Int J Clin Pharm (2011) 33:155–164
DOI 10.1007/s11096-011-9490-5
SHORT RESEARCH REPORT
Use of gastrointestinal prophylaxis in NSAID patients: a cross
sectional study in community pharmacies
Elsa López-Pintor • Blanca Lumbreras
Received: 11 May 2010 / Accepted: 7 February 2011 / Published online: 12 March 2011
 Springer Science+Business Media B.V. 2011
Abstract Objective To assess the appropriateness of gas-
troprotective agents (GPA)\ NSAID use in patients’ access
medication through community pharmacy and the factors
associated with any inappropriateness found. Methods A
cross-sectional study in which patients requesting NSAIDs
through community pharmacy was undertaken. Information
was collected through a structured questionnaire included
data of patients’ pharmacotherapy and gastropathy risk
factors. Patients were classified as ‘‘overprotected’’ or ‘‘un-
derprotected’’ according to the use of gastroprotective-drugs
and presence/absence of gastropathy risk factors. We cal-
culated the risk for under-or over-protection using logistic
regression controlling for potential confounders. Results
Twenty-seven community pharmacies of Southeast of Spain
participated in the study. Out of 670 NSAID users recruited
in the study, 243 (36.3%) were not appropriately protected:
197(81.1%) patients were underprotected, and 46 (18.9%)
patients were overprotected. Compared to patients with ulcer
history, patients with cardiovascular disease or chronic
morbidity (aOR 18.55; 95% CI l 3.68–93.52, P \ 0.001) and
aged over 60 years (aOR 23.97; 95% CI 3.93–145.9) were
associated with underuse of gastroprotective-drugs. OTC-
NSAID-users were more likely to be underprotected than
those with medical prescription (aOR 3.47; 95% CI l
1.84–6.55). Conclusions Inappropriate GPA use is relatively
E. López-Pintor (&)
Pharmacy and Pharmaceutics Division, Department of
Engineering, University Miguel Hernandez, Carretera
Alicante-Valencia, Km.87, San Juan de Alicante, Alicante, Spain
e-mail: elsa.lopez@umh.es
B. Lumbreras
Department of Public Health, CIBER en Epidemiologı́a y Salud
Pública, History of Science and Ginecology, University Miguel
Hernandez, San Juan de Alicante, Alicante, Spain
frequent among NSAD users, especially in those using OTC-
NSAIDs. Community pharmacists should be aware of fac-
tors contributing to NSAID-induced GI complications and
assess its presence in the consumer when dispensing an
OTC-NSAID.
Keywords Community pharmacy
Gastroprotective
drugs
Non Steroidal Antiinflammatory Drugs
OTC-
drugs
Risk factors
Spain
Impact of findings on practice
• 36.3% of NSAID users in Spain are not appropriately
protected against potential gastrointestinal toxicity:
29.4% are underprotected and 6. 9% are overprotected.
• Self-medication users tend to be underprotected while
medical prescription users have more risk of being
overprotected.
• Educational programmes for doctors and pharmacists
are needed to improve the use of gastroprotection with
NSAID use, where appropriate.
• Community pharmacists should ultimately be respon-
sible for the educational programs, especially with
regard to the self-medication of patients.
Introduction
Non-steroidal antiinflammatory drugs (NSAID), a hetero-
geneous therapeutic group with analgesic, antipyretic and
anti-inflammatory propperties, are one of the most widely
used, prescribed, and over-the-counter (OTC) drugs in the
world [1, 2]. It is estimated that more than 30 million people
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take NSAID daily [3]. In Spain, the consumption of NSAIDs
has increased enormously, doubling in the last 14 years [4].
Out of the 20 more commonly used drugs in Valencian
Community, Spain, in the year 2009, 7 were NSAIDs [5].
The major adverse effect of NSAIDs is gastrointestinal
(GI) toxicity, ranging from symptoms such as nausea and
dyspepsia to serious ulcer complications [6]. The use of
NSAID is associated with a high hospital admission rates
due to upper gastrointestinal bleeding and perforation [7, 8].
In the United States, NSAIDs are responsible for approxi-
mately 30% of admissions due to GI haemorrhage [9]. In
Spain, of 3,293 patients with osteoarthritis who require
NSAIDs, 86.6% were at increased GI risk and cardiovas-
cular risk was high in 44.2% of the patients [10]. Most of
these NSAIDs-related complications occur in self-medi-
cated patients [11, 12] and Spain have the seventh highest
rate in the EU with a higher rate of OTC- patients [13]
The risk factors associated with this NSAID associated
gastrointestinal toxicity are largely known [3] (advanced
age ([60 years), previous ulcer or ulcer complication,
concomitant use of oral anticoagulants or corticosteroids,
high NSAIDs dose, use of more than one NSAID and
presence of other chronic comorbilities [14]) and affected
patients should be protected with anti-ulcer therapy,
according to Gastroenterology Spanish Society Recom-
mendations and other International Guidelines [15, 16].
Previous studies have shown inappropriate use of gas-
troprotection in patients taking NSAIDs [17, 18]. These
studies mainly included patients taking prescription NSA-
IDs and did not include OTC use, thus the problem could
be more significant.
Overall, no observational study has been carried out
overall on the appropriateness of GPA/NSAID use in a
community setting, including both patients with medical
prescription and OTC users. Moreover, we think that this
information could help to develop more effective approa-
ches to improve the quality use of NSAID.
Aim of the study
The main objective of this study is to assess the appropri-
ateness of GPA\ NSAID use in patients’ access medication
through community pharmacy. In addition of this, we eval-
uate the factors associated with any inappropriateness found.
Methods
Study design
A 3 month cross-sectional study was conducted from July
to September 2004 in 27 community pharmacies located in
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Int J Clin Pharm (2011) 33:155–164
the provinces of Alicante, Murcia and Albacete (Southeast
of Spain). Patients C 18 years old who asked for a non-
selective NSAID formulation either by medical prescrip-
tion or self-medication were included in the study. Exclu-
sion criteria were patients asking for paracetamol and
metamizol formulations or a topical NSAID.
Patients visiting the pharmacy twice or more times were
included only once in the study: before each interview we
asked the patient if he/she had previously responded to the
questionnaire.
Pharmacy students in their last year of training com-
pleted a structured questionnaire using the information
provided by the patient (Appendix 1). Information col-
lected included: (a) sociodemographic variables (age, sex
and nationality) and smoking habits; (b) type, dose,
posology and indication for both NSAID and GPA;
(c) previous or current GI disorders, and (d) presence of
serious comorbidities (cardiovascular disease, diabetes,
renal or hepatic failure). The patient’s oral consent was
required. Patients visiting the pharmacy two or more times
were included only once in the study. As there was not any
previous validated questionnaire with same objectives as
ours, the questionnaire was designed by the authors based
on the available evidence on NSAID and GI toxicity. A
pilot study was carried out to assess its validity and
reliability.
According to current recommendations [3], we have
considered patients at risk of NSAID-GI complications to
be those with at least one of the following NSAID gas-
tropathy risk factors (GRF): advanced age ([60 years),
prior history of ulcer or ulcer complication, concomitant
use of oral anticoagulants or corticosteroids, high NSAID
dose (higher than 75% of maximum recommended daily
dose) or use of C1 NSAID and presence of any serious
comorbidity (cardiovascular disease, diabetes, renal or
hepatic failure). The GPA agents considered were: Miso-
prostol, Proton Pump Inhibitors (PPIs) or double doses than
therapeutic levels of H2 receptor antagonists.
We have classified the patients according to the presence
of a GRF and the use of a GPA (Table 1).
Statistical analysis
Categorical characteristics, which included sex, nationality,
NSAID recommendation, smoking habit, type of NSAID
and GRF were compared between: (1) AP and NAP
patients; (2) NN-U and NN-NU patients and (3) N-NU and
N-U patients, through the Pearson c test of overall asso-
ciation. Continuous baseline characteristics, which inclu-
ded age, were compared between patients using the
t-student test. To assess the association between the out-
come variable (patients underprotected/patients protected
and patients overprotected/patients without protection) and
Int J Clin Pharm (2011) 33:155–164
the collected variables (sex, age, nationality, NSAID rec-
ommendation, smoking habit, type of NSAID and GRF),
Odds ratios and their 95% CI were computed through
unconditional logistic regression. Multivariable models
considered all variables with P \ 0.05 in univariate anal-
yses and used a stepwise forward selection. Statistical
analysis was assisted by the SPSS 16.0 statistical package
(now, IBM SPSS Statistics).
Results
Descriptive analyses
Out of 670 patients, 243 (36.3%) were NAP (Table 1, 2):
6.9% were overprotected and 29% were underprotected.
Most of the patients (509/670;76.0%) presented a NSAID
medical prescription, and propionic (255/670, 38.1%) acids
were the most demanded NSAIDs. 335/670 (50.0%)
patients received a GPA and PPIs were the most used drug
(255/670, 38.0%). Cardiovascular disease or chronic
comorbidity (186/670, 38.3%) and age over 60 years old
together with any other GRFs (157/670, 32.3%) were the
most frequently identified GRFs. Patients with an ulcer or
history of GI bleeding were more likely to be AP (15/17,
88.2%) than patients with other GRFs (P \ 0.001).
Our results have shown that 36% of NSAID users are
not being appropriately protected against NSAID-induced
GI toxicity; nearly 7% are overprotected and 29% are
underprotected.
Overprotected patients
Of 184 (27.4%) patients not needing GPA, 46 (25%) were
classified as ‘‘overprotected NSAID users’’ (NN-U) (data
not shown). These patients were older than NN_NU
patients (mean age: 46.1, SD: 12.4 and 37.27, SD:
13.1 years old, respectively) (P \ 0.001). Patients using
medical prescription (40/96; 41.7%) and taking acetic acid
Table 1 Classification of the patients included in the study according
to the presence of a GRF (need of a GPA) and use of a GPA
Patients use Patients do not
a GPA use a GPA
Patients need a GPA N_U N_NU (underprotected
users)
Patients do not NN_U (overprotected NN_NU
need a GPA users)
N_U and NN_NU are patients appropriately protected (AP)
NN_U and NN_NU are patients not appropriately protected (NAP)
GPA Gastroprotective agents
157
(20/38, 52.6%) or oxicam derivatives (4/6 66.7%) were
more likely to be overprotected (P \ 0.001). Multivariable
analysis did not show any association.
Underprotected patients
Of 486 (72.5%) patients needing GPA, 197 (40.5%) were
classified as ‘‘underprotected NSAID users’’ (N_NU
patients) (data not shown). N_U patients were signifi-
cantly older than N_NU patients (mean age: 58.9, SD:
17.9 and 49.6, SD: 19.5 years old, respectively)
(P \ 0.001). OTC- NSAID users (50/73; 68.5%) were
more likely to be underprotected than those with a med-
ical prescription (147/413; 35.6%) (P \ 0.001). Patients
with cardiovascular disease or chronic comorbidity (108/
186, 58.1%) showed higher prevalence of underprotection
than patients with other GRF such as ulcer, history of GI
bleeding (2/17, 11.8%) or aged over 60 years (18/48,
37.5%) (P \ 0.001).
In multivariable analysis (Table 3), self-medication
users were more likely to be underprotected than those with
medical prescription (adjusted OR: 3.47; 95% CI1.84–6.55,
P \ 0.001). Patients with cardiovascular disease or chronic
morbidity (adjusted OR = 18.55; 95% CI = 68–93.52,
P \ 0.001), aged over 60 years (adjusted OR = 23.97;
95% CI = 3.93–145.9, P \ 0.001) or age [60 years
together with other GRF (adjusted OR = 19.74; 95%
CI = 3.44–113.04, P \ 0.001) were more likely to be
underprotected than those who had an ulcer or history of
gastrointestinal bleeding.
Discussion
Our results have shown that 36% of NSAID users are not
being appropriately protected against NSAID-induced GI
toxicity; nearly 7% are overprotected and 29% are un-
derprotected. Overprotected patients were more likely to
be older, with a NSAID-medical prescription and were
taking acetic or oxicam acid derivatives. Underprotected
users were usually younger, OTC-NSAID users, with a
cardiovascular disease or chronic comorbidity (physicians
could have a different risk perception of the individual
factors related with and increased gastrointestinal toxicity:
a previous history of ulcer or GI bleeding would be the
most known risk factor, in contrast of other chronic
comorbidities such as cardiovascular disease) and were
taking propionic acid derivatives (although the type of
NSAID used is not a risk factor, their different gastro-
toxicity [19] could infraestimate the use of GP in risk
patients).
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Table 2 Characteristics of the

Characteristics Adequately protected Total (n/%) Pa
670 patients included in the
study of the 27 community Yes (n/%) No (n/%)
pharmacies (AP) (NAP)

Sex
Male 171 (65.5) 90 (34.5) 261 (100.0) 0.4929
Female 256 (62.6) 153 (37.4) 409 (100.0)
Age (years) (mean, SD) 54.0 (18.9) 48.0 (18.4) 52.0 (18.8) 0.054b
Nationality
Spanish 418 (63.4) 241 (36.6) 659 (100.0)
Others 9 (81.8) 2 (18.2) 11(100.0)
Smoking habit 0.4149
Yes 140 (61.4) 88 (38.6) 442 (100.0)
No 287 (64.9) 155 (35.1) 228 (100.0)
NSAID recommendation 0.7219
Prescription NSAID-users 322 (63.3) 187 (36.7) 509 (100.0)
Self-medication NSAID-users 105 (65.2) 56 (34.8) 161 (100.0)
NSAID subgroup 0.1316
Propionics acids derivatives 150 (58.5) 105 (41.2) 255 (100.0)
Acetics acids derivatives 78 (63.4) 45 (36.6) 123 (100.0)
Salicylates 67 (69.8) 29 (30,2) 96 (100.0)
Other combinations of 2 or more NSAIDs 39 (67.2) 19 (32.7) 58 (100.0)
Oxicam derivatives 32 (59.3) 22 (40.7) 54 (100.0)
Salicylates ? other NSAID 32 (78.0) 9 (21.9) 41 (100.0)
Other NSAIDs groups alone 29 (67.4) 14 (32.6) 43 (100.0)
Risk factors \0.001
No 138 (74.6) 46 (25.4) 184 (100.0)
Yes 289 (59.5) 197 (40.5) 486 (100.0)
Cardiovascular disease/chronic comorbidity 78 (42.2) 108 (57.8) 186 (100.0)
Age [60 years and other/s GRF 109 (69.4) 48 (30.6) 157 (100.0)
Other combinations of multiple GRF 47 (75.8) 15 (24.2) 62 (100.0)
GI Gastrointestinal, GPA Age [60 years 30 (62.5) 18 (37.5) 48 (100.0)
Gastroprotective agent, GRF Ulcer/GI bleeding history 15 (88.2) 2 (11.8) 17 (100.0)
Gastropathy risk factor, H2RAs
Histamine2-receptor Oral anticoagulants/corticosteroids 6 (60.0) 4 (40.0) 10 (100.0)
antagonists, IPP Proton pump High NSAIDs dose/multiple NSAIDs 4 (66.7) 2 (33.3) 6 (100.0)
Inhibitors, NSAID Non-steroidal GPA 0.634
anti-inflammatory drugs
IPPs 272 (85.8) 45 (14.2) 317(100.0)
* Other NSAIDs: Lysine
H2RAs 10 (90.9) 1 (0.1) 11 (100.0)
clonixinate; Proglumetacine
a Misoprostol 7 (100.0) 0 (0.0) 7 (100.0)
Chi-squared test
b TOTAL 427 (63.7) 243 (36.3) 670 (100)
Anova test

An inadequate use of GPA has been previously identi-
fied in Spain [17] and elsewhere with similar results [20],
although these studies included different populations and
the criteria defining the presence of risk factors were not
similar. Nevertheless, none of these previous studies have
considered the use of GPA in OTC- NSAID users. Our
results show that the NSAID recommendation is an
important determinant of the use of gastric protection:
while OTC patients are more likely to be underprotected,
patients with medical prescription are more likely to be
overprotected. This suggests that OTC- NSAID users are
less controlled than prescription-users in relation to the use
of GPA. This is an even more important finding if we
consider that a number of these NSAID-related complica-
tions (such as those related with gastrointestinal toxicity)
occur in OTC patients [12]. In Spain, as in other countries,
in the OTC drug selecting process, a patient can choose the
most appropriate NSAID for his/her condition; however,

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Table 3 Multivariable
Variable OR adjusted* 95%CI P
analyses: variables significantly
associated with the under- use NSAIDs Recommendation
of gastropathy prophylaxis
Prescription NSAID-users 1.00
Self-medication NSAID-users 3.47 1.84–6.55 \0.001
Smoking habit
No 1.00
yes 1.33 0.84–2.10 0.224
Type of NSAID
Salicylates 1.00
Propionics acids derivatives 0.84 0.41–1.76 0.653
Acetics acids derivatives 0.41 0.18–0.91 0.029
Oxicam derivatives 0.69 0.28–1.67 0.414
Other NSAIDs groups alone** 1.86 0.67–5.14 0.231
Salicylates ? other NSAID 0.35 0.13–0.91 0.031
Other Combinations of 2 or more NSAIDs 0.60 0.26–1.39 0.235
Risk factors
Ulcer/GI bleeding history 1.00
High NSAIDs dose/multiple NSAIDs 11.15 0.99–125.40 0.051
Oral anticoagulants/corticosteroids 15.41 1.89–125.04 0.010
* Adjusted by age. NSAID Cardiovascular disease/chronic comorbidity 18.55 3.68–93.52 \0.001
recommendation. smoking Age [60 years 23.97 3.93–145.9 \0.001
habit. type of NSAID. GRF
Age [60 years and other/s GRF 19.74 3.44–113.04 \0.001
** Other NSAIDs: Lysine
Other combinations of multiple GRF 3.89 0.73–20.71 0.111
clonixinate; Proglumetacine

most patients do not know the potential gastrointestinal
adverse reactions. Community pharmacists should assume
the responsibility of assessing the need of a GPA when
evaluating patients requesting an NSAID [21].
This study has also shown how physicians tended to
prescribe a GPA in patients without a GRF. The overuse of
gastric prophylaxis is associated with other adverse reac-
tions and moreover, it is not a cost effective measure [22].
For example, omeprazole, the most widely taking GPA has
been related with an increased risk of hip fracture in
postmenopausal women [23].
As in previous studies [18, 20], not all GRF were con-
sidered by clinicians as equally important: patients with a
history of gastric ulcer or GI bleeding were more likely to
receive a GPA, while patients with cardiovascular disease
or other comorbidities, or aged less than 60 years had a
greater likelyhood of being underprotected. These results
are coincident with those obtained by Van Dijk et al. [24]
in an ambulatory cohort of 17,060 patients in The Neth-
erlands. They showed that age and cardiovascular disease
were not taking into account by physicians as potential
gastric factors when prescribing NSAID. Finally, our
results show that the use of GPA is related to the type of
NSAID: users of acetic acid derivatives or combinations of
salycilates and another NSAID have less risk of under-
protection than salycilate consumers.
This study has some limitations. Firstly, although we
included a reasonable sample size, its classification into
different subgroups to achieve a greater knowledge of the
different situations, has led to a lesser precision in some
analysis. Secondly, we have considered being over
60 years old as a potential GRF, while other authors have
established the limit at 65 [4] years old or above.
Therefore, our results relating to underprotected users
could be considered as overestimated; however, there is
increasing evidence supporting the limit of 60 years old
as a potential risk factor [3]. Thirdly, we collected some
digestive disorders through the data collection form such
us gastric or duodenal ulcer. However, some important
disorders such as gastroesophageal reflux disease should
be marked as ‘others’ and therefore, were difficult to
assess in a community setting. These variables could be
an important confounder in the overprotected group,
where we did not find a significant association in the
multivariable analysis. Finally, we have obtained the
information directly from the NSAID-user. Since the
participation in our study was voluntary, we could think
that patients who agreed to participate were more con-

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cerned about their health than those who did not partici-
pate, and consequently better controlled. This error in
patient selection would have tended to ascribe an
increased proportion of adequately protected patients and
therefore, the real percentage of inadequacy showed in
this study would be even greater.
Conclusion
It is necessary to improve quality use of NSAID among
consumers: nearly 40% of them are not being appropriately
protected against NSAID-induced gastropathy. NSAID-
OTC patients are more likely to be underprotected, while
patients with medical prescription are more likely to be
overprotected. Physicians and community pharmacists
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Int J Clin Pharm (2011) 33:155–164
should be more aware about the factors contributing to
NSAID-induced GI complications, particularly with
respect to age, cardiovascular disease and chronic comor-
bidities. OTC NSAID-users should be better controlled and
community pharmacists should assume their responsibility
when evaluating each patient asking for a NSAID to assess
the need of a GPA according to the presence of GRF.
Acknowledgments The authors would like to acknowledge the
pharmacy students and the 27 participating community pharmacies
for their support to the project.
Funding We have not received any external financing for this
project.
Conflicts of interest None.
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Appendix

Evaluation of the use of gastrointestinal prophylaxis in NSAID patients

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Evaluation of the use of gastrointestinal prophylaxis in NSAID patients

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Evaluation of the use of gastrointestinal prophylaxis in NSAID patients

APPENDIX I-TABLES OF DATA COLLECTION

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