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Nilemdo · 4.8 Undesirable effects · 1
Eintrag öffnenNilemdo · 4.8 · 6 Tabulated list of adverse reactions
Eintrag öffnenNilemdo · 4.8 · 7 patients treated with placebo (see section 4.4). In the CLEAR Outcomes study, a mean increase of 47.6 microm
Eintrag öffnenNilemdo · 4.8 · 8 Reporting of suspected adverse reactions
Eintrag öffnenNilemdo · 4.8 · Adverse reactions reported with bempedoic acid, based on incidence rates from phase 3 primary hyperlipidaemia
Eintrag öffnenNilemdo · 4.8 · Decreased haemoglobin Decreases in haemoglobin were observed in clinical trials with bempedoic acid. In the ph
Eintrag öffnenNilemdo · 4.8 · Description of selected adverse reactions
Eintrag öffnenNilemdo · 4.8 · Effects on serum creatinine and blood urea nitrogen Bempedoic acid has been shown to increase serum creatinine
Eintrag öffnenNilemdo · 4.8 · Elderly population
Eintrag öffnenNilemdo · 4.8 · Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100);
Eintrag öffnenNilemdo · 4.8 · Hepatic enzyme elevations Increases in serum transaminases (AST and/or ALT) have been reported with bempedoic
Eintrag öffnenNilemdo · 4.8 · Increased serum uric acid Increases in serum uric acid were observed in clinical trials with bempedoic acid po
Eintrag öffnenNilemdo · 4.8 · Of the 3 621 patients treated with bempedoic acid in the phase 3 primary hyperlipidemia studies, 2 098 (58%) w
Eintrag öffnenNilemdo · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenNilemdo · 4.8 · Summary of the safety profile
Eintrag öffnenNilemdo · 4.8 · Table 1: Adverse reactions System organ class (SOC) Adverse reactions Frequency categories Blood and lymphatic
Eintrag öffnenNilemdo · 4.8 · The most commonly reported adverse reactions with bempedoic acid during pivotal trials were hyperuricaemia (3.
Eintrag öffnenNilemdo · 4.8 · The observed elevations in serum creatinine may be associated with bempedoic acid inhibition of OAT2-dependent
Eintrag öffnenNilemdo · 4.8 · a. See section 4.5 b. Hyperuricaemia includes hyperuricaemia and blood uric acid increased c. (CLEAR Outcomes
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