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Table 1 Pharmacodynamic effects of lesogaberan 30, 90, 120 and 240 mg relative to placebo (efficacy analysis set; n = 25)

From: Dose-dependent effects of lesogaberan on reflux measures in patients with refractory gastroesophageal reflux disease: a randomized, placebo-controlled study

Lesogaberan dose (mg) Difference in geometric mean (%) 95% CI p value*
Total number of reflux episodes†
30 -26.2 -12.7 to -37.6 0.0006
90 -37.0 -25.0 to -47.1 < 0.0001
120 -45.0 -35.5 to -53.1 < 0.0001
240 -52.8 -44.3 to -60.0 < 0.0001
Number of reflux episodes in upright position
30 -25.2 -11.1 to -37.1 0.0013
90 -38.4 -26.3 to -48.5 < 0.0001
120 -46.1 -36.5 to -54.2 < 0.0001
240 -50.7 -41.5 to -58.4 < 0.0001
Number of reflux episodes in supine position
30 -37.3 +2.0 to -61.5 0.0597
90 -12.3 +45.2 to -47.0 0.6042
120 -31.2 +9.3 to -56.7 0.1117
240 -69.1 -50.0 to -80.9 < 0.0001
Number of acid reflux episodes†
30 -34.7 +3.2 to -58.6 0.0677
90 -45.5 -12.3 to -66.1 0.0132
120 -57.9 -35.0 to -72.7 0.0002
240 -57.1 -32.5 to -72.7 0.0004
Number of weakly acid reflux episodes†
30 -28.3 -7.5 to -44.5 0.0113
90 -31.4 -10.7 to -47.4 0.0059
120 -44.5 -29.2 to -56.4 < 0.0001
240 -45.1 -29.3 to -57.3 < 0.0001
Number of pure liquid reflux episodes†
30 -27.9 +0.6 to -48.3 0.0540
90 -53.0 -33.6 to -66.7 < 0.0001
120 -44.1 -23.3 to -59.2 0.0005
240 -51.9 -33.1 to -65.4 < 0.0001
Number of mixed gas/liquid reflux episodes†
30 -25.0 -5.1 to -40.7 0.0175
90 -28.3 -8.4 to -43.8 0.0084
120 -42.5 -28.1 to -54.0 < 0.0001
240 -56.7 -45.4 to -65.7 < 0.0001
Proximal extent of reflux (cm)†
30 -39.1 -4.5 to -61.2 0.0312
90 -58.9 -34.4 to -74.2 0.0003
120 -66.3 -48.3 to -78.0 < 0.0001
240 -63.3 -42.8 to -76.5 < 0.0001
Proportion of time with esophageal pH < 4,%†
30 -69.8 -27.3 to -87.4 0.0083
90 -56.1 +9.0 to -82.3 0.0752
120 -65.7 -21.1 to -85.1 0.0126
240 -73.0 -35.6 to -88.6 0.0037
Proportion of time with intragastric pH < 4,%†
30 +40.4 +10.3 to +78.8 0.0066
90 +23.7 -3.8 to +58.9 0.0957
120 +3.6 -17.7 to +30.3 0.7625
240 +27.7 +0.6 to +62.1 0.0451
  1. CI, confidence interval.
  2. *Based on a mixed-effect analysis of variance model for log-transformed data.
  3. †In upright or supine position.
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BMC Gastroenterology

ISSN: 1471-230X

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