Santarus, Inc. (NASDAQ:SNTS), a specialty pharmaceutical company focused on therapies for gastrointestinal diseases and disorders, today announced the publication of clinical trial results in the June 15, 2005 issue of Alimentary Pharmacology & Therapeutics, a peer-reviewed gastroenterology journal. The trial results showed that immediate-release ZEGERID(R) (omeprazole) Powder for Oral Suspension 40 mg significantly reduced gastric acidity throughout the night compared to Protonix(R) (pantoprazole) Delayed-Release Tablets 40 mg when dosed once a day in the evening. Both drugs are proton pump inhibitors (PPIs) used to reduce gastric acid and treat symptoms of gastroesophageal reflux disease (GERD).
“ZEGERID’s effectiveness in controlling nocturnal gastric acidity when dosed at bedtime is intriguing and worthy of further study,” said Donald Castell, MD, lead author on the article. “The goal of PPI use in the evening is to reduce nocturnal gastric acidity, which reduces the possibility of acid reflux in patients with GERD,” Dr. Castell added. Dr. Castell is professor of medicine and director, Esophageal Disorders Program at the Medical University of South Carolina, and is past president of the American Gastroenterological Association.
In this study, 36 patients with nighttime symptoms of GERD participated in an open-label, randomized crossover trial. The patients received repeated evening doses of either ZEGERID or Protonix for one week, followed by twice-daily dosing for one day. After a washout period, patients were treated with the alternative drug, following the same schedule.
During once-daily dosing, ZEGERID was administered at bedtime; however, reflecting current practice for evening dosing of delayed-release PPIs, Protonix was administered before dinner. During twice-daily dosing, both drugs were administered before breakfast and at bedtime. The protocol allowed 18 patients to return for additional once-daily dosing of ZEGERID 40 mg on six consecutive days, with 24-hour pH monitoring beginning at the last dose. Gastric acidity was calculated separately over an 8-hour nighttime interval and over 24 hours.
Measurements included median gastric pH, percentage of time gastric pH was greater than 4 and percentage of patients with nocturnal acid breakthrough (NAB), defined as the occurrence of continuous gastric pH of less than 4 for more than one hour during the night while receiving PPI therapy. The amount of time that pH is greater than 4 is a parameter frequently used to evaluate the clinical effects of treatment with PPIs in patients with acid-related diseases.
Data from 32 patients were available for analysis. After repeated once-daily dosing, ZEGERID 40 mg produced significantly better nocturnal gastric acid control than Protonix 40 mg: median gastric pH was 4.7 vs. 2.0; the time with gastric pH greater than 4 was 55 percent vs. 27 percent; and patients with NAB totaled 53 percent vs. 78 percent (P less than or equal to 0.005 for all comparisons). After twice-daily dosing of ZEGERID 40 mg and Protonix 40 mg, respectively: median gastric pH was 6.5 vs. 1.5; the time with gastric pH greater than 4 was 92 percent vs. 37 percent; and patients with NAB totaled 12 percent vs. 71 percent (P less than or equal to 0.002 for all comparisons).
Once-daily bedtime dosing of ZEGERID 40 mg also achieved better nocturnal gastric acid control than twice-daily dosing of Protonix 40 mg: median gastric pH was 4.7 vs. 1.7 (P less than 0.001); the time with gastric pH greater than 4 was 55 percent vs. 34 percent (P less than 0.001); and patients with NAB totaled 53 percent vs. 75 percent (P = 0.035). In addition, ZEGERID 40 mg dosed once-daily achieved similar 24-hour pH control as Protonix 40 mg dosed twice-daily.
Important Safety Information
ZEGERID Powder for Oral Suspension 40 mg is indicated for reduction of risk of upper GI bleeding in critically ill patients and short-term treatment (four to eight weeks) of active benign gastric ulcers. ZEGERID Powder for Oral Suspension 20 mg is indicated for short-term treatment of active duodenal ulcers, for heartburn and other symptoms associated with GERD, for short-term treatment (four to eight weeks) of erosive esophagitis diagnosed by endoscopy, and for maintenance of healing of erosive esophagitis (controlled studies do not extend beyond 12 months). ZEGERID is contraindicated in patients with known hypersensitivity to any components of the formulation.
The most frequently reported adverse events with ZEGERID are headache, diarrhea and abdominal pain. Symptomatic response to therapy does not preclude the presence of gastric malignancy. Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long term with omeprazole. In critically ill patients treated with ZEGERID, adverse events generally reflected the serious, underlying medical condition of the patients, and were similar for patients treated with ZEGERID and with the comparator (acid-controlling) drug.
ZEGERID contains 460 mg sodium per dose in the form of sodium bicarbonate (1680 mg/20 mEq), which should be considered for patients on a sodium-restricted diet. Sodium bicarbonate is contraindicated in patients with metabolic alkalosis and hypocalcemia.
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