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

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 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Relevance of the Interaction Between Antihypertensive and Antirheumatic Drugs in a Family Practice

Resource links provided by NLM:

MedlinePlus related topics: Blood Pressure Medicines Drug Reactions High Blood Pressure

Drug Information available for: Acetaminophen Ibuprofen Ibuprofen sodium Piroxicam Ibuprofen lysine

U.S. FDA Resources

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
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	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 Other Name: paracetamol 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
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	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 Other Name: paracetamol 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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:	Ivancica Pavlicevic, Split University School of Medicine
ClinicalTrials.gov Identifier:	NCT00631514 History of Changes
Other Study ID Numbers:	1-Pavlicevic
Study First Received:	February 27, 2008
Last Updated:	March 7, 2008
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

Additional relevant MeSH terms:


Acetaminophen Anti-Inflammatory Agents Anti-Inflammatory Agents, Non-Steroidal Antihypertensive Agents Ibuprofen Piroxicam Analgesics Analgesics, Non-Narcotic Antipyretics Antirheumatic Agents	Cardiovascular Agents Central Nervous System Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015