PRILOSEC (Page 9 of 11)
14.2 Gastric Ulcer
In a U.S. multicenter, double-blind, study of omeprazole 40 mg once daily, 20 mg once daily, and placebo in 520 patients with endoscopically diagnosed gastric ulcer, the following results were obtained.
| PRILOSEC 20 mg once daily (n = 202) | PRILOSEC 40 mg once daily (n = 214) | Placebo (n = 104) | |
| Week 4 | 47.5* | 55.6† | 30.8 |
| Week 8 | 74.8† | 48.1 | |
For the stratified groups of patients with ulcer size less than or equal to 1 cm, no difference in healing rates between 40 mg and 20 mg was detected at either 4 or 8 weeks. For patients with ulcer size greater than 1 cm, 40 mg was significantly more effective than 20 mg at 8 weeks.
In a foreign, multinational, double-blind study of 602 patients with endoscopically diagnosed gastric ulcer, omeprazole 40 mg once daily, 20 mg once daily, and ranitidine 150 mg twice a day were evaluated.
| PRILOSEC 20 mg once daily (n = 200) | PRILOSEC 40 mg once daily (n = 187) | Ranitidine 150 mg twice daily (n = 199) | |
| Week 4 | 63.5 | 56.3 | |
| Week 8 | 81.5 | 78.4 | |
14.3 Gastroesophageal Reflux Disease (GERD)
Symptomatic GERD
A placebo-controlled study was conducted in Scandinavia to compare the efficacy of omeprazole 20 mg or 10 mg once daily for up to 4 weeks in the treatment of heartburn and other symptoms in GERD patients without erosive esophagitis. Results are shown below.
| PRILOSEC 20 mg a.m. | PRILOSEC 10 mg a.m. | Placebo a.m. | |
| All patients |
(n = 205) | 31‡ (n = 199) | 13 (n = 105) |
| Patients with confirmed GERD |
(n = 115) | 36‡ (n = 109) | 14 (n = 59) |
14.4 Erosive Esophagitis
In a U.S. multicenter double-blind placebo controlled study of 20 mg or 40 mg of PRILOSEC Delayed-Release Capsules in patients with symptoms of GERD and endoscopically diagnosed erosive esophagitis of grade 2 or above, the percentage healing rates (per protocol) were as follows:
| Week | 20 mg PRILOSEC (n = 83) | 40 mg PRILOSEC (n = 87) | Placebo (n = 43) |
| 4 | 39* | 45† | 7 |
| 8 | 74† | 75† | 14 |
In this study, the 40 mg dose was not superior to the 20 mg dose of PRILOSEC in the percentage healing rate. Other controlled clinical trials have also shown that PRILOSEC is effective in severe GERD. In comparisons with histamine H2 -receptor antagonists in patients with erosive esophagitis, grade 2 or above, PRILOSEC in a dose of 20 mg was significantly more effective than the active controls. Complete daytime and nighttime heartburn relief occurred significantly faster (p < 0.01) in patients treated with PRILOSEC than in those taking placebo or histamine H2 -- receptor antagonists.
In this and five other controlled GERD studies, significantly more patients taking 20 mg omeprazole (84%) reported complete relief of GERD symptoms than patients receiving placebo (12%).
Long Term Maintenance Of Healing of Erosive Esophagitis
In a U.S. double-blind, randomized, multicenter, placebo controlled study, two dose regimens of PRILOSEC were studied in patients with endoscopically confirmed healed esophagitis. Results to determine maintenance of healing of erosive esophagitis are shown below.
| |||
| PRILOSEC 20 mg once daily (n = 138) | PRILOSEC 20 mg 3 days per week (n = 137) | Placebo (n = 131) | |
| Percent in endoscopic remission at 6 months | 70* | 34 | 11 |
In an international multicenter double-blind study, PRILOSEC 20 mg daily and 10 mg daily were compared with ranitidine 150 mg twice daily in patients with endoscopically confirmed healed esophagitis. The table below provides the results of this study for maintenance of healing of erosive esophagitis.
| PRILOSEC 20 mg once daily (n = 131) | PRILOSEC 10 mg once daily (n = 133) | Ranitidine 150 mg twice daily (n = 128) | |
| Percent in endoscopic remission at 12 months | 77* | 58† | 46 |
In patients who initially had grades 3 or 4 erosive esophagitis, for maintenance after healing 20 mg daily of PRILOSEC was effective, while 10 mg did not demonstrate effectiveness.
