Table 6.
Adverse events of special interest from randomized controlled trials of aliskiren
| A. Short-term placebo-controlled studies | |||||||
| Adverse event of special interest | Placebo n = 1555 | Aliskiren 150 mg n = 1246 | Aliskiren 300 mg n = 1363 | Aliskiren/HCTZ n = 1464 | HCT n = 555 | Aliskiren/ARB n = 624 | ARB n = 1069 |
| Angioedema/urticaria | 8 (0.5) | 2 (0.2) | 4 (0.3) | 1 (0.1) | 1 (0.2) | 0 | 3 (0.3) |
| Cough | 11 (0.7) | 18 (1.4) | 10 (0.7) | 20 (1.4) | 4 (0.7) | 3 (0.5) | 4 (0.4) |
| Rash | 6 (0.4) | 3 (0.2) | 3 (0.2) | 3 (0.2) | 4 (0.7) | 0 | 1 (0.1) |
| Hypotension | 34 (2.2) | 16 (1.3) | 37 (2.7) | 54 (3.7) | 19 (3.4) | 16 (2.6) | 25 (2.3) |
| Hyperkalemia | 1 (0.1) | 0 | 1 (0.1) | 0 | 1 (0.2) | 0 | 0 |
| Peripheral edema | 12 (0.8) | 6 (0.5) | 18 (1.3) | 13 (0.9) | 7 (1.3) | 1 (0.2) | 5 (0.5) |
| Renal dysfunction | 2 (0.1) | 7 (0.6) | 3 (0.2) | 1 (0.1) | 0 | 2 (0.3) | 2 (0.2) |
| Diarrhea | 19 (1.2) | 18 (1.4) | 27 (2.0) | 24 (1.6) | 10 (1.8) | 10 (1.6) | 17 (1.6) |
| Gastrointestinal bleeding or ulceration | 2 (0.1) | 1 (0.1) | 1 (0.1) | 3 (0.2) | 1 (0.2) | 1 (0.2) | 1 (0.1) |
| B. Long-term active-controlled studies | |||||||
| Adverse event of special interest | Aliskiren alone (all doses) n = 1594 | Aliskiren 150 mg n = 871 | Aliskiren 300 mg n = 723 | All aliskiren* n = 1749 | ARB n = 154 | ACEi n = 866 | HCTZ n = 557 |
| Angioedema/urticaria | 7 (0.4) | 4 (0.5) | 3 (0.4) | 8 (0.5) | 0 | 4 (0.5) | 2 (0.4) |
| Cough | 62 (3.9) | 38 (4.4) | 24 (3.3) | 64 (3.7) | 3 (1.9) | 104 (12.0) | 22 (3.9) |
| Rash | 14 (0.9) | 6 (0.7) | 8 (1.1) | 15 (0.9) | 1 (0.6) | 4 (0.5) | 5 (0.9) |
| Hypotension | 121 (7.6) | 73 (8.4) | 48 (6.6) | 135 (7.7) | 7 (4.5) | 79 (9.1) | 36 (6.5) |
| Hyperkalemia | 2 (0.1) | 1 (0.1) | 1 (0.1) | 2 (0.1) | 1 (0.6) | 2 (0.2) | 0 |
| Peripheral edema | 76 (4.8) | 41 (4.7) | 35 (4.8) | 79 (4.5) | 2 (1.3) | 34 (3.9) | 34 (6.1) |
| Renal dysfunction | 6 (0.4) | 2 (0.2) | 4 (0.6) | 6 (0.3) | 1 (0.6) | 3 (0.3) | 2 (0.4) |
| Diarrhea | 74 (4.6) | 52 (6.0) | 22 (3.0) | 81 (4.6) | 9 (5.8) | 33 (3.8) | 17 (3.1) |
| Gastrointestinal bleeding or ulceration | 3 (0.2) | 1 (0.1) | 2 (0.3) | 5 (0.3) | 1 (0.6) | 2 (0.2) | 2 (0.4) |
Reprinted from the Journal of Clinical Hypertension, volume 12, issue 10, White et al, ‘Safety and tolerability of the direct renin inhibitor aliskiren: a pooled analysis of clinical experience in more than 12,000 patients with hypertension’, pp 765–775, Copyright 2010, with permission from John Wiley and Sons.16
Notes:
“All aliskiren” includes patients who have received aliskiren as monotherapy or in combination with other antihypertensive agents. Data are number (%) of patients. Data are presented according to the treatment group to which patients were randomized, irrespective of doses used during any titration periods.
Abbreviations: ACEi, angiotensin-converting enzyme inhibitor; ARB, angiotensin receptor blocker; HCTZ, hydrochlorothiazide.