Interaction Between Antihypertensives and Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

Study Overview
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Brief Summary
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NSAIDs may increase blood pressure and blunt the effects of many antihypertensives. Members of these drug classes differ in their propensity to such an interaction.

Detailed Description
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To compare prospectively the effects of piroxicam, ibuprofen and acetaminophen on blood pressure control in hypertensive patients with osteoarthritis.

Official Title
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Relevance of the Interaction Between Antihypertensive and Antirheumatic Drugs in a Family Practice

Conditions
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Hypertension

Intervention / Treatment
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* Drug: acetaminophen
* Drug: ibuprofen
* Drug: piroxicam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Treated hypertensives of either gender aged between 55 and 76 years About 50% with concomitant osteoarthritis of the hip or knee Exclusion Criteria: Normotensive persons or untreated hypertensives Individuals outside the age limits General exclusion criteria (e.g. uncooperative persons, advanced malignancies, participants in other studies)

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 78 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>Hypertensive persons taking either lisinopril/hydrochlorothiazide fixed combination or amlodipine all the time. | |
| Experimental: 2<br>Intervention: NSAID. Hypertensives with osteoarthritis taking already amlodipine (5-10 mg o.d. per os) were randomized to the following drug interventions: to take either acetaminophen (1000 mg t.i.d. per os), piroxicam (10-20 mg o.d. per os) or ibuprofen (400-600 mg t.i.d. per os) for 1 month | Drug: acetaminophen<br>* acetaminophen 1000 mg t.i.d. per os ibuprofen 400-600 mg t.i.d. per os piroxicam 10-20 mg o.d. per os<br>* Other names: paracetamol;Drug: ibuprofen<br>* acetaminophen 1000 mg t.i.d. per os ibuprofen 400-600 mg t.i.d. per os piroxicam 10-20 mg o.d. per os<br>Drug: piroxicam<br>* acetaminophen 1000 mg t.i.d. per os ibuprofen 400-600 mg t.i.d. per os piroxicam 10-20 mg o.d. per os<br>|
| Experimental: 3<br>Hypertensives with osteoarthritis taking already lisinopril/hydrochlorothiazide (20/12.5 mg o.d. per os), were sequentially randomized to the following drug interventions: acetaminophen (1000 mg t.i.d.), ibuprofen (400-600 mg t.i.d.) or piroxicam (10-20 mg o.d.), for 1 month each | Drug: acetaminophen<br>* acetaminophen 1000 mg t.i.d. per os ibuprofen 400-600 mg t.i.d. per os piroxicam 10-20 mg o.d. per os<br>* Other names: paracetamol;Drug: ibuprofen<br>* acetaminophen 1000 mg t.i.d. per os ibuprofen 400-600 mg t.i.d. per os piroxicam 10-20 mg o.d. per os<br>Drug: piroxicam<br>* acetaminophen 1000 mg t.i.d. per os ibuprofen 400-600 mg t.i.d. per os piroxicam 10-20 mg o.d. per os<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial blood pressure |  | 3 months (3 individual blocks of 1 month each) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight,serum electrolytes, urinary electrolytes (Na, K) |  | 3 months (3 periods of 1 month) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antihypertensive drugs, non-steroidal anti-inflammatory drugs, interaction, family practice, arterial blood pressure