Worsening of pre-existing heart failure during treatment was reported as a very common adverse reaction where most cases were resolved with appropriate clinical management without withdrawing Lokelma. The commonly reported adverse reactions were hypokalaemia, oedema related events and constipation.1
In a pooled analysis of three placebo-controlled clinical studies of LOKELMA in non-dialysis patients, some patients with pre-existing heart failure experienced worsening of heart failure, which occurred at a frequency of 13.6% (30/220) on LOKELMA and 5.7% (12/209) on placebo. Most cases resolved with appropriate clinical management without withdrawing LOKELMA1
In clinical trials:
- 5.7% of patients receiving LOKELMA reported oedema-related events, including fluid retention, generalised oedema, hypervolaemia, localised oedema, oedema, oedema peripheral and peripheral swelling.
- 4.1% of patients receiving LOKELMA developed hypokalaemia (serum K+ level <3.5 mmol/L), due to LOKELMA’s mechanism as a highly selective potassium (K+ binder). This side effect was resolved with a dosage adjustment or discontinuation of LOKELMA.
In 2 clinical trials involving 874 patients, the following LOKELMA adverse events were reported:
- Gastrointestinal (GI) events: LOKELMA GI side effects include constipation (2.9%), nausea (1.6%), diarrhoea (0.9%), abdominal pain or distension (0.5%), and vomiting (0.5%).
- Hypersensitivity reactions: rash (0.3%) and pruritus (0.1%).