17  May 18

ASPIPEN-DSR


DR SANJAY AGRAWAL
LEADING PHARMACEUTICAL CONSULTANT AND EDITOR-IN CHIEF OF IJMTODAY

Gastro-esophageal reflux disease (GERD) ,reflux oesophagitis ,peptic ulcer and other gastric acid related disorders are associated with reduced gastric motility and release of excessive gastric acid. Similar conditions are also seen in chronic gastritis, functional dyspepsia, and diabetic gastro paresis, Functional dyspepsia (FD) is a well known cause of upper gastrointestinal symptoms and discomfort. It is defined as a chronic, recurrent pain or discomfort centered in the upper abdomen. The gastrointestinal symptoms observed in functional dyspepsia are early satiety, fullness, epigastric pain, bloating, retching, retro sternal burning, nausea and vomiting. Functional dyspepsia causes substantial reduction in quality of life, which may be equivalent or higher than peptic ulcer disease, severe reflux disease or gastrointestinal cancer. In adults, its prevalence ranges from 25% to 40%. Similarly, diabetic gastroparesis is the impaired transit condition affecting gastric emptying in the absence of mechanical obstruction. It is common among both type 1 and type 2 diabetics, the symptoms being postprandial abdominal pain , nausea, vomiting and bloating secondary to gastric dysfunction. Prokinetic accelerate delayed gastric empting, they are used in the treatment of diabetes gastro paresis. These drugs tend to alter visceral sensation thereby reduce gastric dysrhythemia . A range of gastric acid inhibitors and acid –suppressing agents have successful treated GERD and gastric ulcer. Stimulation of gastric motility has been proposed to accelerate the healing of gastric ulcer.

Patient compliance is a major factor influencing favorable outcome. Administration of two, three or even more different tablets to the patients is not convent to achieve the optimal results. Therefore, having a combination of drugs in sustained release forms is an attractive and effective approach than monotherapy of the individual drugs, studies describe formulation composition with a proton pump inhibitor (PPI) in the form of either immediate release enteric coated and the prokinetic agent in the sustained release form would be an ideal formulation for once a day oral administration. Since prokinetic are primarily absorbed in the intestine, sustained release form of the prokinetic agent are highly advantages. Domperidone , a prokinetic exerts its activity through its dual action of antiacetylcholinesterase activity as well as dopamine D2 receptor antagonist activity and the PPI, Pantoprazole , acts by inhibiting H+K+ATPase , which is activated in the acidic lumen of gastric parietal cells.

Advantages of the combination- The combination of Domperidone as sustained release and Pantoprazole as enteric coated provide distinct advantage over available dosage forms in acid reflux disorders. The combination tends to possess a synergistic effect. The duration of the actions of agents are anticipated to be similar. Ease of administration and better patient compliance is achieved through the once daily administration. Prolonged duration of action effectively controls nocturnal esophageal reflux. The lowest possible daily therapeutic dose administration makes it less vulnerable to cause side effects.

Clinical Efficacy-
Gastro Esophageal Reflux Disease (GERD) - Domperidone 10 mg tid is effective on decreasing pathologic reflux in patient with GERD and therefore it has the potential to be effective in the treatment of this disease. Patients with GERD symptoms were treated with 10 mg three times a day in random order. Domperidone 10 mg significantly decreased the total per cent time with pH <4 and De Meester score. No serious adverse effects were observed. Diabetic Gastro paresis- Domperidone promotes gastric motility, increases the lower esophageal sphincter pressure, accelerates gastric empting and improves gastro-duodenal coordination. Pantoprazole provides a symptomatic relief in patients with diabetic gastro paresis. It does not alter gastrointestinal motility, hence is an ideal proton pump inhibitor to continue with Domperidone in the treatment of diabetes gastro paresis.

Functional Dyspepsia (FD)-Domperidone significantly improves symptoms of Functional Dyspepsia. A double –blind, placebo controlled trial revealed that treatment with Domperidone in all groups resulted in statistically significant improvement of the Leeds Dyspepsia questionnaire score. In addition to motility disorders. Functional dyspepsia is also associated with hyperacidity. Pantoprazole does not significantly alter gastric emptying, myoelectrical activity or threshold to fullness. In addition, a pilot study demonstrated reduced symptoms in Pantoprazole treated patients. As per consensus guidelines. Proton Pump Inhibitors are also recommended for the treatment of functional dyspepsia. Thus, combing Domperidone with Pantoprazole can be beneficial in treating Functional Dyspepsia.

Conclusion- Most gastric disturbances are characterized with increased gastric acid secretion and decreased gastric motility. Thus, prokinetic and proton pump inhibitors combination has been found effective in providing symptomatic relief in these gastric disorders. The combination of Domperidone and Pantoprazole has been found to be effective in GERD, diabetic gastro paresis and functional dyspepsia with very less side effects due to the dual mechanism and safety profiles of the individual drugs.

  Dr. Sandhya

12 Jul 2018
Excellent formulation for gastro intestinal disturbances.

  Dr Reena

11 Jul 2018
very useful information for the clinicians


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