Transcript Slide 1

Efficacy of a Nitazoxanide Based Regimen for Helicobacter pylori (HP) Eradication
Campitelli E1, Paszkiewich A1, Ibarra D1, Zanotti B1, Peré F1, Ronchetti R1, Lago N1, Corti R2, Améndola R2,
Doweck J2, Chaar E3, Perissé E3, Di Risio C3, Barcia T4, Pignataro S4, Rubio H4, Díaz M5
1Hospital
Aeronáutico, Buenos Aires, Argentina; 2Hospital Udaondo, Buenos Aires, Argentina; 3Hospital Penna, Buenos Aires, Argentina;
4CEED, Buenos Aires, Argentina;5Hospital Británico, Buenos Aires, Argentina
BACKGROUND:
Claritromycin and metronidazole are widely utilized as the basis
of HP therapy. Unfortunately, increasing drug resistance to these
drugs is one of the most prevalent reasons for HP treatment
failures. Nitazoxanide is an anti-infective drug with demonstrated
activity against protozoa and anaerobic bacteria including HP.
Nitazoxanide exerts its clinical efficacy on HP by interfering with
anaerobic energy metabolism at the PFOR enzyme. In vitro data
indicates nitazoxanide and tizoxanide (an active metabolite) are
highly active against HP including metronidazole resistant strains.
Other studies have demonstrated that nitazoxanide does not
possess mutagenic activity, cause DNA fragmentation, or promote
cross-resistance with metronidazole.
Table 1: Scheme of Treatment
• Active Superficial
Gastritis (ASG)
• HP infection.
• 14C- Urea Breath
Test
• Endoscopic biopsy
Treatment
Failure
• Nitazoxanide 500
mg BID x 7 days
• Lansoprazole 30
mg BID x 7 days
• Amoxicillin 1000
mg BID x 7 days
RESULTS:
Figure 1: Patients flowchart
AIM:
This study evaluates the efficacy and safety of nitazoxanide in
conjunction with lansoprazole and amoxicillin in a 7-day regimen
for the eradication of HP in previously untreated patients.
METHODS:
 An open label study to evaluate the safety and efficacy of a oneweek triple drug regimen of nitazoxanide, lansoprazole and
amoxicillin in adult patients with treatment naïve HP.
 All patients had Active Superficial Gastritis (ASG) and active HP
infection.
 The diagnosis of HP was confirmed by both 14C-Urea Breath Test
(14C-UBT) and endoscopic biopsy, overall 100 patients were
enrolled in the study.
 Patients received nitazoxanide 500 mg BID, lansoprazole 30 mg
BID and amoxicillin 1000 mg BID for 7 days. Proton pump
inhibitors were discontinued post treatment and therapeutic
efficacy was assessed by 14C-UBT performed between the 6th and
8th week after the completion of therapy.
 Eradication was defined as a negative 14C-UBT, and failure as a
positive 14C-UBT at the 6 to 8 week follow-up assessment.
 Evaluations for safety and tolerability of the regimen were made
via interview and physical examination.
Diagnostic
Method
Pathology
Figure 3: Treatment outcome
9 patients withdrawn
(6 were 14C-UBT negative)
91 evaluable
14C- Urea
Breath Test
negative
9/91
82/91
9%
90%
REFERENCES
Figure 2: Endoscopic biopsy
B
14C- Urea
Breath Test
positive
CONCLUSIONS
 A 7-day regimen of nitazoxanide , lansooprazole , and
amoxicillin twice daily is effective for the eradication of HP
infection in treatment naïve patients
 In addition, the regimen was well-tolerated and associated
with good patient compliance
 Due to increasing patterns observed with claritromycin and
metronidazole, nitazoxanide may offer a valuable alternative to
these medications as a foundation for HP therapy.
100 patients enrolled
A
Cure
C
Histology of endoscopic biopsy samples by three different
methods. A. Warting Starring specific Stain for HP B. Giemsa
stain to improve SP vision. C. Hematoxilin-eosin stain from
antrum mucosae.
1. Hemphill A, Mueller J, Esposito thiazolide anti-infective agent for the treatment of gastrointestinal
infections. Exp Opinion. Pharmacotherapy 2006 May; 7: 953-6
2. Megraud F., Occhialini A., Rossignol J.F. 1998. Nitazoxanide, a Potential Drug for Eradication of
Helicobacter pylori with No Cross-Resistance to Metronidazole. 42: 2836-2840.
3. Sisson G, Goodwing A, Raudonikiene A, Birks N, Mukhopadhayay A.K, Berg D, & Hoffman, P. 2002.
Identification of Enzymes Associated with Reductive Activation and Action of Nitazoxanide, Nitrofurans,
and Metronidazole in Helicobacter pylori. 46: 2116-2123
4. Hoffman P., Sisson G., Croxen M., Welch K., Harman W., Cremades N., Morash M. 2007. Antiparasitic
Drug Nitazoxanide Inhibits the Pyruvate Oxidoreductases of Helicobacter pylori, Selected Anaerobic
Bacteria and Parasites, and Campylobacter jejuni. 51;3: 868-876
AKNOWLEDGEMENT:
This study was supported by a grant
from Roemmers-Argentina
Presented at American College of Gastroenterology Annual Scientific Meeting • October 3-8, 2008; Orlando, Florida