BACKGROUND/AIMS: To evaluate the effects of the phosphodiesterase type 5 (PDE5) inhibitor vardenafil on esophageal function, including bolus transit, using multichannel intraluminal impedance and esophageal manometry (MII-EM). METHODS:Sixteen healthy volunteers (15 men) underwent an MII-EM study including 10 liquid swallows and 10 viscous swallows in a seated position after fasting. Then, each subject was asked to ingest 50 mL distilled water or 10 mg vardenafil dissolved in 50 mL water, in a double-blind manner. After 25 minutes, the MII-EM study was repeated. RESULTS: Eight men received vardenafil and eight subjects received water. Resting and residual lower esophageal sphincter pressures differed significantly only in the vardenafil group (from 18 ± 6.7 to 6.6 ± 5.3 mmHg, P < 0.001 and from 4.9 ± 2.6 to 2.1 ± 3.6 mmHg, P = 0.006, respectively). Mean distal esophageal amplitude decreased significantly only in the vardenafil group (from 86.7 ± 41.6 to 34.0 ± 38.0 mmHg, P < 0.05). Complete bolus transits of liquid and viscous meals decreased significantly only after vardenafil ingestion (from 80.2% ± 13.8% to 49.4% ± 27.9%, P < 0.05 and from 72.8% ± 33.6% to 21.5% ± 29.0%, P = 0.01, respectively). CONCLUSIONS:Vardenafil decreased esophageal bolus transit in the seated position, despite decreased lower esophageal sphincter pressure.
RCT Entities:
BACKGROUND/AIMS: To evaluate the effects of the phosphodiesterase type 5 (PDE5) inhibitor vardenafil on esophageal function, including bolus transit, using multichannel intraluminal impedance and esophageal manometry (MII-EM). METHODS: Sixteen healthy volunteers (15 men) underwent an MII-EM study including 10 liquid swallows and 10 viscous swallows in a seated position after fasting. Then, each subject was asked to ingest 50 mL distilled water or 10 mg vardenafil dissolved in 50 mL water, in a double-blind manner. After 25 minutes, the MII-EM study was repeated. RESULTS: Eight men received vardenafil and eight subjects received water. Resting and residual lower esophageal sphincter pressures differed significantly only in the vardenafil group (from 18 ± 6.7 to 6.6 ± 5.3 mmHg, P < 0.001 and from 4.9 ± 2.6 to 2.1 ± 3.6 mmHg, P = 0.006, respectively). Mean distal esophageal amplitude decreased significantly only in the vardenafil group (from 86.7 ± 41.6 to 34.0 ± 38.0 mmHg, P < 0.05). Complete bolus transits of liquid and viscous meals decreased significantly only after vardenafil ingestion (from 80.2% ± 13.8% to 49.4% ± 27.9%, P < 0.05 and from 72.8% ± 33.6% to 21.5% ± 29.0%, P = 0.01, respectively). CONCLUSIONS:Vardenafil decreased esophageal bolus transit in the seated position, despite decreased lower esophageal sphincter pressure.