Blood Pressure Changes After Oral 5-Aminolevulinic Acid Hydrochloride Administered 4–8 h Before TURBT: An Additional Analysis of a Phase III Study (SPP2C102)

This study evaluated changes in blood pressure and hypotension-related adverse drug reactions (ADRs) following oral administration of 5-aminolevulinic acid hydrochloride (5-ALA) in patients undergoing transurethral resection of bladder tumor (TURBT). Photodynamic diagnosis under blue light has demonstrated superior sensitivity compared with that of white light when 5-ALA is administered 4 to 8 h before TURBT (95.3% vs. 61.1%, p < 0.001); however, data regarding associated blood pressure change remain limited. In this study, blood pressure changes were monitored for 24 h after 5-ALA administration (20 mg/kg) and hypotension-related ADRs were assessed within 14 days post-dose. Both systolic and diastolic blood pressures reached their nadir at 2 h after 5-ALA administration. Absolute blood pressure values were lower in patients with ADRs, whereas the magnitude of blood pressure changes was not different between patients with and without ADRs. The incidence of hypotension, defined as systolic blood pressure ≤ 80 mmHg, was 2.1%, which was lower than that reported in previous retrospective studies (40.0–75.6%). Although hypotension-related ADRs occurred in 25.5% of patients, all events were non-serious and resolved without clinical sequelae. The lower incidence may partly reflect the exclusion criteria and medication restrictions applied in this protocol-controlled trial.