G. Maconi et al., Do some patients with Helicobacter pylori infection benefit from an extension to 2 weeks of a proton pump inhibitor-based triple eradication therapy?, AM J GASTRO, 96(2), 2001, pp. 359-366
OBJECTIVES: Seven-day proton pump inhibitor (PPI)-based triple therapies ar
e the first-line anti-Helicobacter pylori regimens; to date, however, there
is still no agreement concerning all the predictors of H. pylori cure unde
r these regimens. The aim of this prospective study was to evaluate whether
patients with certain pretreatment characteristics may benefit from an ext
ension from 1 to 2 wk of treatment with lansoprazole, amoxycillin, and clar
ithromycin.
METHODS: A total of 142 patients with H. pylori infection ascertained by me
ans of gastric histopathology and C-13 urea breath test (UBT) participated
in this study. In all patients H. pylori density was determined at histolog
y both on antral and corpus biopsies, and H. pylori culture with antibiotic
susceptibility testing; Ige anti-H. pylori titers were also determined bef
ore therapy. Patients were randomized to receive 1-wk versus 2-wk of treatm
ent with lansoprazole (30 mg b.i.d.), clarithromycin (500 mg b.i.d), and am
oxycillin (1 g b.i.d.). The association between eradication and potential p
redictors was analyzed by means of unconditional logistic regression models
and stratified according to the duration of treatment. A stepwise regressi
on analysis was performed to identify variables discriminated between subje
cts, using eradication status as the dependent variable.
RESULTS: The overall eradication rates for 1- and 2-wk treatments were 74.6
% and 85.9% (intention-to-treat analysis) and 81.5% and 89.1% (per-protocol
analysis), respectively (p = NS). Multivariate discriminant analysis selec
ted as the variables independently related to eradication cigarette smoking
(OR = 3.98), delta of C-13-UBT higher than 35 (OR = 9.21) and IgG anti-H.
pylori titer greater than or equal to 93 (OR = 0.24) for the whole series o
f subjects. Stratified analysis according to the duration of therapy select
ed H. pylori density as the only predictor of eradication in the group trea
ted for 1 wk (OR = 8.11). In contrast, no significant predictors were found
in the group treated for 2 wk.
CONCLUSIONS: Patients with a high intragastric bacterial load, as detected
by histology (grade 3) or C-13-UBT (delta = 35) may benefit from an extensi
on to 2 wk of triple therapy with lansoprazole. amoxycillin, and clarithrom
ycin.