OTC (over-the-counter) antacids and acid suppressants are appropriate initial patient-directed therapy for mild heartburn.Patients should be advised to take these agents when symptoms arise or if they anticipate symptoms after an activity that can promote heartburn (eg, a heavy meal, spicy food, alcohol consumption). Antacids have the most rapid onset of action, followed by H2RAs, while it may take one to four days to experience full symptom relief from OTC omeprazole.
If symptoms are severe or do not resolve with OTC (over-the-counter) treatment, further work-up and prescription therapy are necessary due to the serious nature of complications of GERD. With the approval of an OTC PPI, many have raised concerns that patients will misuse it and not follow directions on the package insert. Pharmacists should emphasize appropriate use of OTC (over-the-counter) therapies and warn patients about potential complications of poorly managed gastroesophageal reflux disease (GERD). Patients who present to the pharmacist with warning signs of GERD complications should be referred to their health care provider without delay.
Many patients with gastroesophageal reflux disease (GERD) have persistent symptoms despite OTC (over-the-counter) therapy and should undergo a proper evaluation. The presence of esophagitis and/or complications should be assessed. Of several strategies available for initial treatment, experts recommend the step-down approach as initial management. Step-down therapy begins with a standard-dose PPI and gradually reduces the intensity of treatment to maintain remission.Rapid symptom relief and no need for additional doctor visits justify higher initial drug costs. Step-up approach begins with the least costly and least effective therapy and progresses to more effective agents if symptoms persist. Often this fails to ensure swift symptom improvement and is inefficient for the doctor.
Long-term management is required in most patients. Step-down therapy should be used to individually determine the least costly but still effective therapy to control gastroesophageal symptoms. Patients who experience relapse in symptoms should be restarted on the initially successful treatment and step-down should be attempted when the patient regains control of the disease. Patients with severe esophagitis should remain on proton pump inhibitors (PPIs) since other treatments are not likely to prevent the relapse of esophagitis and its complications.
On-demand therapy is another option for chronic management once control is well established. This strategy allows for discontinuation of therapy once symptoms are initially controlled. Patients should be instructed to resume therapy upon symptom recurrence and to stop treatment when they have been free of symptoms for at least 24 hours. Even though this approach allows symptoms to recur, most patients accept this as long as effective therapy is readily available. Lind et al compared the efficacy of omeprazole 20 mg, omeprazole 10 mg, and placebo when used as on-demand therapy with patients in whom initial control of symptomatic gastroesophageal reflux disease (GERD) was achieved.
Patients were instructed to take study medication on demand once daily upon recurrence of symptoms until symptoms resolved over a six-month period. Use of antacids was allowed for symptom management. After six months, the remission rates were 83% (95% confidence interval [CI], 77% to 89%) with omeprazole 20 mg, 69% (CI, 61% to 77%) with omeprazole 10 mg, and 56% (CI, 46% to 64%) with placebo (P < .01 for all intergroup differences). Mean numbers of study medication doses per day in these groups were 0.43 (0.27), 0.41 (0.27) and 0.47 (0.27), respectively. The use of antacids was highest in the placebo group and lowest in the omeprazole 20-mg group.
With intermittent therapy, patients who respond to initial treatment are instructed to discontinue therapy and resume it if symptoms recur. Patients then receive two to four weeks of therapy and can attempt to discontinue the treatment again. Intermittent therapy was investigated in a randomized, multicenter, double-blind, controlled study.Patients with gastroesophageal reflux disease (GERD) with or without mild erosive esophagitis were randomized to receive omeprazole 10 or 20 mg daily or ranitidine 150 mg twice daily for two weeks. Patients who did not experience symptom relief were instructed to double their omeprazole 10 mg or ranitidine dose for another two weeks while omeprazole 20 mg was continued for two more weeks.
Recurrences of moderate or severe heartburn during 12-month follow-up were treated with the dose that was successful for initial symptom control. The study enrolled 677 patients, but only 318 reached the end without recourse to maintenance antisecretory drugs. About half of the remaining patients did not require treatment for at least six months; this was similar in all treatment groups. Omeprazole 20 mg provided faster relief of heartburn. Achieving asymptomatic state after two weeks of therapy predicted the likelihood of success with intermittent therapy. In this regard, omeprazole 20 mg/day was more effective than ranitidine (P < .001).