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Dexlansoprazole

This article examines the use of dexlansoprazole, a medication for treating acid-related disorders, in various clinical trials. These studies aim to assess the drug’s effectiveness, safety, and potential applications in different patient populations, including adults and adolescents with conditions such as erosive esophagitis and gastroesophageal reflux disease (GERD).

Table of Contents

What is Dexlansoprazole?

Dexlansoprazole is a medication used to treat various conditions related to stomach acid. It belongs to a class of drugs called proton pump inhibitors (PPIs). Dexlansoprazole is known by several brand names, including Dexilant, Kapidex, and DelanzoTMDR[1][2]. This medication is designed to reduce the amount of acid your stomach produces, helping to relieve symptoms and promote healing in certain digestive disorders.

What Conditions Does Dexlansoprazole Treat?

Dexlansoprazole is used to treat several conditions related to excess stomach acid production:

  • Gastroesophageal Reflux Disease (GERD): This is a condition where stomach acid frequently flows back into the esophagus, causing symptoms like heartburn and regurgitation[2].
  • Erosive Esophagitis (EE): This is a severe form of GERD where stomach acid causes damage and inflammation to the lining of the esophagus[4].
  • Non-erosive GERD: This is a milder form of GERD where there’s no visible damage to the esophagus, but symptoms are still present[4].
  • Maintenance of Healed Erosive Esophagitis: Dexlansoprazole is also used to prevent the recurrence of erosive esophagitis after it has been successfully treated[8].

How Does Dexlansoprazole Work?

Dexlansoprazole works by reducing the amount of acid your stomach produces. It does this by blocking a system in the cells of your stomach called the “proton pump.” This pump is responsible for producing stomach acid. By inhibiting this pump, dexlansoprazole decreases the amount of acid in your stomach, which helps relieve symptoms and allows damaged tissue in the esophagus or stomach to heal[4].

Dosage Forms and Strengths

Dexlansoprazole comes in delayed-release capsules. These capsules are designed to release the medication in two stages as they pass through your digestive system, providing longer-lasting acid suppression. The common strengths available are:

  • 30 mg capsules[8]
  • 60 mg capsules[1]

The specific dosage prescribed will depend on the condition being treated and the individual patient’s needs.

Clinical Studies and Effectiveness

Several clinical studies have been conducted to evaluate the effectiveness of dexlansoprazole:

  • Healing of Erosive Esophagitis: Studies have shown that dexlansoprazole is effective in healing erosive esophagitis. In one study, 60 mg and 90 mg doses of dexlansoprazole were compared to lansoprazole (another PPI) for healing erosive esophagitis over 8 weeks[4].
  • Maintenance of Healed Erosive Esophagitis: Research has also demonstrated that dexlansoprazole is effective in maintaining the healing of erosive esophagitis and providing relief from heartburn. A study in adolescents showed that after initial healing with 60 mg dexlansoprazole, a 30 mg dose was effective for maintaining healing over 16 weeks[8].
  • Non-cardiac Chest Pain: A study investigated the use of dexlansoprazole in treating non-cardiac chest pain related to GERD. This research aimed to determine if dexlansoprazole could help reduce the frequency and intensity of chest pain episodes[3].

Potential Side Effects

Like all medications, dexlansoprazole can cause side effects, although not everyone experiences them. Common side effects reported in clinical trials include:

  • Diarrhea
  • Abdominal pain
  • Nausea
  • Upper respiratory tract infection
  • Vomiting
  • Flatulence (gas)

It’s important to note that these side effects were reported in studies, but their direct relationship to dexlansoprazole was not always clear[8]. If you experience any persistent or severe side effects, you should contact your healthcare provider.

Use in Special Populations

Research has been conducted to understand how dexlansoprazole works in different populations:

  • Pediatric Use: Studies have been conducted in children and adolescents aged 1 to 17 years to evaluate the safety and effectiveness of dexlansoprazole in treating GERD and erosive esophagitis[2][8].
  • Ethnic Differences: A study was conducted to evaluate how dexlansoprazole is processed in the body (pharmacokinetics) of healthy Chinese participants. This type of research helps ensure that the medication is safe and effective across different ethnic groups[9].

It’s important to note that the use of dexlansoprazole in pregnant women, nursing mothers, and patients with severe liver problems may require special consideration. Always consult with your healthcare provider about the appropriate use of this medication in your specific situation.

Aspect Details
Main Conditions Studied Erosive Esophagitis, Gastroesophageal Reflux Disease (GERD), Barrett’s Esophagus
Age Groups Adults, Adolescents (12-17 years)
Dosages Tested 30 mg, 60 mg, 90 mg (daily or twice daily)
Primary Outcomes Healing of erosive esophagitis, maintenance of healing, relief of heartburn symptoms
Safety Assessments Adverse events, vital signs, clinical laboratory tests
Study Designs Randomized controlled trials, bioequivalence studies, open-label studies
Comparators Placebo, lansoprazole, other formulations of dexlansoprazole
Duration of Studies Ranging from single-dose to 36 weeks

FAQ

  • What is dexlansoprazole used for? Dexlansoprazole is primarily used to treat acid-related disorders such as erosive esophagitis, gastroesophageal reflux disease (GERD), and to maintain healing of erosive esophagitis. It's also being studied for its potential in treating non-cardiac chest pain related to GERD.
  • How does dexlansoprazole work? Dexlansoprazole is a proton pump inhibitor (PPI) that reduces stomach acid production. It works by blocking the enzyme in the wall of the stomach that produces acid, helping to relieve symptoms and promote healing in conditions like GERD and erosive esophagitis.
  • What are some of the clinical trials studying dexlansoprazole? Clinical trials are studying dexlansoprazole for various purposes, including its effectiveness in healing erosive esophagitis, maintaining healed erosive esophagitis, relieving heartburn, and its potential use in preventing recurrence of Barrett's esophagus after radiofrequency ablation treatment.
  • Are there studies on dexlansoprazole use in children or adolescents? Yes, there are clinical trials studying the use of dexlansoprazole in adolescents aged 12 to 17 years with erosive esophagitis and GERD. These studies aim to assess the safety and effectiveness of the drug in this younger population.
  • What are some common outcomes measured in dexlansoprazole clinical trials? Common outcomes measured in dexlansoprazole trials include the percentage of patients with healed erosive esophagitis, maintenance of healing, relief of heartburn symptoms, changes in quality of life scores, and the occurrence of adverse events to assess safety.

Ongoing Clinical Trials on Dexlansoprazole

  • Study on Dexlansoprazole for Treating and Maintaining Healing of Erosive Esophagitis in Children Aged 2 to 11 Years

    Not recruiting

    2 1 1
    Investigated drugs:
    Poland

  • Study on the Safety and Effectiveness of Dexlansoprazole for Treating Nonerosive GERD in Children Aged 2 to 11 Years

    Not recruiting

    2 1 1
    Investigated drugs:
    Poland

Glossary

  • Erosive Esophagitis: A condition where the lining of the esophagus becomes inflamed and damaged due to stomach acid, often causing symptoms like heartburn and difficulty swallowing.
  • Gastroesophageal Reflux Disease (GERD): A digestive disorder that occurs when stomach acid frequently flows back into the esophagus, causing symptoms such as heartburn and regurgitation.
  • Barrett's Esophagus: A condition where the lining of the esophagus changes, becoming similar to the lining of the intestine. It's often caused by long-term GERD and can increase the risk of esophageal cancer.
  • Proton Pump Inhibitor (PPI): A class of medications that reduce stomach acid production by blocking the enzyme in the stomach wall that produces acid.
  • Bioequivalence: The property of two drugs having the same biological effect and availability in the body. It's often used to compare generic medications to brand-name drugs.
  • Endoscopy: A medical procedure where a long, thin tube with a camera is inserted into the body to examine internal organs, often used to assess conditions in the esophagus and stomach.
  • Pharmacokinetics: The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Randomized Controlled Trial: A type of scientific experiment where participants are randomly assigned to different treatment groups, often used to test the effectiveness of new medications or treatments.
  • Placebo: An inactive substance or treatment used in clinical trials to compare the effects of a real drug or treatment. Participants receiving a placebo serve as a control group.
  • Adverse Event: Any unfavorable and unintended sign, symptom, or disease that occurs during a clinical trial, whether or not it is related to the treatment being studied.

References

  1. https://clinicaltrials.gov/study/NCT04877834
  2. https://clinicaltrials.gov/study/NCT01045096
  3. https://clinicaltrials.gov/study/NCT01637571
  4. https://clinicaltrials.gov/study/NCT00251719
  5. https://clinicaltrials.gov/study/NCT00251693
  6. https://clinicaltrials.gov/study/NCT02529787
  7. https://clinicaltrials.gov/study/NCT02162758
  8. https://clinicaltrials.gov/study/NCT01642615
  9. https://clinicaltrials.gov/study/NCT03316976