Risk of sudden sensorineural hearing loss in adults using phosphodiesterase type 5 inhibitors: Population-based cohort study.
Level 3 - non-randomized controlled study
Retrospective non-randomized controlled cohort study using claims data
PubMed 29512263 · doi:10.1002/pds.4405
What was done
Researchers conducted a retrospective cohort study using the MarketScan Commercial Claims and Encounters Database from 1998 to 2007 to determine the risk of sudden sensorineural hearing loss (SNHL) associated with phosphodiesterase type 5 (PDE5) inhibitors. The study followed 377,722 adult men who initiated a PDE5 inhibitor and 1,957,233 nonusers. Weekly drug exposure was modeled from pharmacy billing data assuming one dose per week for current use. Incident sudden SNHL was identified by ICD-9 diagnostic codes accompanied by at least two procedure codes for audiometric testing within ±30 days. Risk during current or recent use compared with nonuse was assessed using age- and propensity score-adjusted Cox proportional hazards models.
What was found
Across 1,233 sudden SNHL cases, incidence rates were 4.35, 5.58, and 2.38 per 10,000 person-years for current, recent, and nonuse of PDE5 inhibitors, respectively. Compared with nonuse: - Current use: adjusted hazard ratio 1.25 (95% CI: 1.01–1.55); risk difference 1.97 (95% CI: 1.12–2.82) per 10,000 person-years. - Recent use: adjusted hazard ratio 1.60 (95% CI: 1.33–1.94); risk difference 3.19 (95% CI: 2.24–4.14) per 10,000 person-years. Results remained consistent across sensitivity analyses altering drug utilization assumptions and case definitions.
Why it matters
This large observational study provides quantitative evidence that PDE5 inhibitor exposure is associated with sudden sensorineural hearing loss, though the absolute excess risk is small (approximately 2 to 3 excess cases per 10,000 person-years).
Limits
The study relies on retrospective claims data, which cannot confirm exact timing or adherence of pill ingestion (utilization frequency was assumed). Administrative billing codes may misclassify cases or miss patients who did not seek audiometric testing, and residual confounding from unmeasured clinical or lifestyle variables cannot be excluded. The population was restricted to adult men with commercial insurance.
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