DUAAL (Double-blind Atorvastatin Amlodipine)

18 Mar, 14

Aim

To investigate whether atorvastatin decreases ischemia by a vascular benefit, independent of LDL-C lowering, in patients with coronary artery disease (CAD)

Patient Profile

311 patients with stable angina (2 attacks/week), CAD history, 3 transient myocardial ischemia (TMI) episodes and/or 15 min ischemia on 48 h ambulatory electrocardiographic (AECG) monitoring

Study Design

Randomized, 2-week, single-blind, placebo run-in phase followed by double-blind treatment phase.
Patients were randomized in 1:1:1 ratio to receive treatment with atorvastatin, amlodipine or both atorvastatin and amlodipine, once-daily for 24 weeks.

Primary Efficacy Endpoint

Number of ischemic episodes during 48 h AECG monitoring at Week 26

Results

At week 26, the median number of ischemic episodes in all three groups decreased significantly (p<0.001, within treatment group).
There was no significant difference among the three treatment groups in the change from baseline.

Fig. Median number of TMI episodes/week, recorded by ambulatory electrocardiographic 48 h monitoring. **P<0.001 vs. baseline

The median duration of TMI episodes decreased by >75% in all three groups.
The mean number of diary reported angina attacks/week in all three arms decreased significantly from baseline by week 18 (P<0.001 for each arm) and effects were maintained at week 26 (p<0.001 for each arm).

Fig. Mean angina attacks/week based on patients' diaries. **P<0.001 vs. baseline.

In the analysis of time to onset of angina or time to onset of ST depression using the log-rank test, there was no statistically significant difference among the three treatment groups at the end of the study.
In each of the three treatment groups, 62-66% of patients had angina at baseline and this was reduced by ~50% at Weeks 18 and 26.
The proportion of patients with ST depression at baseline was between 33 and 40% and this was reduced by ~25-50% at Weeks 18 and 26.

Conclusion

Atorvastatin was as potent an anti-ischemic agent as amlodipine.

Eur Heart J. 2010; 31: 2650-9