November 2, 2009 (San Diego, California) — A new combination regimen consisting of 4 drugs, known as LOAD (levofloxacin, omeprazole, Alinia [nitazoxanide], and doxycycline), is more effective in the eradication of Helicobacter pylori infection than the standard 3-therapy treatment of lansoprazole, amoxicillin, and clarithromycin (LAC), according to a new open-label study presented here at the American College of Gastroenterology (ACG) 2009 Annual Scientific Meeting.
|Dr. Patrick Basu|
"Approximately 50% of the world's population is infected with H pylori, while the estimated infection rate in the United States is 40%," said lead investigator Patrick Basu, MD, from Columbia University College of Physicians and Surgeons in New York City. He presented the results of the study, which won this year's ACG Auxiliary Award, during the President's Plenary Session.
Dr. Basu reported that H pylori is a primary cause of gastritis, peptic ulcer disease, and gastric carcinoma. "And the World Health Organization considers H pylori a type 1 carcinogen." In addition, he said, recurrence of the infection is often due to noncompliance or resistance.
Because there are currently so many different combinations of therapies for treating bacteria being used all over the world, Dr. Basu said that he did extensive research and "ransacked" all the databases he could find to come up with his own database of resistance factors. Then, based on these considerations, "I came up with what I considered the best treatment regimen possible."
His team enrolled 135 treatment-naïve patients (55.5% male) with H pylori gastritis or peptic ulcers and randomized them to receive either the LOAD combination therapy for 10 (n = 45) or 7 (n = 45) days, or the LAC combination for 10 days (n = 45).
Dosing Schedules for All 3 Therapies
|Dosing Schedule||LOAD (10 and 7 Day)||LAC (10 Day)|
|Before breakfast||Omeprazole 40 mg||Lansoprazole 30 mg|
|With breakfast||Levofloxacin 250 mg + nitazoxanide 500 mg||Amoxicillin 1000 mg + clarithromycin 500 mg|
|With dinner||Nitazoxinide 500 mg + doxycycline 100 mg||Amoxicillin 1000 mg + clarithromycin 500 mg|
Each patient was contacted by phone each night during the course of their therapy. To test for H pylori, the investigators examined stool antigen 2 weeks after therapy.
H pylori Eradication Rates Higher With LOAD
At the end of the study, H pylori was eradicated in significantly more LOAD-treated patients (95.23% and 95.34% for 10 and 7 days, respectively) than LAC-treated patients (80.95%; intention to treat, P = .0384; per protocol, P = .0195).
"This study demonstrates the therapeutic superiority of LOAD over LAC therapy for the treatment-naïve [H pylori] population," said Dr. Basu.
Although the results were similarly effective between the 2 LOAD groups, Dr. Basu noted that the 7-day program is potentially more cost effective than the 10-day treatment. "Therefore, we propose that 7-day LOAD therapy be considered as the first line in fighting H pylori infection."
When asked during the presentation's Q&A session about the cost of the regimens, Dr. Basu explained that although his team didn't do a formal cost comparison, he estimates that the cost of the LOAD therapy is about $445 retail in New York City, compared with about $400 for LAC.
He also reported that his team plans to continue following the study patients for 2 more years to watch for recurrence.
"One Big Bang" With LOAD
"I think this is a very interesting study that addresses a very important issue — the concern that we're seeing more resistance to some of the more conventional therapies in terms of [H pylori] eradication," said session moderator Eamonn Quigley, MD, professor of medicine and human physiology at the National University of Ireland in Cork, and outgoing president of the ACG. Dr. Quigley was not involved with this study.
He continued: "They were trying to achieve a number of factors — to be very effective and to get around the problems we have with patient [acceptance of treatment regimens]. So this was trying to get 1 big bang and to get a very high rate of eradication in 7 or 10 days. I was very impressed with their eradication rates."
His main concern with the study related to costs. "That's important because you're talking about 4 drugs [as opposed to] 3, and some are quite new. You have to weigh the benefits. In the future. I'd like to see a long-term cost-efficacy study to tell us if this was well tolerated, cost effective, and had long-term efficacy," Dr. Quigley concluded.
Dr. Basu and Dr. Quigley have disclosed no relevant financial relationships.
American College of Gastroenterology (ACG) 2009 Annual Scientific Meeting: Abstract 2. Presented October 26, 2009.
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Cite this: LAC and LOAD: 4-Drug Regimen Better at Eliminating H Pylori Than Standard 3-Drug Treatment - Medscape - Nov 02, 2009.