120 Effect of Testosterone Enanthate on 24-hour Ambulatory Blood Pressure is Less in Patients with Hypertension at Baseline

The diagnostic threshold for hypertension according to the JNC-7 is a BP measurement of ≥140/90 mm Hg in the clinic. However, ABPM is a more precise method to quantify BP levels and diagnose hypertension with a lower diagnostic threshold of >130/80 mm Hg. Consensus thresholds for ABPM diagnosis of hypertension are a mean nighttime and daytime BP of 120/70 and 135/85 mm Hg, respectively To determine the impact of self-administered subcutaneous TE autoinjection (Xyosted) on ABP in adult males with testosterone deficiency (TD), both clinical cuff measurements and 24-hour ABP monitoring (ABPM) were assessed. In this 26-week, single-arm, registration phase trial, adult males with TD initiated treatment with Xyosted 75 mg as a single, once-weekly dose. Safety assessments included clinical laboratory, treatment-related adverse events (ADRs), and injection site reactions (ISRs). BP assessments according to JNC-7 were used at the time of study design and conduct. Clinic BP (at all visits through Week 26) and 24-hour ABPM data were collected at Baseline, Week 6, and Week 12. The impact of Xyosted on hypertension status based on JNC-7 classifications as well as ABP consensus thresholds, as well as patients’ concurrent use of BP-lowering medications, were analyzed.