Table III.
AEs Associated With Irbesartan/HCTZ Combination Therapy, Irbesartan Monotherapy, and HCTZ Monotherapy
| %of Patients | |||
|---|---|---|---|
| Irbesartan/HCTZ (n=796) | Irbesartan (n=333)a | HCTZ (n=104) | |
| Total AEs | 37.0 | 39.0 | 39.4 |
| Treatment‐related AEs | 12.5 | 10.5 | 7.7 |
| Treatment discontinuations due to AEs | 3.5 | 2.7 | 4.8 |
| Serious AEs | 0.9 | 0.3 | 2.9 |
| Deaths | 0 | 0 | 0 |
| AEs of special interest | 9.6 | 9.9 | 6.7 |
| Dizziness | 3.4 | 1.5 | 1.0 |
| Headache | 4.8 | 5.7 | 4.8 |
| Hyperkalemia | 0.6 | 0 | 1.0 |
| Hypokalemia | 0.7 | 0.3 | 0 |
| Hypotension | 0.7 | 0 | 0 |
| Syncope | 0 | 0 | 1.0 |
| aTwo patients discontinued the study before receiving therapy. Abbreviations: AE, adverse event; HCTZ, hydrochlorothiazide. | |||