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Triple Therapy
The
2007
American
College
of
Gastroenterology
(ACG),
the
Canadian
Helicobacter Study Group (2004), and the
Canadian Dyspepsia Working Group (2005)
recommend proton pump inhibitor (PPI)-based
triple therapy (standard PPI dose BID +
clarithromycin 500 mg BID + amoxicillin
1000 mg BID [or metronidazole 500 mg BID if
penicillin allergic]) as first-line treatment of H.
pylori infection.2-4 The ACG recommends 14
days of treatment duration whereas the Canadian
guidelines recommend at least seven days of
treatment.4 The optimal duration of PPI-based
triple therapy with amoxicillin and clarithromycin
is an ongoing debate. A prospective, randomized
trial found no therapeutic gain from extending
standard triple therapy from seven to 14 days.5 A
meta-analysis of 21 randomized trials showed that
the eradication rate differences among the
Quadruple Therapy
An alternative to the triple therapy treatment
regimen is the bismuth quadruple therapy. U.S.
and Canadian guidelines both recommend the
bismuth quadruple therapy of PPI or H2-blocker
(U.S. guidelines only) + bismuth + metronidazole
+ tetracycline for ten to 14 days as a first-line
therapy for H. pylori eradication.2,4 The ACG also
recommends such quadruple therapy as a salvage
therapy in those who have failed clarithromycinbased triple therapy.2 Quadruple therapy was
previously considered a rescue regimen rather
than first-line treatment regimen due to the
perception that the dosing was too complex and
less well tolerated than PPI triple therapies.4
However, two meta-analyses concluded that the
efficacy, tolerability, and patient compliance were
similar between PPI triple therapies and quadruple
therapy.17,18
Due to the increase in clarithromycin
resistance rate, quadruple therapy regimens are
increasingly being recommended as first-line
empiric therapy.8,11
Pylera (each capsule contains bismuth
subcitrate 140 mg, metronidazole 125 mg, and
tetracycline 125 mg [three capsules per dose]) or
Helidac (bismuth subsalicylate 525 mg,
metronidazole 250 mg, tetracycline 500 mg per
dose) combo packs (doses for both given four
times daily) plus a PPI can be used for quadruple
therapy in light of the current tetracycline
shortage.
However, due to concerns about
metronidazole
resistance,
additional
metronidazole should be added to Helidac
treatment, aiming for at least 1500 mg of
metronidazole per day. Total daily dose of
Sequential Therapy
A 10-day sequential therapy, combining a 5day course of PPI BID with amoxicillin
1000 mg BID immediately followed by a second
course of clarithromycin 500 mg BID,
metronidazole 500 mg or tinidazole 500 mg BID,
and a PPI BID for five additional days, is another
promising regimen.1,11,12 Cure rates of such
sequential therapy has been shown to be as high
as 92% in Europe.19
Two pooled analyses of European studies
support the efficacy of sequential therapy,
especially in those infected with macrolideresistant H. pylori.20-22 Another meta-analysis
found comparable efficacy of sequential therapy
vs triple therapy.22
Trials conducted in the Asian population also
show promising results with sequential therapy.
In one study conducted in Thailand, treatment
with lansoprazole 30 mg + amoxicillin 1000 mg
BID for five days, then lansoprazole 30 mg +
metronidazole 500 mg BID + clarithromycin
More. . .
Four-drug
Therapy
Nonbismuth
Concomitant
Salvage Therapy
For salvage therapy, a regimen that has been
studied besides quadruple therapy is the
levofloxacin-based triple therapy, which shows
eradication rates ranging from 63% to 94% in
Asian and European populations. A meta-analysis
including four randomized, controlled trials
showed that a 10-day levofloxacin-based triple
therapy regimen had a superior eradication rate
and was associated with fewer side effects
compared to a 7-day course of bismuth-based
quadruple therapy.2,30 However, these results
require validation in the North American
population.
Furthermore,
the
optimal
levofloxacin
dose
(250
mg
BID
vs
500 mg daily vs 500 mg BID) and duration of
therapy has yet to be determined (seven day vs
ten day). However, another meta-analysis did
find a higher eradication rate with the 10-day over
7-day regimen.31 Unfortunately, resistance to
fluoroquinolones is rapidly increasing. Experts
now recommend using fluoroquinolone therapy
only when susceptibility data are available.11
Rifabutin-based salvage therapy (rifabutin
150 mg + amoxicillin 1000 mg + PPI BID for 14
days) has also been tried in patients who have
failed other therapies. Due to concerns of adverse
drug effects and increased mycobacterium
More. . .
LOAD Therapy
An investigational four-drug regimen known
as LOAD therapy (levofloxacin 250 mg daily with
breakfast + omeprazole 40 mg daily before
breakfast + nitazoxanide 500 mg BID +
doxycycline 100 mg daily at dinner) was found to
be an effective regimen with eradiation rates of
88.9% (10-day therapy) and 89.4% (7-day
therapy) in an open-label study.32 A larger
randomized controlled trial is warranted to further
evaluate the efficacy of this treatment regimen.
Dual Therapy
Although dual therapy (e.g., PPI + amoxicillin)
for ten to 14 days is an FDAapproved regimen,
such regimens should not be recommended since
the eradication rate falls below 80%.2
Commentary
In treating H. pylori infection, it is important to
achieve a high eradication rate in order to reduce
symptoms and complications of the infection.2
The eradication rate of H. pylori is highly
dependent on patient compliance to the treatment
regimen. An ideal treatment regimen should be
simple, well tolerated, cost effective, encourage
patient compliance, and provide a bacterial
eradication rate of >80% (IT) or >90% (PP).2 See
our PL Chart, H. Pylori Treatment Regimens, for
regimens and their efficacy. To avoid repeated
treatments of dyspepsia symptoms not attributable
to H. pylori, follow-up testing with urea breath
test or fecal antigen test is recommended.1 For
Levels of Evidence
In accordance with the trend towards Evidence-Based
Medicine, we are citing the LEVEL OF EVIDENCE
for the statements we publish.
Level
A
C
D
Definition
High-quality randomized controlled trial (RCT)
High-quality meta-analysis (quantitative
systematic review)
Nonrandomized clinical trial
Nonquantitative systematic review
Lower quality RCT
Clinical cohort study
Case-control study
Historical control
Epidemiologic study
Consensus
Expert opinion
Anecdotal evidence
In vitro or animal study
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
References
1.
2.
16.
Gastroenterology.
American
College
of
Gastroenterology guideline on the management of
Helicobacter pylori infection. Am J Gastroenterol
2007;102:1808-25.
Veldhuyzen van Zanten SJ, Bradette M, Chiba N,
et al. Evidence-based recommendations for shortand long-term management of uninvestigated
dyspepsia in primary care: an update of the
Canadian Dyspepsia Working Group (CanDys)
clinical management tool. Can J Gastroenterol
2005;19:285-303.
Hunt R, Fallone C, Veldhuyzan van Zanten S, et al.
Canadian Helicobacter Study Group consensus
conference: update on the management of
Helicobacter pylori--an evidence-based evaluation
of six topics relevant to clinical outcomes in
patients evaluated for H. pylori infection. Can J
Gastroenterol 2004;18:547-54.
Zagari RM, Bianchi-Porro G, Fiocca R, et al.
Comparison of 1 and 2 weeks of omeprazole,
amoxicillin and clarithromycin treatment for
Helicobacter pylori eradication: the HYPER Study.
Gut 2007;56:475-9.
Fuccio L, Minardi ME, Zagari RM, et al. Metaanalysis: duration of first-line proton-pump inhibitor
based triple therapy for Helicobacter pylori
eradication. Ann Intern Med 2007;147:553-62.
Calvet X. Helicobacter pylori infection: treatment
options. Digestion 2006;73(Suppl1):119-28.
Graham DY, Fischbach L. Helicobacter pylori
treatment in the era of increasing antibiotic
resistance. Gut 2010;59:1143-53.
Sun Q, Liang X, Zheng Q, et al. High efficacy of
14-day triple therapy-based, bismuth-containing
quadruple therapy for initial Helicobacter pylori
eradication. Helicobacter 2010;15:233-8.
Malfertheiner P. Infection: bismuth improves PPIbased triple therapy for H. pylori eradication. Nat
Rev Gastroenterol Hepatol 2010;7:538-9.
Rimbara E, Fischbach LA, Graham DY. Optimal
therapy for Helicobacter pylori infections. Nat Rev
Gastroenterol Hepatol 2011;8:79-88.
Chuah SK, Tsay FW, Hsu PI, Wu DC. A new look
at anti-Helicobacter pylori therapy.
World J
Gastroenterol 2011;17:3971-5.
Graham DY, Lu H, Yamaoka Y. A report card to
grade Helicobacter pylori therapy. Helicobacter
2007;12:275-8.
Quintiliani R. Pharmacodynamics of antimicrobial
agents:
time-dependent vs concentrationdependent
killing.
http://www.antimicrobe.org/h04c.files/history/PKPD%20Quint.pdf. (Accessed January 15, 2012).
Rapp RP, Nogid B, Goldberg T. Principles of
treatment of CAPPart2:
implications of
antimicrobial
pharmacokinetics/pharmacodynamics.
https://secure.pharmacytimes.com/lessons/200711
-01.asp. (Accessed January 15, 2012).
Silva FM, Eisig JN, Teixeira AC, et al. Short-term
triple therapy with azithromycin for Helicobacter
pylori eradication: low cost, high compliance, but
low efficacy. BMC Gastroenterol 2008;8:20.
More. . .
Copyright 2012 by Therapeutic Research Center
P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com ~ www.pharmacytechniciansletter.com
27. Johnston C.
Sequential therapy eradicates
Helicobacter pylori better than triple therapy in
Aklavik Natives: Presented at CDDW. March 2,
2010.
Doctors
Guide.
http://canhelpworkinggroup.ca/Doctor's%20Guide
%20Dispatch_2010-03-02.pdf. (Accessed January
15, 2012).
28. Essa AS, Kramer JR, Graham DY, Treiber G.
Meta-analysis: four drug, three antibiotic, nonbismuth-containing concomitant therapy versus
triple therapy for Helicobacter pylori eradication.
Helicobacter 2009;14:109-18.
29. Wu DC, Hsu PI, Wu JY, et al. Sequential and
concomitant therapy with four drugs is equally
effective for eradication for H. pylori infection. Clin
Gastroenterol Hepatol 2010;8:36-41.
30. Saad RJ, Schoenfeld P, Kim HM, Chey WD.
Levofloxacin-based triple therapy versus bismuthbased
quadruple
therapy
for
persistent
Helicobacter pylori infection: a meta-analysis. Am
J Gastroenterol 2006;101:488-96. [Abstract].
31. Jodlowski TZ, Lam S, Ashby CR Jr. Emerging
therapies for the treatment of Helicobacter pylori
infections. Ann Pharmacother 2008;42:1621-39.
32. Basu PP, Rayapudi K, Pacana T, et al.
A
randomized
study
comparing
levofloxacin,
omeprazole, nitazoxanide, and doxycycline versus
triple therapy for the eradication of Helicobacter
pylori. Am J Gastroenterol 2011;106;1970-5.
33. Liou JM, Lin JT, Chang CY, et al. Levofloxacinbased and clarithromycin-based triple therapies as
first-line
and
second-line
treatments
for
Helicobacter pylori infection:
a randomised
comparative trial with crossover design.
Gut
2010;59:572-8.
34. Cammarota G, Martino A, Pirozzi G, et al. High
efficacy of 1-week doxycycline- and amoxicillinbased quadruple regimen in a culture-guided, thirdline treatment approach for Helicobacter pylori
infection. Aliment Pharmacol Ther 2004;19:78995.
An Update.
Pharmacists
PL Detail-Document #280201
This Detail-Document accompanies the related article published in
ESOMP 20 mg
BID2,3
or
ESOMP 40 mg
once daily1
CLAR 500 mg
BID
MET 500 mg
BID
14 days1
U.S.
--
No
No
7 or 10
days3
Canada
More. . .
Copyright 2012 by Therapeutic Research Center
Pharmacists Letter / Prescribers Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
PPI or
H2-Blockera,f,g
Antibiotic 1
Antibiotic 2
Bismuth
Compound
Duration Comments
Efficacyb,c
FDATPDApprovedd Approvede
(U.S.)
(Canada)
Recommended Oral Regimens per ACG Guidelines (2007), Canadian Helicobacter Study Group Consensus (2004), or Dyspepsia Working Grp (2005)1-3
Yes
Yes
LANS 30 mg
CLAR 500 mg
AMOX 1 gm
14 days
Both 10-day and 14-day 7-day
regimen
BID1-3
BID
BID
U.S.
regimens are FDA
90% (PP)
approved.6,7
85% (IT)
7 or 10
days
7-day, 10-day, and 1410-day
Canada
day regimens are TPD
6-8
regimen
approved.8
84% (PP)
1-3
81% (IT)
Available as Prevpac in
U.S. and Hp-Pac in
Canada.
LANS 30 mg
BID1-3
CLAR 500 mg
BID
MET 500 mg
BID
14 days
U.S.
7 or 10
days
Canada
14-day
regimen6,7
85-92%
(PP)
82-86%
(IT)
90%
(PP)1
80%
(IT)1
More. . .
Copyright 2012 by Therapeutic Research Center
Pharmacists Letter / Prescribers Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
No
No
PPI or
H2-Blockera,f,g
Antibiotic 1
PANT 40 mg
BID1-3
CLAR 500 mg
BID
Antibiotic 2
Duration Comments
Efficacyb,c
FDATPDApprovedd Approvede
(U.S.)
(Canada)
Recommended Oral Regimens per ACG Guidelines (2007), Canadian Helicobacter Study Group Consensus (2004), or Dyspepsia Working Grp (2005)1-3
OMP 20 mg
10-day regimen is FDA
10-day
Yes
Yes
CLAR 500 mg
AMOX 1 gm
14 days
BID1-3
BID
BID
U.S.
approved.9
regimen
77-90%
7-day regimen is TPD
10
7 or 10
(PP)9
approved.
days
69-83%
Also known as Losec 1- (IT)9
Canada
2-3 A in Canada.
7-day
Give additional 18 days
regimen
of OMP 20 mg daily for 95-98%
ulcer healing and
(PP)10
symptom relief.9 Give
94%-96%
additional OMP 20 mg
(IT)10
daily for up to 3 wks for
active DU and OMP 2040 mg daily for up to 12
wks for active GU.10
CLAR 250 mg or MET 500 mg
14 days
7-day regimen with
No
Yes
OMP 20 mg
9194%
500 mg BID
BID
U.S.
CLAR 250 mg BID is
(PP)10
BID1-3
TPD approved.10
87-95%
7 or 10
(IT)10
days
Also known as Losec
(with
Canada
1-2-3 M in Canada (with CLAR
CLAR 250 mg).
250 mg
BID)
AMOX 1 gm
BID
Bismuth
Compound
1-3
14 days
U.S.
86%-93%
(IT)11
7 or 10
days
Canada
More. . .
Copyright 2012 by Therapeutic Research Center
Pharmacists Letter / Prescribers Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
No
Yes
PPI or
H2-Blockera,f,g
Antibiotic 1
Antibiotic 2
Bismuth
Compound
Duration Comments
Efficacyb,c
FDATPDApprovedd Approvede
(U.S.)
(Canada)
Recommended Oral Regimens per ACG Guidelines (2007), Canadian Helicobacter Study Group Consensus (2004), or Dyspepsia Working Grp (2005)1-3
PANT 40 mg
83%-96% No
Yes
CLAR 500 mg
MET 500 mg
14 days
7-day regimen is TPD
BID1-3
(IT)11
BID
BID
U.S.
approved.11
1-3
7 or 10
days
Canada
RAB 20 mg
BID1-3
CLAR 500 mg
BID
AMOX 1 gm
BID
14 days
U.S.
7 or 10
days
Canada
RAB 20 mg
BID1-3
CLAR 500 mg
BID
MET 500 mg
BID
14 days
U.S.
7-day
regimen
84%
(PP)12
77%
(IT)12
10-day
regimen
86%
(PP)12
78%
(IT)12
--
7 or 10
days
Canada
More. . .
Copyright 2012 by Therapeutic Research Center
Pharmacists Letter / Prescribers Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
Yes
Yes
No
No
PPI or
H2-Blockera,f,g
TCN 500 mg
QID
Antibiotic 2
MET 250 mg to
500 mg QID
Bismuth
Compound
BSS 525 mg
QID
Duration Comments
Efficacyb,c
FDATPDApprovedd Approvede
(U.S.)
(Canada)
Recommended Oral Regimens per ACG Guidelines (2007), Canadian Helicobacter Study Group Consensus (2004), or Dyspepsia Working Grp (2005)1-3
ESOMP 20 mg
BSS/MET/TCN
-No
No
TCN 500 mg
MET 250 mg
BSS 525 mg 10 or 14
BID or ESOMP
combination is available
QID
QID
QID
days1
40 mg once daily
in U.S. as Helidac.14
or LANS 30 mg
Experts recommend total
or
OMP 20 mg or
daily dose of MET to be
PANT 40 mg or
at least 1500 mg/day for
RAB 20 mg BID1
better efficacy and to
overcome MET
resistance.15 Consider
additional MET 250 mg
TID with meals when
using Helidac.
ESOMP 20 mg
BID or
LANS 30 mg
BID or
OMP 20 mg BID
or PANT 40 mg
BID or
RAB 20 mg BID3
Antibiotic 1
1-3
10 or 14
days
Considered a first-line
therapy per 2007 U.S.
H. pylori treatment
guidelines.1
Considered the
preferred therapy for
H. pylori treatment
failures per 2005
Canadian dyspepsia
treatment guidelines.3
---
No
More. . .
Copyright 2012 by Therapeutic Research Center
Pharmacists Letter / Prescribers Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
No
PPI or
H2-Blockera,f,g
Antibiotic 1
Antibiotic 2
Bismuth
Compound
Duration Comments
Efficacyb,c
FDATPDApprovedd Approvede
(U.S.)
(Canada)
Recommended Oral Regimens per ACG Guidelines (2007), Canadian Helicobacter Study Group Consensus (2004), or Dyspepsia Working Grp (2005)1-3
Ranitidine
MET 250 mg
TCN 500 mg
BSS 525 mg 10 or 14
BSS/MET/TCN combo
71%
Yes
No
150 mg BID or
QID
QID
days
is available in U.S. as
QID
(PP)14
standard dose
Helidac.14
72%
H2-blockers
Experts recommend total (IT)14
(Famotidine
daily dose of MET to be
40 mg/day, or
at least 1500 mg/day for
Nizatidine
better efficacy and to
300 mg/day
overcome MET
[given as single
resistance.15 Consider
or divided
additional MET 250 mg
doses]).1
TID with meals when
using Helidac.
Ranitidine-based
regimen is considered a
first-line therapy per
2007 U.S. H. pylori
guidelines, but not listed
as an option in the
Canadian guidelines.1
Give BSS, antibiotics
and H2-blocker together
for 14 days. Then give
H2-blocker alone for an
additional 14 days. H2blocker may be given
QD at bedtime or in two
equally divided doses
BID. Avoid cimetidine
to reduce risk of drugdrug interactions.14
1-3
More. . .
Copyright 2012 by Therapeutic Research Center
Pharmacists Letter / Prescribers Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
PPI or
H2-Blockera,f,g
Antibiotic 1
Antibiotic 2
Bismuth
Compound
Duration Comments
Efficacyb,c
FDATPDApprovedd Approvede
(U.S.)
(Canada)
Recommended Oral Regimens per ACG Guidelines (2007), Canadian Helicobacter Study Group Consensus (2004), or Dyspepsia Working Grp (2005)1-3
ESOMP 20 mg
>80%
No
No
MET 375 mg or
TCN 375 or
BSS 525 mg 10 or 14
Considered a first-line
BID or
(IT)2
500 mg QID
500 mg QID
QID
days2
therapy per 2004
LANS 30 mg
Canadian Helicobacter
BID or
Study Group.2
OMP 20 mg BID
or PANT 40 mg
BID or
RAB 20 mg BID2
1-3
Followed by:
CLAR 500 mg
BID
(Days 6-10)
10 days
TIN 500 mg
BID
(Days 6-10)
92%
(PP)17
90%
(IT)16
(in
European
population)
Recommended as a
first-line therapy for H.
pylori infected patients
with DU or GU per
Sanford Guide to
Antimicrobial Therapy
web edition.16
Experts now consider
sequential therapy an
acceptable first-line
therapy in those who
have not been exposed
clarithromycin or
metronidazole
recently.15,19,20
More. . .
No
No
PPI or
H2-Blockera,f,g
Antibiotic 1
Antibiotic 2
Bismuth
Compound
Duration Comments
Efficacyb,c
FDAApprovedd
(U.S.)
TPDApprovede
(Canada)
95%18
(not
specified
PP or IT)
No
No
90-99%17
(not
specified
PP or IT)
No
No
--
No
No
1-3
AMOX 1 gm
BID (Days 1-5)
LAN 30 mg BID
(Days 1-10)18
OMP 20 mg
BID16
ESOMP 20 mg
BID or
LANS 30 mg
BID or
OMP 20 mg BID
or PANT 40 mg
BID or
RAB 20 mg BID
CLAR 1 gm
Daily (Days 610)
TCN 500 mg
QID
TCN 500 mg
QID
MET 500 mg
BID (Days 6-10)
MET 250 mg
QID
BSS 525 mg
QID
14 days16
MET 500 mg
TID or
MET 400 mg
QID or
TIN 500 mg
TID
BSS 525 mg
QID
10 or 14
days15,19,
20
(in Asian
population)
More. . .
Copyright 2012 by Therapeutic Research Center
Pharmacists Letter / Prescribers Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
PPI or
H2-Blockera,f,g
Antibiotic 1
OMP 20 mg BID
AMOX 1 gm
BID
OMP 20 mg
BID21
OMP 40 mg once
daily9
Antibiotic 2
Bismuth
Compound
Duration Comments
Efficacyb,c
FDAApprovedd
(U.S.)
TPDApprovede
(Canada)
1-3
Efficacy needs to be
validated in North
American population.28
92%
(PP)
91%
(IT)
No
No
10 days
93%
(PP)21
88%
(IT)21
Yes
CLAR 500 mg
TID
14 days
64-74%
(PP)22
Yes
Yes (as
Helizide in
2003,
reapproved
as Pylera in
2011, but
not
marketed)
Yes
DOX 100 mg
BID
BIS 420 mg
BID
55-60%
(IT)23
Regimens containing
clarithromycin as a
single antimicrobial
agent are more likely to
develop clarithromycin
resistance among
patients who fail
treatment.22
More. . .
Copyright 2012 by Therapeutic Research Center
Pharmacists Letter / Prescribers Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
PPI or
H2-Blockera,f,g
Antibiotic 1
Antibiotic 2
Bismuth
Compound
ESOMP 20 mg
BID or
LANS 30 mg
BID or
OMP 20 mg BID
or PANT 40 mg
BID or
RAB 20 mg
BID21
ESOMP 20 mg
BID or
LANS 30 mg
BID or
OMP 20 mg BID
or PANT 40 mg
BID or
RAB 20 mg BID1
AMOX 1 gm
BID
10 or 14
days
LEV 500 mg
once daily
AMOX 1 gm
BID
10 or 14
days15
Efficacyb,c
FDAApprovedd
(U.S.)
TPDApprovede
(Canada)
70-85%
(IT)24
No
No
May be considered as
salvage therapy for
patients with persistent
H. pylori who have
failed other treatment
regimens.1
10-day
regimen1
63-94%
(not
specified
PP or IT)1
No
No
No
No
Duration Comments
1-3
ESOMP 20 mg
BID or
LANS 30 mg
BID or
OMP 20 mg BID
or PANT 40 mg
BID or
RAB 20 mg
BID19
LEV 500 mg
once daily
AMOX 500 mg
QID
BSS 525 mg
QID
10 days
More. . .
Copyright 2012 by Therapeutic Research Center
Pharmacists Letter / Prescribers Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
PPI or
H2-Blockera,f,g
Antibiotic 1
Antibiotic 2
Antibiotic 3
OMP 20 mg BID
or LANS 30 mg
BID25
CLAR 250 mg
BID
MET 400 mg
BID
AMOX 1gm
BID
5 days
ESOMP 40 mg
BID26
CLAR 500 mg
BID
MET 500 mg
BID or
TIN 500 mg
BID
AMOX 1 gm
BID
10 days26
Efficacyb,c
FDAApprovedd
(U.S.)
TPDApprovede
(Canada)
90-96%
(PP)25
88-91%
(IT)25
No
No
10-day
regimen26
93% (PP
and IT)
(ESOMP
40 mg
BID)26
No
No
Duration Comments
1-3
More. . .
Copyright 2012 by Therapeutic Research Center
Pharmacists Letter / Prescribers Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
PPI or H2 Blockera,f,g
Antibiotic 1
ESOMP 20 mg
BID or
LANS 30 mg
BID or
OMP 20 mg BID
or PANT 40 mg
BID or
RAB 20 mg
BID15
(Days 1-14)
AMOX 1 gm
BID (Days 1-7)
Antibiotic 2
Antibiotic 3
Duration Comments
Efficacyb,c
FDAApprovedd
(U.S.)
TPDApprovede
(Canada)
99%
(PP)15
97%
(IT)15
No
No
77%
(PP)6
70%
(IT)6
Yes
No
--
No
No
AMOX 1 gm
BID (Days 8-14)
14 days
CLAR 500 mg
BID
(Days 8-14)
MET 500 mg
BID or
TIN 500 mg
BID
(Days 8-14)
LANS 30 mg
TID6
AMOX 1 gm
TID
14 days
OME 40 mg or
LAN 30 mg QID
AMOX 500 mg
QID
14 days
b.
c.
d.
e.
f.
g.
dose) for H. pylori regimens. Dexlansoprazole is not approved by the FDA or TPD for the treatment of H. pylori infection. To help with PPI
dose comparisons, see our PL Chart, Proton Pump Inhibitor Dose Comparison (U.S. subscribers #250801; Canadian subscribers #250820).
Efficacy reported as cure rate (eradication rate) by intention-to-treat (IT) analysis or by per protocol (PP) analysis. IT means that outcomes
were analyzed for all patients, based on the treatment to which they were randomized, regardless of whether they dropped out. PP means that
outcomes were analyzed for all patients who completed the study and complied with protocol. Based on the American College of
Gastroenterology and Canadian Helicobacter Study Group Consensus criteria, the range for the 95% confidence interval should remain above
80% (IT) and above 90% (PP) for an effective regimen.1,2
H. pylori resistance to clarithromycin is on the rise. Recent data suggest that cure rates for first-line triple therapy (PPI + CLAR + AMOX [or
MET]) fall below 80%.20
Treatment regimen is approved by the FDA.
Treatment regimen is approved by the Therapeutic Products Directorate (Health Canada).
For guideline recommendations, efficacy of all PPIs (excluding dexlansoprazole; see footnote a) appear comparable.1,3 For regimens with
only one PPI listed, the listed regimen is the specific regimen studied or listed in product labeling.
The 2007 U.S. guidelines provide specific dosing for PPIs.1 The Canadian guidelines do not provide specific PPI dosing,2,3 but the 2005
Canadian guidelines state that all PPIs (excluding dexlansoprazole; see footnote a), dosed twice daily have similar efficacy in curing H.
pylori.3
Users of this PL Detail-Document are cautioned to use their own professional judgment and consult any other necessary or appropriate sources prior to making
clinical judgments based on the content of this document. Our editors have researched the information with input from experts, government agencies, and national
organizations. Information and Internet links in this article were current as of the date of publication.
More. . .
Copyright 2012 by Therapeutic Research Center
Pharmacists Letter / Prescribers Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
References
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
Cite this document as follows: PL Detail-Document, H. Pylori Treatment Regimens for Adults. Pharmacists
Letter/Prescribers Letter. February 2012.
More. . .
Copyright 2012 by Therapeutic Research Center
Pharmacists Letter / Prescribers Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
Subscribers to Pharmacists Letter and Prescribers Letter can get PL Detail-Documents, like this one, on
any topic covered in any issue by going to www.pharmacistsletter.com or www.prescribersletter.com