Lopressor clinical studies: Difference between revisions
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{{Metoprolol}} | {{Metoprolol}} | ||
{{CMG}} | {{CMG}} | ||
===Hypertension=== | ===Hypertension=== | ||
In controlled clinical studies, Lopressor has been shown to be an effective antihypertensive agent when used alone or as concomitant therapy with [[thiazide]]-type [[diuretics]], at dosages of 100-450 mg daily. In controlled, comparative, clinical studies, Lopressor has been shown to be as effective an antihypertensive agent as [[propranolol]], [[methyldopa]], and [[thiazide]]-type [[diuretics]], to be equally effective in supine and standing positions. | In controlled clinical studies, Lopressor has been shown to be an effective antihypertensive agent when used alone or as concomitant therapy with [[thiazide]]-type [[diuretics]], at dosages of 100-450 mg daily. In controlled, comparative, clinical studies, Lopressor has been shown to be as effective an [[antihypertensive]] agent as [[propranolol]], [[methyldopa]], and [[thiazide]]-type [[diuretics]], to be equally effective in supine and standing positions. | ||
===Angina Pectoris=== | ===Angina Pectoris=== | ||
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In a large (1,395 patients randomized), double-blind, placebo-controlled clinical study, Lopressor was shown to reduce 3-month mortality by 36% in patients with suspected or definite [[myocardial infarction]]. | In a large (1,395 patients randomized), double-blind, placebo-controlled clinical study, Lopressor was shown to reduce 3-month mortality by 36% in patients with suspected or definite [[myocardial infarction]]. | ||
Patients were randomized and treated as soon as possible after their arrival in the hospital, once their clinical condition had stabilized and their hemodynamic status had been carefully evaluated. Subjects were ineligible if they had [[hypotension]], [[bradycardia]], peripheral signs of [[shock]], and/or more than minimal basal [[rales]] as signs of [[congestive heart failure]]. Initial treatment consisted of intravenous followed by oral administration of Lopressor or placebo, given in a coronary care or comparable unit. Oral maintenance therapy with Lopressor or placebo was then continued for 3 months. After this double-blind period, all patients were given Lopressor and followed up to 1 year. | Patients were randomized and treated as soon as possible after their arrival in the hospital, once their clinical condition had stabilized and their hemodynamic status had been carefully evaluated. Subjects were ineligible if they had [[hypotension]], [[bradycardia]], peripheral signs of [[shock]], and/or more than minimal basal [[rales]] as signs of [[congestive heart failure]]. Initial treatment consisted of intravenous followed by oral administration of Lopressor or placebo, given in a [[coronary care unit|coronary care]] or comparable unit. Oral maintenance therapy with Lopressor or placebo was then continued for 3 months. After this double-blind period, all patients were given Lopressor and followed up to 1 year. | ||
The median delay from the onset of symptoms to the initiation of therapy was 8 hours in both the Lopressor- and placebo-treatment groups. Among patients treated with Lopressor, there were comparable reductions in 3-month mortality for those treated early (≤8 hours) and those in whom treatment was started later. Significant reductions in the incidence of ventricular fibrillation and in chest pain following initial intravenous therapy were also observed with Lopressor and were independent of the interval between onset of symptoms and initiation of therapy. | The median delay from the onset of symptoms to the initiation of therapy was 8 hours in both the Lopressor- and placebo-treatment groups. Among patients treated with Lopressor, there were comparable reductions in 3-month mortality for those treated early (≤8 hours) and those in whom treatment was started later. Significant reductions in the incidence of [[ventricular fibrillation]] and in [[chest pain]] following initial [[intravenous]] therapy were also observed with Lopressor and were independent of the interval between onset of symptoms and initiation of therapy. | ||
In this study, patients treated with metoprolol received the drug both very early (intra-venously) and during a subsequent 3-month period, while placebo patients received no [[beta-blocker]]treatment for this period. The study thus was able to show a benefit from the overall metoprolol regimen but cannot separate the benefit of very early intravenous treatment from the benefit of later [[beta-blocker]] therapy. Nonetheless, because the overall regimen showed a clear beneficial effect on survival without evidence of an early adverse effect on survival, one acceptable dosage regimen is the precise regimen used in the trial. Because the specific benefit of very early treatment remains to be defined however, it is also reasonable to administer the drug orally to patients at a later time as is recommended for certain other [[beta blockers]].<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = LOPRESSOR (METOPROLOL TARTRATE) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION] | url =http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=bb05420c-fd24-4672-9f62-fdd313819287 | publisher = | date = | accessdate = }}</ref> | In this study, patients treated with metoprolol received the drug both very early (intra-venously) and during a subsequent 3-month period, while placebo patients received no [[beta-blocker]]treatment for this period. The study thus was able to show a benefit from the overall metoprolol regimen but cannot separate the benefit of very early [[intravenous]] treatment from the benefit of later [[beta-blocker]] therapy. Nonetheless, because the overall regimen showed a clear beneficial effect on survival without evidence of an early adverse effect on survival, one acceptable dosage regimen is the precise regimen used in the trial. Because the specific benefit of very early treatment remains to be defined however, it is also reasonable to administer the drug orally to patients at a later time as is recommended for certain other [[beta blockers]].<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = LOPRESSOR (METOPROLOL TARTRATE) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION] | url =http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=bb05420c-fd24-4672-9f62-fdd313819287 | publisher = | date = | accessdate = }}</ref> | ||
==References== | ==References== |
Revision as of 06:22, 13 March 2014
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Clinical data | |
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Trade names | Lopressor, Toprol-xl |
AHFS/Drugs.com | Monograph |
MedlinePlus | a682864 |
[[Regulation of therapeutic goods |Template:Engvar data]] |
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Pregnancy category | |
Routes of administration | Oral, IV |
ATC code | |
Legal status | |
Legal status |
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Pharmacokinetic data | |
Bioavailability | 12% |
Metabolism | Hepatic via CYP2D6, CYP3A4 |
Elimination half-life | 3-7 hours |
Excretion | Renal |
Identifiers | |
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CAS Number | |
PubChem CID | |
IUPHAR/BPS | |
DrugBank | |
ChemSpider | |
UNII | |
KEGG | |
ChEBI | |
ChEMBL | |
E number | {{#property:P628}} |
ECHA InfoCard | {{#property:P2566}}Lua error in Module:EditAtWikidata at line 36: attempt to index field 'wikibase' (a nil value). |
Chemical and physical data | |
Formula | C15H25NO3 |
Molar mass | 267.364 g/mol |
3D model (JSmol) | |
Melting point | 120 °C (248 °F) |
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Hypertension
In controlled clinical studies, Lopressor has been shown to be an effective antihypertensive agent when used alone or as concomitant therapy with thiazide-type diuretics, at dosages of 100-450 mg daily. In controlled, comparative, clinical studies, Lopressor has been shown to be as effective an antihypertensive agent as propranolol, methyldopa, and thiazide-type diuretics, to be equally effective in supine and standing positions.
Angina Pectoris
In controlled clinical trials, Lopressor, administered two or four times daily, has been shown to be an effective antianginal agent, reducing the number of angina attacks and increasing exercise tolerance. The dosage used in these studies ranged from 100-400 mg daily. A controlled, comparative, clinical trial showed that Lopressor was indistinguishable from propranolol in the treatment of angina pectoris.
Myocardial Infarction
In a large (1,395 patients randomized), double-blind, placebo-controlled clinical study, Lopressor was shown to reduce 3-month mortality by 36% in patients with suspected or definite myocardial infarction.
Patients were randomized and treated as soon as possible after their arrival in the hospital, once their clinical condition had stabilized and their hemodynamic status had been carefully evaluated. Subjects were ineligible if they had hypotension, bradycardia, peripheral signs of shock, and/or more than minimal basal rales as signs of congestive heart failure. Initial treatment consisted of intravenous followed by oral administration of Lopressor or placebo, given in a coronary care or comparable unit. Oral maintenance therapy with Lopressor or placebo was then continued for 3 months. After this double-blind period, all patients were given Lopressor and followed up to 1 year.
The median delay from the onset of symptoms to the initiation of therapy was 8 hours in both the Lopressor- and placebo-treatment groups. Among patients treated with Lopressor, there were comparable reductions in 3-month mortality for those treated early (≤8 hours) and those in whom treatment was started later. Significant reductions in the incidence of ventricular fibrillation and in chest pain following initial intravenous therapy were also observed with Lopressor and were independent of the interval between onset of symptoms and initiation of therapy.
In this study, patients treated with metoprolol received the drug both very early (intra-venously) and during a subsequent 3-month period, while placebo patients received no beta-blockertreatment for this period. The study thus was able to show a benefit from the overall metoprolol regimen but cannot separate the benefit of very early intravenous treatment from the benefit of later beta-blocker therapy. Nonetheless, because the overall regimen showed a clear beneficial effect on survival without evidence of an early adverse effect on survival, one acceptable dosage regimen is the precise regimen used in the trial. Because the specific benefit of very early treatment remains to be defined however, it is also reasonable to administer the drug orally to patients at a later time as is recommended for certain other beta blockers.[1]
References
Adapted from the FDA Package Insert.
- Pages with script errors
- Template:drugs.com link with non-standard subpage
- Drugs with non-standard legal status
- E number from Wikidata
- ECHA InfoCard ID from Wikidata
- Chemical articles with unknown parameter in Infobox drug
- Infobox drug articles with non-default infobox title
- Beta blockers
- Cardiovascular Drugs
- Drugs