Efficacy of 14-d vs 7-d moxifloxacin-based triple regimens for second-line Helicobacter pylori eradication

Table 1 Demographic and clinical data at baseline (intention-to-treat population) n (%)

	RAM-7	RAM-14	P value
Included in ITT analysis	79	81
Male/female (n)	36/43	35/46	0.741
Age (yr), mean ± SD	63.1 ± 10.6	63.5 ± 10.7	0.354
Smoking	6 (7.6)	5 (6.1)	0.785
Alcohol use	9 (11.4)	11 (13.5)	0.659
Previous history of peptic ulcer	2 (2.5)	4 (4.9)	0.348
Endoscopic finding			0.576
Gastric ulcer	1 (1.9)	1 (1.2)	0.775
Duodenal ulcer	3 (3.8)	4 (4.9)	0.182
Gastric and duodenal ulcer	0 (0.0)	1 (1.2)	0.411
HPAG	75 (94.9)	75 (92.7)	0.287
Drop out	7 (8.8)	8 (9.8)	0.125
Noncompliance	0 (0.0)	0 (0.0)	-
Follow-up loss	7 (8.8)	8 (9.8)	0.453
Discontinued therapy	0 (0.0)	0 (0.0)	-
Due to adverse events
First-line regimen			0.359
RPZ/AMX/CLA	21 (26.6)	23 (28.3)	0.176
RPZ/BIS/MET/TEC	29 (36.7)	31 (38.2)	0.207
Sequential therapy	29 (36.7)	27 (33.5)	0.478

RAM-7: Rabeprazole/amoxicillin/moxifloxacin triple therapy x 7 d; RAM-14: Rabeprazole/amoxicillin/moxifloxacin triple therapy x 14 d; ITT: Intention-to-treat; HPAG: Helicobacter pylori associated gastritis; RPZ: Rabeprazole 20 mg b.i.d; AMX: Amoxicillin 1000 mg b.i.d; CLA: Clarithromycin 500 mg b.i.d.; BIS: Tripotassium dicitrato bismuthate 300 mg q.i.d.; MET: Metronidazole 500 mg t.i.d.; TEC: Tetracycline 500 mg q.i.d.; Sequential therapy: 1 g amoxicillin and 20 mg rabeprazole (or 40 mg esomeprazole) b.i.d. for the first week, followed by 500 mg clarithromycin, 500 mg metronidazole, and 20 mg rabeprazole (or 40 mg esomeprazole) b.i.d for the second week.

Table 2 Helicobacter pylori eradication rates and compliance

	RAM-7	RAM-14	P value
ITT analysis
Eradication rate, n (%)	56 (70.8)	66 (81.4)	0.034
95%CI	63.3%-77.1%	74.6%-88.3%
PP analysis
Eradication rate, n (%)	56 (77.7)	66 (90.4)	0.017
95%CI	70.2%-85.3%	82.8%-98.1%
Compliance	100%	100%	-

RAM-7: Rabeprazole/amoxicillin/moxifloxacin triple therapy x 7 d; RAM-14: Rabeprazole/amoxicillin/moxifloxacin triple therapy x 14 d; ITT: Intention-to-treat; PP: Per-protocol.

Table 3 Adverse events n (%)

Adverse events	RAM-7 (n = 72)	RAM-14 (n = 73)	P value
Epigastric discomfort	3 (4.1)	5 (6.8)	0.874
Constipation	0 (0.0)	1 (1.4)	0.411
Diarrhea	4 (5.5)	6 (8.2)	0.991
Dizziness	1 (1.4)	1 (1.4)	0.667
Headache	0 (0.0)	1 (1.4)	0.667
Nausea or vomiting	6 (8.3)	1 (1.4)	0.415
Skin rash	0 (0.0)	0 (0.0)	-
Total	14 (19.4)	15 (20.5)	0.441

RAM-7: Rabeprazole/amoxicillin/moxifloxacin triple therapy x 7 d; RAM-14: Rabeprazole/amoxicillin/moxifloxacin triple therapy x 14 d; ITT: Intention-to-treat; PP: Per-protocol.