Nocturnal acid breakthrough on proton pump inhibitor therapy: To treat or not to treat

Katz, Philip O.; Dudnick, Robert S.

doi:10.1007/s11938-008-0004-z

Cited by 1 publication

(1 citation statement)

References 23 publications

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“…A single dose of PPI does not result in maximum acid inhibition, which is achieved only when irreversible binding and de novo synthesis are balanced, following 3 5 days of treatment . Suboptimal relief of GERD symptoms, such as nocturnal heartburn with PPIs, has been ascribed to a slow onset of action and insufficient gastric pH control resulting from their short duration of action . Following administration of 40 mg of esomeprazole, the gastric pH rose slowly compared to the tegoprazan.…”

Section: Discussionmentioning

confidence: 48%

Randomised clinical trial: safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of tegoprazan (CJ‐12420), a novel potassium‐competitive acid blocker, in healthy male subjects

Han

Choi

Kim

et al. 2019

Aliment Pharmacol Ther

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Summary Background Tegoprazan (CJ‐12420) is a potassium‐competitive acid blocker (P‐CAB) with therapeutic potential for gastro‐oesophageal reflux disease (GERD) by reversibly suppressing gastric H+/K+‐ATPase. Aims To investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of tegoprazan Methods A phase I, randomised, double‐blind and placebo‐controlled clinical trial was conducted in 56 healthy male subjects without Helicobacter pylori infection. In the single ascending dose study, 50, 100, 200 and 400 mg tegoprazan were administered to 32 subjects. In the multiple ascending dose study, 100 and 200 mg tegoprazan were administered every 24 hours to each of the eight subjects for 7 days. In the comparative pharmacodynamics study, 40 mg esomeprazole was administered to eight subjects every 24 hours for 7 days. The assessment included safety, tolerability, pharmacodynamics through monitoring of 24‐hour gastric pH and pharmacokinetics of tegoprazan in plasma and urine. Results Tegoprazan was generally well tolerated. Most adverse events reported in the study were mild in intensity and resolved without any sequelae. Exposure to tegoprazan increased in a dose‐proportional manner. Multiple dosing with tegoprazan showed no accumulation in plasma on day 7. The pharmacodynamic analysis revealed that tegoprazan showed rapid, dose‐dependent gastric acid suppression. Conclusions Tegoprazan was well tolerated and showed rapid and potent gastric acid suppression. This supports the further development of tegoprazan as a treatment for acid‐related disorders.

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Section: Discussionmentioning

confidence: 48%

Randomised clinical trial: safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of tegoprazan (CJ‐12420), a novel potassium‐competitive acid blocker, in healthy male subjects

Han

Choi

Kim

et al. 2019

Aliment Pharmacol Ther

View full text Add to dashboard Cite

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Nocturnal acid breakthrough on proton pump inhibitor therapy: To treat or not to treat

Abstract: Nocturnal acid breakthrough is misunderstood and infrequently requires treatment in everyday practice. There are important subgroups of patients in whom esophageal reflux occurs in the presence of nocturnal acid breakthrough in which treatment may be needed.

Cited by 1 publication

References 23 publications

Randomised clinical trial: safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of tegoprazan (CJ‐12420), a novel potassium‐competitive acid blocker, in healthy male subjects

Randomised clinical trial: safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of tegoprazan (CJ‐12420), a novel potassium‐competitive acid blocker, in healthy male subjects

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