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The objective of the study was to compare treatment with two different oral formulations of metoprolol, metoprolol immediate release (IR) and metoprolol extended release (CR/XL) in patients with acute myocardial infarction regarding the following:
Pharmacokinetics, peak and trough plasma concentrations and area under the plasma concentration curve.
Pharmacodynamics, hourly means of Holter recorded heart rate. Tolerability. An open, randomised design with two parallel groups was employed.
A pharmacokinetic and pharmacodynamic study comparing metoprolol IR and metoprolol CR/XL subsequent to initial treatment with intravenous and/or oral metoprolol in patients with suspected acut myocardial infarction
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metoprolol- Toprol XL | Experimental | Metoprolol extended release (CR/XL) tablet 200 mg once daily |
|
| Metoprolol- Lopressor | Active Comparator | Metoprolol immediate release (IR) tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metoprolol- Toprol XL | Drug | Extended release tablet, 200mg once daily for 4 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile in terms of Cmax, Cmin, AUC | Assesment following multiple dosing of metoprolol CR/XL 200 mg once daily, or multiple dosing of metoprolol IR 200 mg daily in divided doses | Treatment duration: 4 days |
| Pharmacodynamics in terms of Hourly means of heart rate (Holter recorded) | Assesment following multiple dosing of metoprolol CR/XL 200 mg once daily, or multiple dosing of metoprolol IR 200 mg daily in divided doses | Treatment duration: 4 days |
| Safety profile in terms of adverse events | Treatment duration: 4 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dag Elmfeldt, MD, PHD | AstraZeneca R&D Mölndal | Study Director |
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| ID | Term |
|---|---|
| D008790 | Metoprolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| Metoprolol- Lopressor |
| Drug |
Immediate release tablet, Day 1 50 mg four times daily, Day 2, 3 and 4 100 mg twice daily |
|
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |