Abstract P232: Topical Testosterone Gel Use is Associated with Reduced Risk of CVD Events in Younger Men with CVD Risk Factors and No Increased Risk in Men Aged 65+

Abstract

Introduction: A recent safety announcement from the U.S. Food and Drug Administration (FDA) has cautioned about the use of topical testosterone gel (TTG) for low testosterone due to aging, so that product labels need to reflect that use may lead to an increased risk of heart attack and stroke. Hypothesis: We hypothesized that an increased risk of cardiac events associated with TTG use would be explained by age and associated cardiovascular risk factors. Methods: We analyzed claims records in Truven Marketscan databases (Commercial Claims and Encounters and Medicare Supplemental) for two groups of male patients (younger: aged 50-64 years and older: aged 65+ years) who filled prescriptions for TTG for ≥1 year between 2000-2013, who were continuously enrolled for ≥ 1 year both before and after index, and had no pre-index diagnosis of coronary heart disease (CHD), stroke, pulmonary embolism (PE), or diabetes mellitus (DM). Each user was assigned three controls (i.e. non-users) matched for age, region, presence of hypertension (HTN) and/or hyperlipidemia (H-Lip) and year of user’s first visit, who were continuously enrolled during the user’s study period and had no prescription for TTG and no pre-index diagnosis of CHD, stroke, PE, or DM. The association of TTG use with future occurrence of CVD events (CHD, stroke, PE or related surgeries) was assessed by Cox proportional hazards analysis. Results: Data were available for 16,516,227 men aged >50 years. After applying exclusion criteria, there were 18,474 younger TTG users and 51,545 younger non-users, and 2,867 older TTG users and 6,941 older non-users. Mean follow-up was 737 days. Among men aged 50-64 with HTN, 7.9% of TTG users (of 11,574) experienced CVD events versus 8.9% of non-users (of 31,616), HR 0.87 (95% CI: 0.81-0.93). Similarly, among men aged 50-64 with H-Lip, 8.1% of TTG users (of 11,087) experienced CVD events versus 8.7% of non-users (of 30,359), HR 0.91 (95% CI: 0.85-0.98). Among men aged 50-64 without HTN or H-Lip, 4.3% of TTG users (out of 3,434) experienced CVD events versus 1.9% of the non-users (of 10,103), hazard ratio (HR) 2.24 (95% CI: 1.81-2.78). Among men aged >65 years, there were no significant differences in CVD event rates between TTG users and non-users overall, or among those with HTN or H-Lip. Similar findings were seen in both age groups in men having both HTN and H-Lip (rather than either alone). Conclusions: For men aged >65, there was no difference in CVD events between TTG users and non-users overall, or in strata based on presence of HTN, H-Lip, both, or none. Among TTG users aged 50-64 years the presence of HTN, H-Lip, or both, was not associated with an increased risk of CVD events. For men aged 50-64 years without HTN or H-Lip, TTG use was associated with an increase in CVD events, compared to men without these conditions. The increase in CVD events observed in male TTG users aged 50-64 years without HTN or H-Lip needs further exploration.