Table 3.
Adverse Events and Serious Adverse Events That Occurred during the Treatment Period.
| Event | Chlorthalidone (N = 81) | Placebo (N = 79) | ||
|---|---|---|---|---|
| no. of patients with event (%) | no. of events | no. of patients with event (%) | no. of events | |
| Adverse events | ||||
| Total | 74 (91) | 330 | 68 (86) | 219 |
| Infection | 6 (7) | 6 | 10 (13) | 10 |
| Cardiovascular event | 2 (2) | 2 | 3 (4) | 3 |
| Other | 42 (52) | 57 | 39 (49) | 64 |
| Event of interest | 69 (85) | 265 | 56 (71) | 142 |
| Hypokalemia | 8 (10) | 10 | 0 | 0 |
| Hypomagnesemia | 19 (23) | 35 | 13 (16) | 26 |
| Hyponatremia | 9 (11) | 12 | 6 (8) | 6 |
| Hypocalcemia | 1 (1) | 1 | 1 (1) | 3 |
| Hypercalcemia | 2 (2) | 3 | 2 (3) | 3 |
| Hyperglycemia | 13 (16) | 18 | 4 (5) | 5 |
| Hyperuricemia | 16 (20) | 32 | 7 (9) | 9 |
| Hyperkalemia | 5 (6) | 5 | 7 (9) | 8 |
| Hypernatremia | 0 | 0 | 1 (1) | 1 |
| Acute gout | 2 (2) | 2 | 3 (4) | 3 |
| Syncope | 2 (2) | 2 | 1 (1) | 1 |
| Orthostatic hypotension* | 8 (10) | 12 | 5 (6) | 8 |
| Dizziness† | 20 (25) | 33 | 13 (16) | 24 |
| Asymptomatic orthostatic hypotension‡ | 21 (26) | 39 | 18 (23) | 33 |
| Acute kidney injury | 33 (41) | 61 | 10 (13) | 12 |
| Serious adverse events § | ||||
| Infection | 2 (2) | 3 | 1 (1) | 1 |
| Cardiovascular event | 3 (4) | 3 | 5 (6) | 7 |
| Renal event | 1 (1) | 1 | 1 (1) | 1 |
| Event of interest | 3 (4) | 4 | 0 | 0 |
| Other | 3 (4) | 3 | 5 (6) | 6 |
| Total | 8 (10) | 14 | 11 (14) | 15 |
Orthostatic hypotension was defined as a decrease in the standing systolic blood pressure greater than 20 mm Hg, accompanied by a feeling of dizziness or light-headedness.
Dizziness was recorded when the patient felt dizzy when standing from a seated position but did not have a decrease in the systolic blood pressure greater than 20 mm Hg.
Asymptomatic orthostatic hypotension was defined as a decrease in the standing systolic blood pressure greater than 20 mm Hg that was not accompanied by a feeling of dizziness or light-headedness.
Some patients had multiple serious adverse events. The four events of interest that occurred among the three patients in the chlorthalidone group were orthostatic hypotension, acute kidney injury, hyperglycemia, and hypokalemia.