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| ID | Type | Description | Link |
|---|---|---|---|
| NA-7122 | Other Grant/Funding Number | Heart & Stroke Foundation of Ontario |
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Coffee is a globally popular beverage. More than half of the United States population spends an estimated $ 40 billion on the purchase of coffee each year. Personal consumption habits can vary. For example, the frequency of ingestion ranged from 59% for every day to 8% for less than one day per week consumption in one survey. In the case of occasional consumption, coffee can markedly elevate blood pressure in normotensive and hypertensive individuals. This pressor effect can occur with a caffeine dose of 200 - 250 mg, which can be found 2 - 3 cups of coffee. A major active constituent in coffee is caffeine, which is the most widely used pharmacological substance in the world.
Drug therapy plays a major role in the management of hypertension. However, the interaction between coffee or caffeine and blood pressure lowering drugs has been assessed in only three clinical studies that were reported more than three decades ago.
We conducted a comprehensive interaction study involving a commonly ingested amount of a particular Colombian coffee and felodipine in healthy middle-aged men and women. Peripheral (brachial) and central (aortic) hemodynamics and caffeine and felodipine pharmacokinetics were evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Water plus Felodipine | Placebo Comparator | Felodipine extended-release tablet ,10 mg, single dose, 8 hours |
|
| Black Coffee | Active Comparator | Black Coffee, 300 ml, 0 and 1 hour |
|
| Black Coffee plus Felodipine | Experimental | Black Coffee, 300 ml, 0 and 1 hour Felodipine extended-release tablet ,10 mg, single dose, 8 hours |
|
| Grapefruit Juice plus Felodipine | Active Comparator | Grapefruit Juice, 300 ml, 0 and 1 hour Felodipine extended-release tablet ,10 mg, single dose, 8 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Black Coffee | Other |
| ||
| Grapefruit Juice |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of felodipine on coffee-mediated increases in peripheral and central blood pressure . | Peripheral (brachial systolic and diastolic blood pressure) and central (aortic systolic blood pressure) measurements were the mean of at least 3 readings after 5 minutes of sitting at rest. The respective instruments used were BpTRU™ Vital Signs Monitor (BpTRU Medical Devices, Coquitlam BC, Canada) and SphygmoCor® CP Pulse Wave Analysis System - Research (AtCor Medical, Inc., Itasca, IL USA). | Change from Baseline to 8 hours Post Dose |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of coffee on the oral pharmacokinetics of felodipine. | Area Under Curve (AUC) Time Frame: predose, 1,2,3,4,5,6,7,8 hours post-dose | Change from Baseline to 8 hours Post Dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David G Bailey, BScPhm, PhD | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Victoria Clinical Trials Centre | London | Ontario | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27481881 | Background | Bailey DG, Dresser GK, Urquhart BL, Freeman DJ, Arnold JM. Coffee-Antihypertensive Drug Interaction: A Hemodynamic and Pharmacokinetic Study With Felodipine. Am J Hypertens. 2016 Dec 1;29(12):1386-1393. doi: 10.1093/ajh/hpw081. | |
| 28971609 | Background | Dresser GK, Urquhart BL, Proniuk J, Tieu A, Freeman DJ, Arnold JM, Bailey DG. Coffee inhibition of CYP3A4 in vitro was not translated to a grapefruit-like pharmacokinetic interaction clinically. Pharmacol Res Perspect. 2017 Oct;5(5):e00346. doi: 10.1002/prp2.346. |
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| ID | Term |
|---|---|
| D014867 | Water |
| D015736 | Felodipine |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 |
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| Other |
|
| Water | Other |
|
| Felodipine | Drug |
|
|
| Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |