Effect of Statins on Patients With Osteoradionecrosis of the Jaw

Background: Osteoradionecrosis of the jaw (ORN) is a late complication of radiation therapy. Radiation-induced fibrosis is the most likely mechanism for developing ORN, and statins are effective against radiation-induced fibrosis. However, no reports have indicated the direct effectiveness of statins in treating ORN.

Purpose: This study aimed to measure the association between statin exposure and ORN disease resolution.

Study design, setting, sample: This retrospective cohort study included patients with ORN diagnosed between January 2008 and December 2020 at the Hospital's Department of Oral and Maxillofacial Surgery. Patients who were immunocompromised or followed up for < 6 months were excluded.

Predictor variable: The predictor variable was statin exposure, which was defined as the use of statins for dyslipidemia.

Main outcome variable: The main outcome variable was ORN disease progression status (good prognosis). Patients who showed full recovery and improvement were included in the good prognosis group, and those who showed invariance and deterioration were included in the poor prognosis group.

Covariates: We analyzed the clinicodemographic including the age of onset, sex, history of smoking, alcohol consumption, history of chemotherapy, tumor site, association with dental treatment, location (maxilla or mandible), the time to ORN onset from radiation therapy, and stage of ORN, and treatment characteristics including hyperbaric oxygen therapy, long-term macrolide administration, and sequestrectomy.

Analyses: We analyzed the association between statin exposure or covariates and time to ORN improvement using bivariate and multivariate Cox regression. The significance level was set at P = .05.

Results: We analyzed 102 patients, and the improvement rate was 32.4%. The favorable prognostic factors were statin exposure (adjusted hazard ratio [HR], 3.71; 95% confidence interval [CI], 1.62 to 8.50; P = .002), onset in the maxilla (HR, 2.15; 95% CI, 1.02 to 4.55; P = .045), and stage 1 of ORN (HR, 2.65; 95% CI, 1.20 to 5.83; P = .016).

Conclusion and relevance: In this study, statin exposure, onset in the maxilla, and stage 1 of Lyons's classification were favorable prognostic factors for ORN. Although this study's findings were insufficient to recommend statin use for ORN, statins may be a novel and effective treatment for ORN.