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HEARTBURN RELIEF AND HEALING

DEXILANT WORKS TO PROVIDE FULL 24-HOUR HEARTBURN RELIEF

A majority of 24-hour periods were heartburn free for symptomatic non-erosive GERD patients with DEXILANT 30 mg

% heartburn free 24-hour periods over 4 weeks. (median)1,2 - DEXILANT 3O mg 55% (n=312) - Placebo 19% (n=310) *p<0.00001
Results of a multicenter, double-blind, placebo-controlled, randomized, 4-week study of patients diagnosed with symptomatic, endoscopically confirmed non-erosive GERD.

A majority of symptomatic non-erosive GERD patients experienced full 24-hour heartburn relief with DEXILANT 30 mg

% patients with 24-hour hearburn relief at day 28 (median)1,2 - DEXILANT 30 mg 63% (n=132) - Placebo 40% (n=110)
Results of a multicenter, double-blind, placebo-controlled, randomized, 4-week study of patients diagnosed with symptomatic, endoscopically confirmed non-erosive GERD.
  • More DEXILANT patients had full 24-hour heartburn relief vs placebo as early as the first 3 days of treatment, and this was sustained throughout the treatment period (day 3: 38% with DEXILANT 30 mg [n=291] vs 15% with placebo [n=291]1,2

DEXILANT WORKS TO PROVIDE CONSISTENTLY HIGH EE HEALING RATES

DEXILANT 60 mg provided effective healing of erosive esophagitis

8-week EE healing rates (all grades; crude-rate analysis)1,2 - Study 1 DEXILANT 60 mg 87% (n=657) Lansoprazole 30 mg 85% (n=648) - Study 2 DEXILANT 60 mg 85% (n=639) Lansoprazole 30mg 79% (n=656) - *p=0.004
At week 8, noninferiority was demonstrated in both studies and superiority was demonstrated in study 2.
4-week EE healing rates (all grades; crude-rate analysisis)1 - Study 1 DEXILANT 60 mg 70% (n=657) Lansoprazole 30 mg 65 % (n=648) - Study 2 DEXILANT 60 mg 66% (n=639) Lansoprazole 30 mg 65% (n=656)
Results of 2 multicenter, double-blind, active-controlled, randomized, 8-week studies in patients with endoscopically confirmed EE. Based on crude-rate estimates, patients who did not have endoscopically documented healed EE and prematurely discontinued were considered not healed.

DEXILANT WORKS TO PROVIDE EFFECTIVE MAINTENANCE OF HEALED EE

Two thirds of healed patients remained healed at 6 months

Overall maintenance rates over 6 months (crude-rate analysis)1,2 - DEXILANT 30mg 66% (n=125) Placebo 14% (n=119)
Results of a 6-month, multicenter, double-blind, placebo-controlled, randomized study in patients who successfully completed a phase 3 EE study and showed endoscopically confirmed healed EE. Based on crude-rate estimates, patients who did not have endoscopically documented relapse and prematurely discontinued were considered to have relapsed.

References: 1. DEXILANT (dexlansoprazole) package insert, Takeda Pharmaceuticals America, Inc. 2. Data on file, Takeda Pharmaceuticals North America, Inc.

DEXILANT is indicated for:

  • Healing all grades of erosive esophagitis (EE) for up to 8 weeks
  • Maintaining healing of EE and relief of heartburn for up to 6 months
  • Treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for 4 weeks

Important Safety Information

  • DEXILANT is contraindicated in patients with known hypersensitivity to any component of the formulation. Hypersensitivity and anaphylaxis have been reported with DEXILANT use.
  • Symptomatic response with DEXILANT does not preclude the presence of gastric malignancy.
  • Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
  • Hypomagnesemia has been reported rarely with prolonged treatment with PPIs.
  • Most commonly reported adverse reactions were diarrhea (4.8%), abdominal pain (4.0%), nausea (2.9%), upper respiratory tract infection (1.9%), vomiting (1.6%), and flatulence (1.6%).
  • Do not co-administer atazanavir with DEXILANT because atazanavir systemic concentrations may be substantially decreased. DEXILANT may interfere with absorption of drugs for which gastric pH is important for bioavailability (e.g., ampicillin esters, digoxin, iron salts, ketoconazole). Patients taking concomitant warfarin may require monitoring for increases in international normalized ratio (INR) and prothrombin time. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Concomitant tacrolimus use may increase tacrolimus whole blood concentrations.

Please see the full Prescribing Information for DEXILANT.

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