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Journal Club
PPI for Bleeding UlcersIntermittent vs Continuous
Hassan M. Al Tomy BSc Pharm, BCPS
Introduction
Upper gastrointestinal (GI) bleeding represents a
substantial clinical and economic burden.
Prevalence: 170 cases per 100 000 adults per year,
at an estimated total cost of $750 million
Peptic ulcer disease accounts for 50% to 70% of
cases of acute non variceal upper GI bleeding
Mortality rates have remained essentially unchanged
at 6% to 8%
Jiranek GC, Kozarek RA. Surg Clin North Am. 1996;76:83-103.
Marshall JK, Collins SM, Gafni A. Am J Gastroenterol. 1999;94:1841-6.
What did guidelines recommend for pharmacotherapy
management of bleeding ulcer?
What is recommended intragastric PH which required
to promote clot formation and stability
What is the cost of intermittent regimen compared to
recommended regimen
Current Recommendations For patients with bleeding ulcers who have high-risk
endoscopic findings (active bleeding, non bleeding visible vessels, and adherent clots) receive an intravenous bolus dose followed by a continuous infusion of a proton pump inhibitor after endoscopic treatment.
Hwang, J.H., et al., The role of endoscopy in the management of acute non-variceal upper GI bleeding. Gastrointest Endosc, 2012. 75(6): p. 1132-8.
Laine, L. and D.M. Jensen, Management of patients with ulcer bleeding. Am J Gastroenterol, 2012. 107(3): p. 345-60; quiz 361.
Barkun, A.N., International Consensus Recommendations on the Management of Patients With Nonvariceal Upper Gastrointestinal Bleeding. Annals of Internal Medicine, 2010. 152(2): p. 101.
Sung, J.J., et al., Asia-Pacific Working Group consensus on non-variceal upper gastrointestinal bleeding. Gut, 2011. 60(9): p. 1170-7.
In Vitro Data
In vitro data suggested that an intragastric PH
above 6 may
be required to promote clot formation and stability
Half life
Intermittent vs continous
Green FW Jr, Kaplan MM, Curtis LE, Levine PH. Gastroenterology.
1978;74(1):38-43
Clinical practice issue
is whether intermittent PPI therapy can be
substituted for the currently recommended bolus
plus continuous-infusion PPI therapy.
If intermittent PPI treatment achieves comparable
clinical efficacy, it would be the preferred regimen
given the decrease in cost and resources (eg,
infusion pump, nursing and pharmacy personnel
time, and requirement for monitored setting), the
decrease in the PPI dose, and the greater ease of
administration.
Sachar, H., K. Vaidya, and L. Laine, JAMA Intern Med, 2014. 174(11): p. 1755-
62.
Research hypothesis
a systematic review and meta-analysis was done
to assess the clinical efficacy of intermittent PPI
regimens vs the standard bolus plus continuous-
infusion regimen after successful endoscopic
therapy in patients with
The primary hypothesis that intermittent PPI is
noninferior to current regimen
Search methods
3 database were searched MEDLINE, EMBASE,
and the Cochrane Central Register of Controlled
Trials
Study Selection
Study
Design and
Population
Inclusion
Criteria
Randomized clinical trials
Studies were included if patients
presented with upper GI bleeding
Have a gastric or duodenal ulcer with
active bleeding
A non bleeding visible vessel
Or an adherent clot
And had received successful
endoscopic hemostatic therapy
Study Selection
Patients who had ulcers with flat
spots and clean bases
have a very low rate of clinically
significant rebleeding
Study
Design
and
Populatio
n
Exclusion
Criteria
Study Selection
Interventi
on
Intermittent PPI iv or PO
The control regimenwas the
standard PPI bolus plus continuous
infusion: 80-mg intravenous bolus
followed bya continuous 8-mg/h
intravenous infusion for72 hours
Study Selection
Outcom
es
Studies reporting1or more of the following
outcomes were included
Recurrent bleeding,
Mortality,
Need for urgent intervention(subsequent
endoscopic therapy, surgery)
Radiologic intervention
Red blood cell transfusions,
Length of hospitalization
Endpoints
The primary endpoint was defined as recurrent
bleeding within 7 days
Secondary endpoints on the
Recurrent bleeding within3 days and 30 days
Forest Plot of Studies Comparing Intermittent With Bolus Plus Continuous-Infusion PPI in Patients
With High-Risk Bleeding Ulcers
Strengths and Limitations
Strengths Limitations
Only randomized
controlled trials were
included
different databases
were used to ensure
that all were included
in the analysis.
variations in the study protocol in the different studies,
variation in endoscopic therapies used across studies
the nature of study also cannot provide the optimal PPI bolus doses or length of time, since these were variable in the studies.
Conclusion
Intermittent PPI regimens are comparable to
continuous PPI
infusion regimens in patients with bleeding ulcers
and high risk endoscopic findings
Because of ease of use and lower cost and
resource utilization, intermittent PPI therapy may
be the regimen of choice after endoscopic
therapy in such patients