SUMMARY
Metoprolol tartrate and hydrochlorothiazide tablet has the antihypertensive effect of metoprolol tartrate, a selective beta1-adrenoreceptor blocking agent, and the antihypertensive and diuretic actions of hydrochlorothiazide. It is available as tablets for oral administration. The 50/25 tablets contain 50 mg of metoprolol tartrate USP and 25 mg of hydrochlorothiazide USP; the 100/25 tablets contain 100 mg of metoprolol tartrate USP and 25 mg of hydrochlorothiazide USP; and the 100/50 tablets contain 100 mg of metoprolol tartrate USP and 50 mg of hydrochlorothiazide USP.
Metoprolol tartrate and hydrochlorothiazide tablets are indicated for the management of hypertension.
This fixed-combination drug is not indicated for initial therapy of hypertension. If the fixed combination represents the dose titrated to the individual patients needs, therapy with the fixed combination may be more convenient than with the separate components.
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NEWS HIGHLIGHTSMedia Articles Related to Metoprolol and Hydrochlorothiazide (Metoprolol / Hydrochlorothiazide)
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Published Studies Related to Metoprolol and Hydrochlorothiazide (Metoprolol / Hydrochlorothiazide)
Antihypertensive efficacy of metoprolol XL/low dose chlorthalidone (6.25 mg) combination: a randomized, comparative study in indian patients with mild-to-moderate essential hypertension. [2009.07.22] OBJECTIVE: High blood pressure is one of the most important risk factors, directly responsible for increasing the cardiovascular morbidity and mortality. The primary objective was to evaluate the efficacy of metoprolol XL/chlorthalidone against metoprolol XL/hydrochlorothiazide with respect to mean fall in systolic and diastolic blood pressure. The secondary objective was to compare the response rates and to evaluate the tolerability of study medications in patients with mild-to-moderate essential hypertension... CONCLUSION: Chlorthalidone in combination with metoprolol XL is as effective and well tolerated as widely used combination of metoprolol XL/HCTZ, thus providing an alternative therapeutic option.
Factorial antihypertensive study of an extended-release metoprolol and hydrochlorothiazide combination. [2006.12] BACKGROUND: To attain goal blood pressure (BP), many hypertensive patients require combination antihypertensive therapy. Thiazide diuretic/beta-blocker regimens lower BP, and clinical studies indicate that they reduce the risk for cardiovascular consequences of hypertension. Fixed-dose combination tablets can simplify multidrug treatment regimens... CONCLUSIONS: Extended-release metoprolol/hydrochlorothiazide is an effective antihypertensive combination that offers additive antihypertensive contributions from both components.
Metabolic effects of carvedilol vs metoprolol in patients with type 2 diabetes mellitus and hypertension: a randomized controlled trial. [2004.11.10] CONTEXT: Beta-blockers have been shown to decrease cardiovascular risk in patients with hypertension and type 2 diabetes mellitus (DM); however, some components of the metabolic syndrome are worsened by some beta-blockers. OBJECTIVE: To compare the effects of beta-blockers with different pharmacological profiles on glycemic and metabolic control in participants with DM and hypertension receiving renin-angiotensin system (RAS) blockade, in the context of cardiovascular risk factors... CONCLUSIONS: Both beta-blockers were well tolerated; use of carvedilol in the presence of RAS blockade did not affect glycemic control and improved some components of the metabolic syndrome relative to metoprolol in participants with DM and hypertension. The effects of the 2 beta-blockers on clinical outcomes need to be compared in long-term clinical trials.
Reduction (TELMAR) as assessed by magnetic resonance imaging in patients with mild-to-moderate hypertension--a prospective, randomised, double-blind comparison of telmisartan with metoprolol over a period of six months rationale and study design. [2003.12] The Telmisartan Effectiveness on Left ventricular MAss Reduction (TELMAR) trial will assess the effect of the angiotensin II (Ang II) receptor blocker, telmisartan, on left ventricular hypertrophy (LVH) compared with the b-blocker, metoprolol, at similar antihypertensive doses.A separate study was performed prior to the main trial to define the normal range of MRI data in an age-matched population.
[Comparative study between bisoprolol and metoprolol, combined with hydrochlorothiazide, as antihypertensive therapy] [2000.11] The main objective of this research was to compare the efficacy and security of bisoprolol (B), a new cardioselective beta-blocker, that does not have intrinsic sympathomimetic activity, and metoprolol associated to hydrochlorothiazide (HCTZ), in the treatment of patients with mild to moderate hypertension...
Clinical Trials Related to Metoprolol and Hydrochlorothiazide (Metoprolol / Hydrochlorothiazide)
Nebivolol Versus Metoprolol: Comparative Effects on Fatigue and Quality of Life [Completed]
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 ata 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.
Comparative Effects of Nebivolol and Metoprolol on Femal Sexual Function [Recruiting]
Beta-blockers (BB) are an important treatment for high blood pressure and heart disease.
However beta-blockers can cause sexual dysfunction (SD) and this common side effect limits
successful use of this class of medications. Sexual side effects often result in drug
discontinuation, compromising therapy goals. The investigators are conducting the study to
determine if nebivolol, a newer beta blocker that is selective for receptors in the heart
and causes vasodilation in the body causes fewer sexual side effects, or even improves
sexual function, compared with metoprolol succinate.
Open-Labeled PK-PD Studies of Metoprolol ER [Not yet recruiting]
Recently, the quality of generic metoprolol extended-release (ER) (Toprol XL,
Activas,Wockhardt) products has been called into question with reports of inconsistent
effects when switching from the brand name product to a generic formulation. Problems with
how the body processes these drugs could have serious and widespread consequences given the
high frequency of metoprolol ER use in the management of various cardiovascular disorders,
including high blood pressure, coronary heart disease, heart failure, and cardiac
arrhythmias. Investigators hypothesize that both product- and subject-specific factors lead
to variability in the way the body breaks down the drug (pharmacokinetics) and clinical
response to generic versus name brand metoprolol ER formulation. Investigators will study
the brand name and generic metoprolol ER formulations in subjects with high blood pressure
to compare the pharmacokinetics and cardiovascular responses among equivalent labeled doses
of each product.
The study objective is to provide information on how the body breaks down generic and brand
name metoprolol ER products (pharmacokinetics) and how the body responds to generic and
brand name metoprolol ER products (pharmacodynamics) to better understand if generic
metoprolol ER products are as good as the brand name product.
Study to Evaluate the Effect of Eliglustat on the Pharmacokinetics, Safety and Tolerability of Metoprolol in Healthy Adults [Completed]
The primary objective is to determine the effect of repeated oral doses of eliglustat 150 mg
twice daily (BID) on the pharmacokinetics (PK) of orally administered metoprolol 50 mg in
healthy adults.
The secondary objective is to assess the safety and tolerability of a single oral dose of
metoprolol 50 mg when administered alone and in combination with repeated oral doses of
eliglustat 150 mg BID in healthy adults.
Assessment of Metoprolol in the Prevention of Vasovagal Syncope in Aging Subjects [Recruiting]
Syncope affects about 50% of Canadians, is the cause of 1-2% of emergency room visits, and
probably is responsible for CDN $250 million in health care spending each year. It is
associated with decreased quality of life, trauma, loss of employment, and limitations in
daily activities. The most common cause is vasovagal syncope.
This occurs in people of all ages, and is a lifelong predilection. While the median number
of faints in the population is 2, those who come to the investigators care have a median
10-15 lifetime spells, and have an increased frequency in the year before presentation.
Vasovagal syncope is due to abrupt hypotension and transient bradycardia, which cause
cerebral hypoperfusion. The pathophysiology may be either failure of venous return or
progressive vasodilation, both due to inappropriately low sympathetic outflow. Sympathetic
stimulation might be involved early in the reflex cascade. There is no known medical
treatment for frequent fainting. The investigators performed the pivotal CIHR-funded
randomized trials that showed that neither permanent pacing, beta blockers, nor
fludrocortisone help the majority of patients.
However 3 observational studies suggested that beta blockers prevent syncope in older
subjects, and the Prevention of Syncope Trial (POST1) showed in a prespecified, - stratified
analysis that patients ≥42 years tended to benefit. The investigators recent meta-analysis
showed a benefit from metoprolol in these patients, with a hazard ratio of 0. 52 (CI 0. 27 to
1. 01), and an age-specific response to beta blockers (p = 0. 007). These results suggest the
need for a randomized clinical trial of metoprolol for the prevention of vasovagal syncope
in older subjects. Accordingly,the investigators conducted a poll of 48 cardiologists and
neurologists in Canada and abroad: 98% stated that a randomized trial was necessary, and 92%
agreed to participate in such a trial. Separately, this study emerged as the first choice
for syncope randomized trials after consultation with Canadian and international experts.
Objective: To determine if treatment with metoprolol in patients ≥40 years old with moderate
to severely frequent vasovagal syncope will better suppress syncope recurrences than
placebo.
Methods: This will be a longitudinal, prospective, parallel design, placebo-controlled,
randomized clinical trial.
Patients will be enrolled during a recruitment period of 4 years and followed for a fixed
period of 1 year. Subjects will have had ≥1 faint in the previous year, and a diagnosis of
vasovagal syncope based on a quantitative diagnostic score. They will be randomized to
receive either metoprolol or placebo at an initial dose of 50 mg bid. Dose adjustments will
be made according to treating physician discretion to optimize tolerance and compliance
while maximizing dose. The primary outcome measure will be the time to the first recurrence
of syncope (after a 2 week dose titration wash-in period) over the 1-year observation
period. The primary analysis will be performed on an intention-to-treat basis. Secondary
analyses will include an on-treatment analysis, as well as analyses comparing syncope and
presyncope frequency, number needed to treat, quality of life, impact of syncope on daily
living, and cost from the perspective of the publicly funded health care system. The
investigators will enroll 248 patients to have an 85% power to detect a reduction (p<0. 05)
in the primary outcome from 50% (placebo group) to 30% (midodrine group), a 40% relative
risk reduction. This sample size also allows for a 11% rate of subject dropout with loss to
follow-up before a syncopal event. The University of Calgary Syncope Clinic has a
well-functioning clinical trial apparatus that successfully completed the randomized,
multicenter Prevention of Syncope Trials (POST1: metoprolol for vasovagal syncope; POST2:
fludrocortisone for vasovagal syncope) and SIRCAT (Statin-Induced Reduction of
Cardiomyopathy Trial). Enrolment is underway in the CIHR-funded POST3 (pacing versus loop
recorders in syncope patients with bifascicular block) and POST4 (midodrine for vasovagal
syncope). Study centres that were highly productive in POST1-4 have agreed to participate.
The investigators therefore will have ample syncope enrolling centres.
Relevance: This study will provide evidence to inform the use of metoprolol in the treatment
of moderate to severely frequent syncope in older patients with vasovagal syncope. Given the
lack of any other conventional medical therapy the investigators expect it to have rapid
impact on care.
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Page last updated: 2017-09-19
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