Bodger, K

Hughes, D

Kikuchi, T

Elsevier - Publisher Connector 

A147Abstracts
GASTROINTESTINAL DISORDERS—
Clinical Outcomes Studies
PGI1
COMORBIDITIES DURING THE YEAR FOLLOWING
DIAGNOSIS FOR PERSONS WITH AND WITHOUT GERD
USING THE AGENCY FOR HEALTH RESEARCH AND QUALITY
(AHRQ) 261 SPECIFIC CATEGORIES
Wallander MA1,Wahlqvist P1, Kleinman N2, Campbell S2,Talley NJ3,
Brook R4
1AstraZeneca R&D, Mölndal, Sweden, 2The HCMS Group, Cheyenne,
WY, USA, 3Mayo Clinic, Jacksonville, FL, Rochester, MN, USA, 4The
JeSTARx Group, Newfoundland, NJ, USA
OBJECTIVES: Evaluate the prevalence and costs of selected
comorbidities in GERD patients using a systematic approach.
METHODS: An employer database query of >300,000 US
employees from 2001–2005 to identify subjects with GERD
ICD9s and a cohort without GERD (Control). For each GERD
subject 10 control patients were matched using logistic regres-
sion and propensity scores from demographic differences, region,
and the Charlson Comorbidity Index Score. Analysis focused on
the 12 months post-diagnosis (Dx). Direct medical cost data
were inﬂated to constant dollars and assigned based on ICD9
codes from the AHRQ’s 261 Speciﬁc Categories. Prevalence rates
were based on persons within the cohort with claims for each
category. Average costs for each category were calculated for the
entire cohort. Prevalence comparisons used z-scores of log odds
ratios (Woolf method), and the average cost comparisons used
Sattherthwaite t-tests. RESULTS: Data were available for 11,653
GERD and 116,530 matched controls. Differences between cases
with GERD and controls are presented as: (% prevalence in
GERD: % prevalence in controls, $ cost in GERD: $ cost in con-
trols). Gastrointestinal disorders: Abdominal pain (27.3%
GERD : 6.8% Control, $165 GERD : $32 Control); Gastritis +
duodenitis (15.2% : 1.0%, $87 : $5); GI hemorrhage (6.6% :
1.8%, $37 : $9); Stomach/duodenum disorders (5.4% : 0.5%,
$17 : $1); Noninfectious gastroenteritis (5.0% : 1.6% $19 : $5);
Biliary tract disease (3.9% : 0.7%, $150 : $25); Gastroduodenal
ulcer (2.5% : 0.2%, $11 : $1); Other GI disorders (30.8% : 3.6%,
$116 : $13); Respiratory disorders: Upper respiratory infections
(31.5% : 18.0%, $64 : $23); Asthma (6.9% : 2.8%, $23 : $7);
COPD+bronchiectasis (4.9% : 2.4%, $10 : $6); Other upper res-
piratory disease (21.0% : 8.5%, $79 : $24); Other lower respira-
tory disease (17.6% : 6.8%, $52 : $19); Other disorders:
Nonspeciﬁc chest pain (18.8% : 6.2%, $163 : $46); Nutrit/
endocrine/metabolic (8.6% : 3.3%, $159 : $23); Thyroid disor-
ders (8.0% : 4.8%, $31 : $12). All costs and prevalence of comor-
bidities were higher in the GERD cohort compared to controls
(P < 0.05). CONCLUSION: Patients with GERD have more
prevalent conditions than subjects without GERD. From an
insurer’s perspective, this increased burden for GERD sufferers
is also associated with higher costs.
PGI2
BIOLOGICAL AGENTS FOR THE MANAGEMENT OF CROHN’S
DISEASE IN ADULTS:A SYSTEMATIC REVIEW, META-ANALYSIS
AND MULTIPLE TREATMENT COMPARISON
Hughes D1, Kikuchi T1, Bodger K2
1University of Wales, Bangor, Bangor, UK, 2University of Liverpool,
Liverpool, UK
OBJECTIVES: To conduct a systematic review of the clinical
effectiveness of biological agents in adult Crohn’s disease (CD),
a meta-analysis of treatment effect, and an indirect comparison
of individual therapies. METHODS: Searches were conducted to
identify RCTs assessing efﬁcacy of monoclonal antibodies to
TNF (inﬂiximab, certolizumab pegol and adalimumab), inter-
feron (fontolizumab) and a selective adhesion molecule inhibi-
tor (natalizumab) in adult CD. A meta-analysis, applying the
Mantel-Haenszel test, was used to estimate the pooled odds ratio
for all agents (versus placebo), assuming a ﬁxed effects model.
Indirect comparisons among treatments, for remission (CDAI <
150) at the end of the induction and maintenance phases, were
made by use of a Bayesian analysis of indirect evidence for mul-
tiple treatments. RESULTS: Fifteen studies were identiﬁed; 1 for
fontolizumab; 2 each for certolizumab and adalimumab; 3 for
natalizumab and 7 for inﬂiximab. These were categorised
broadly into: (1) single and (2) multiple dose induction studies
with placebo control group; maintenance studies without
placebo control group after (3) single and (4) multiple dose
induction; and (5) maintenance studies with placebo control
group after multiple dose induction. Biological agents were supe-
rior to placebo at the end of induction (pooled OR = 1.61,
95%CI 1.22–2.13; heterogeneity I2 = 0%, 95%CI 0%-64%).
End of maintenance studies were deemed too heterogeneous 
(I2 = 89%, 95%CI 62%-95%) for analysis. The multiple treat-
ment comparison analysis suggested that at the end of induction,
the probability that inﬂiximab is best is 77% (SD 42%);
fontolizumab 21% (41%); certolizumab and natalizumab 1%.
For maintenance, the probability that adalimumab is best is 60%
(SD 49%); inﬂiximab 33% (47%); natalizumab 7% (25%); cer-
tolizumab <1%. CONCLUSION: Several agents have shown
superiority to placebo in moderate-to-severe CD. Head-to-head
trial data for rival agents are lacking but a multiple treatment
comparison analysis (acknowledging the limitations) failed to
identify an individual agent as dominant for both induction and
maintenance end-points.
PGI3
CONSTIPATION IN PERSONS RECEIVING HOSPICE CARE:
PRELIMINARY ESTIMATES
Strassels SA1, Reifsnyder J2, Maxwell T2
1University of Texas at Austin College of Pharmacy, Austin,TX, USA,
2excelleRx, Inc, Philadelphia, PA, USA
OBJECTIVES: Pain at the end of life is common and often sub-
optimally treated, though treatment of pain can also result in
adverse events. One of these adverse events is constipation,
which can interfere with pain management, health-related
quality of life, and result in avoidable medical resource use. The
epidemiology of constipation in persons at the end of life remains
incompletely described, thus we sought to determine the preva-
lence and severity of constipation among persons receiving
hospice care in the United States from 2000 to 2004.
METHODS: Data for this study were obtained from excelleRx,
Inc., a national provider of pharmaceutical services to US hos-
pices. Patient-level information included primary diagnosis (by
ICD-9 code), type of hospice care received, constipation inten-
sity, and prescription of opioid analgesics. Constipation intensity
during the previous 24 hours was assessed by hospice nurses
using a 0–10 numeric rating scale (NRS; 0 = none, 10 = worst)
at admission and periodically during hospice care. RESULTS:
During the study period, 347,555 discharged or deceased
persons received hospice services; 55% of these persons were
female, 87% were Caucasian, and mean age was 75 years. Con-
stipation was assessed at least once for 180,239 (45%) individ-
uals, an average of 3 times per person. Overall, mean intensity
of constipation was mild, though moderate and severe constipa-
tion was reported by 29,132 (8%) and 13,748 (4%) of persons,
respectively. Among individuals who reported severe constipa-
tion at least once, 67% had a primary diagnosis of cancer. CON-
CLUSION: Moderate to severe constipation was reported at


PGI2 BIOLOGICAL AGENTS FOR THE MANAGEMENT OF CROHN'S DISEASE IN ADULTS:A SYSTEMATIC REVIEW, META-ANALYSIS AND MULTIPLE TREATMENT COMPARISON 

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PGI2 BIOLOGICAL AGENTS FOR THE MANAGEMENT OF CROHN'S DISEASE IN ADULTS:A SYSTEMATIC REVIEW, META-ANALYSIS AND MULTIPLE TREATMENT COMPARISON

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