New Drug Update 2009-2010 - LAFP
New Drug Update 2009-2010 - LAFP
New Drug Update 2009-2010 - LAFP
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DEXLANSOPRAZOLE - Kapidex by Takeda 2S Now Dexilant<br />
INDICATIONS: Dexlansoprazole is indicated for the healing of all grades of erosive esophagitis, the<br />
maintenance of healing of erosive esophagitis, and the treatment of heartburn associated with nonerosive<br />
gastroesophageal reflux disease (GERD).<br />
The Food and <strong>Drug</strong> Administration (FDA)-approved indications for the oral proton pump inhibitors are<br />
summarized in Table 1.<br />
Table 1. FDA-Approved Indications for Oral Proton Pump Inhibitors<br />
Dexlansoprazole<br />
(Kapidex)<br />
Esomeprazole<br />
(Nexium)<br />
Lansoprazole<br />
(Prevacid)<br />
Omeprazole<br />
(Prilosec)<br />
Pantoprazole<br />
(Protonix)<br />
Rabeprazole<br />
(AcipHex)<br />
Erosive esophagitis<br />
Healing X X X X X<br />
Maintenance X X X X X<br />
Symptomatic<br />
GERD<br />
X X X X X<br />
Duodenal ulcers<br />
Healing X X X<br />
Maintenance<br />
Helicobacter<br />
pylori eradication<br />
to prevent<br />
recurrence<br />
X<br />
X X X X<br />
Gastric ulcers<br />
Healing X X<br />
Healing NSAIDassociated<br />
a gastric<br />
ulcers<br />
Risk reduction of<br />
NSAIDassociated<br />
gastric<br />
ulcer<br />
X<br />
X<br />
X<br />
Pathological hypersecretory conditions (eg, Zollinger-Ellison syndrome)<br />
Treatment X X X X X<br />
a NSAID = nonsteroidal anti-inflammatory drug.<br />
CLINICAL PHARMACOLOGY: Dexlansoprazole is the R-enantiomer of lansoprazole. It is formulated as<br />
a dual delayed-release formulation for oral administration, with each capsule containing a mixture of<br />
enteric-coated granules with different pH-dependent dissolution profiles that are designed to release drug<br />
at different locations in the GI tract.<br />
The proton pump inhibitors suppress gastric acid secretion at the final step of acid production by specific<br />
inhibition of the (H+,K+)-ATPase in the gastric parietal cell.<br />
The effects of dexlansoprazole 60 mg and lansoprazole 30 mg once daily for 5 days on 24-hour<br />
intragastric pH have been assessed in healthy volunteers enrolled in a crossover study. On day 5, mean<br />
intragastric pH was 4.55 after dexlansoprazole and 4.13 after lansoprazole. The percentage of time with<br />
intragastric pH greater than 4 was 71% (17 hours) with dexlansoprazole and 60% (14 hours) with<br />
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