Partial response to proton pump inhibitor therapy for GERD: observational study of patient characteristics, burden of disease, and costs in the USA

Figures & data

Figure 1 Flow of patients through the REMAIN US study.

Abbreviations: REMAIN US, Partial Response to PPI treatment: the Cost to Society and the Burden to the Patient in the US; GERD, gastroesophageal reflux disease; PPI, proton pump inhibitor; RESQ-7, Reflux Symptom Questionnaire 7-day.

Table 1 Summary of patients’ clinical characteristics at baseline

Variable	Patientsa
Duration of GERD, years	7.3 (6.5)b
Elapsed time from first observation of persistent symptoms of GERD, years	2.6 (4.3)b
Body mass index, kg/m^2	31.5 (7.7)b
Gastrointestinal history
Dyspeptic symptoms	304 (55.1)
History of hiatal hernia	117 (32.1)
Diagnosis of irritable bowel syndrome	92 (16.7)
Reflux esophagitis	76 (13.8)
Endoscopic findingsc
Hiatal hernia	103 (40.6)
Esophagitis	46 (18.1)
Barrett’s esophagus	32 (12.6)
Gastric ulcer	31 (12.2)
Esophageal stricture	15 (5.9)
Duodenal ulcer	4 (1.6)
Non-GERD medical historyd
Hypertension	206 (11.0)
Anxiety and/or depression	156 (8.3)
Hyperlipidemia	118 (6.3)
Diabetes mellitus	69 (3.7)
Allergies	65 (3.5)
Hypothyroidism	63 (3.4)
Asthma/asthmatic bronchitis	53 (2.8)
Osteoarthritis	52 (2.8)
Back pain/chronic pain, low back pain/lower back pain	41 (2.2)

Notes:

a All values are n (%), unless specified otherwise;

b mean (standard deviation);

c proportions of patients are based on 254 patients who had endoscopic data for the previous 6 months;

d reported in ≥2% of patients.

Abbreviation: GERD, gastroesophageal reflux disease.

Figure 2 Mean EQ-5D Index and VAS scores by symptom frequency (A) and intensity (B) of RESQ-7 heartburn domain symptoms (using the symptom with the highest frequency) at 6 months’ follow-up.

Notes: For both EQ-5D scores, 0 represents a health state of being dead and 1 a health state of being at full health (the EQ-5D VAS score was normalized between 0 and 1 for comparative purposes). The relationship between symptoms and EQ-5D results is described at the 6-month assessment, since the number of patients in each symptom category was most evenly distributed at this time point.
Abbreviations: EQ-5D, European Quality of Life-5 Dimensions; VAS, visual analog scale; RESQ-7, Reflux Symptom Questionnaire 7-day.

Table 2 Mean (± SD) SF-36v2, EQ-5D Index, and VAS scores at baseline and 6 months among evaluable patients (n = 550)

	Baseline	6 months
SF-36v2 domain
Physical functioning	57.2 ± 30.2	55.2 ± 31.8
Role – physical	55.6 ± 30.7	55.6 ± 31.9
Bodily pain	43.4 ± 23.6	46.0 ± 27.1
General health	49.8 ± 23.2	46.0 ± 24.7
Vitality	43.3 ± 21.3	43.6 ± 22.8
Social functioning	59.7 ± 28.2	59.4 ± 30.9
Role – emotional	65.0 ± 31.9	64.2 ± 32.8
Mental health	61.4 ± 21.5	60.7 ± 23.6
Physical component summary score	38.9 ± 10.9	39.1 ± 11.8
Mental component summary score	42.2 ± 13.0	42.0 ± 14.0
EQ-5D Index score	0.69 ± 0.21	0.68 ± 0.23
EQ-5D VAS scorea	0.65 ± 0.20	0.65 ± 0.22

Note:

a Normalized between 0 and 1 for purposes of comparison.

Abbreviations: EQ-5D, European Quality of Life-5 Dimensions; SD, standard deviation; SF-36v2, 36-item Short-Form Health Survey version 2 acute; VAS, visual analog scale.

Figure 3 Results from the WPAI-GERD.

Note: Results are mean hours (95% confidence interval) for work absence due to GERD and reduced productivity due to GERD over the 7 days prior to assessment, at baseline, and at the 3- and 6-month follow-up visits.
Abbreviations: WPAI-GERD, Work Productivity and Activity Impairment questionnaire for patients with Gastroesophageal Reflux Disease; GERD, gastroesophageal reflux disease.

Figure 4 Mean number of hours absent from work and number of hours lost due to reduced work productivity by symptom frequency (A) and intensity (B) of RESQ-7 heartburn domain symptoms (using the symptom with the highest frequency) at 6 months’ follow-up.

Note: The relationship between symptoms and productivity results is described at the 6-month assessment, since the number of patients in each symptom category was most evenly distributed at this time point.
Abbreviation: RESQ-7, Reflux Symptom Questionnaire 7-day.

Table 3 Mean (± SD) number of health care visits (excluding screening visit) among all patients across the 12-month study period

	Health care visits per patient
Visits between 6 months prior to baseline and baseline (n = 552), physician-reported; 6 months of retrospective data
Primary care physician visits	1.42 ± 2.14
Specialist visits	1.11 ± 1.92
Emergency room visits	0.07 ± 0.29
Hospitalizations	0.03 ± 0.17
Visits between baseline and 3-month follow-up (n = 451), patient-reported; 3 months of prospective data
Primary care physician visits	0.95 ± 1.23
Specialist visits	0.62 ± 1.11
Emergency room visits	0.15 ± 0.62
Outpatient hospital visits	0.14 ± 0.57
Inpatient hospitalizations	0.07 ± 0.44
Visits between 3- and 6-month follow-up (n = 404), patient-reported; 3 months of prospective data
Primary care physician visits	0.82 ± 1.36
Specialist visits	0.43 ± 0.97
Emergency room visits	0.11 ± 0.48
Outpatient hospital visits	0.14 ± 0.58
Inpatient hospitalizations	0.02 ± 0.17

Abbreviation: SD, standard deviation.

Table 4 Cost analysis

Type of cost	Mean ± SD cost per patient, US$
	6 months prior to baseline, physician-reported (n = 552)	Months 1–6 after baseline, patient-reported (n = 404)	6 months prior to baseline to 6-month follow-up (annual costs), physician- and patient-reported (n = 404)a
Total costs	5814 ± 8189	4934 ± 423	9944 ± 11,427
Total direct costs	1485 ± 1174	2564 ± 3111	4068 ± 3415
Primary care physician visits	82 ± 85	70 ± 90	155 ± 143
Specialist visits	65 ± 103	106 ± 176	171 ± 229
Emergency room visits	4 ± 18	84 ± 285	88 ± 289
Outpatient visits		25 ± 81
Hospitalizations	132 ± 807	354 ± 1481	523 ± 1780
Prescribed medication (GERD-related)	1074 ± 665	1606 ± 2170	2754 ± 2325
OTC GERD medications		67 ± 263
Tests and procedures	128 ± 270	253 ± 444	378 ± 549
Upper GI endoscopy		180 ± 302
Dilation of stricture		55 ± 181
Acid perfusion		5 ± 25
Esophageal motility study		14 ± 61
Total work productivity loss cost	4329 ± 7934	2370 ± 5528	5876 ± 10,787
Cost of absence from work	777 ± 3125	354 ± 3303	1114 ± 5060
Cost of reduced productivity at work	3552 ± 6932	2016 ± 4127	4762 ± 8783

Note:

a Costs are derived based on the 404 patients with 12 complete months of data.

Abbreviations: GERD, gastroesophageal reflux disease; GI, gastrointestinal; OTC, over-the-counter; SD, standard deviation.

Table S1 Unit cost data for medical consultations, hospitalizations, tests, procedures, and surgeries

Description	Unit cost (US$)	Comment
Medical consultation charges
Primary care physician visits	40.41	10-minute consultation for an established patient
Specialist visits	102.10	30-minute consultation
Emergency room visits	353.57	Presenting with a problem of moderate severity
Outpatient visits	91.64	30-minute consultation for an established patient
Charges for hospitalizations
Inpatient visits: general care	2501.90	Mean length of stay: 3.5 days
Inpatient visits: intermediate care	6271.83	Mean length of stay: 5.1 days
Charges for surgeries
Gastric ulcer surgery	1443.20	Stomach, esophageal, and duodenal procedures without CC/MCC
Charges for tests/procedures
Blood sample for laboratory tests	3.39
Upper gastrointestinal endoscopy	254.72	Requires moderate sedation (with anesthesiologist cost is US$471.19)
Upper gastrointestinal endoscopy with biopsy	309.56	Requires moderate sedation (with anesthesiologist cost is US$562.11)
Radiologic examination	99.58
Upper abdominal ultrasound	231.27
24-hour pH monitoring	167.05
Esophageal motility study/esophageal manometry	211.42
Bernstein test (acid perfusion test)	122.67
Resting ECG	12.27
Exercise ECG	76.49
X-ray	158.39
24-hour Holter monitor (ambulatory ECG)	80.10
Abdominal MRI	289.72
Breath hydrogen	62.42
Electrogastrogram	26.70	Professional component only
Gastric emptying scan	248.95
HIDA scan	294.77	Hepatobiliary ductal system imaging, including gallbladder, with or without pharmacologic intervention, with or without quantitative measurement of gallbladder function
Pill cam	611.54	Capsule endoscopy
Pulmonary function test (spirometry)	31.75
Sleep study: unattended	195.91
Sleep study: attended	406.61
Small bowel enteroscopy	154.06	Requires moderate sedation (with anesthesiologist cost is US$442.69)
Stretta procedure	318.94	Requires moderate sedation (with anesthesiologist cost is US$1198.55)
Echocardiogram	101.02
Stool culture	13.51	Stool, aerobic, additional pathogens, isolation, and presumptive identification of isolates
Dilatation of stricture	513.04	Requires moderate sedation

Abbreviations: CC/MCC, complications and comorbidities/major complications and comorbidities; ECG, electrocardiogram; HIDA, hepatobiliary iminodiacetic acid; MRI, magnetic resonance imaging.