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. Author manuscript; available in PMC: 2022 Jun 30.
Published in final edited form as: N Engl J Med. 2021 Nov 5;385(27):2507–2519. doi: 10.1056/NEJMoa2110730

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.