Aliskiren and Hyperkalaemia: is the FAERS signal real?
Aliskiren ↔ Hyperkalaemia
Aliskiren is a direct renin inhibitor; by suppressing the renin–angiotensin–aldosterone axis it lowers aldosterone and raises serum potassium, so hyperkalaemia is mechanistically expected (76 co-reports here, PRR 20.2), especially in kidney disease, diabetes, or with ACE inhibitors, ARBs, or potassium-sparing diuretics. The ALTITUDE trial combined it with an ACE inhibitor or ARB in diabetic patients and was stopped early for lack of benefit plus excess hyperkalaemia, hypotension, and kidney events; the label now warns against such combinations.
Regulatory basis: aliskiren (Tekturna) prescribing information — hyperkalaemia; ALTITUDE trial (NEJM 2012).
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Potassium rises with therapy |
| Strength | met | PRR 20.2, large |
| Consistency | met | Seen in ALTITUDE and practice |
| Specificity | partial | Shared with ACE inhibitors and ARBs |
| Biological gradient | met | Worse with renal impairment and RAAS blockers |
| Plausibility | met | Direct consequence of renin inhibition |
| Coherence | met | Fits the mechanism |
| Experiment | met | ALTITUDE arm comparison showed the excess |
| Analogy | met | Analogous to ACE-inhibitor hyperkalaemia |
This table is this page's own qualitative read of the literature cited above, not an automated or citation-gated assessment — see the note at the bottom of this page.
✓ Trial evidence found — Efficacy and Safety of Aliskiren and Aliskiren/Enalapril Combination on Morbidity-mortality in Patients With Chronic Heart Failure (NCT00853658)
| Adverse event | Combination of Aliskiren and Enalapril (n=2347) · Aliskiren (n=2348) · Enalapril (n=2345) | ||
|---|---|---|---|
| Hyperkalaemia | 21/2347 | 13/2348 | 20/2345 |
Post-marketing signal terms appear in this trial's posted adverse-event tables; per-arm counts shown as affected/at-risk. View on ClinicalTrials.gov →