Cure of Helicobacter pylori infection in elderly patients: comparison of low versus high doses of clarithromycin in combination with amoxicillin and pantoprazole.
BACKGROUND
Advancing age may influence clarithromycin's pharmacokinetics. No studies have yet compared the effects of different dosages of clarithromycin in combination with a proton pump inhibitor and amoxicillin in elderly patients.


OBJECTIVE
To compare the efficacy and tolerability of clarithromycin 250 mg vs. clarithromycin 500 mg twice daily (b.d.) in combination with pantoprazole and amoxicillin in elderly patients.


METHODS
One hundred and fifty-four elderly patients with H. pylori-associated ulcer disease or chronic gastritis were consecutively randomized to receive pantoprazole 40 mg daily plus amoxicillin 1 g, and either clarithromycin 250 mg b.d. (PAC 250) or clarithromycin 500 mg b.d. (PAC 500). Two months after therapy, endoscopy and gastric biopsies were repeated.


RESULTS
The cure rates of H. pylori infection in the PAC 250 and PAC 500 groups were, respectively, 83% and 79% (ITT analysis) and 94% and 88% (PP analysis) (P=N.S.). Significant decreases in chronic gastritis activity both in the body (P < 0.00001) and the antrum (P < 0.0001) of the stomach were found in H. pylori-cured patients, independently of clarithromycin dosage. Four patients in PAC 250 (5%) and seven in PAC 500 (9%) reported adverse events (P=N.S.). One patient in PAC 250 (25%) and three in PAC 500 (43%) discontinued the study because of these drug-related side-effects (P=N.S.).


CONCLUSIONS
In elderly patients, 1-week triple therapy with a proton pump inhibitor, amoxicillin and clarithromycin is a highly effective and well tolerated anti-H. pylori treatment. With this combination, clarithromycin at the lower dose of 250 mg b.d. achieved excel- lent cure rates and minimized adverse events and costs.
Pilotto
A
A
Department of Geriatrics, Pathophysiology Center for the Elderly, S. Bortolo Hospital, Vicenza, Italy. alberto.pilotto@libero.it
Franceschi
M
M
Leandro
G
G
Bozzola
L
L
Rassu
M
M
Soffiati
G
G
Di Mario
F
F
Valerio
G
G
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000375:Aging; D000658:Amoxicillin / Q000008:administration & dosage / Q000494:pharmacology; D000900:Anti-Bacterial Agents / Q000493:pharmacokinetics* / Q000494:pharmacology*; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000494:pharmacology; D001562:Benzimidazoles / Q000008:administration & dosage / Q000494:pharmacology; D001706:Biopsy; D017291:Clarithromycin / Q000493:pharmacokinetics* / Q000494:pharmacology*; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D004724:Endoscopy; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000472:pathogenicity; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000031:analogs & derivatives; D000077402:Pantoprazole; D010406:Penicillins / Q000008:administration & dosage / Q000494:pharmacology; D054328:Proton Pump Inhibitors; D013454:Sulfoxides / Q000008:administration & dosage / Q000494:pharmacology; D016896:Treatment Outcome
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D001562:Benzimidazoles; D010406:Penicillins; D054328:Proton Pump Inhibitors; D013454:Sulfoxides; D000658:Amoxicillin; D000077402:Pantoprazole; D017291:Clarithromycin; D009853:Omeprazole