Table 2.
Patients with adverse events (AEs)
| Losartan (N = 152), n (%) | Amlodipine/Placebo (N = 154), n (%) | Difference Losartan versus Amlodipine/Placebo, % (95% CI)a | |
|---|---|---|---|
| Clinical AEs | |||
| one or more AEs | 93 (61.2) | 85 (55.2) | 6.0 (−5.1 to 16.9) |
| no AE | 59 (38.8) | 69 (44.8) | |
| drug-relatedb AEs | 8 (5.3) | 8 (5.2) | 0.1 (−5.3 to 5.5) |
| serious AE | 7 (4.6) | 5 (3.2) | 1.4 (−3.4, 6.4) |
| serious drug-related AEs | 0 | 2 (1.3) | −1.3 (−4.6 to 1.2) |
| died | 0 | 0 | – |
| discontinuedd due to AE | 1 (0.7) | 6 (3.9) | −3.2 (−7.7 to 0.2) |
| discontinued due to drug-related AE | 0 | 3 (1.9) | – |
| discontinued due to a serious AE | 1 (0.7) | 2 (1.3) | – |
| discontinued due to a serious drug-related AE |
0 | 2 (1.3) | – |
| Laboratory AEs | |||
| one or more AEs | 8 (5.3) | 12 (7.8) | −2.5 (−8.5 to 3.3) |
| no AE | 144 (94.7) | 142 (92.2) | – |
| drug-relatedb AEs | 0 | 3 (1.9) | −1.9 (−5.6 to 0.6) |
| serious AE | 0 | 0 | – |
| serious drug-related AEs | 0 | 0 | – |
| discontinuedc due to AE | 0 | 0 | – |
| discontinued due to drug-related AE | 0 | 0 | – |
| discontinued due to a serious AE | 0 | 0 | – |
| discontinued due to a serious drug-related AE |
0 | 0 | – |
| AEs of special interestd | |||
| renal dysfunction | 2 (1.3) | 3 (1.9) | −0.63 (−4.42 to 2.95) |
| hyperkalemia | 0 | 0 | – |
| hypotension | 1 (0.7) | 0 | 0.7 (−1.8 to 3.6) |
| angioedema | 0 | 0 | – |
Based on Miettinen-Nurminen method.
Determined by the investigator to be related to the drug.
Study medication withdrawn.
Renal dysfunction, hyperkalemia, hypotension, and angioedema: Five instances of renal dysfunction were reported: two on losartan (one hypertensive patient with GFR decrease from 80 to 58 ml/min per 1.73 m2, deemed study drug-related, and one normotensive patient with a GFR drop from 161 to 76 ml/min per 1.73 m2, felt to be related to worsening of nephrotic syndrome but not to study drug); one on placebo (GFR change 54 to 30 ml/min per 1.73 m2), considered drug-related; and two in the amlodipine group, which were not drug-related (GFR decreases of 47 to 32 ml/min per 1.73 m2 and 40 to 36 ml/min per 1.73 m2). One case of non-drug-related hyperkalemia occurred at the end of the 4-week run-in on the day of randomization before study drug (losartan) was started. One report of hypotension in a normotensive patient on losartan, considered drug-related: a 7-year-old was “quieter than usual,” and upon reducing the losartan dose, the patient resumed his previous level of activity.