About two extra cases of sudden hearing loss per 10,000 years of use
Sudden hearing loss occurred at 4.35 cases per 10,000 person-years during use against 2.38 among non-users: about two extra cases per 10,000 person-years.
What the study found
The hearing-loss signal is real, statistically, and very small
Among 377,722 men starting one of these drugs and nearly two million who did not, sudden hearing loss occurred at 4.35 cases per 10,000 person-years during use against 2.38 among non-users. That is a hazard ratio of 1.25, and about two extra cases per 10,000 person-years.
The caveat · Recent, not current, use ran higher
Recent use carried a higher hazard ratio than current use, 1.60 against 1.25, which points at something other than the drug. The lower edge of the confidence interval sits at 1.01. Exposure was inferred from pharmacy fills, and the finding covers the whole drug class rather than sildenafil alone.
What we don't know
Recent use carried a higher hazard ratio than current use, 1.60 against 1.25, which points at something other than the drug. The lower edge of the confidence interval sits at 1.01. Exposure was inferred from pharmacy fills, and the finding covers the whole drug class rather than sildenafil alone.