Effect of Combined Antihypertensive Therapy on Blood Pressure and Sexual Function in Patients With Essential Hypertension
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Female Sexual Function Index (FSFI)
研究概览
简要总结
This randomized,active controlled study aimed to compare the effects on sexual function of treatment with combined antihypertensive drugs.
The researchers hypothesize that:
- Both felodipine-irbesartan combination and felodipine-metoprolol combination are effective in lowing blood pressure in patients with essential hypertension.
- Felodipine-metoprolol combination induces a worse sexual function and a reduction of sex hormone,whereas felodipine-irbesartan combination does not impair sexual function and does not change hormone levels.
- Oxidative stress decline after both combination regimens. Felodipine-irbesartan combination has a greater impact on oxidative stress indicators than felodipine-metoprolol combination.
详细描述
The effects of hypertension and its pharmacotherapy on sexual function are well known in men,although this topic remains unexplored in women.There is evidence suggests that some classes of antihypertensive drugs such as diuretics and beta-blockers have more negative impact on male sexual function than other classes such as calcium channel blockers(CCBs) and angiotensin-converting enzyme inhibitors(ACEI).Some data suggest that angiotensin Ⅱ antagonists（ARBs) not only do not exacerbate sexual function in males,but even improve it.
Treatment with multiple antihypertensive medications was often necessary to attain blood-pressure goals recommended by guidelines.More than two third of patients with 2 or 3 degree of essential hypertension require combination therapy at the beginning of treatment to avoid target organ damage and to minimize the accidence of adverse events.
CCBs were recommended by both JNC-7 and ESH / ESC 2007 hypertension guidelines as the basic for the treatment of hypertension.The purpose of this study is to compare the impacts of different CCB-based antihypertensive drugs combination on sexual behavior in both male and female patients with essential hypertension,thus provide evidences for physicians to increase patients adherence to the treatment regimens beside lowing blood pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with essential hypertension.
- •Initial hypertension, or without taking any antihypertensive for at least one month.
- •Sexual active.
排除标准
- •Patients with secondary hypertension.
- •Patients with malignant hypertension, coronary heart disease, diabetes, a history of syncope, bradycardia (heart rate <45 beats / min), atrioventricular block(Ⅱ or Ⅲ degree), sick sinus syndrome, congestive heart failure, a history of cerebral vascular accidents, serious hepatic and kidney dysfunction, a history of serious mental illness, pregnant, taking oral exogenous estrogens (including contraceptives), hysterectomy, breastfeeding, a history of alcohol or drug abuse, having serious conflict with sexual partner, severity sexual dysfunction.
- •Patients refuse to answer questions, refuse to fill in the questionaires,or do not willing to take blood examination.
研究组 & 干预措施
Felodipine,Irbesartan,Sexual Dysfunction
干预措施: Felodipine add Irbesartan (Drug)
Felodipine,Metoprolol,Sexual Dysfunction
干预措施: Felodipine add Metoprolol (Drug)
结局指标
主要结局
Female Sexual Function Index (FSFI)
时间窗: 48 weeks
The Female Sexual Function Index (FSFI) is a multidimensional self-report scale for assessing sexual function in women.The FSFI hase been validated in women with various sexual disorders,and in non-dysfunctional controls showing good discriminant validity,internal consistency,and test-retest reliability.
International Index of Erectile Function(IIEF)
时间窗: 48 weeks
The 15-item International Index of Erectile Function (IIEF) was developed to diagnose the presence and severity of erectile dysfunction (ED).
次要结局
- Change of Systolic Blood Pressure in 2 Weeks(2 weeks)
- Change of Systolic Blood Pressure in 4 Weeks(4 weeks)
- Change of Systolic Blood Pressure in 8 Weeks(8 weeks)
- Change of Systolic Blood Pressure in 12 Weeks(12 weeks)
- Change of Systolic Blood Pressure in 24 Weeks(24 weeks)
- Change of Systolic Blood Pressure in 48 Weeks(48 weeks)
- Change of Diastolic Blood Pressure in 2 Weeks(2 weeks)
- Change of Diastolic Blood Pressure in 4 Weeks(4 weeks)
- Change of Diastolic Blood Pressure in 8 Weeks(8 weeks)
- Change of Diastolic Blood Pressure in 12 Weeks(12 weeks)
- Change of Diastolic Blood Pressure in 24 Weeks(24 weeks)
- Change of Diastolic Blood Pressure in 48 Weeks(48 weeks)
- Serum Estradiol in 24 Weeks(24 weeks)
- Serum Estradiol in 48 Weeks(48 weeks)
- Serum Testosterone in 24 Weeks(24 weeks)
- Serum Testosterone in 48 Weeks(48 weeks)
- Serum MDA in 24 Weeks(24 weeks)
- Serum MDA in 48 Weeks(48 weeks)
- Serum 8-OHdG in 24 Weeks(24 weeks)
- Serum 8-OHdG in 48 Weeks(48 weeks)
- Serum HNE in 24 Weeks(24 weeks)
- Serum HNE in 48 Weeks(48 weeks)