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M. W. F. Van Leen et al.
Age and Ageing 2007; 36: 414–418
doi:10.1093/ageing/afm049
Published electronically 30 May 2007
 The Author 2007. Published by Oxford University Press on behalf of the British Geriatrics Society.
All rights reserved. For Permissions, please email: [email protected]
Prevention of NSAID gastropathy in elderly
patients. An observational study in general
practice and nursing homes
M. W. F. VAN LEEN1 , I. VAN DER EIJK2 , J. M. G. A. SCHOLS3
1
Nursing Home Physician and General Geriatrician, Avoord Zorg & Wonen, Etten-Leur, The Netherlands
ALTANA Pharma bv, Scientific Affairs, Hoofddorp, The Netherlands
3 Nursing Home Physician, Universities of Tilburg and Maastricht, The Netherlands
Address correspondence to: M. W. F. Van Leen. Tel: 0031-76-5135000. Email: [email protected]
2
Abstract
Objectives: the objectives of this study were to (i) survey the risk factors for NSAID gastropathy in outpatients (elderly
patients in the community), compared to those living in old people’s homes or nursing homes, (ii) study the prescription
of medication prophylaxis during use of NSAIDs conform the current national guidelines and (iii) survey the influence on
gastrointestinal symptoms and safety of pantoprazole 20 mg as prophylaxis for NSAID gastropathy.
Methods: patients over 65 years of age, using an NSAID without prophylaxis or newly starting NSAID treatment were
included in the study. Pantoprazole 20 mg was prescribed as prophylaxis. Patients using an NSAID with prophylaxis being
a proton pump inhibitor at the first visit were registered for epidemiological reasons. Demographic data, risk factors,
gastrointestinal complaints, and adverse events were collected at t = 0, t = 2 weeks, t = 3 months and t = 6 months.
Differences between groups were analysed with Chi-square tests and Mann-Whitney U tests; changes in time in GI symptoms
were tested using Wilcoxon signed ranks tests and McNemar tests.
Results: one hundred eighty one general practitioners (treating outpatients and patients in old people’s homes) and five
nursing home physicians participated in the study and a total of 615 patients were included (522 patients treated by general
practitioners (GP) and 93 patients in nursing homes). Four hundred thirty two patients were using NSAIDs without
prophylaxis or started using an NSAID at the first visit; 269 (62.1%) and 163 (37.9%) patients respectively. 65.3% of the
outpatients (224 out of 343) did not receive indicated prophylaxis, versus 76.2% (16 out of 21) in old people’s homes and
42.6% in nursing homes (29 out of 69) (P<0.001). Patients in nursing homes had more risk factors for gastrointestinal
complications (2.94 ± 1.3 versus 1.77 ± 0.9) than outpatients.
More patients using an NSAID prior to the study complained of gastrointestinal symptoms compared to new users (P<0.001).
This seems to indicate that NSAIDs caused these symptoms. After 2 weeks of treatment with pantoprazole, there was no
statistical difference between the two groups. Moreover, both groups showed improvement in complaints (P<0.001).
Only nine patients in the study population (3.1%) reported mild adverse events (e.g. nausea, headache) with an average of
1.1 adverse events per patient. Five patients (1% of the included population) died during the study period, but there was no
relation to the NSAID or pantoprazole.
Discussion and Conclusion:patients in nursing homes had more risk factors for NSAID gastropathy than patients in old
people’s homes or outpatients (>65 years). Although in nursing homes co-prescription of prophylaxis during NSAID use
is more common, in general the Dutch guidelines on adequate NSAID use are still not fully implemented at this moment.
The results also showed that pantoprazole was effective in diminishing gastrointestinal complaints, as well as preventing
symptomatic NSAID gastropathy. Moreover, pantoprazole showed to be a safe and well-tolerated drug in our treatment group.
Keywords: NSAID, gastropathy, elderly
414
Prevention of NSAID gastropathy in elderly patients
Introduction
Non-steroidal anti-inflammatory drugs (NSAIDs) belong
to the most frequently used drugs in the Netherlands. In
2004, from every 1,000 prescriptions of general physicians
in the Netherlands, 122 were for the NSAID diclofenac [1],
which made it the second most often prescribed drug in
the Netherlands. On top of these prescriptions, NSAIDs are
also frequently purchased over the counter.
Guidelines for the use of non-selective NSAIDs advise
gastric protection with a proton pump inhibitor (PPI) or
misoprostol for patients with risk factors for gastrointestinal
complications, i.e. age over 70 years, history of a peptic ulcer,
heart failure, diabetics or severe rheumatic arthritis, use of
high doses of NSAID and concomitant use of anticoagulants
drugs, acetylsalicylic acid, oral corticosteroids or selective
serotonin re-uptake inhibitors (SSRIs) [2].
There is no evidence that prescription of the standard
dose of H2 receptor antagonists, mucosa protective drugs or
antacid drugs offer gastric protection [2–4].
The risk of developing adverse drug reactions (ADRs)
increases with the number of additional risk factors. A study
in patients with gastrointestinal haemorrhages caused by
NSAIDs, showed that 70% of the patients had three or more
risk factors [5].
ADRs caused by NSAIDs often result in hospital admissions. In a large prospective observational study in the
UK, ADRs caused by NSAIDs (including aspirin) were
responsible for 29% of all ADR-related hospital admissions
[6]. Other studies have also shown that the majority of
patients with a bleeding ulcer or an active peptic ulcer had
used NSAIDs [7]. Due to many factors (e.g. comorbidity,
polypharmacy, altered pharmacokinetics) elderly patients are
more susceptible to adverse drug reactions of NSAIDs like
dyspeptic complaints, bleeding ulcers, erosions and perforations caused by inhibition of the prostaglandin synthesis
[8–10]. Moreover, elderly patients often show less transparent clinical symptoms of damage of the gastro-intestinal tract
[11]. Despite the increased risk of complications, NSAIDs
are often used by elderly patients [12,13].
Several studies have shown that in the majority of patients
for which gastric protection should be prescribed, this
protection is not provided [14–17].
The objectives of the current study were to (i) survey the
risk factors for NSAID gastropathy in outpatients (elderly
patients in the community), compared to those living in old
people’s homes or nursing homes, (ii) study the prescription
of medication prophylaxis during use of NSAIDs according
to the current national guidelines and (iii) survey the influence
on gastrointestinal symptoms and the safety of pantoprazole
20 mg as prophylaxis for NSAID gastropathy.
The characteristics of and differences between regular
old people’s homes and nursing homes have been described
previously [18]. The main difference between the two groups
is the level for care dependency during activities for daily
living. Patients in nursing homes need help from special
trained nursing staff whereas patients in old people’s homes
usually only need a helping hand.
Methods
An open observational study following a real-life design
(current daily practice) was conducted in 181 randomly
invited general physicians (treating outpatients and patients
in old people’s homes) and five nursing homes [17] in
the Netherlands between April 2003 and March 2005.
Inclusion criteria for patients were: age over 65 years and
use of an NSAID. Indications for prescription of NSAIDs
were complaints of chronic pain in the loco motor system,
arthritis, arthrosis or extra-articulary disorders. Diagnostics
were performed prior to the study. Patients were excluded
when they were not able to give informed consent or in case
of cognitive disorders such as dementia. At the time of this
study only the conceptual Dutch guidelines on the prevention
of NSAID gastropathy were available, in which the age limit
was stated at 65 years instead of 70. Therefore, in this study
patients were included who were older than 65 years of age.
Patients, who used NSAIDs without gastric protection
or started NSAID treatment were prescribed pantoprazole
20 mg o.d. from the first day of the study. At inclusion, demographic data (age, sex, length, weight, smoking, use of alcohol
and type of residence) and risk factors for gastro-intestinal
damage (i.e. history of peptic ulcer, heart failure, diabetes,
severe rheumatoid arthritis, high doses of NSAIDs, use of
aspirin, anticoagulant drugs, corticosteroids or SSRIs), were
collected by the treating physician. Patients were followed for
a maximum period of 6 months. After 2 weeks, 3 months
and 6 months gastrointestinal complaints (i.e. dyspepsia,
heartburn, higher abdominal complaints, nausea and other
possibly related complaints) were assessed, as well as side
effects and alterations in the prescription of NSAIDs and/or
pantoprazole. All patients had to give informed consent.
Statistical analyses
Differences between the three groups based on residency
(outpatients, living in an old people’s home or in a nursing
home) were analysed with χ2 - and Mann–Whitney tests;
while changes of GI symptoms in time were addressed
with Wilcoxon Signed Ranks tests and McNemar tests. All
statistical analyses were performed using SPSS package 12.0
for Windows (SPSS Inc., Chicago, IL).
Results
In the given period, 615 patients of 65 years or older contacted
their physician with complaints of chronic pain in need of
NSAID treatment and were included in the study. Since
the study surveyed daily practice only, there is no reason to
believe that patients who did not participate were different
from the ones included in the study. Demographic data are
shown in Appendix 1 in the supplementary data on the
journal website (http://www.ageing.oxfordjournals.org/).
At first consultation, 432 patients were already using an
415
NSAID. From these patients, 269 used no gastric protection.
A total number of 163 patients started using NSAIDs
following consultation of the physician. In total, 432 patients
started with pantoprazole and were followed.
Risk factors for NSAID gastropathy
Nursing home patients had significantly (P<0.001) more
risk factors for gastro-intestinal problems (mean ± SD:
2.94 ± 1.3) than outpatients (1.77 ± 0.9) or patients living
in old people’s homes (2.22 ± 0.9). Particularly heart
failure, diabetes, use of anticoagulants, and use of SSRIs
occurred more often in patients living in nursing homes
(please see Appendix 2 in the supplementary data on the
journal website (http://www.ageing.oxfordjournals.org/)).
More than 60% of patients living in a nursing home had
three or more risk factors, compared to 21% of outpatients
and 30% of elderly patients living in old people’s homes
(please see Appendix 3 in the supplementary data on the
journal website (http://www.ageing.oxfordjournals.org/).
No difference could be observed, however, between the
groups in prior prevalence of ulcers and more serious
complications.
NSAID use prior to the study
Appendix 4 in the supplementary data on the journal website
(http://www.ageing.oxfordjournals.org/) shows the use of
NSAIDs at the first visit per type of residency. Of the
remaining 183 patients, no records of prior NSAID use
could be retrieved.
In 62.3% of all patients who used an NSAID, no gastrointestinal prophylaxis was given. Especially in outpatients,
prophylaxis was often not provided. In patients receiving
NSAIDs prior to the study, NSAIDs were primarily
prescribed for inflammatory arthritis (16.5%), degenerative
arthritis (47.2%) and pain (29.4%).
Gastro-intestinal complaints
Patients already using NSAIDs without prophylaxis before
entering the study, complained significantly more often
(40%) of gastrointestinal symptoms like dyspepsia, reflux,
pain in the epigastrium and nausea, than patients who newly
started NSAID therapy (16%; P<0.001) (Figure 1). After 2
weeks of treatment with pantoprazole 20 mg, no difference
could be observed between the two groups. Moreover, both
groups showed a significant improvement of complaints
during the study (P<0.001).
Side effects
Nine patients in the overall study population (3.1%) reported
mild adverse events (e.g. nausea, headache) of the used
NSAID or pantoprazole with an average of 1.1 adverse
event per patient.
None of the patients showed severe gastric problems
like bleeding or severe higher abdominal pain leading to
hospitalisation.
416
% patients with GI complaints
M. W. F. Van Leen et al.
#
50
*
40
30
NSAID prior to study
New NSAID
20
10
0
t=0
t=2
t=3 mths t=6 mths
weeks
Consult
Figure 1. Decrease of GI symptoms during the study.
∗ P<0.001 NSAID prior to study versus new NSAID (consult
1). # P<0.001 t = 2 weeks versus t = 0 both groups.
Five patients died during the trial, but none of these
deaths were assessed as being related to the study medication
(NSAID or PPI).
Discussion and conclusion
This study clearly reveals that patients older than 65 years,
living in nursing homes, have more risk factors for NSAIDgastropathy than elderly living independently or in old
people’s homes. It is alarming that, contradictory to existing
guidelines, in the majority of elderly patients with NSAIDs
no adequate gastric protection is prescribed by the physician.
There is a striking difference with regard to the extent of
gastric prophylaxis in the studied settings. In nursing homes
the majority (nearly 60%) received prophylaxis, whereas in
outpatients this was the case in only 34% of patients.
This is an important finding, as on the one hand this study
indicates that use of NSAIDs without gastric protection
in the elderly is associated with a higher prevalence of
GI-symptoms than when prophylaxis is prescribed, and
on the other hand the study also shows that the Dutch
national guidelines [2] regarding the use of NSAIDs and the
prevention of gastric damage, have not been implemented to
full extent yet. This is in line with the results of other Dutch
studies [15,16]. Also in other countries the implementation
of national guidelines gives us the same results [19]. Possible
reasons for inappropriate prescription of gastric prophylaxis
during NSAID use by general practitioners may be due
to lack of accurate determination of the risks to develop
NSAID-related GI-events, or simple a lack of alertness of the
physician or inadequate patient follow-up [17]. The results
of the present study indicate that gastric protection with
pantoprazole leads to a significant decrease of GI symptoms
in the elderly using NSAIDs, which is in agreement with
earlier studies [20–22]. Moreover, no clinical manifestations
of severe side effects of NSAIDs, such as bleeding, were
observed in both groups.
A topic that has not been addressed in this study is
the possibility that complications during the use of NSAIDs
could also develop in the lower GI tract. Currently physicians
Prevention of NSAID gastropathy in elderly patients
mainly pay attention to complications in the upper GI tract.
However, the study of Silverstein [23] showed that 61% of
the serious outcomes developed in the lower GI-tract. It is
reasonable to think that elderly people are at least equally
susceptible for the same damage. The authors however are
unaware of the existence of drugs for protection of the
intestinal mucosa. Nevertheless, it is an important topic
and deserves our full attention in clinical practice. Further
research in this area is warranted.
Due to the ageing process, which is accompanied by an
increase of chronic complaints of the loco motor apparatus,
the use of NSAIDs can be expected to rise. At this moment
14.0% of the total Dutch population is older than 65 years
of age, until 2050 another 1.5 million persons will be added
to this total (21.9% of the total population) [24].
In conclusion, notwithstanding the fact that this study was
not a randomised clinical trial, the importance of effective
gastric protection during use of NSAIDs is evident and in
fact should not be held back from our frail elderly, of which
many are vulnerable for GI side effects of NSAIDs.
Key points
•
•
•
Elderly people are still prescribed NSAIDs without gastric
protection despite National Guidelines.
Using a proton pump inhibitor diminishes gastric
complaints possibly caused by NSAIDs.
In a 6-month period no signs of serious complications
were seen in the patient group using prophylaxis.
Acknowledgements
We thank dr. R van Marum, geriatrician and clinical
pharmacologist at the Utrecht Medical Centre, for his
comments on the manuscript.
Conflicts of Interest
This study is performed with support of ALTANA Pharma
bv. There was no interference with the results.
Dr Van der Eijk (ALTANA Pharma) was very helpful
with the translation and producing the tables/figures; she
had no influence on the collection of data and the statistical
analyses.
Prof. J. Schols did not receive any financial compensation
for support and critical comments.
M. van Leen, chief investigator, collected and analysed the
data and wrote the manuscript, for which he did not receive
financial compensation.
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Received 25 August 2006; accepted in revised form 20 February
2007
 The Author 2007. Published by Oxford University Press on behalf of the British Geriatrics Society.
All rights reserved. For Permissions, please email: [email protected]
‘Faster counting while walking’ as a predictor of
falls in older adults
OLIVIER BEAUCHET1,2 , VÉRONIQUE DUBOST1 , GILLES ALLALI3 , RÉGIS GONTHIER1 , FRANÇOIS R. HERMANN2 ,
RETO W. KRESSIG2,4
1
Department of Geriatrics, Saint-Etienne University Hospitals, Saint-Etienne, France
Department of Rehabilitation and Geriatrics, Geneva University Hospitals, Geneva, Switzerland
3 Department of Neurology, Geneva University Hospitals, Geneva, Switzerland
4 Department of Geriatrics, Basel University Hospitals, Basel, Switzerland
Address correspondence to: O. Beauchet. Tel: ++33 4 77 12 71 96; Fax: ++33 4 77 12 70 49. Email: [email protected]
2
Abstract
Objective: to establish whether changes in a spoken verbal task performance while walking compared with being at rest
could predict falls among older adults.
Design: prospective cohort study of 12 months’ duration.
Setting: twenty-seven senior housing facilities.
Participants: sample of 187 subjects aged 75–100 (mean age 84.8 ± 5.2). During enrollment, participants were asked to
count aloud backward from 50, both at rest and while walking and were divided into two groups according to their counting
performance. Information on incident falls during the follow-up year was monthly collected.
Measurements: the number of enumerated figures while sitting on a chair and while walking, and the first fall that occurred
during the follow up year.
Results: the number of enumerated figures under dual-task as compared to single task increased among 31.5% of the tested
subjects (n = 59) and was associated with lower scores in MMSE (P = 0.034), and higher scores in Geriatric Depression Scale
(P = 0.007) and Timed Up & Go (P = 0.005). During the 12 months follow-up, 54 subjects (28.9%) fell. After adjusting for
these variables, the increase in counting performance was significantly associated with falls (adjusted OR = 53.3, P<0.0001).
Kaplan–Meier distributions of falls differed significantly between subjects who either increased or decreased their counting
performance (P<0.0001).
Conclusions: faster counting while walking was strongly associated with falls, suggesting that better performance in an
additional verbal counting task while walking might represent a new way to predict falls among older adults.
Keywords: dual-task, falls, cognitive performance, older adults
418