Nebivolol Versus Metoprolol: Comparative Effects on Fatigue and Quality of Life
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Metoprolol; Nebivolol
Intervention description: Metoprolol 50 mg, Metoprolol 100 mg,; Nebivolol 5 mg, Nebivolol 10 mg.
Intervention MeSH terms: Metoprolol; Nebivolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 37.0
Sex: All
Minimum age: 21 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: hypertension; beta blockers; Metoprolol; blood pressure, high; antihypertensive agents; vascular resistance; adrenergic beta-receptor blockaders; beta-Adrenergic blockers; beta-Adrenergic Blocking Agents; beta-Adrenergic Receptor Blockaders; beta-Blockers, Adrenergic; Bystolic; Nebivolol; Nebivololum; Nebivololum [Latin]; R65,824; Beloc- Zok; H 93/26 succinate; Metoprolol succinate; Seloken ZOC; Selozok; Spesicor Dos; Toprol XL; Toprol-XL; UNII-TH25PD4CCB

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Individuals who are taking, or are about to begin taking, a beta-blocker, and who have
             the approved indication of hypertension

        Exclusion Criteria:

          -  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)