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Abstract Number: 2357

Topical Application of Aceclofenac Might NOT Produce a Significant Increase of Blood Pressure in Osteoarthritic Patients – a Continuous Automated Blood Pressure Monitor Study

Marius Trandafir1, Ruxandra Ionescu2, Denisa Predeteanu3, Alma Nicu1, MIHAI ABOBULUI4, Andra Rodica Balanescu5, Violeta Bojinca6,7, Daniela Opris3, Violeta Vlad8 and Florian Berghea5,9, 1Sf Maria Hospital, Bucharest, Romania, 2Department of Internal Medicine and Rheumatology, University of Medicine and Pharmacy “Carol Davila”, “, Bucharest, Romania, 3University of Medicine and Pharmacy “Carol Davila”, Department of Internal Medicine and Rheumatology “Sf. Maria” Hospital, Bucharest, Romania, 4RCRD, BUCHAREST, Romania, 5Department of Internal Medicine and Rheumatology “Sf. Maria” Hospital, Bucharest, Romania, 6Internal Medicine and Rheumatology Department,, Carol Davila University of Medicine and Pharmacy,, Bucuresti, Romania, 7Sf. Maria Hospital, Bucharest, Romania, 8RCRD Research Center, Bucharest, Romania, 9Department of Internal Medicine and Rheumatology “Sf. Maria” Hospital, University of Medicine and Pharmacy “Carol Davila”, Bucharest, Romania

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: hypertension

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Session Information

Date: Tuesday, November 15, 2016

Title: Osteoarthritis – Clinical Aspects - Poster II

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose:  Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used in Osteoarthritic patients for their anti-inflammatory and pain-killer proprieties. Various reports suggest an increase in blood pressure of about 3-5 mmHg in relation with systemic use of NSAIDs. This effect is observed from the beginning of the treatment; however, due to his “modest” amplitude, it was largely ignored both by patients and physicians. New epidemiological data suggest that such a small increase in BP could produces in USA about 21.000 deaths per year (higher than in case of gastrointestinal deaths produced by the unprotected usage of nonselective NSAID). For the time being much less is known about the blood pressure effect of topical NSAIDs. The interest for this subject is higher as long as both systemic and topical NSAID seem to have similar therapeutic effect on superficial exposed joints (e.g. knee, wrists, elbows etc.) but different safety profile. The aim of the study was to evaluate whether or not the use of a topical NSAID (acecelofenac) in osteoarthritis affects blood pressure or pulse rate values.

Methods:  52 patients with a clear diagnostic of osteoarthritis have been evaluated, by using a continuous Automated BP Monitoring system (ABPM), before and after the utilization of topical aceclofenac. Blood pressure and pulse rate have been continuously recorded for 48 hours at baseline (24 hours without topical NSAID use) and day1 (24 hours with topical NSAID use). Same NSAID (namely aceclofenac) in same dose have been used in all cases. Subjects that received antihypertensive therapy, those receiving therapeutic regimes with potential impact on blood pressure and those that changed their concomitant medication during the study have been excluded from the analyses. Daytime (0700-2200), nighttime (2201-0659) and all-day (24h) systolic and diastolic BP along with pulse rate values have been analyzed. Difference between Baseline and Day1 have been tested by using ANOVA and Fisher exact test; a p<0.05 was considered significant.

Results:  : No difference has been observed between baseline (no drug) and Day 1 (topical aceclofenac day) regarding diastolic BP or Heart rate (see the table). For systolic BP a statistical significant reduction between Day1 and baseline ( -1.88 mmHg , sd: 5.8 mmHg) has been found. Similar results have been obtained for all-day, nighttime and daytime sub analysis.

N

Minimum

Maximum

Mean

Std. Deviation

Sys BP Baseline

52

101.75

147.90

122.8904

10.16477

Sys BP Day 1

52

103.9

140.3

121.007

7.6768

Dia. BP Baseline

52

55.05

88.10

75.4462

6.41531

Dia. BP Day 1

52

56.4

87.1

75.390

5.9851

HR Baseline

52

60.2

95.9

78.127

6.7779

HR Day 1

52

59.3

90.3

77.313

6.2257

Conclusion: Although this study has certain limitations our data suggest that no significant increase of BP or HR are associated with topic use of NSAID (in our case Aceclofenac). Larger studies should be made to confirm the conclusion of this study. References:  1.Snowden S, Nelson R- The effects of nonsteroidal anti-inflammatory drugs on blood pressure in hypertensive patients. Cardio Rev2011 Jul-Aug;19(4):184-91. 2.Howard Lee,MD; KeeSikKim,MD,- Ambulatory Blood Pressure Response to Once-Daily Fimasartan: An 8-Week, Multicenter, Randomized, Double- Blind, Active-Comparator, Parallel-Group Study in Korean Patients With Mild To Moderate Essential Hypertension Clinical Therapeutics/Volume 35, Number 9, 2013.


Disclosure: M. Trandafir, None; R. Ionescu, None; D. Predeteanu, None; A. Nicu, None; M. ABOBULUI, None; A. R. Balanescu, None; V. Bojinca, None; D. Opris, None; V. Vlad, None; F. Berghea, None.

To cite this abstract in AMA style:

Trandafir M, Ionescu R, Predeteanu D, Nicu A, ABOBULUI M, Balanescu AR, Bojinca V, Opris D, Vlad V, Berghea F. Topical Application of Aceclofenac Might NOT Produce a Significant Increase of Blood Pressure in Osteoarthritic Patients – a Continuous Automated Blood Pressure Monitor Study [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/topical-application-of-aceclofenac-might-not-produce-a-significant-increase-of-blood-pressure-in-osteoarthritic-patients-a-continuous-automated-blood-pressure-monitor-study/. Accessed .
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