Effects of Two Allisartan Isoproxil-Based Antihypertensive Therapies on Sexual Function and Blood Pressure in Male Hypertensive Patients: A Single-Center, Open-Label, and Randomized Controlled Trial

Abstract

This study evaluated the effects of allisartan isoproxil combined with amlodipine besylate tablets (Group A+C) or metoprolol succinate extended-release tablets (Group A+B) on sexual function and nighttime blood pressure (nBP) in 130 male patients with essential hypertension (EH). Patients were randomized to two groups. After 6-month, the IIEF-15 total score (ITS) of sexual function significantly improved in Group A+C (p = 0.015), including intercourse satisfaction (IS) (p = 0.003), orgasmic function (OF) (p = 0.021), and overall satisfaction (OS) (p = 0.019), while erectile function (EF) (p = 0.081) and sexual desire (SD) (p = 0.08) were unchanged. In contrast, the ITS was decreased (p = 0.008), including EF (p = 0.005), IS (p = 0.048), SD (p = 0.003), and OS (p = 0.010), but OF remained unchanged (p = 0.076) in Group A+B. Between-group comparisons confirmed significant differences across IIEF-15 domains (all p < 0.05). Compared to baseline, office systolic BP (OSBP), office diastolic BP (ODBP), nighttime average SBP (nSBP), and nighttime average DBP (nDBP) were significantly reduced at 6 months in two groups (all p < 0.05). Although nSBP fall (nSBPF) (p = 0.010) and nDBP fall (nDBPF) (p = 0.002) significantly increased in Group A+C. In Group A+C, the nighttime-daytime BP fall ratio of SBP was 1.04 (0.45, 1.70) and that of DBP was 1.13 (0.38, 1.44) after treatment, with a median value > 1, indicating that nBP fall after treatment was greater than dBP fall. Compared to Group A+B, ODBP (difference = −4.00 mmHg, 95% CI [−7.64, −0.36], p = 0.032), daytime average DBP (difference = −5.47 mmHg, 95% CI [−10.05, −0.79], p = 0.023) and 24-h average DBP (difference = −5.77 mmHg, 95% CI [−10.31, −1.24], p = 0.014) decreased more significantly in Group A+C, nDBPF increased significantly (difference = 4.99 mmHg, 95% CI [0.04, 9.93], p = 0.048), and the decrease in the nighttime-daytime BP fall ratio of SBP and DBP was higher (p < 0.05). It was concluded that combined antihypertension of allisartan isoproxil with amlodipine besylate tablets improved sexual function in male hypertensive patients in terms of the ITS, IS, OF, and OS, but there was no significant improvement in EF and SD. Both combined antihypertensive regimens were effective in lowering BP, but allisartan isoproxil combined with amlodipine besylate tablets demonstrated more advantageous in lowering DBP and nBP.