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. 2011 Aug 30;2011:0204.
Ref (type) Population Outcome, Interventions Results and statistical analysis Effect size Favours
Headache
[78]
RCT
3-armed trial
642 men aged 18 to 75 years with stable chronic congestive heart failure (all participants were already receiving diuretics and digoxin) Proportion of people with headache
23/186 (12%) with hydralazine plus isosorbide dinitrate
1/273 (0.4%) with placebo

Significance not assessed
[79]
RCT
1050 African-Americans with New York Heart Association (NYHA) class III or IV heart failure with dilated ventricles Proportion of people with headache 6 months
48% with hydralazine plus isosorbide dinitrate
19% with placebo
Absolute numbers not reported

P <0.001
The RCT was terminated early (after 10 months instead of 18 months) because mortality was higher with placebo
Effect size not calculated placebo
Dizziness
[78]
RCT
3-armed trial
642 men aged 18 to 75 years with stable chronic congestive heart failure (all participants were already receiving diuretics and digoxin) Proportion of people with dizziness
12/186 (6%) with hydralazine plus isosorbide dinitrate
5/273 (2%) with placebo

Significance not assessed
[79]
RCT
1050 African-Americans with NYHA class III or IV heart failure with dilated ventricles Proportion of people with dizziness 6 months
29% with hydralazine plus isosorbide dinitrate
12% with placebo
Absolute numbers not reported

P <0.001
The RCT was terminated early (after 10 months instead of 18 months) because mortality was higher with placebo
Effect size not calculated placebo