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"The innovative dual delayed release technology delivers TAK-390MR in twoseparate releases, which is a first in the PPI class and makes TAK-390MR avery interesting potential future treatment option," said Dr. David Peura,professor of medicine, University of Virginia Health System, past president ofthe American Gastroenterological Association.
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Data from the two separate EE healing studies demonstrated that patientstreated with TAK-390MR 60 mg and 90 mg experienced higher overall healingafter eight weeks, versus patients taking lansoprazole 30 mg. In addition,data from a six-month maintenance of healed EE study demonstrated thatpatients treated with TAK-390MR 30 mg and 60 mg experienced statisticallysignificant overall maintenance and symptom relief over placebo.
Healing of Erosive Esophagitis Studies
TAK-390MR was compared to lansoprazole in two identically designed,double-blind, randomized, controlled trials in patients with confirmed EE. Atotal of 4,092 patients were enrolled in the two global studies. The primaryobjective was to evaluate overall healing rates over eight weeks afteronce-daily administration of TAK-390MR 60 mg or 90 mg or lansoprazole 30 mg.The results for each study were analyzed using life table and crude ratemethods.
Results from these trials demonstrated that TAK-390MR 60 mg and 90 mgproduced consistently high healing rates for patients with EE. In one study,the life table analysis showed that 93 percent and 95 percent of TAK-390MRpatients (60 mg and 90 mg, respectively) experienced healing versus 92 percentof lansoprazole 30 mg patients. The crude rate analysis showed that 87percent of 60 mg and 89 percent of 90 mg TAK-390MR patients experiencedhealing versus 85 percent of lansoprazole 30 mg patients.
In a second study, the life table analysis demonstrated that 92 percent ofboth 60 mg and 90 mg patients experienced healing versus 86 percent ofpatients on lansoprazole 30 mg. The crude rate evaluation showed that 85percent and 86 percent of patients treated with TAK-390MR (60 mg and 90 mg,respectively) experienced healing versus 79 percent of patients takinglansoprazole 30 mg. The results for TAK-390MR 90 mg were statisticallysignificantly higher than lansoprazole 30 mg in both studies using crude rateanalysis.
The most frequent treatment-related adverse event (AE) for patients in thecombined healing studies was diarrhea, which occurred in similar rates acrossgroups (three percent for TAK-390MR 60 mg and 90 mg, versus two percent forlansoprazole 30 mg).
"Findings from both studies demonstrated that patients taking TAK-390MR 60mg and 90 mg showed numerically higher overall healing than those takinglansoprazole with a similar rate of AEs across groups," said Dr. PrateekSharma, professor of medicine, gastroenterology section, University of KansasSchool of Medicine.
Maintenance of Healed Erosive Esophagitis
TAK-390MR was compared to placebo in a double-blind, randomized,controlled trial in patients with confirmed healing of EE. A total of 445patients were enrolled in the global, six-month study. The primary objectivewas to evaluate the overall maintenance rate of healed EE after once-dailyadministration of TAK-390MR 30 mg, 60 mg, or placebo. A secondary objectivewas to evaluate the frequency of heartburn over the six-month study.
Results from the trial showed that TAK-390MR 30 mg and 60 mg produced highmaintenance rates for patients with healed EE.
