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

University Hospital of Split

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: piroxicam; Drug: ibuprofen; Drug: acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT00631514

1-Pavlicevic

Details and patient eligibility

About

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.

Full description

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

Enrollment: 88 patients

Sex: All

Ages: 55 to 78 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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88 participants in 3 patient groups

1

No Intervention group

Description:

Hypertensive persons taking either lisinopril/hydrochlorothiazide fixed combination or amlodipine all the time.

2

Experimental group

Description:

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

Treatment:

Drug: acetaminophen

Drug: ibuprofen

Drug: piroxicam

3

Experimental group

Description:

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

Treatment:

Drug: acetaminophen

Drug: ibuprofen

Drug: piroxicam