PPI for esophagitis and nonerosive GERD

Product: Kapidex

Company: Takeda

Pharmacologic class: Acid-pump inhibitor

Active ingredient: Dexlansoprazole 30 mg, 60 mg; delayed-release caps.

Indications: Treatment of erosive esophagitis (EE) and heartburn related to nonerosive gastroesophageal reflux disease (GERD). Maintenance of healing of EE. 

Pharmacology: Dexlansoprazole is an acid pump inhibitor that suppresses gastric acid secretion by specific inhibition of the (H+, K+)-ATPase in the gastric parietal cell. By acting specifically on the proton pump, dexlansoprazole blocks the final step of acid production. Dexlansoprazole is the R-entantiomer of lansoprazole and is supplied as a dual delayed-release formulation for oral administration.

Clinical trials: Two double-blind, active-controlled, eight-week studies were conducted in 4,092 patients with endoscopically confirmed EE. Based on the LA Classification, 71% had mild EE and 29% had moderate-to-severe EE before treatment. Patients were given one of the following treatments: dexlansoprazole 60 mg daily, dexlansoprazole 90 mg daily, or lansoprazole 30 mg daily. The primary efficacy endpoint was percentage healed at Week 8 of treatment. In study 1, 87% of patients given dexlansoprazole 60 mg were healed compared with 85% of patients given lansoprazole 30 mg. In study 2, 85% of patients given dexlansoprazole 60 mg were healed compared with 79% of patients given lansoprazole 30 mg. Both studies demonstrated non-inferiority to lansoprazole.

A double-blind, placebo-controlled study was conducted in patients who successfully completed an EE study and showed endoscopically confirmed healed EE. Maintenance of healing and symptom resolution over a six-month period was evaluated with dexlansoprazole 30 mg or 60 mg once daily compared with placebo. A total of 445 patients were enrolled; 66% of patients treated with dexlansoprazole 30 mg remained healed over the six-month period as confirmed by endoscopy. Dexlansoprazole 30 mg demonstrated a higher median percent of 24-hour heartburn-free days compared with placebo over the six-month period.

A double-blind, placebo-controlled four-week study was conducted in patients with a diagnosis of symptomatic, nonerosive GERD.

Patients were randomized to one of the following groups: dexlansoprazole 30 mg daily, dexlansoprazole 60 mg daily, or placebo. A total of 947 patients were enrolled. Dexlansoprazole 30 mg provided statistically significantly greater median percent of days with heartburn-free 24-hour periods (54.9%) over placebo (18.5%) as assessed by daily diary over four weeks. 

Adults: >18 years: Swallow whole, or sprinkle granules on 1 tbsp of applesauce and swallow immediately. EE treatment: 60 mg once daily for up to eight weeks. Maintenance of healed EE: 30 mg once daily for up to six months. Symptomatic GERD: 30 mg once daily for four weeks. Moderate hepatic impairment (Child-Pugh Class B): maximum 30 mg/day.

Children: <18 years: not recommended.

Precautions: Severe hepatic impairment. Pregnancy (Cat. B). Nursing mothers: not recommended. 

Interactions: Concomitant atazanavir: not recommended (may decrease atazanavir levels). May alter absorption of pH-dependent drugs (e.g., ketoconazole, digoxin, iron, ampicillin). Monitor warfarin. 

Adverse reactions: GI upset, abdominal pain, upper respiratory tract infection, flatulence.

How supplied: Caps—30; 90; 1,000

For more information, call 866.985.2743 or visit www.Kapidex.com.

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