Metoprolol (Metoprolol Tartrate) - Summary

METOPROLOL SUMMARY

Metoprolol tartrate, USP is a selective beta₁-adrenoreceptor blocking agent, available as 25, 50 and 100 mg tablets for oral administration.

Metoprolol tartrate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.

Metoprolol tartrate tablets are indicated in the long-term treatment of angina pectoris.

Metoprolol tartrate injection and tablets are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment with intravenous metoprolol tartrate can be initiated as soon as the patient’s clinical condition allows (see DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, and WARNINGS). Alternatively, treatment can begin within 3 to 10 days of the acute event (see DOSAGE AND ADMINISTRATION).

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NEWS HIGHLIGHTS

Published Studies Related to Metoprolol

Effect of fixed dose combinations of metoprolol and amlodipine in essential hypertension: MARS ? A randomized controlled trial. [2011.12]
Abstract Aim. To compare two strengths of a fixed drug combination (FDC) containing metoprolol XL and amlodipine (metoprolol/amlodipine 50/5; and metoprolol/amlodipine 25/2.5) with its components in hypertension...

Endothelial function is unaffected by changing between carvedilol and metoprolol in patients with heart failure-a randomized study. [2011.10.15]
ABSTRACT: BACKGROUND: Carvedilol has been shown to be superior to metoprolol tartrate to improve clinical outcomes in patients with heart failure (HF), yet the mechanisms responsible for these differences remain unclear. We examined if there were differences in endothelial function, insulin stimulated endothelial function, 24 hour ambulatory blood pressure and heart rate during treatment with carvedilol, metoprolol tartrate and metoprolol succinate in patients with HF... CONCLUSION: Endothelial function remained unchanged when switching the beta blocker treatment from carvedilol to either metoprolol tartrate or metoprolol succinate in this study, where blood pressure and heart rate also remained unchanged in patients with mild HF. TRIAL REGISTRATION: Current Controlled Trials NCT00497003.

beta-Blockers in patients with intermittent claudication and arterial hypertension: results from the nebivolol or metoprolol in arterial occlusive disease trial. [2011.08]
The use of beta-receptor blockers in peripheral arterial disease is controversial for their impact on vasomotor tone... In the direct comparison, there was no significant difference between nebivolol and metoprolol.

Differential effects of nebivolol and metoprolol on central aortic pressure and left ventricular wall thickness. [2011.06]
The aim of this study was to investigate the effects of the vasodilating beta-blocker nebivolol and the cardioselective beta-blocker metoprolol succinate on aortic blood pressure and left ventricular wall thickness... This proof-of-principle study provides evidence to suggest that beta-blockers with vasodilating properties may offer advantages over conventional beta-blockers in antihypertensive therapy; however, this remains to be tested in a larger trial.

The effect of nebivolol versus metoprolol succinate extended release on asymmetric dimethylarginine in hypertension. [2011.05]
This study sought to determine if metoprolol succinate ER (MET), and nebivolol (NEB), a beta1-AR with increased bioavailability of nitric oxide (NO), would have differing effects on plasma asymmetric dimethylarginine concentration in hypertensives. It was hypothesized that NEB, a beta1-AR antagonist and beta3-AR agonist with NO-releasing properties, and MET, only a beta1-AR antagonist, would have different effects on plasma asymmetric dimethylarginine (ADMA) concentration...

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Clinical Trials Related to 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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Reports of Suspected Metoprolol Side Effects

Completed Suicide (26),  Cardiogenic Shock (22),  Hypotension (16),  Cardiac Arrest (14),  Overdose (13),  Intentional Overdose (11),  Hypokalaemia (10),  Bradycardia (10),  Dyspnoea (9),  Hypoglycaemia (8), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

Metoprolol review by 53 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		tachycardia
Dosage & duration:		50mg taken once per day for the period of on-going since 2006
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		I have very few racing heart episodes since I have been on this medication.
Side effects:		The side effect has been a slight decrease in my metabolism. I gained 5 pounds within 3 weeks of starting the medication. But, the benefit greatly outweighs this minor side effect. A purposeful increase in daily exercise has helped to prevent further weight gain.
Comments:		I take one 50 mg pill once per day with food or milk.

Metoprolol review by 56 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		hypertension
Dosage & duration:		100 mg taken 1 x daily for the period of 3 years
Other conditions:		none
Other drugs taken:		Lotrel
		Reported Results
Benefits:		My blood pressure readings have improved.
Side effects:		There were no side effects. I have tolerated the drug very well.
Comments:		I have taken this drug daily for three years for hypertension in combination with Lotrel. My blood pressure readings have dropped from 160/120 to 120/80. The drug has been effective and well-tolerated.

Metoprolol review by 36 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		high blood pressure
Dosage & duration:		50 MG taken once daily for the period of 1 year and counting
Other conditions:		diabetes sarcoidosis
Other drugs taken:		none
		Reported Results
Benefits:		no headaches (had salt sensitive migraines)
Side effects:		dizzy, vomiting. my bp is sometimes too low especially after exercise but I am not having headaches as long or often
Comments:		once daily, bp check every 3 months, bp checks at home, watch diet (no added salt), lose weight. I have to go to dr. every so often for liver/kidney/glucose check too.