278 patients were recruited by 75 French GPs and 241 included for efficacy analysis in the PP population: 120 in the Gaviscon® group and 121 in the omeprazole 20 mg group (Figure 1).
At inclusion, PP population characteristics were comparable between groups (Table 1) and did not differ from those of the ITT population (data not shown).
The mean age of included patients (PP population) was 45.4 ± 11.5 years (SD). Mean body mass index (BMI) was 26.1 ± 5.0 kg/m2, and 20% of patients had BMI ≥ 30 kg/m2. Patients had suffered from GERD for a mean 6.5 ± 7.1 years and reported a mean 4.4 days of heartburn episodes in the week preceding inclusion.
Before inclusion, 78 patients (32.4%) underwent endoscopy: results were normal for 34.6%; 30.8% showed hiatus hernia and 28.2% mild to moderate esophagitis. No patients reported history of severe esophagitis. Alcohol consumption and smoking were moderate and comparable between groups.
The percentage of patients with very good or good compliance with medication was similar (p = 0.08) between the Gaviscon® (95.7%) and omeprazole (95.9%) groups.
Primary Outcome Mean time to onset of the first 24-h heartburn-free period after initial dosing was 2.0 ± 2.2 days in the Gaviscon® group vs. 2.0 ± 2.3 days in the omeprazole group (p = 0.93). Mean intergroup difference was 0.01 ± 1.55 days (95% CI:-0.41 to 0.43): i.e., less than the lower limit of the predetermined 95% CI (-0.5), thus demonstrating the non-inferiority of Gaviscon® compared to omeprazole 20 mg (Table 2).
Secondary Outcomes The mean number of heartburn-free days by D7 was significantly greater in the omeprazole 20 mg than in the Gaviscon® group: 3.7 ± 2.3 vs. 3.1 ± 2.1 days (absolute difference = 0.6 days; p = 0.02) (Table 3).
By D7, overall self-assessed qualitative pain relief was also in favour of omeprazole: p = 0.049 (Table 4).
There was no significant difference between groups in clinically relevant reduction in pain intensity: p = 0.11 by D7 and p = 0.08 by D14 (Table 5).
Safety All patients took at least one dose of Gaviscon® or omeprazole 20 mg, and were thus included in the safety analysis. Results are therefore presented for the ITT population.
Seventeen (12.6%) of the 135 patients in the Gaviscon® group vs. 20 (14.2%) of the 141 patients in the omeprazole 20 mg group experienced at least one AE during the study (p = 0.70). The percentage of patients with at least one AE was also comparable, regardless of time period: 9.1% in the Gaviscon® group vs. 9.2% in the omeprazole group between D0 and D7 (p = 0.97) and respectively 5.5% vs. 5.8% between D7 and D14 (p = 0.91).
The most frequently observed AEs were nausea (1.8%), constipation (1.5%), rhinopharyngitis (1.5%), drug intolerance (1.1%), abdominal pain, diarrhoea, abdominal distension, rhinitis and cough (0.7% each). All other AEs had an incidence of 0.4% each.
One patient in the omeprazole 20 mg group experienced one SAE (bowel obstruction).
BMC Gastroenterol. 2012;12(18) © 2012 BioMed Central, Ltd.
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