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

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

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.

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

Intervention(s) in this Clinical Trial

• Drug: acetaminophen
  • 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
• Drug: ibuprofen
  • 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
• Drug: piroxicam
  • 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

Arms, Groups and Cohorts in this Clinical Trial

• No Intervention: 1
  • Hypertensive persons taking either lisinopril/hydrochlorothiazide fixed combination or amlodipine all the time.
• Experimental: 2
  • 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
• Experimental: 3
  • 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 Measures

• Arterial blood pressure
  • Time Frame: 3 months (3 individual blocks of 1 month each)
    Safety Issue?: Yes

Secondary Measures

• Body weight,serum electrolytes, urinary electrolytes (Na, K)
  • Time Frame: 3 months (3 periods of 1 month)
    Safety Issue?: Yes

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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 55 Years

Maximum Age for this Clinical Trial: 78 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: University of Split Other

Overall Clinical Trial Officials and Contacts

Zvonko - Rumboldt, MD, PhD Study Director Split University School of Medicine  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00631514

Study ID Number: 1-Pavlicevic

ClinicalTrials.gov Identifier: NCT00631514

Health Authority: Croatia: National Ethics Committee; Zagreb, Croatia

Split University School of Medicine