Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Nilemdo

Nilemdo 180 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 8

HOS-143241 · Präparat HOS-098954

Decreased haemoglobin Decreases in haemoglobin were observed in clinical trials with bempedoic acid. In the phase 3 primary hyperlipidaemia studies, a decrease in haemoglobin from baseline of ≥ 20 g/L and < lower limit of normal (LLN) was observed in 4.6% of patients in the bempedoic acid group compared with 1.9% of patients on placebo. Greater than 50 g/L and < LLN decreases in haemoglobin were reported at similar rates in bempedoic acid and placebo groups (0.2% versus 0.2%, respectively). The decreases in haemoglobin usually occurred within the first 4 weeks of treatment and returned to baseline following discontinuation of treatment. Among patients who had normal haemoglobin values at baseline, 1.4% in the bempedoic acid group and 0.4% in the placebo group experienced haemoglobin values below LLN while on treatment. In the phase 3 primary hyperlipidemia studies, anaemia was reported in 2.5% of patients treated with bempedoic acid and 1.6% of patients treated with placebo. In the CLEAR Outcomes study, similar decreases in haemoglobin were observed, and anaemia was also reported more frequently in bempedoic acid-treated patients (4.7%) compared to placebo-treated patients (3.9%). An increase in the incidence of anaemia was observed in patients treated concomitantly with bempedoic acid and a fibrate. In the CLEAR outcomes study, anaemia was reported more frequently in bempedoic acid-treated patients taking a fibrate at baseline (9.6%) compared to patients not taking a fibrate (4.5%).

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