Two-week Triple Therapy with either Standard or High-dose Esomeprazole for First-line H. pylori Eradication

Abstract

Background & Aims: The updated Italian guidelines advise a standard 14-day triple therapy for first-line H. pylori eradication. This prospective study evaluated the cure rate following a 14-day triple therapy with either a standard or double-dose proton pump inhibitor (PPI).
 Methods. A total of 145 consecutive patients with H. pylori infection were randomized to receive a 14-day, first-line triple therapy with clarithromycin 500 mg, amoxicillin 1 g and esomeprazole at either 20 mg (standard therapy) or 40 mg (double-dose therapy), each given twice daily.
 Results. At intention-to-treat analysis, H. pylori infection was cured in 73.9% (95% CI: 63.9−84) and 81.9% (95% CI: 73−90.8) following standard and double-dose therapy, respectively, and in 78.2% (95% CI: 68.5−87.9) and 85.5% (95% CI: 77.2−93.8) at per-protocol analysis. No statistically significant difference occurred. Overall, 16.4% and 19.4% patients in the standard and double-dose therapy regimen complained of side effects.
 Conclusion. The success rate of both standard and double-dose 14-day triple therapies for first-line H. pylori treatment was unsatisfactory. A prolonged 14-day levofloxacin-based triple therapy for second-line H. pylori eradication seems to be promising.
 Abbrevations: ITT: Intention To Treat; NUD: non ulcer dyspepsia; PP: PerAdd Contributor Protocol; PPI: proton pump inhibitors; PUD: peptic ulcer disease; UBT: urea breath test.

Bismuth-based Quadruple Therapy Following H. pylori Eradication Failures: a Multicenter Study in Clinical Practice

“…However, it remains challenging since no firstline therapy achieves a 100% cure rate [3]. Conversely, the success rate following standard therapies is declining [4,5], mainly due to the increased resistance towards both clarithromycin and metronidazole worldwide [6], a trend seen in Italy as well [7]. Similarly, the efficacy of levofloxacin-amoxicillin triple therapy, generally used as a second-line treatment [8], has decreased so that the therapeutic options for curing H. pylori infection in clinical practice are quite limited [9,10].…”

First-line therapies for Helicobacter pylori eradication: a critical reappraisal of updated guidelines

“…Surprisingly, the use of a 14-day triple therapy is still suggested in the Italian guidelines, even though the primary clarithromycin resistance rate is definitely >15% in Italy [5,7]. Moreover, there are only 3 studies on 14-day triple therapy performed in Italy, which concordantly found that the success rate was lower than 75% and 80% in intention-to-treat (ITT) and per-protocol analyses, respectively (Table 3) [24-26]. Unfortunately, the eradication rate of 14-day triple therapy was not significantly increased even by using a double-dose proton-pump inhibitor (PPI) (i.e.…”

“…esomeprazole 40 mg b.i.d.) [26]. Therefore, the recommendation for using a 14-day triple therapy in the updated Italian guidelines would appear at least questionable.…”

“…However, in the last decade, an eradication rate of >90% has repeatedly been found in all multicenter Italian trials involving thousands of patients [35,36], apart from one study published in 2010 where the infection was cured in 83% of 122 patients [37]. When considering only data from studies published in the last 5 years, the cure rate following sequential therapy was still 90-92.6% in 5 Italian studies with more than 1000 patients [26,38-41], and 73% in another study with 100 cases [42]. A similarly high success rate of sequential therapy has been observed in studies recently performed in Slovenia (94.2%) [43], Portugal (90%) [44], Belgium (90%) [3], Israel (95.9%) [45], Thailand (94%) [46], Taiwan (91.9%) [47], Singapore (90.3%) [48], and the United Arab Emirates (88.6%) [49], suggesting that this therapy is still effective in several countries.…”

Sequential Therapy for First-Line Helicobacter pylori Eradication: 10- or 14-Day Regimen?

“…Current Italian guidelines suggested the use of either 14day triple therapy or 10-day sequential therapy for first-line therapy [3]. However, data of different Italian studies showed that prolonged triple therapy achieved a success rate of only 77% in 619 patients, even when a high-dose proton pump inhibitor was used [4][5][6]. On the contrary, a high success rate was obtained following 10-day sequential therapy in Italy [7], as well as in several other countries [8].…”