Proton pump inhibitor step-down therapy for GERD: A multi-center study in Japan

Table 1 Population characteristics of study 1 n (%)

Characteristic	ITT population(n = 108)
Gender
Male/female	62 (57.4)/46 (42.6)
Age (yr)
Range	20-88
Median	63
BMI (kg/m2)
≤ 24.9 (normal or below normal)	77 (71.3)
25-29.9 (overweight)	28 (25.9)
≥ 30 (obese)	3 (2.8)
Previous treatment for GERD	38 (35.2)
Duration of GERD symptoms before initial treatment (mo)
< 1	21 (19.4)
1-11	47 (43.5)
≥ 12	40 (37.0)
Tobacco use	24 (22.2)
Alcohol use	44 (40.7)
Helicobacter pylori infection	31 (28.7)
The modified Los Angeles Classification
N/M	20 (18.5)/17 (15.7)
A/B	32 (29.6)/32 (29.6)
C/D	5 (4.6)/2 (1.9)
Atrophic gastritis1	18 (16.7)
Hiatus hernia	57 (52.8)
Ischemic heart disease	9 (8.3)
Diabetes mellitus	11 (10.2)
Bronchial asthma	4 (3.7)

¹Atrophic gastritis was defined as only the O-type of the Kimura-Takemoto classification[20]. BMI: Body mass index; GERD: Gastroesophageal reflux disease; ITT: Intention-to-treat.

Table 2 Population characteristics of study 2 n (%)

Characteristic	ITT population(n = 83)
Gender
Male/female	50 (60.2)/33 (39.8)
Age (yr)
Range	25-88
Median	64
BMI (kg/m2)
≤ 24.9 (normal or below normal)	60 (72.3)
25-29.9 (overweight)	20 (24.1)
≥ 30 (obese)	3 (3.6)
Previous treatment for GERD	27 (32.5)
Duration of GERD symptoms before initial treatment (mo)
< 1	14 (16.9)
1-11	42 (50.6)
≥ 12	27 (32.5)
Tobacco use	21 (25.3)
Alcohol use	39 (47.0)
Helicobacter pylori infection	27 (32.5)
The modified Los Angeles Classification
N/M	15 (18.1)/9 (10.8)
A/B	24 (28.9)/30 (36.1)
C/D	3 (3.6)/2 (2.4)
Atrophic gastritis1	15 (18.1)
Hiatus hernia	44 (53.0)
Ischemic heart disease	8 (9.6)
Diabetes mellitus	7 (8.4)
Bronchial asthma	3 (3.6)
GERD symptom before step-down
Complete remission	55 (66.3)
Partial remission	28 (33.7)

¹Atrophic gastritis was defined as only the O-type of the Kimura-Takemoto classification[20]. BMI: Body mass index; GERD: Gastroesophageal reflux disease; ITT: Intention-to-treat.

Table 3 Predictors of successful step-down (univariate analysis)

Variable	ITT population(n = 83)		PP population(n = 70)
	OR	P	OR	P
Age	0.984	0.428	0.965	0.212
BMI	3.667	0.073	2.108	0.251
Past history of treatment for GERD	0.497	0.161	0.228	0.019
Duration of GERD symptoms	1.004	0.416	1.199	0.536
Alcohol use	1.182	0.732	1.486	0.487
Tobacco use	1.125	0.834	0.692	0.531
Helicobacter pylori infection	0.963	0.942	1.500	0.577
Erosive esophagitis	2.599	0.062	1.402	0.620
LA classification	1.431	0.070	1.238	0.360
Atrophic gastritis	0.930	0.906	0.568	0.411
Hiatus hernia	1.333	0.566	1.476	0.545
complete remission of GERD symptoms before step-down	1.355	0.539	3.676	0.042
GSRS total score (at the beginning of step-down)	0.771	0.647	0.208	0.045
Reflux score in GSRS (at the beginning of step-down)	0.917	0.803	0.477	0.072
Indigestion score in GSRS (at the beginning of step-down)	0.594	0.209	0.218	0.011

BMI: Body mass index; GERD: Gastroesophageal reflux disease; GSRS: Gastrointestinal Symptom Rating Scale; ITT: Intention-to-treat; PP: Per-protocol; OR: Odds ratio; LA: Los Angeles.

Table 4 Predictors of successful step-down (multivariate analysis, per-protocol population: n = 70)

Variable	OR	95% CI	P
Past history of treatment for GERD	0.255	0.066-0.980	0.047
Indigestion score in GSRS (at the beginning of step down)	0.214	0.063-0.731	0.014

GERD: Gastroesophageal reflux disease; GSRS: Gastrointestinal Symptom Rating Scale; OR: Odds ratio; CI: Confidence interval.