Dooley, J

Lapane, K

Pettitt, D

Spooner, J

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PAD5: RETROSPECTIVE EVALUATION OF CONCOMITANT GASTROINTESTINAL DRUG USE WITH NSAID THERAPY AMONG PATIENTS WITH ARTHRITIS 

Abstracts 191
CONCLUSION: Using change scores responding to a
one-level improvement of PtGA or PhGA or using the av-
erage difference of change between any two levels im-
provement of PtGA or PhGA, the clinically meaningful
improvement for WOMAC pain, stiffness, physical func-
tioning, and total WOMAC scores were approximately
2, 1, 7, and 10, respectively.
PAD4
CLINICALLY MEANINGFUL IMPROVEMENT OF 
HEALTH-RELATED QUALITY OF LIFE (HRQoL) 
AMONG OSTEOARTHRITIS (OA) PATIENTS
Zhao SZ, Arguelles L, Burke TA, Osterhaus JT
G.D. Searle & Co., Skokie, IL, USA
HRQoL measures are becoming important for evaluating
the effects of arthritis treatments. Interpreting changes in
HRQoL scores, however, has not been fully evaluated. 
OBJECTIVE: To determine the clinically meaningful im-
provement of HRQoL as measured by the SF-36 among
OA patients. 
METHODS: Data were obtained from three 12-week ran-
domized clinical trials among 3369 OA flare patients. The
SF-36 and Patient Global Assessment (PtGA) were admin-
istered to patients at baseline and week 12. PtGA was
measured on the following 1- to 5-point scale: very good,
good, fair, poor, or very poor. Change scores were com-
puted by subtracting patient’s baseline from week 12 fol-
low-up scores. Clinically meaningful improvement was es-
timated as the mean change score corresponding to a one-
level improvement in PtGA. A similar interpretation of
clinically meaningful changes was also performed using
physician-global assessment, pain, and functional-status. 
RESULTS: At week 12, the following patients experi-
enced improvements in their PtGA rating: one-level
(1158), two-levels (745), three or more levels (311),
which corresponded to standardized physical and mental
component scores (PCS & MCS) improvements of: one-
level (3.8 and 1.4), two-levels (8.3 and 2.7), and three or
more levels (10.4 and 4.2), respectively. The clinically
meaningful improvement based on PtGA among OA pa-
tients were approximately 3.8 and 1.4 for PCS and MCS,
respectively. The clinically meaningful changes for eight
SF-36 domains were 7.2 for physical function, 13.1 for
role physical, 11.6 for bodily pain, 2.1 for general health,
5.6 for vitality, 6.2 for social function, 7.7 for role emo-
tion, 2.7 for mental health. 
CONCLUSION: Clinically meaningful improvement var-
ies between SF-36 domains and summary scores among
OA patients. These results provide guidance in interpret-
ing HRQoL results and planning clinical trials.
PAD5
RETROSPECTIVE EVALUATION OF 
CONCOMITANT GASTROINTESTINAL DRUG 
USE WITH NSAID THERAPY AMONG PATIENTS 
WITH ARTHRITIS
Lapane K1, Pettitt D2, Dooley J2, Spooner J1
1Brown University, Providence, RI, USA; 2Outcomes 
Research, Pfizer Inc., New York, NY, USA
Given the widespread use of NSAIDs and its association
with gastric injury, the patterns and costs of gastric toxic-
ity are of interest. 
OBJECTIVE: The goal of this study was to describe the
prevalence of concomitant antiulcer medication with
NSAIDs. 
METHODS: We identified patients diagnosed with os-
teoarthritis (OA) (ICD-9 codes: 715, 721.0, 721.3,
721.9), rheumatoid arthritis (RA) (ICD-9 codes: 714.0,
714.1, 714.2, 714.9) or both (OA/RA) between 1992
and 1997 using a managed care claims database. Study
participants had at least 12 months of continuous health
coverage (including drug benefits). We examined initial
NSAID choice and the prevalence of concomitant gas-
trointestinal (GI) drug use (H2 antagonists [H2], proton
pump inhibitors [PPI], prostaglandins [PS]) during the
study period. 
RESULTS: Among NSAID users (n  40,350), ibuprofen
(28.6%) and naproxen (18.2%) were most likely to be
prescribed initially. Antiulcer medication use was more
prevalent in patients receiving NSAID therapy, appeared
to increase with age and vary by diagnosis: rates varied
from 19.1% (OA), 19.6% (RA), 34.3% (OA/RA) in pa-
tients aged 18–39 to 29.2%, 32.3%, and 40.0% in pa-
tients aged 70–79. Fifteen percent of patients had a con-
comitant GI prescription added to their therapy within
60 days after the first NSAID prescription. Most of the
anti-ulcerant use was H2 (76.9%), although PPI use
(10.7%) and PS use (12.4%) increased in latter years. 
CONCLUSIONS: We found that the prevalence of GI
therapy varied by age and diagnosis and that concomi-
tant GI medication use began soon after the initiation of
NSAID therapy.
PAD6
ASSESSMENT OF THE ECONOMIC AND 
HUMANISTIC OUTCOMES OF THE WEST 
VIRGINIA MEDICAID’S PRIOR AUTHORIZATION 
POLICY FOR NSAIDS
Momani A, Madhavan SS, Small S
West Virginia University School of Pharmacy, Morgantown, 
WV, USA
The West Virginia Medicaid’s (WVM) prior authoriza-
tion (PA) policy for NSAIDs is expected to produce sav-
ings to the WVM for two reasons: 1) NSAIDs are among
the most frequently utilized drugs in WVM, and 2) while
prices for NSAIDs vary substantially, most of the pre-
scribed NSAIDs are the expensive ones. However, a con-
cern arises whether the anticipated savings of policy im-
plementation may be offset by increased costs of
substitutable drugs and/or medical services. It is also im-


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PAD5: RETROSPECTIVE EVALUATION OF CONCOMITANT GASTROINTESTINAL DRUG USE WITH NSAID THERAPY AMONG PATIENTS WITH ARTHRITIS

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