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

Sponsors and Collaborators:	University of Split Dr Ivancica Pavlicevic Family Practice Office
Information provided by:	University of Split
ClinicalTrials.gov Identifier:	NCT00631514

Purpose

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.

Condition	Intervention	Phase
Hypertension	Drug: acetaminophen Drug: ibuprofen Drug: piroxicam	Phase IV

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Ibuprofen Dexibuprofen Acetaminophen Piroxicam

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Factorial Assignment, Efficacy Study
Official Title:	Relevance of the Interaction Between Antihypertensive and Antirheumatic Drugs in a Family Practice

Further study details as provided by University of Split:

Primary Outcome Measures:

Arterial blood pressure [ Time Frame: 3 months (3 individual blocks of 1 month each) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Body weight,serum electrolytes, urinary electrolytes (Na, K) [ Time Frame: 3 months (3 periods of 1 month) ] [ Designated as safety issue: Yes ]

Enrollment:	88
Study Start Date:	January 2005
Study Completion Date:	September 2006
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

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

Detailed Description:

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

Eligibility

Ages Eligible for Study:	55 Years to 78 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631514

Locations

Croatia
Split University School of Medicine. Family Practice Department
Split, Croatia, 21000

Sponsors and Collaborators

University of Split

Dr Ivancica Pavlicevic Family Practice Office

Investigators

Study Director:

Zvonko - Rumboldt, MD, PhD

Split University School of Medicine

More Information

Split University School of Medicine This link exits the ClinicalTrials.gov site

Publications:

Pavlicević I, Rumboldt M, Rumboldt Z. [Untoward interactions between antihypertensives and nonsteroidal anti-inflammatory drugs] Lijec Vjesn. 2005 Jul-Aug;127(7-8):168-72. Review. Croatian.

Publications indexed to this study:

Pavlicević I, Kuzmanić M, Rumboldt M, Rumboldt Z. Interaction between antihypertensives and NSAIDs in primary care: a controlled trial. Can J Clin Pharmacol. 2008 Fall;15(3):e372-82. Epub 2008 Oct 24.

Responsible Party:	Split University School of Medicine ( Ivancica Pavlicevic )
Study ID Numbers:	1-Pavlicevic
Study First Received:	February 27, 2008
Last Updated:	March 7, 2008
ClinicalTrials.gov Identifier:	NCT00631514
Health Authority:	Croatia: National Ethics Committee; Zagreb, Croatia

Keywords provided by University of Split:

antihypertensive drugs
non-steroidal anti-inflammatory drugs
interaction
family practice
arterial blood pressure

Study placed in the following topic categories:

Ibuprofen
Piroxicam
Vascular Diseases
Acetaminophen
Hypertension

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents

Therapeutic Uses
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009