TAK-390MR Maintains Treatment and Relieves Multiple Symptoms in Patients With Healed Erosive Oesophagitis: Presented at ACG

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Title: TAK-390MR Maintains Treatment and Relieves Multiple Symptoms in Patients With Healed Erosive Oesophagitis: Presented at ACG
URL: http://www.pslgroup.com/dg/22E67A.htm
Doctor's Guide
October 8, 2008

By Deborah Brauser

ORLANDO, Fla -- October 8, 2008 -- Two doses of TAK-390MR, a dual delayed-release formulation of TAK-390 (an enantiomer of lansoprazole) maintains healing of erosive oesophagitis and significantly controls heartburn over a 6-month period, according to results of a double-blind trial.

Colin Howden, MD, Northwestern University, Chicago, Illinois, reported the findings here on October 5 in a poster session at the American College of Gastroenterology (ACG) 73rd Annual Scientific Meeting.

This study was designed to evaluate the safety and efficacy of 2 oral doses of TAK-390MR in maintaining healed erosive oesophagitis in patients who had previously participated in 1 of 2 acute-healing studies that compared TAK-390MR with lansoprazole.

Dr. Howden and colleagues re-randomised 451 patients with healed erosive oesophagitis to TAK-390MR 60 mg once daily before breakfast (n = 159), TAK-390MR 90 mg once daily before breakfast (n = 152), or placebo (n = 140).

The study's primary endpoint was the percentage of patients who maintained healed erosive oesophagitis over 6 months based on gastroduodenoscopy at the final visit of the acute-healing trial and then at months 1, 3, and 6 using analyses by life-table and crude-rate methods.

Secondary endpoints were percentage of heartburn-free days and nights based on patients' daily diaries, treatment group analysis, and maintenance status (post hoc). Additional endpoints were mean heartburn severity, percentage of days without rescue medication based on diary data, and gastro-oesophageal reflux disease (GERD) symptoms based on investigator assessments.

Six-month maintenance rates by life-table analysis were 86.6% in the TAK-390MR 60-mg group, 82.1% in the 90-mg group, and 25.7% for placebo (P < .0025 for each group vs placebo). Six-month maintenance rates by crude-rate analysis were 66.4% and 64.5% in the 2 TAK-390MR groups, respectively, and 14.3% for placebo (P < .0025 for each group vs placebo). No significant difference was observed when comparing the 2 active-treatment groups with each other.

Both TAK-390MR doses were also statistically superior to placebo in controlling both daytime (97% vs 31%) and nighttime (100% vs 63%) heartburn, respectively (P < .001 for both groups vs placebo). The majority of patients receiving TAK-390MR were free of heartburn for 94% to 96% of the treatment days. Both doses also showed superior efficacy versus placebo for mean severity of heartburn, percentage of days without rescue medication, and investigator-assessed GERD symptoms.

"It's no surprise that patients on active treatment were more likely to maintain healed [erosive oesophagitis] than placebo. That demonstrates proof of concept," Dr. Howden said.

"What is surprising is the symptom data of the total number of days and nights in which patients are free of heartburn," said Dr. Howden. "The figures are higher than 90% heartburn-free [patients] with no difference between the 60- and the 90-mg dose."

"So we know from the healing studies that [TAK-390MR] heals oesophagitis, which is what we'd expect. We know from the maintenance studies that it maintains healing, which is what we'd expect. Now, we have what I think is quite interesting and promising data in turns of symptom control," he concluded.

Funding for this trial was provided by TAP Pharmaceuticals Products Inc.

[Presentation title: Placebo-Controlled Trial of 2 Doses of TAK-390MR, a PPI With Novel Dual Delayed Release Technology, as Maintenance Treatment for Patients With Healed Erosive Esophagitis (EE)]

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