Abiraterone Acetate (Page 5 of 11)
LATITUDE
Patients with Metastatic High-Risk CSPC
LATITUDE enrolled 1199 patients with newly-diagnosed metastatic, high-risk CSPC who had not received prior cytotoxic chemotherapy. Patients were ineligible if AST and/or ALT ≥ 2.5 x ULN or if they had liver metastases. All the patients received GnRH analogs or had prior bilateral orchiectomy during the trial. The median duration of treatment with abiraterone acetate tablets and prednisone was 24 months.
Table 5 shows adverse reactions on the abiraterone acetate tablets arm that occurred in ≥ 5% of patients with a ≥ 2% absolute increase in frequency compared to those on the placebos arm.
| System/Organ Class Adverse reaction | Abiraterone Acetate Tablets with Prednisone (N = 597) | Placebos (N = 602) | ||
| All Grades † % | Grade 3-4 % | All Grades % | Grade 3-4 % | |
| Vascular disorders | ||||
| Hypertension | 37 | 20 | 13 | 10 |
| Hot flush | 15 | 0.0 | 13 | 0.2 |
| Metabolism and nutrition disorders | ||||
| Hypokalemia | 20 | 10 | 3.7 | 1.3 |
| Investigations | ||||
| Alanine aminotransferase increased ‡ | 16 | 5.5 | 13 | 1.3 |
| Aspartate aminotransferase increased ‡ | 15 | 4.4 | 11 | 1.5 |
| Infections and infestations | ||||
| Urinary tract infection | 7.0 | 1.0 | 3.7 | 0.8 |
| Upper respiratory tract infection | 6.7 | 0.2 | 4.7 | 0.2 |
| Nervous system disorders | ||||
| Headache | 7.5 | 0.3 | 5.0 | 0.2 |
| Respiratory, Thoracic and Mediastinal Disorders | ||||
| Cough § | 6.5 | 0.0 | 3.2 | 0 |
Table 6 shows laboratory abnormalities that occurred in ≥ 15% of patients, and more frequently (> 5%) in the abiraterone acetate tablets arm compared to placebos.
| Laboratory Abnormality | Abiraterone Acetate Tablets with Prednisone (N = 597) | Placebos (N= 602) | ||
| Grade 1-4 % | Grade 3-4 % | Grade 1-4 % | Grade 3-4 % | |
| Hematology | ||||
| Lymphopenia | 20 | 4.1 | 14 | 1.8 |
| Chemistry | ||||
| Hypokalemia | 30 | 9.6 | 6.7 | 1.3 |
| Elevated ALT | 46 | 6.4 | 45 | 1.3 |
| Elevated total bilirubin | 16 | 0.2 | 6.2 | 0.2 |
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