Lee Min-Kyung, Lee Jae-Hyuk, Sohn Seo-Young, Lee Seo Yeon, Jeong Tae-Yoong, Kim Sae Chul
Division of Endocrinology and Metabolism, Department of Internal Medicine, Myongji Hospital, Hanyang University College of Medicine, Goyang-si, Republic of Korea.
Department of Urology, Myongji Hospital, Hanyang University College of Medicine, Goyang-si, Republic of Korea.
Diabetol Metab Syndr. 2022 Apr 21;14(1):56. doi: 10.1186/s13098-022-00825-w.
Phosphodiesterase type 5 inhibitors restore nitric oxide signaling, that plays a significant role in erectile function, and appears to counteract insulin resistance in animal and human models. This study was aimed to evaluate the glycemic and metabolic effects of low-dose tadalafil once daily in patients with type 2 diabetes and erectile dysfunction.
A 6-month, randomized, double-blind, placebo-controlled pilot trial was conducted. Eligible patients were randomly assigned in a ratio of 2:1 to the tadalafil 5 mg and placebo groups; all patients received either tadalafil or placebo once a day. The primary efficacy endpoint was the absolute change in glycated hemoglobin (HbA1c) levels during the 6-month study period. The secondary efficacy endpoints included metabolic parameters and erectile function.
Of the 68 patients who completed this study, 45 and 23 patients were allocated to the tadalafil and placebo groups, respectively. The mean HbA1c level was significantly different between the groups over the 6-month study period (P = 0.021). After 6 months of treatment, the HbA1c decrement in the tadalafil group was greater than that in the placebo group (- 0.14 ± 0.53% vs. 0.20 ± 0.69%, P = 0.030). The International Index of Erectile Function-5 scores improvement was significantly greater in the tadalafil group than in the placebo group at 6 months (P = 0.003).
This prospective pilot study showed that low-dose tadalafil administered once a day was effective in improving glycemic control and erectile function in patients with type 2 diabetes and erectile dysfunction. Trial registration KCT0005666.
5型磷酸二酯酶抑制剂可恢复一氧化氮信号传导，一氧化氮信号传导在勃起功能中起重要作用，并且在动物和人体模型中似乎可对抗胰岛素抵抗。本研究旨在评估每日一次低剂量他达拉非对2型糖尿病合并勃起功能障碍患者血糖和代谢的影响。
进行了一项为期6个月的随机、双盲、安慰剂对照的试点试验。符合条件的患者按2:1的比例随机分配至他达拉非5mg组和安慰剂组；所有患者每天接受一次他达拉非或安慰剂治疗。主要疗效终点是6个月研究期间糖化血红蛋白（HbA1c）水平的绝对变化。次要疗效终点包括代谢参数和勃起功能。
在完成本研究的68例患者中，分别有45例和23例患者被分配至他达拉非组和安慰剂组。在6个月的研究期间，两组间平均HbA1c水平存在显著差异（P = 0.021）。治疗6个月后，他达拉非组的HbA1c下降幅度大于安慰剂组（-0.14±0.53% vs. 0.20±0.69%，P = 0.030）。6个月时，他达拉非组国际勃起功能指数-5评分的改善显著大于安慰剂组（P = 0.003）。
这项前瞻性试点研究表明，每日一次服用低剂量他达拉非对改善2型糖尿病合并勃起功能障碍患者的血糖控制和勃起功能有效。试验注册号KCT0005666。
