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

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: acetaminophen; Drug: ibuprofen; Drug: piroxicam

• Registration Number: NCT00631514
• Lead Sponsor: University Hospital of Split

Brief Summary

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

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

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2006-09
• Study Completion: 2006-09
• Status Verified: 2008-02
• Study First Submitted: 2008-02-27
• Study First Submitted QC: 2008-03-06
• Study First Posted: 2008-03-07
• Last Update Submitted: 2008-03-07
• Last Update Posted: 2008-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
2	piroxicam	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
3	acetaminophen	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
3	ibuprofen	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
2	acetaminophen	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
2	ibuprofen	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
3	piroxicam	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

Primary Outcome Measures

Name	Time	Method
Arterial blood pressure	3 months (3 individual blocks of 1 month each)

Secondary Outcome Measures

Name	Time	Method
Body weight,serum electrolytes, urinary electrolytes (Na, K)	3 months (3 periods of 1 month)

Trial Locations

Locations (1)

Split University School of Medicine. Family Practice Department; 🇭🇷 Split, Croatia