Esomeprazole regimens for reflux symptoms in Chinese patients with chronic gastritis

Table 1 Patient demographic and baseline clinical characteristics n (%)

Parameter	ITT (n = 305)			MITT (n = 262)
	8-wk group	2-wk group	Total	8-wk group	2-wk group	Total
Age, yr, mean ± SD	45.9 ± 12.72	44.9 ± 13.12	45.4 ± 12.91	45.3 ± 12.88	45.1 ± 13.36	45.2 ± 13.09
Sex
Men	80 (51.9)	54 (35.8)	134 (43.9)	74 (54.4)	46 (36.5)	120 (45.8)
Women	74 (48.1)	97 (64.2)	171 (56.1)	62 (45.6)	80 (63.5)	142 (54.2)
Symptom
Heartburn	142 (92.2)	136 (90.1)	278 (91.1)	126 (92.6)	113 (89.7)	239 (91.2)
Regurgitation	138 (89.6)	135 (89.4)	273 (89.5)	124 (91.2)	113 (89.7)	237 (90.5)
Duration, mo, mean ± SD
Heartburn	36.3 ± 56.47	35.8 ± 49.05	36.1 ± 52.87	39.0 ± 59.20	39.1 ± 52.55	39.0 ± 56.04
Regurgitation	36.4 ± 56.72	34.9 ± 47.41	35.6 ± 52.24	38.4 ± 59.28	37.7 ± 50.71	38.1 ± 55.24
HP test positive	48 (31.2)	44 (29.1)	92 (30.2)	39 (28.7)	35 (27.8)	74 (28.2)
GerdQ score, mean ± SD	10.7 ± 1.78	10.4 ± 1.89	10.5 ± 1.84	10.7 ± 1.76	10.4 ± 1.94	10.6 ± 1.85

GerdQ: Gastroesophageal Reflux Disease Questionnaire; ITT: Intention-to-treat; MITT: Modified intention-to-treat.

Table 2 Adverse events leading to discontinuation of study medication, and their relationship to study medication n (%)

	2-wk group (n = 151)		8 wk group (n = 154)		Total (n = 305)
	Mild	Moderate	Mild	Moderate	Mild	Moderate
Patients with at least one AE	0	1 (0.7)	3 (1.9)	2 (1.3)	3 (1.0)	3 (1.0)
Gastrointestinal disorders	0	0	3 (1.9)	2 (1.3)	3 (1.0)	2 (0.7)
Nausea	0	0	1 (0.6)1	2 (1.3)2	1 (0.3)	2 (0.7)
Abdominal discomfort	0	0	1 (0.6)1	1 (0.6)1	1 (0.3)	1 (0.3)
Constipation	0	0	0	1 (0.6)1	0	1 (0.3)
Frequent bowel movements	0	0	1 (0.6)1	0	1 (0.3)	0
Abdominal pain, upper	0	0	0	1 (0.6)1	0	1 (0.3)
Eye disorders	0	0	1 (0.6)	0	1 (0.3)	0
Vision blurred	0	0	1 (0.6)	0	1 (0.3)	0
Musculoskeletal and connective tissue disorders	0	1 (0.7)	0	0	0	1 (0.3)
Back pain	0	1 (0.7)	0	0	0	1 (0.3)
Renal and urinary disorders	0	1 (0.7)	0	0	0	1 (0.3)
Dysuria	0	1 (0.7)	0	0	0	1 (0.3)
Respiratory, thoracic and mediastinal disorders	0	0	0	1 (0.6)	0	1 (0.3)
Cough	0	0	0	1 (0.6)	0	1 (0.3)

¹Related to study medication;

²One case related to study medication. One patient was counted at most once per category.