Aciphex, a proton pump inhibitor (PPI) widely prescribed for gastroesophageal reflux disease (GERD), is now approved by the Food and Drug Administration (FDA) as part of the first seven-day treatment for Helicobacter pylori (H. pylori) infection, the single most common cause of peptic ulcers. Taken in combination with certain antibiotics, Aciphex offers a faster therapy option than other PPIs, treating H. pylori in up to half the time of current 10 to 14 day treatments.
When used in combination with amoxicillin and clarithromycin as a three-drug regimen, Aciphex is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or history within the last five years) to eradicate H. pylori.
Up to 60 million American adults are currently infected with H. pylori (a type of bacteria in the stomach); as many as one in 10 Americans will develop an ulcer in their lifetime.
"Using Aciphex, plus antibiotics for one week to eradicate H. pylori is a faster treatment option than what is currently available," said Nimish Vakil, M.D., Clinical Professor of Medicine at the University of Wisconsin Medical School (Milwaukee, Wis.). "When you consider the fact that the majority of duodenal and gastric ulcers are caused by H. pylori infection and that a short treatment course eradicates the infection and prevents relapse, you can understand the importance of this infection in ulcer disease."
A multicenter, double-blind, placebo-controlled trial was conducted in 803 patients infected with H. pylori at 47 centers nationwide. In the study, 84 per cent of patients treated with Aciphex (rabeprazole sodium), amoxicillin and clarithromycin taken twice daily were free of H. pylori after seven days of therapy. Eighty-six percent of patients taking the identical regimen achieved the same result after 10 days of treatment, with no significant difference obtained with three additional days of therapy. H. pylori was eradicated in 82 percent of patients treated with a combination of omeprazole, amoxicillin and clarithromycin taken twice daily for 10 days based on per protocol analysis. The three-day Aciphex, amoxicillin and clarithromycin treatment arm was clinically sub-optimal for H. pylori eradication. Eradication of bacteria was determined by a negative Urea Breath Test (13C-UBT) at 42 or more days after the end of therapy.
In clinical trials using combination therapy with rabeprazole plus amoxicillin and clarithromycin (RAC), no adverse events unique to this drug combination were observed. In the U.S. multicenter study, the most frequently reported drug related adverse events for patients who received RAC therapy for seven or 10 days were diarrhea (8 per cent and 7 per cent) and taste perversion (6 per cent and 10 per cent) respectively.
No clinically significant laboratory abnormalities particular to the drug combinations were observed.
Aciphex is also indicated for the treatment of symptomatic GERD, healing of erosive GERD, maintenance of healed erosive GERD, healing of duodenal ulcers and treatment of symptoms related to these conditions. In addition, Aciphex is approved for the treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome, a rare disorder that causes the stomach to produce excess acid.
Aciphex has a well-established safety record. In studies, the most common side effect possibly related to Aciphex was headache (2.4 per cent vs 1.6 per cent for sugar pill). Aciphex should not be used if you have had an allergic reaction to Aciphex, its tablet ingredients, or any proton pump inhibitor (PPI). Reduction in symptoms during treatment with Aciphex does not rule out the presence of gastric malignancy. Patients treated with a PPI, like Aciphex, and warfarin (such as Coumadin) may need to be monitored more closely by their doctor.