Nebivolol Vs. Metoprolol: Comparative Effects on Fatigue and Quality of Life
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Multidimensional Assessment of Fatigue (MAF) Questionnaire: Global Fatigue Score After 4 Weeks of Treatment on Each Drug/Dose Combination.
研究概览
简要总结
Beta-blockers are prescribed to millions of people for treatment of hypertension. Fatigue is a recognized and common side effect of beta-blockers that can have significant effects on quality of life. Worse, many people taking a beta-blocker for years are not even aware of the reduction of energy with which they are living.
A new vasodilating beta-blocker, nebivolol, which is approved by the FDA for treatment of hypertension, appears to be far less associated with fatigue than are most currently available beta-blockers. The purpose of this study is to compare nebivolol with the current best-selling beta-blocker, metoprolol, and determine whether there is a significant difference in side effects including fatigue, reduced exertion tolerance, and reduced quality of life.
In this study, 30 subjects will take each of the 2 study drugs for 8 weeks, consisting of 4 weeks at a lower dose, and 4 weeks at a higher dose. All dosages are FDA-approved for treatment of hypertension. Subjects and investigators will not know which drug is being administered until completion of the study. Subjects will undergo a treadmill stress test and will complete fatigue and quality of life questionnaires after each 4 weeks of treatment. An echocardiogram and non-invasive measurement of aortic blood pressure will be performed after 8 weeks on each drug. Also, blood will be drawn and stored for possible measurement of drug levels, after 4 and 8 weeks on each drug. Results on each drug will then be compared. If nebivolol is found to cause significantly less fatigue, it would be of substantial importance to the many millions of people who are on life-long beta-blocker therapy, and are living with reduced energy.
详细描述
- Hypothesis: the beta-blocker nebivolol is associated with less fatigue than metoprolol, the most widely-prescribed beta-blocker
- Methods: a double-blinded crossover trial comparing nebivolol with metoprolol. Experimental procedures: Subjects will undergo electrocardiogram and routine blood testing, unless such tests have been performed within 6 months and are available for review. Subjects entered into the study will receive each of the two study drugs for 8 weeks. Metoprolol succinate will be given at a dose of 50 mg daily for 4 weeks, then 100 mg daily for 4 weeks. For nebivolol, dosage will be 5 mg daily for 4 weeks and 10mg daily for 4 weeks. Identical-appearing pills will be given, and the drugs will be given in randomized order without a placebo run-in period.
At the end of each 4-week treatment period on each drug, subjects will undergo a treadmill stress test (using the standard Cornell protocol), complete Quality of Life and fatigue questionnaires, and have blood drawn and frozen for later analysis for drug levels.
At the end of 8 weeks of treatment on each drug, subjects will undergo echocardiography and applanation tonometry (non-invasive measurement of aortic blood pressure) to assess heart function.
At the end of the study, the blinded subjects will be asked which of the two study drugs they preferred, and the extent to which their energy differed between the two drugs.
-Rationale: Millions of hypertensive patients are on life-long beta-blocker therapy. In many, it reduces cardiac output and increases peripheral resistance to blood flow (1). It is well-established that beta-blockers cause fatigue in many patients and reduce exertion tolerance. Every physician knows this, and tacitly accepts that many patients are living with this unwelcome side effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals who are taking, or are about to begin taking, a beta-blocker, and who have the approved indication of hypertension
排除标准
- •Orthopedic ailments that would interfere with performance of treadmill testing
- •Stroke or heart attack within the previous 1 year
- •Symptomatic coronary disease within the past year (angina, shortness of breath)
- •Clinically significant pulmonary disease (e.g. emphysema or asthma).
- •Poorly controlled hypertension (blood pressure above 160 systolic or 100 diastolic)
- •Patients with contra-indications to taking a beta-blocker (asthma or bradyarrhythmia)
- •History of tachyarrhythmia (abnormal rapid heart rate)
研究组 & 干预措施
Nebivolol, followed by Metoprolol
Participants first received Nebivolol at a dose of 5 mg daily for 4 weeks, followed by 10 mg daily for another 4 weeks (i.e., weeks 1-8 in total). The participants then received Metoprolol at a dose of 50 mg daily for 4 weeks, followed by 100 mg daily for another 4 weeks (i.e., weeks 9-16 in total).
干预措施: Metoprolol (Drug)
Nebivolol, followed by Metoprolol
Participants first received Nebivolol at a dose of 5 mg daily for 4 weeks, followed by 10 mg daily for another 4 weeks (i.e., weeks 1-8 in total). The participants then received Metoprolol at a dose of 50 mg daily for 4 weeks, followed by 100 mg daily for another 4 weeks (i.e., weeks 9-16 in total).
干预措施: Nebivolol (Drug)
Metoprolol, followed by Nebivolol
Participants first received Metoprolol at a dose of 50 mg daily for 4 weeks, followed by 100 mg daily for another 4 weeks (i.e., weeks 1-8 in total). The participants then received Nebivolol at a dose of 5 mg daily for 4 weeks, followed by 10 mg daily for another 4 weeks (i.e., weeks 9-16 in total)
干预措施: Metoprolol (Drug)
Metoprolol, followed by Nebivolol
Participants first received Metoprolol at a dose of 50 mg daily for 4 weeks, followed by 100 mg daily for another 4 weeks (i.e., weeks 1-8 in total). The participants then received Nebivolol at a dose of 5 mg daily for 4 weeks, followed by 10 mg daily for another 4 weeks (i.e., weeks 9-16 in total)
干预措施: Nebivolol (Drug)
结局指标
主要结局
Multidimensional Assessment of Fatigue (MAF) Questionnaire: Global Fatigue Score After 4 Weeks of Treatment on Each Drug/Dose Combination.
时间窗: After 4 weeks of treatment on each drug/dose combination
A 16 item scale that measures 4 dimensions of fatigue: severity, distress, timing, and degree of interference in activities of daily living. Range: 1 (no fatigue) to 50 (extreme fatigue).
Treadmill Exercise Time After 4 Weeks of Treatment on Each Drug/Dose Combination.
时间窗: After 4 weeks of treatment on each drug/dose combination
Treadmill Exercise Time After 4 Weeks of Treatment on Each Drug/Dose Combination (in minutes). The Treadmill Test was Performed at the 4-week Visit of Each Drug/Dose Combination.
次要结局
未报告次要终点