Why the study?
To investigate whether atorvastatin decreases ischaemia through vascular benefit independent of LDL-C lowering in CAD, alone and combined with amlodipine.
Does atorvastatin alone or in combination with amlodipine reduce transient myocardial ischaemia episodes on 48 h ambulatory ECG monitoring compared with amlodipine alone in patients with chronic stable angina and coronary artery disease?
RCT (n=311)
Double-blind, double-dummy (with 2-week single-blind placebo run-in)
1:1:1 ratio using a computer-generated randomization code
Yes
Does atorvastatin alone or in combination with amlodipine reduce transient myocardial ischaemia episodes on 48 h ambulatory ECG monitoring compared with amlodipine alone in patients with chronic stable angina and coronary artery disease?
In patients with chronic stable angina and coronary artery disease, high-dose atorvastatin reduced transient myocardial ischaemia, angina frequency, and nitroglycerin consumption as potently as amlodipine while additionally lowering high-sensitivity C-reactive protein, though combining both agents provided no additional anti-ischaemic benefit.
Statin monotherapy matches amlodipine for ischaemia reduction in stable angina; confirms anti-ischaemic effects beyond LDL lowering.
AIMS: The DoUble-blind Atorvastatin AmLodipine (DUAAL) trial investigated whether atorvastatin decreases ischaemia by a vascular benefit, independent of low-density lipoprotein cholesterol lowering, in patients with coronary artery disease (CAD), both alone and in combination with the traditional anti-anginal therapy, amlodipine. METHODS AND RESULTS: Randomized, double-blind, parallel-group, multicountry trial (2 weeks run-in and 24 weeks active therapy) comparing three treatments: amlodipine, atorvastatin, and amlodipine + atorvastatin; in 311 patients (78% male; mean age 62 years) with stable angina (≥ 2 attacks/week), CAD history, ≥ 3 transient myocardial ischaemia (TMI) episodes, and/or ≥ 15 min ischaemia on 48 h ambulatory electrocardiographic (AECG) monitoring. Efficacy variables were change in TMI by AECG, exercise ischaemia, angina diary data, and inflammatory biomarkers at Week 26. There was a comparable, highly significant decrease in TMI with amlodipine and atorvastatin, but no additional benefit for the combination. More than 50% of patients became TMI-free in all three groups and this was accompanied by a comparable, marked reduction in angina and nitroglycerin consumption. High-sensitivity C-reactive protein fell by 40% in patients receiving atorvastatin but there was no change with amlodipine. Adverse events were comparable among groups. CONCLUSION: Atorvastatin was as potent an anti-ischaemic agent as amlodipine. Future studies of combination therapies will be instructive. CLINICAL TRIAL REGISTRATION INFORMATION: National clinical trial number: NCT00159718, protocol number A0531031 listed on http://clinicaltrials.gov/.
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Deanfield et al. (2010) conducted an RCT in Chronic stable angina and coronary artery disease (CAD) with transient myocardial ischaemia (TMI) (n=311). Atorvastatin or Amlodipine + Atorvastatin vs. Amlodipine monotherapy (5 mg/day titrated to 10 mg/day at Week 6) was evaluated on Change from baseline in the number of ischaemic episodes during 48 h ambulatory ECG monitoring at Week 26 (p=0.922).
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