By Mike Fillon
ORLANDO, FL -- May 25, 2003 -- New research shows race is not a factor in the ability of antibiotics to eradicate Helicobacter pylori, suggesting that treatment regimens need not be adjusted according to race.
Nimish Vakil, MD, from University of Wisconsin Medical School, in Milwaukee, presented these results here May 19th at the 2003 Digestive Disease Week.
It has previously been suggested that resistance to clarithromycin may compromise the efficacy of triple-therapy regimens to eradicate H. pylori.
Dr. Vakil and colleagues postulated that if clarithromycin resistance could be predicted based on patient demographics, clinicians would be able to tailor H. pylori treatment regimens according to the patient's race.
They therefore conducted a multicentre, double-blind, controlled study to determine the incidence of clarithromycin resistance in a large-scale study of triple therapy with rabeprazole, amoxicillin, and clarithromycin with Hispanic, Caucasian, African-American, and Asian subjects.
The 803 study subjects were aged 18 years or older and had either peptic ulcer disease or non-peptic ulcer disease. The researchers randomised 194 subjects to receive rabeprazole 20 mg, amoxicillin 1 g, and clarithromycin 500 mg twice daily for 3 days (RAC-3); 200 subjects to receive RAC for 7 days (RAC-7); 202 subjects to receive RAC for 10 days (RAC-10); and 207 subjects to receive a control regimen of omeprazole 20 mg, amoxicillin 1 g, and clarithromycin 500 mg twice daily for 10 days (OAC-10).
Results of pre-treatment antimicrobial sensitivity testing in 560 subjects revealed that 51 were resistant to clarithromycin (defined as minimal inhibitory concentration [MIC] 1.0 mcg/mL) and two were intermediate (MIC 0.5 mcg/mL). Two of the clarithromycin-resistant subjects were also resistant to amoxicillin.
The researchers discovered that overall eradication rates with RAC-7 and RAC-10 were high across all racial groups, equivalent to rates with OAC-10. Efficacy with RAC-3 was low.
They concluded that race had no effect on rates of clarithromycin-resistance and that, therefore, primary treatment regimens should not vary based on race in U.S. populations.
They also concluded that, since RAC-7 produced efficacy equivalent to the 10-day courses, with less taste disturbance, the researchers believe there may be a possible therapeutic advantage for this shorter course.
Funding for the study was provided by Eisai Inc. and Janssen Pharmaceutica Inc.
[Study title: Clarithromycin Resistance and H pylori Eradication Rates in US Racial Groups with Rabeprazole-Based Triple Therapy. Abstract 102237]
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