For well over a decade, proton pump inhibitors (PPIs) have been considered the first-line treatment for gastroesophageal reflux disease, or GERD. In 2003, U.S. sales of the five delayed-release PPI brands totaled $12.9 billion, with total U.S. prescriptions for PPIs growing 10%, from 86.3 million in 2002 to 95.2 million in 2003, according to IMS Health.

Now added to this field of acid suppressors is the first immediate-release oral PPI, Zegerid (omeprazole) Powder for Oral Suspension 20 mg. The new formulation is indicated for the short-term treatment of active duodenal ulcer, for the treatment of heartburn and other symptoms associated with GERD, and for the short-term (four to eight weeks) treatment of erosive esophagitis. Santarus and Otsuka America Pharmaceutical will be copromoting this new formulation.

"Nearly one-half of patients report they do not receive adequate relief with their current [PPI] medications, which results in a 15% to 20% switch rate between different PPI brands per year," commented Gerald Proehl, president and CEO of Santarus, during a recent conference call.

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Patients who can't swallow pills, those who prefer liquid formulations, or those who require alternative methods of administration such as through a nasogastric (NG) tube may be good candidates for Zegerid, according to Brian A. Hemstreet, Pharm.D., BCPS, assistant professor in the department of clinical pharmacy, University of Colorado School of Pharmacy. He also noted that while the capsules of some other PPIs could be opened and sprinkled on foods such as applesauce, the contents still need to be swallowed whole due to the enteric-coated beads in their formulation and so an oral suspension form offers a possibly more acceptable option for the patient. In addition, he explained, sodium bicarbonate is often used to prepare PPI suspensions for use in NG tubes, so having one commercially available would save preparation time.

The recommended adult oral dose for Zegerid is 20 mg once daily on an empty stomach one hour prior to a meal. It is available as 20-mg single-dose packets, which patients constitute with two tablespoons of water to form the oral suspension. Hemstreet noted that because of the sodium bicarbonate component, consideration should be given to patients on a sodium-restricted diet, such as those with hypertension, heart failure, or kidney disease. Sodium bicarbonate is contraindicated in patients with metabolic acidosis and hypocalcemia and should be used with caution in patients with Bartter's syndrome, hypokalemia, and respiratory alkalosis.

Omeprazole can prolong the elimination of diazepam, warfarin, and phenytoin, drugs that are metabolized by oxidation in the liver. Due to its long-lasting acid suppression, it is theoretically possible that omeprazole could interfere with the absorption of drugs for which the gastric pH is an important determinant of bioavailability (e.g., ketoconazole, ampicillin esters, and iron salts).

In clinical trials, the most frequently reported adverse events with Zegerid were headache, diarrhea, and abdominal pain. The wholesale acquisition cost (WAC) for Zegerid is expected to be $3.89 per dose.