Toprol-XL (Metoprolol Succinate) - Summary

TOPROL-XL SUMMARY

TOPROL-XL®
(metoprolol succinate)
EXTENDED-RELEASE TABLETS
TABLETS: 25 MG, 50 MG, 100 MG, AND 200 MG

TOPROL-XL, metoprolol succinate, is a beta₁-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended release tablets. TOPROL-XL has been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 23.75, 47.5, 95 and 190 mg of metoprolol succinate equivalent to 25, 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±)1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt).

Hypertension

TOPROL-XL is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.

Angina Pectoris

TOPROL-XL is indicated in the long-term treatment of angina pectoris.

Heart Failure

TOPROL-XL is indicated for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin. It was studied in patients already receiving ACE inhibitors, diuretics, and, in the majority of cases, digitalis. In this population, TOPROL-XL decreased the rate of mortality plus hospitalization, largely through a reduction in cardiovascular mortality and hospitalizations for heart failure.

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NEWS HIGHLIGHTS

Published Studies Related to Toprol-XL (Metoprolol)

Effect of metoprolol on quality of life in the prevention of syncope trial. [2009.10]
INTRODUCTION: Vasovagal syncope is common, often recurrent, and reduces quality of life. No therapies have proven useful to improve quality of life in adequately designed randomized clinical trials. Beta-blockers have mixed evidence for effectiveness in preventing syncope... CONCLUSION: Metoprolol does not improve quality of life in patients with recurrent vasovagal syncope and a positive tilt test.

Beta-receptor selectivity of carvedilol and metoprolol succinate in patients with heart failure (SELECT trial): a randomized dose-ranging trial. [2009.08]
STUDY OBJECTIVE: To determine whether metoprolol succinate (a beta(1)-selective beta-blocker) remains beta(1)-selective compared with carvedilol (a nonselective beta-blocker) during upward titration of doses in patients with American College of Cardiology (ACC) stage C heart failure... CONCLUSION: In this ACC stage C heart failure population, carvedilol was nonselective at all clinically relevant doses, whereas metoprolol succinate was beta(1)-selective at low doses and became progressively nonselective at higher doses.

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.

Prevention of perioperative atrial fibrillation with betablockers in coronary surgery: betaxolol versus metoprolol. [2009.07]
In this study, we tried to compare the efficacy and safety of betaxolol vs. metoprolol immediately postoperatively in coronary artery bypass grafting (CABG) patients and to determine whether prophylaxy for atrial fibrillation (AF) with betaxolol could reduce hospitalization and economic costs after cardiac surgery...

The influence of renal function on clinical outcome and response to beta-blockade in systolic heart failure: insights from Metoprolol CR/XL Randomized Intervention Trial in Chronic HF (MERIT-HF). [2009.05]
CONCLUSIONS: Renal function as estimated by eGFR was a powerful predictor of death and hospitalizations from worsening HF. Metoprolol CR/XL was at least as effective in reducing death and hospitalizations for worsening HF in patients with eGFR < 45 as in those with eGFR > 60.

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Clinical Trials Related to Toprol-XL (Metoprolol)

Carvedilol Versus Metoprolol for the Prevention of Atrial Fibrillation After Off-Pump Coronary Bypass Surgery [Completed]
Postoperative new-onset atrial fibrillation (AF) is the most common complication stemming from coronary artery bypass graft surgery, and is associated with increased early and late mortality risk. Standard guidelines recommend β blockers for the prevention of AF; however, no prospective study has compared the relative efficacy of β-blocking agents. We hypothesize that carvedilol, a non-selective adrenergic blocker with both anti-inflammatory and antioxidant properties, is more effective than metoprolol, a conventional β1-selective antagonist, in suppressing new-onset AF following off-pump coronary bypass surgery. We have designed the Carvedilol or Metoprolol Post-Revascularization Atrial Fibrillation Controlled Trial (COMPACT) to test our hypothesis in a multi-center, open-label, and randomized controlled trial.

Metoprolol and Formoterol in Chronic Obstructive Pulmonary Disease (COPD) [Recruiting]
We want to study the effect of the combination of metoprolol (a beta-blocker) with formoterol (a beta-agonist) on long function in patients with Chronic Obstructive Pulmonary Disease (COPD). There are more and more clues that a beta-blocker, when well chosen and in the right dosage, won't harm the long function in patients with COPD. Since a beta-blocker can be a valuable addition to treating patients with heart problems we would like to see if this category of medication can be available for COPD patients in the future.

Efficacy and Safety of Adding Clopidogrel to Aspirin or Use of Metoprolol in Myocardial Infarction [Completed]
COMMIT/CCS2 is a large randomised trial of the effects of clopidogrel plus Aspirin versus Aspirin alone in acute heart disease. Patients presenting within 24 hours of the onset of suspected acute MI were potentially eligible provided they were thought to have ST elevation or other ischaemic ECG abnormality with no clear indication for, or contraindication to, trial treatment. All patients were to be given 162 mg ASA daily and, in addition, 75 mg clopidogrel daily or matching placebo for 4 weeks or until prior discharge or death. (Patients were also randomised separately in a 2 X 2 factorial design between metoprolol versus placebo.) The two main study endpoints are death and the composite outcome of death, non-fatal reinfarction or stroke during the scheduled treatment period in hospital.

A Comparison of the Effect of Carvedilol and Metoprolol on Airways Tone in Patients With Heart Failure [Terminated]
This study looks at the effect of two drugs (carvedilol and metoprolol) which are used for patients with CHF (chronic heart failure).

These agents are beta-blockers and, although effective in heart failure, may cause increases in airways tone and thus limit air getting into the lower parts of the lungs. Carvedilol is more active at blocking the receptor that opens up the airways and therefore theoretically may be more likely to reduce airways tone than metoprolol, although this has never been studied in patients with heart failure, and that is the purpose of the present study.

We are looking to enrol 45 patients with heart failure and mild obstruction to the flow of air in their lungs. Patients will be randomised to either carvedilol or metoprolol (standard doses). Following a minimum of 2 weeks of therapy of study medication the patient will undergo a study day involving an assessment of their lung function, an assessment of their heart failure, a "living with heart failure" questionnaire, blood tests and blood pressure and heart rate readings.

Patients will then be crossed over to the alternate medication. Following 2 weeks on the target dose the patient will undergo their second study day which will be the same as the first.

The results obtained from each study day will be compared.

Study to Evaluate Symptoms in Patients Treated With Nebivolol or Metoprolol Extended-Release (ER) for Hypertension [Completed]
The purpose of this study is to compare the tolerability of nebivolol to metoprolol ER in a populatoin of patients with mild to moderate hypertension also receiving hydrochlorothiazide (HCTZ)

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PATIENT REVIEWS / RATINGS / COMMENTS

Toprol-XL review by 47 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		High Blood pressure
Dosage & duration:		50 mg. taken 1 daily for the period of 2 years
Other conditions:		breast cancer
Other drugs taken:		Dexameth 4mg., Vicodin 500mg., Compazine 10mg. Chemotherapy- Taxotere/Cytoxan 4tx., Neulasta
		Reported Results
Benefits:		Vicodin 500mg- reduced bone pain caused by Neulasta shot. Dexameth 4mg.- reduced drug reactions caused by chemotherapy. Compazine 10mg.- reduced nausea caused by chemotherapy. Taxotere/Cytoxan- going thru tx. at this time. hope to be cancer free! Neulasta shot- increased whit blood count so we could continue with chemotherapy.
Side effects:		Vicodin 500mg.- some drowsiness Dexameth 4mg.- hot flashes, flushed face,insomnia Compazine 10mg.- none Taxotere- hairloss, very dry skin, some gum bleeding, tiredness, metalic taste in mouth, short term memory loss, confusion, liver toxin level increasing. Cytoxan- ? since I receive the Taxotere at the same time I'm not sure which side effects are which. Neulasta shot- extreme bone pain
Comments:		Vicodin 500mg- take as needed for bone pain caused by Neluasta shot. Dexameth 4mg.- Take 2 tablets night before chemo tx., 2 tablets morning of tx, tablets evening of tx., two tablets am after tx. Compazine 10mg.- take one tablet every six hours as needed for nasuea from chemo. Taxotere/Cytoxan- total of four treatments for IDC breast cancer, Grade 1, Stage 2, 0ne lymph node involved. Prior treatment completed- Dec.08 lumpectomy and sentiel node removal, Jan 09 full mastectomy with lypmh node dissection (removed 18), started chemotherapy Feb 22 09 once every three weeks, just had third tx on Mar 31 09. Neulasta shot- total of four treatments given 48 hours after chemotherapy tx. Shot is given in the stomach area to reduce the side effects.

Toprol-XL review by 45 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		high blood pressure and
Dosage & duration:		25mg taken once daily for the period of one year to date
Other conditions:		none
Other drugs taken:		tylenol and advil; ketorolac: frova
		Reported Results
Benefits:		It seems to keep my blood pressure and headaches in check, especially during hormonal changes right before my period begins. I am also sleeping better at night (falling asleep and staying asleep; able to get back to sleep during the night), whereas before I was getting only a couple of hours of sleep a night.
Side effects:		none so far
Comments:		I had been dealing with more frequent "migraine" headaches (headaches unresponsive to OTC pain relievers)and began to notice a pattern that was related to my menstrual cycle. During treatment for the headaches with frova and ketorolac I had an episode where I had sudden and severe pain in my head and felt like my head was going to explode, which sent me to the emergency room. The cause was never really determined but in the process it was noticed that my blood pressure was elevated and remained elevated during following doctor visits. Since being on toprol, the headaches and blood pressure have remained managable throughout monthly hormonal changes.