PRoFESS® - Results
Please note: Aggrenox® did not meet the predefined statistical non-inferiority margin versus clopidogrel. Both regimens show comparable efficacy.
Secondary outcomes
The composite endpoint of PRoFESS is not part of the current Aggrenox® / Asasantin® product label. Therefore, the data concerning the secondary outcomes of PRoFESS is not presented here in detail. For more information regarding the result of PRoFESS, please see Sacco et al. N Engl J Med 2008.
Tertiary outcomes
| ER-DP +ASA | Clopidogrel | HR (ER-DP+ASA) | 95% CI | |
|---|---|---|---|---|
| Sacco RL, Diener HC, Yusuf S et al. N Engl J Med 2008; 359. | ||||
| Number of randomised patients | 10,181 | 10,151 | ||
| MI | 178 (1.7%) | 197 (1.9%) | 0.90 | 0.73, 1.10 |
| New/worsening CHF | 144 (1.4%) | 182 (1.8%) | 0.78 | 0.62, 0.96 |
| Death | 739 (7.3%) | 756 (7.4%) | 0.97 | 0.87, 1.07 |
| Other designated vascular events | 533 (5.2%) | 517 (5.1%) | 1.03 | 0.91, 1.16 |
- The rates of most tertiary (efficacy) outcomes were similar in the
two groups. - A significantly lower incidence of new or worsening congestive heart failure was found in patients treated with extended-release dipyridamole plus ASA (144 patients [1.4%]) than in patients receiving clopidogrel (182 patients [1.8%]; hazard ratio, 0.78; 95% CI, 0.62 to 0.96).
- The occurrence of recurrent stroke or major haemorrhagic events
did not differ significantly in patients receiving extended-release dipyridamole plus ASA (1194 [11.7%]) or clopidogrel (1156 [11.4%]; hazard ratio, 1.03; 95% CI, 0.95 to 1.11).
Recurrent ischaemic strokes (the most common event after stroke) were numerically less frequent in the Aggrenox® group (7.7 % vs. 7.9 %, statistically not significant), while haemorrhagic strokes were more common (0.9 % vs. 0.5 %, p<0.01).
References
Sacco RL, Diener HC, Yusuf S et al. N Engl J Med 2008; 359.
PubMed Abstract
