Relief for reflux sufferers

In a recent edition of Therapeutics and Clinical Risk Management, the role of proton pump inhibitors (PPIs) in the treatment of gastroesophageal reflux disease (GERD) was investigated. GERD is a chronic disease that affects many people in the community with the possibility of serious long-term complications, such as erosive oesophagitis. In at risk patients, long-term acid suppression therapy is required and this can present a cost and time burden. Proton pump inhibitors such as oral pantoprazole (Somac) are accepted as the most effective first line and maintenance treatment for GERD. The effective treatment of GERD provides symptom resolution and high rates of remission, lowers the incidence of complications, improves health-related quality of life, and reduces the cost of this disease. The article concluded that the PPIs, pantoprazole in particular, are safe, well tolerated and effective initial and maintenance treatments for patients with non-erosive GERD or erosive oesophagitis. Pantoprazole was also shown to greatly improve the quality of life of patients, with particular improvements evident in the elderly population.

Gastroesophageal reflux disease (GERD) is a chronic, relapsing disease that commonly progresses to a range of potentially serious oesophageal complications from oesophageal ulcers through to oesophageal cancer and extra-oesophageal diseases such as respiratory problems, chest pain and angina. It is characterized by reflux of the stomach contents into the oesophagus, oropharynx, larynx, or airway and is associated with heartburn, acid regurgitation, and dyspepsia. Gastroesophageal reflux disease is one of the most common chronic gastrointestinal disorders. It has been reported that GERD affects an estimated 19 million individuals in the US and can affect up to one-third of adults.

Adequate treatment of GERD should either prevent repeated reflux of gastric contents into the oesophagus or reduce the damaging effect of gastric acid. As no pharmaceutical agent can fully correct the motor dysfunction responsible for acid reflux into the oesophagus, acid suppression remains the most effective way to relieve symptoms and to promote healing of oesophagitis in patients with GERD.

In a recent review published in Therapeutics and Clinical Risk Management, it found most studies recommended initial acid suppressive therapy with a PPI as first line treatment. The article compiled results of major randomized control trials and large retrospective meta-analyses which showed PPI treatment to be the most effective agents for treating GERD. PPIs provide more rapid symptom control and better healing of erosive esophagitis than other therapies such as H2-receptor antagonists and antacids. PPIs are also associated with a low rate of drug-drug reactions, other than those expected by the lowering of intragastric pH.

The PPI pantoprazole (Somac) was found to have one of the lowest hepatic-based interaction risk profiles, with omeprazole having the highest risk. When comparing PPIs at higher doses, oral pantoprazole (Somac) was also found to be the most effective PPI in healing erosive oesophagitis, a severe complication of GERD. It had similar efficacy to other PPIs when compared on a mg per mg basis, however all PPIs were found to be more efficacious than H2-receptor antagonists.

In maintenance treatment of GERD, pantoprazole and other PPIs such as rabeprazole was found to relieve symptoms as well as decrease the chance of progression to more severe GERD associated diseases. When compared to esomeprazole in a study of on-demand administration of PPIs, pantoprazole provided significantly more symptom relief.

In the elderly population, results of a retrospective analysis, based on combined data from two prospective, double-blind, randomized trials in patients with Hetzel-Dent grade greater or equal to 2 erosive oesophagitis showed pantoprazole was more effective than a combined placebo/nizatidine treatment group (p < 0.001). Results of a prospective study have confirmed the efficacy of oral pantoprazole in 164 patients aged greater or equal to 65 years with Savary-Miller grade I-III GERD, where on continued therapy of pantoprazole 20 mg daily for a further 6 months maintained a remission rate of 80% at 1 year. Also in elderly patients, it is crucial that medical practitioners consider drug interaction profiles carefully when choosing a PPI, as adverse events are more likely in this population.

The interaction profiles of omeprazole and pantoprazole have been studied most extensively: omeprazole carries a considerable potential for drug interactions, whereas pantoprazole appears to have lower potential for interactions with other medications.

Results of numerous clinical trials indicate that oral pantoprazole is safe and well tolerated for short-term treatment of GERD and for longer term maintenance therapy in patients with healed erosive esophagitis. Oral pantoprazole at dosages of up to 40 mg daily was safe and well tolerated in studies of 1 to 2 years in duration. From this evidence, the pharmacokinetic profile of pantoprazole suggests it is well suited for use in elderly patients who as a group frequently present with co-morbidities and are at risk of polypharmacy. The article therefore confirms that PPIs are accepted as the most effective treatment for GERD and are the mainstay of initial GERD management, providing more rapid symptom control and better healing of erosive oesophagitis than H2-receptor antagonists and antacids. PPIs are also the preferred agents for maintenance therapy in patients with healed erosive oesophagitis.

The data reviewed here show that oral pantoprazole (Somac) is a safe, well tolerated and effective initial and maintenance treatment. It has been shown to improve the quality of life of patients with GERD and is associated with high levels of patient satisfaction with therapy. In the elderly population where GERD is more common and severe, pantoprazole has also shown to be an effective and safe treatment for this at-risk population.

Reference:

1. Scholen T. Long-term management of gastroesophageal reflux disease with pantoprazole. Therapeutics and Clinical Risk Management, 2007; 3(2): 231-43.