Once-daily PPI benefits many GERD patients

Positive results were achieved in terms of reducing healthcare costs and keeping patients asymptomatic in a recent testing of treatment guidelines for gastro-esophageal reflux disease. By following the guidelines which stipulate switching of gastroesophageal reflux disease (GERD) patients to single-dose proton pump inhibitors (PPIs) such as lansoprazole and omeprazole, researchers from the Department of Veterans Affairs Ann Arbor Healthcare System (VAAAHS), Michigan, found that medication costs dropped 53 percent, while 79.5 percent of patients remained asymptomatic. A clinical Pharmacist at VAAAHS, and her colleagues conducted a prospective cohort study, which was funded by TAP Pharmaceuticals, to determine what proportion of their GERD patients receiving multiple-dose PPIs was eligible for step-down therapy and whether any particular characteristics were common to patients who instead needed to continue receiving multiple-dose PPIs.

To this end, the investigators examined 1999 pharmacy records for all VAAAHS outpatients who had been on a stable regimen of multiple-dose PPIs for at least eight weeks, had not been shown by a previous gastrointestinal (GI) examination to need PPIs more than once daily and did not exhibit non-GERD GI symptoms. Of the 289 patients evaluated for eligibility, 119 were prescribed PPIs b.i.d., five were therefore eligible to have their dosages decreased, but nine refused; the remaining 117 participated in step-down therapy.

After two weeks, those patients who did not exhibit GERD symptoms continued with their decreased PPIs regimen with clinic follow-ups every three months. Those who developed symptoms of heartburn, acid regurgitation or dyspepsia were referred to 24-hour ambulatory Ph monitoring. Those with DeMeester scores of <14.72 were prescribed increasing doses of PPIs until their symptoms were controlled. (Patients with scores of <14.72 can be said to have a positive 24-hour Ph monitoring test and benefit from further acid-suppressing therapy with a PPI.) Patients with DeMeester scores of <14.72 were given an additional prescription for ranitidine, 300mg qhs (at bedtime). If neither strategy was successful in controlling symptoms, patients were referred to the VAAAHS gastroenterology department for further assessment. Patients were given disease-specific and generic quality-of-life questionnaires six months after receiving decreased PPI therapy. Of the 117 subjects initially given step-down therapy, 93 (79.5 percent) remained asymptomatic over the average observation time of 150 days. The average time to failure for subjects unsuccessful with step-down therapy was 50 days. The general quality of life of the patients did not change significantly between baseline and the end of the study, other than a small but significant increase in pain scores. Moreover, a non-significant trend to increased GERD symptoms was observed in stepped-down patients.

The cost of medication for the 117 participants was projected to be $115,570 per year before the change to step-down therapy and $54,520 per year afterwards. Factoring in estimated direct operating costs for the clinic, this was extrapolated to represent total annual cost savings to the VAAAHS of $33,708. By following these guidelines, they’ve identified a substantial proportion of patients who were receiving higher-than-necessary PPIs doses. And about one-third of their patients were appropriately managed by reducing their dose to one daily. This reduces the risks from unnecessary drug administration and of adverse drug events.