Drug Design, Development and Therapy · Nov 7, 2026

Atorvastatin for the Prevention of Cisplatin-Induced Ototoxicity: A Randomized Controlled Trial

By Helmy NH, Sadek EM, Fahim DFM et al.

PURPOSE: Cisplatin is used to treat a variety of tumors, it has a significant ototoxic effect; as studies show that about 40% to 70% of patients treated with cisplatin suffer hearing loss to some extent, which may lead to social isolation, anxiety, depression, and an overall negative effect on quality of life. Atorvastatin has a promising otoprotective potential based on preclinical and observational evidence, but the clinical evidence remains limited and not definitive. This is a randomized controlled trial aimed to investigate the efficacy of Atorvastatin co-administered during cisplatin chemotherapy against its ototoxicity in patients with solid tumors. PATIENTS AND METHODS: This randomized controlled trial was conducted at the oncology center and the audio-vestibular unit, Minia university, Egypt, involving 56 patients with different solid tumors scheduled to receive cisplatin. Patients were randomized to receive either Atorvastatin 10 mg daily or no intervention. Baseline and final audiograms were obtained, the primary outcome is to measure change in pure-tone audiometric thresholds from baseline to post-treatment in both groups. The secondary outcome is to assess severity (grade) of hearing loss as well as the subjective hearing impairment in both groups using the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) V.6 and the Speech, Spatial, and Qualities of Hearing Scale (SSQ) short version (SSQ12) questionnaire, respectively. RESULTS: A percentage of 41.38% of the case group and 44.4% of the control group experienced cisplatin-induced ototoxicity (CIO) according to NCI-CTCAE V.6 criteria. No significant difference was found between cases and controls regarding CIO measured by audiogram or data obtained from patients through the SSQ12 questionnaire. CONCLUSION: Use of atorvastatin (10 mg daily) was not significantly associated with a reduction in CIO, as assessed by change in hearing thresholds, CTCAE criteria, or SSQ12 questionnaire. TRIAL REGISTRATION: https://clinicaltrials.gov/study/NCT06553157. IDENTIFIER: NCT06553157.

doi.org/10.2147/dddt.s649303Open accessPubMed 43031616Interventions