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Lopressor HCT (Hydrochlorothiazide / Metoprolol Tartrate) - Summary

 
 



LOPRESSOR HCT SUMMARY

Lopressor HCT has the antihypertensive effect of Lopressor®, 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.

Lopressor HCT is 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 patient’s needs, therapy with the fixed combination may be more convenient than with the separate components.


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NEWS HIGHLIGHTS

Media Articles Related to Lopressor HCT (Hydrochlorothiazide / Metoprolol)

High Blood Pressure (Hypertension) Quiz: Symptoms, Signs & Causes
Source: MedicineNet Facial Nerve Problems Specialty [2017.09.19]
Title: High Blood Pressure (Hypertension) Quiz: Symptoms, Signs & Causes
Category: MedicineNet Quiz
Created: 2/9/2011 12:00:00 AM
Last Editorial Review: 9/19/2017 6:02:11 PM

Pulmonary Hypertension (Symptoms, Treatment Medications, Life Expectancy)
Source: MedicineNet Congenital Heart Disease Specialty [2017.07.26]
Title: Pulmonary Hypertension (Symptoms, Treatment Medications, Life Expectancy)
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 7/26/2017 12:00:00 AM

High Blood Pressure (Hypertension)
Source: MedicineNet Polycystic Ovary Specialty [2017.03.31]
Title: High Blood Pressure (Hypertension)
Category: Symptoms and Signs
Created: 1/15/2014 12:00:00 AM
Last Editorial Review: 3/31/2017 12:00:00 AM

Portal Hypertension
Source: MedicineNet nitroglycerin Specialty [2016.09.06]
Title: Portal Hypertension
Category: Diseases and Conditions
Created: 1/31/2005 12:00:00 AM
Last Editorial Review: 9/6/2016 12:00:00 AM

Picture of Hypertension
Source: MedicineNet betaxolol ophthalmic Specialty [2014.12.09]
Title: Picture of Hypertension
Category: Images
Created: 2/3/2011 12:00:00 AM
Last Editorial Review: 12/9/2014 12:00:00 AM

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Published Studies Related to Lopressor HCT (Hydrochlorothiazide / Metoprolol)

Simultaneous quantitation of hydrochlorothiazide and metoprolol in human plasma by liquid chromatography-tandem mass spectrometry. [2010.05.01]
A rapid and sensitive method for the simultaneous quantitation of hydrochlorothiazide (HCT) and metoprolol (MET) in human plasma based on liquid chromatography-tandem mass spectrometry (LC-MS/MS) has been developed and validated. MS/MS detection involved switching the electrospray ionization (ESI) mode during chromatography from negative to detect HCT and its internal standard (I.S.) 5-bromouracil to positive to detect MET and its I.S...

Metoprolol succinate extended release/hydrochlorothiazide combination tablets. [2007]
Lowering elevated blood pressure (BP) with drug therapy reduces the risk for catastrophic fatal and nonfatal cardiovascular events such as stroke and myocardial infarction. Given the heterogeneity of hypertension as a disease, the marked variability in an individual patient's BP response, and low response rates with monotherapy, expert groups such as the Joint National Committee (JNC) emphasize the value of combination antihypertensive regimens, noting that combinations, usually of different classes, have additive antihypertensive effects...

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.

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Clinical Trials Related to Lopressor HCT (Hydrochlorothiazide / Metoprolol)

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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