated for effects on all-cause mortality and morbidity in patients with left-ventricular dysfunction after myocardial infarction. METHODS: In 37 Danish coronary-care units, 1510 patients with severe left-ventricular dysfunction (wall motion index < or = 1.2, corresponding to ejection fraction < or = 0.35) were enrolled in a randomised, double-blind study comparing dofetilide (n=749) with placebo (n=761). The primary endpoint was all-cause mortality. Secondary endpoints included cardiac and arrhythmic mortality and total arrhythmic deaths. Analyses were by intention to treat. FINDINGS: No significant differences were found between the dofetilide and placebo groups in all-cause mortality (230 [31%] vs 243 [32%]), cardiac mortality (191 [26%] vs 212 [28%]), or total arrhythmic deaths (129 [17%] vs 140 [18%]). Atrial fibrillation or flutter was present in 8% of the patients at study entry. In these patients, dofetilide was significantly better than placebo at restoring sinus rhythm (25 of 59 vs seven of 56; p=0.002). There were seven cases of torsade de pointes ventricular tachycardia, all in the dofetilide group. INTERPRETATION: In patients with severe left-ventricular dysfunction and recent myocardial infarction, treatment with dofetilide did not affect all-cause mortality, cardiac mortality, or total arrhythmic deaths. Dofetilide was effective in treating atrial fibrillation or flutter in this population.",

author = "L K{\o}ber and {Bloch Thomsen}, {P E} and M M{\o}ller and C Torp-Pedersen and J Carlsen and E Sand{\o}e and K Egstrup and E Agner and J Videbaek and B Marchant and Camm, {A J} and {Danish Investigations of Arrhythmia and Mortality on Dofetilide (DIAMOND) Study Group}",

note = "Keywords: Adult; Aged; Aged, 80 and over; Anti-Arrhythmia Agents; Atrial Fibrillation; Atrial Flutter; Double-Blind Method; Female; Humans; Male; Middle Aged; Myocardial Infarction; Phenethylamines; Sulfonamides; Ventricular Dysfunction, Left",

year = "2000",

language = "English",

volume = "356",

pages = "2052--8",

journal = "Lancet",

issn = "0140-6736",

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TY - JOUR

T1 - Effect of dofetilide in patients with recent myocardial infarction and left-ventricular dysfunction: a randomised trial

AU - Køber, L

AU - Bloch Thomsen, P E

AU - Møller, M

AU - Torp-Pedersen, C

AU - Carlsen, J

AU - Sandøe, E

AU - Egstrup, K

AU - Agner, E

AU - Videbaek, J

AU - Marchant, B

AU - Camm, A J

AU - Danish Investigations of Arrhythmia and Mortality on Dofetilide (DIAMOND) Study Group

N1 - Keywords: Adult; Aged; Aged, 80 and over; Anti-Arrhythmia Agents; Atrial Fibrillation; Atrial Flutter; Double-Blind Method; Female; Humans; Male; Middle Aged; Myocardial Infarction; Phenethylamines; Sulfonamides; Ventricular Dysfunction, Left

PY - 2000

Y1 - 2000

N2 - BACKGROUND: Arrhythmias cause much morbidity and mortality after myocardial infarction, but in previous trials, antiarrhythmic drug therapy has not been convincingly effective. Dofetilide, a new class III agent, was investigated for effects on all-cause mortality and morbidity in patients with left-ventricular dysfunction after myocardial infarction. METHODS: In 37 Danish coronary-care units, 1510 patients with severe left-ventricular dysfunction (wall motion index < or = 1.2, corresponding to ejection fraction < or = 0.35) were enrolled in a randomised, double-blind study comparing dofetilide (n=749) with placebo (n=761). The primary endpoint was all-cause mortality. Secondary endpoints included cardiac and arrhythmic mortality and total arrhythmic deaths. Analyses were by intention to treat. FINDINGS: No significant differences were found between the dofetilide and placebo groups in all-cause mortality (230 [31%] vs 243 [32%]), cardiac mortality (191 [26%] vs 212 [28%]), or total arrhythmic deaths (129 [17%] vs 140 [18%]). Atrial fibrillation or flutter was present in 8% of the patients at study entry. In these patients, dofetilide was significantly better than placebo at restoring sinus rhythm (25 of 59 vs seven of 56; p=0.002). There were seven cases of torsade de pointes ventricular tachycardia, all in the dofetilide group. INTERPRETATION: In patients with severe left-ventricular dysfunction and recent myocardial infarction, treatment with dofetilide did not affect all-cause mortality, cardiac mortality, or total arrhythmic deaths. Dofetilide was effective in treating atrial fibrillation or flutter in this population.

AB - BACKGROUND: Arrhythmias cause much morbidity and mortality after myocardial infarction, but in previous trials, antiarrhythmic drug therapy has not been convincingly effective. Dofetilide, a new class III agent, was investigated for effects on all-cause mortality and morbidity in patients with left-ventricular dysfunction after myocardial infarction. METHODS: In 37 Danish coronary-care units, 1510 patients with severe left-ventricular dysfunction (wall motion index < or = 1.2, corresponding to ejection fraction < or = 0.35) were enrolled in a randomised, double-blind study comparing dofetilide (n=749) with placebo (n=761). The primary endpoint was all-cause mortality. Secondary endpoints included cardiac and arrhythmic mortality and total arrhythmic deaths. Analyses were by intention to treat. FINDINGS: No significant differences were found between the dofetilide and placebo groups in all-cause mortality (230 [31%] vs 243 [32%]), cardiac mortality (191 [26%] vs 212 [28%]), or total arrhythmic deaths (129 [17%] vs 140 [18%]). Atrial fibrillation or flutter was present in 8% of the patients at study entry. In these patients, dofetilide was significantly better than placebo at restoring sinus rhythm (25 of 59 vs seven of 56; p=0.002). There were seven cases of torsade de pointes ventricular tachycardia, all in the dofetilide group. INTERPRETATION: In patients with severe left-ventricular dysfunction and recent myocardial infarction, treatment with dofetilide did not affect all-cause mortality, cardiac mortality, or total arrhythmic deaths. Dofetilide was effective in treating atrial fibrillation or flutter in this population.

M3 - Journal article

C2 - 11145491

SN - 0140-6736

VL - 356

SP - 2052

EP - 2058

JO - Lancet

JF - Lancet

IS - 9247

ER -

Effect of dofetilide in patients with recent myocardial infarction and left-ventricular dysfunction: a randomised trial

Abstract

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