Safety
ESPS 2: Adverse Events (Percent within each group)
| Treatment group | Dyspepsia | GI Bleeding | Headache |
|---|---|---|---|
| ER-DP = Extended-Release Dipyridamole ASA = Acetylsalicylic Acid |
|||
| ER-DP + ASA | 18.4 | 4.1 | 39.2 |
| Placebo | 16.7 | 2.1 | 32.9 |
| ASA | 18.1 | 3.2 | 33.8 |
| ER-DP | 17.4 | 2.2 | 38.3 |
This table summarises the incidences of the most common adverse events reported in the four study groups. Dyspepsia, gastrointestinal bleedings, and headache were the most frequently reported adverse events, including the placebo group.
Gastrointestinal events were comparable to ASA
The incidence of dyspepsia with ER-DP + ASA was similar to that with ASA alone (18.4% vs. 18.1%). The incidence of GI bleeding with ER-DP + ASA was comparable to ASA (4.1% vs. 3.2%).
Headache
The most common adverse event with ER-DP + ASA was headache: (39.2% vs. 32.9% with placebo).
Headache was more frequent at the onset of therapy, but diminished over time:
- In healthy volunteers, tolerance developed in a few days.
- Rates fell by half on the second day of dosing, and by the 11th day were 3%-12% (27,35)
References
ESPS 2 Group. J Neurol Sc i 1997; 151 (Suppl): S1-S77.
J Neurol Sci Abstract
