6)  Gastritis 6 (7 6) 13 (16 0) 6 (5 9) 13 (12 4)  Diarrhea 3 (3

6)  Gastritis 6 (7.6) 13 (16.0) 6 (5.9) 13 (12.4)  Diarrhea 3 (3.8) 11 (13.6) 6 (5.9) 12 (11.4) Nervous system disorders 32 (40.5) 21 (25.9) 37 (36.3) 24 (22.9)  Headache 22 (27.8) 10 (12.3) 24 (23.5) 12 (11.4)  Dizziness

10 (12.7) 10 (12.3) 13 (12.7) 12 (11.4) Musculoskeletal disorders 35 (44.3) 32 (39.5) 41 (40.2) 39 (37.1)  Arthralgia 26 (32.9) 18 (22.2) 30 (29.4) 21 (20.0) Ear and labyrinth disorders 24 (30.4) learn more 26 (32.1) 32 (31.4) 37 (35.2)  Deafness 9 (11.4) 6 (7.4) 12 (11.8) 11 (10.5)  Tinnitus 2 (2.5) 10 (12.3) 2 (2.0) 10 (9.5) Respiratory disorders 25 (31.6) 28 (34.6) 28 (27.5) 33 (31.4)  Hemoptysis 14 (17.7) 9 (11.1) 17 (16.7) 13 (12.4) Infections and infestations 25 (31.6) 28 (34.6) 28 (27.5) 33 (31.4) Chest pain 9 (11.4) 6 (7.4) 9 (8.8) 8 (7.6) Skin and subcutaneous tissues 19 (24.1) 21 (25.9) 25 (24.5) 28 (26.7)  Pruritis 10 (12.7) 11 (13.6) 12 (11.8) 13 (12.4) Psychiatric disorders 15 (19.0) 11 (13.6) 16 (15.7) 13 (12.4)  Insomnia 11 (13.9) 9 (11.1) 11 (10.8) 10 (9.5) Eye disorders 10 (12.7) 14 (17.3) 13 (12.7) 15 (14.3) Blood and lymphatic disorders 8 (10.1) 4 (4.9) 9 (8.8) 4 (3.8) Reproductive system and breast disorders 7 (8.9) 10 (12.3) 8 (7.8) 13 (12.4) No significant difference was identified for any of the listed adverse events, using Fisher’s exact test

and correcting Enzalutamide mouse for multiple testing using the Sidak correction [62]. Source: Modified from [17] BDQ bedaquiline, OBR optimized background regimen a24 weeks: includes only subjects from the second phase 2 study (Study C208 [Stage 2]). This table includes pooled data from the first and second Phase 2 studies (Study C208 [Stage 1] and C208 [Stage 2]) The prevalence of drug-related hepatic disorders was significantly higher in those taking bedaquiline (8.8% in bedaquiline, 1.9% in placebo, P = 0.03), with increases in alanine transferase (ALT) observed in 5.0% of bedaquline and in 1.0% of subjects taking placebo [17]. Two patients taking bedaquiline in the pooled Phase 2 studies

had grade 3 or 4 liver function test abnormalities close to the time of death [17]. The first death, attributed to hepatitis and hepatic cirrhosis, occurred approximately 3 months after the last administered dose of the drug, but MG-132 datasheet pre-treatment transaminases and bilirubin were normal, so it is possible the hepatic failure was bedaquiline-related. A second patient died 513 days after the last dose of bedaquiline, following liver failure and sepsis. Pretreatment liver function was also normal in this patient, and it is possible that the deterioration in liver function was related to the drug. Another patient developed liver injury after taking bedaquiline, with more than a three-fold increase in aspartate aminotransferase (AST) and more than a two-fold increase in bilirubin.

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