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GASTROENTEROLOGIC DISORDERS C.
Wayne Weart, Section Advisor
Four-drug regimen for H. pylori better than standard
three-drugs
Key point: Data from 135 patients with
treatment-naive Helicobacter pylori infections showed that a
four-drug regimen of levofloxacin (Levaquin—Ortho-McNeil-Janssen),
omeprazole, nitazoxanide (Alinia—Romark), and doxycycline (LOAD)
given for 7 or 10 days eradicated the bacterium in 95% of patients
compared with an 81% eradication rate for the standard 10-day three-drug
regimen of lansoprazole (Prevacid—Takeda), amoxicillin, and
clarithromycin (LAC).
Finer points: Patrick Basu, MD, from Columbia
University College of Physicians and Surgeons in New York and colleagues
presented results of their randomized, open-label trial comparing LOAD
versus LAC regimens for patients with treatment-naive H. pylori
gastritis or peptic ulcer (healed) at the 2009 American College of
Gastroenterology Annual Scientific Meeting. Patients were randomized to
7 or 10 days of LOAD therapy or 10 days of LAC therapy (n = 45 per
group). The LOAD regimen was given as omeprazole 40 mg before breakfast,
levofloxacin 250 mg/nitazoxanide 500 mg with breakfast, and nitazoxanide
500 mg/doxycycline 100 mg at dinner. LAC was given as lansoprazole 30 mg
before breakfast and amoxicillin 1,000 mg/clarithromycin 500 mg at
breakfast and dinner.
Patients ranged in age from 18 to 65 years, 55% were male, and the
majority of patients had gastritis without intestinal metaplasia (52%).
The investigators noted that the eradication rate for H. pylori
was significantly higher in patients given 7 or 10 days of LOAD therapy
(approximately 95% of patients per group) compared with those given 10
days of the LAC regimen (81%). No differences were noted between the 7-
and 10-day course of LOAD therapy. The investigators concluded that a
7-day LOAD regimen should be considered as a first-line treatment option
for patients with H. pylori infections.
What you need to know: In recent years, H.
pylori has become increasingly resistant to standard antimicrobial
therapies. It is estimated that approximately 25% of H. pylori
cases are resistant to metronidazole and 12% to 30% of cases are
resistant to clarithromycin. In addition, some strains exhibit multidrug
resistance. Amoxicillin, clarithromycin, tetracycline, and metronidazole
are key antimicrobial agents used in standard regimens of treatment for
H. pylori infections; therefore, regimens that contain some of
these agents may fail to eradicate the infection because of increased
resistance. The investigators of the current trial were able to show
that a regimen that contains agents such as levofloxacin, nitazoxanide,
and doxycycline is extremely effective as a first-line treatment option.
Nitazoxanide is an oral antiprotozoal agent approved for patients with
diarrhea caused by Giardia lamblia or diarrhea caused by
Cryptosporidium parvum. The most common adverse events
associated with this agent include abdominal pain (6.6%), diarrhea
(4.3%), headache (3.1%), and nausea (3.0%). A larger, double-blind trial
is needed to confirm the current findings so clinicians are able to
determine which regimens to select as initial therapy.
What your patients need to know: Counsel patients
that recent data suggest that a four-drug regimen is more effective than
a three-drug regimen for the initial management of H. pylori
infections. If patients are prescribed the LOAD regimen, counsel them on
proper administration and potential adverse reactions.
Source
Related resource on www.pharmacist.com
Posted by Joe Sheffer (jsheffer@aphanet.org)
November 24, 2009
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