Real-world-evidence, prospective-observational study to evaluate safety and effectiveness of rabeprazole dual-delayed-release capsules in patients with gastroesophageal reflux disease

Table 1 Baseline characteristics

Variables	mean ± SD
Age (years)	44.94 ± 10.38
Body mass index (kg/m2)	25.43 ± 3.79
Number of moderate heartburn episodes	7 ± 6.3
Number of severe heartburn episodes	2.91 ± 3.3
Duration of Happi ER treatment (weeks)	4.6 ± 1.71

Table 2 Associated comorbidities in the enrolled participants

Comorbid condition	Frequency	Percentage
Diabetes mellitus	169	16.54
Hypertension	152	14.87
Dyslipidemia	16	1.57
Chronic obstructive pulmonary disease	10	0.98
Hypothyroidism	9	0.88
Arthritis	8	0.78
Asthma	8	0.78
Obesity	6	0.59
Migraine	3	0.29
Osteoarthritis	3	0.29
Allergic asthma	2	0.20
COPS	2	0.20
Hyperlipidemia	2	0.20
Pulmonary tuberculosis	2	0.20
Rheumatoid arthritis	2	0.20
Systemic hypertension	2	0.20
Chronic pancreatitis	1	0.10
Common bile duct stone	1	0.10
Cholelithiasis	1	0.10
Chronic kidney disease	1	0.10
Chronic liver disease	1	0.10
Renal calculi	1	0.10
Lumbar spondylitis	1	0.10
Cardiovascular diseases	1	0.10
Grade II fatty liver	1	0.10
Uterine fibroid	1	0.10

Table 3 Timing and frequency of Happi ER prescribed, antacid consumption, and other ongoing treatments

Variables	Frequency	Percentage
Timing of Happi ER prescribed
Before breakfast	912	89.24
Before lunch	04	0.39
Before dinner	286	27.98
Frequency of Happi ER
Once daily	864	84.54
Twice daily	158	15.46
Antacid consumption in previous week
Yes	190	18.59
No	832	81.41
Other ongoing treatments
Yes	320	31.31
No	702	68.69

Table 4 Comparison of heartburn score and number of awakening episodes at baseline and visit 3

Variables	At baseline	At visit 3	Paired t-test
Heartburn score	2.46 ± 0.67	0.16 ± 0.39	P < 0.0001
Number of episodes of awakening	2 (1–2)	0 (0)	P < 0.0001

Table 5 Effectiveness assessment of Happi ER

Effectiveness	Frequency	Percentage
Excellent	619	60.6
Very good	336	32.9
Good	60	5.9
Fair	7	0.7
Total	1022	100.0

Table 6 Nature and association of adverse events during the study

Variables	Frequency	Percentage
Nature of adverse event
Diarrhea	6	26.09
Constipation	4	17.39
Giddiness	3	13.04
Headache	2	8.70
Acidity	2	8.70
Polydipsia	1	4.35
Loose motion	1	4.35
Polyphagia	1	4.35
Fatigue	1	4.35
Dry mouth	1	4.35
Vomiting	1	4.35
Association of adverse events using causality assessment criteria
Related	15	65.22
Unrelated	7	30.43
Possible	1	4.35