ASSESSMENT OF THE EFFECTS OF ROFECOXIB, CELECOXIB AND NAPROXEN ON BLOOD PRESSURE AND CARDIOVASCULAR RISK- A RETROSPECTIVE CHART REVIEW STUDY
Author(s)
Ronald R. Brown, MS, RPh, Program Specialist, Pharmacoeconomics & Drug Information1, Margaret A. Olmon, RPh, MBA, Clinical Education Consultant2, Michael W. Estoup, PharmD, Team Manager, Clinical Education Consultants31Dept. of Veterans Affairs Medical Center, Portland, OR, USA; 2 Pfizer, Inc, Lake Oswego, OR, USA; 3 Pfizer, Inc, Beaverton, OR, USA
OBJECTIVES: Study objectives were to assess the impact of celecoxib, rofecoxib, or naproxen on blood pressure and BP goal attainment in a veteran population. Secondary objectives included assessment of associated cardiovascular risk, and changes to other medications associated with study drug use. METHODS: Computerized medical and prescription records were used to identify 262 consecutive patients receiving a new prescription for rofecoxib, celecoxib or naproxen, from January 2001 to October 2005. Data collected in eligible patients included patient demographics; drug utilization information for the study drug and concomitant antihypertensives; baseline and follow-up laboratory and clinical data including BP, and lipid panel information. Inclusion criteria included age >49, treatment with study drug for at least two weeks (not PRN), and stabilization of preexisting antihypertensives for at least 30 days, for hypertensive patients. Exclusion criteria included lack of follow-up information or death prior to study completion, and/or use of any of the following: MAO-inhibitors; tricyclic antidepressants; sympathomimetics; glucocorticoids; corticotropin; cyclosporine; oral contraceptives; concomitant NSAID's (including > 325 mg/day of aspirin). Statistical analysis was conducted using the Chi-square test for demographic data. Intra-group comparisons were analyzed using the paired student's t-test, while intra-group differences were assessed by analysis of variance. RESULTS: Analysis revealed significant BP reduction in celecoxib patients (-7/-5mmHg, p<0.01). BP change was not observed in naproxen patients, while BP increase was observed in rofecoxib patients (+5/+2mmHg, p<0.05). A majority of celecoxib patients were switched from an alternate therapy (60% from rofecoxib, 9% from NSAID), while only 29% and 12% of rofecoxib and naproxen patients were switched. BP reduction was associated with improvement in JNC-VII stage in 47% of celecoxib patients (p<0.01), who were hypertensive (BP>140/90) at treatment onset (47.5%). CONCLUSION: Clinically relevant BP reduction may be an additional benefit of celecoxib in hypertensive patients requiring treatment with NSAID.
Conference/Value in Health Info
2006-05, ISPOR 2006, Philadelphia, PA
Value in Health, Vol. 9, No.3 (May/June 2006)
Code
PCV12
Topic
Epidemiology & Public Health
Topic Subcategory
Safety & Pharmacoepidemiology
Disease
Cardiovascular Disorders