Alimentary pharmacology & therapeutics · 1995
Treatment and prevention of relapse of mild oesophagitis with omeprazole and cisapride: comparison of two strategies.
Клиническое исследованиеСравнительное исследованиеСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Kimmig J M
Аннотация
BACKGROUND: Oesophagitis is usually a chronic condition. Healing with omeprazole is often followed by early relapse. Combination treatment and subsequent maintenance treatment with the prokinetic cisapride may be of benefit in relapse prevention.
METHODS: Patients with endoscopically proven oesophagitis, grade I (n = 120) or grade II (n = 105), were randomized in an open fashion to receive 8 weeks of healing treatment with omeprazole 20 mg daily (OM) followed by 12 months of follow-up without maintenance treatment, or 8 weeks of combined treatment of omeprazole 20 mg daily plus cisapride 5 mg t.d.s. (OMCIS) followed by 12 months of maintenance treatment with cisapride 5 mg t.d.s. (CIS). Only the patients healed after acute treatment were included in the 12-month follow-up study for evaluation of endoscopic relapse.
RESULTS: In the group of patients with oesophagitis grade I (n = 58 receiving OM, n = 62 receiving OMCIS), healing rates were comparable for both acute treatment regimens. In the group of patients with grade II (n = 54 receiving OM, n = 51 receiving OMCIS), the healing rates were slightly but not significantly in favour of OMCIS after 4 and 8 weeks of treatment. During the 12 months of follow-up, CIS maintenance treatment was associated with a significant reduction of relapse. In the group of patients with initial grade I oesophagitis, the relapse rates after 3 months were 20% in the OMCIS group receiving CIS maintenance treatment, compared to 48% in the group healed on OM without further maintenance treatment (P = 0.04). After 6 months, these relapse rates were 31% and 85% respectively (P < 0.001), and after 12 months 40% and 96% (P < 0.001). In the group of patients with initial grade II oesophagitis, they were, respectively, 20% vs. 39% after 3 months (P = 0.056), 41% vs. 78% after 6 months (P < 0.001) and 52% vs. 95% after 12 months (P < 0.001).
CONCLUSIONS: The results of this open study indicate that continued treatment with cisapride 5 mg t.d.s. (after initial healing with omeprazole 20 mg daily plus cisapride 5 mg t.d.s.) is beneficial in the long-term management of grade I and II oesophagitis: this treatment approach significantly reduces the high relapse rate observed after stopping healing treatment with omeprazole.
METHODS: Patients with endoscopically proven oesophagitis, grade I (n = 120) or grade II (n = 105), were randomized in an open fashion to receive 8 weeks of healing treatment with omeprazole 20 mg daily (OM) followed by 12 months of follow-up without maintenance treatment, or 8 weeks of combined treatment of omeprazole 20 mg daily plus cisapride 5 mg t.d.s. (OMCIS) followed by 12 months of maintenance treatment with cisapride 5 mg t.d.s. (CIS). Only the patients healed after acute treatment were included in the 12-month follow-up study for evaluation of endoscopic relapse.
RESULTS: In the group of patients with oesophagitis grade I (n = 58 receiving OM, n = 62 receiving OMCIS), healing rates were comparable for both acute treatment regimens. In the group of patients with grade II (n = 54 receiving OM, n = 51 receiving OMCIS), the healing rates were slightly but not significantly in favour of OMCIS after 4 and 8 weeks of treatment. During the 12 months of follow-up, CIS maintenance treatment was associated with a significant reduction of relapse. In the group of patients with initial grade I oesophagitis, the relapse rates after 3 months were 20% in the OMCIS group receiving CIS maintenance treatment, compared to 48% in the group healed on OM without further maintenance treatment (P = 0.04). After 6 months, these relapse rates were 31% and 85% respectively (P < 0.001), and after 12 months 40% and 96% (P < 0.001). In the group of patients with initial grade II oesophagitis, they were, respectively, 20% vs. 39% after 3 months (P = 0.056), 41% vs. 78% after 6 months (P < 0.001) and 52% vs. 95% after 12 months (P < 0.001).
CONCLUSIONS: The results of this open study indicate that continued treatment with cisapride 5 mg t.d.s. (after initial healing with omeprazole 20 mg daily plus cisapride 5 mg t.d.s.) is beneficial in the long-term management of grade I and II oesophagitis: this treatment approach significantly reduces the high relapse rate observed after stopping healing treatment with omeprazole.