Step-down from multiple- to single-dose proton pump inhibitors (PPIs): a prospective study of patients with heartburn or acid regurgitation completely relieved with PPIs

Am J Gastroenterol. 2003 Sep;98(9):1940-4. doi: 10.1111/j.1572-0241.2003.07665.x.


Objectives: Management costs for gastroesophageal reflux disease are high because of the expensive medications used for maintenance therapy. Previous studies have illustrated the success of step-down from proton pump inhibitors (PPIs) to less-expensive therapy once symptoms have abated. This study was conducted to determine whether patients requiring greater than single-dose PPI for initial symptom resolution could be stepped-down to single-dose PPI and whether this intervention decreased costs or adversely affected quality of life.

Methods: Consecutive patients in whom greater than single-dose PPI had completely alleviated reflux-type symptoms (heartburn or acid regurgitation) were recruited through the use of pharmacy records of PPI prescriptions. Eligible subjects completed baseline demographic information and quality-of-life surveys and were stepped-down to single-dose PPI (lansoprazole 30 mg or omeprazole 20 mg daily). Follow-up continued for 6 months or until subjects reported recurrence of reflux-type symptoms, at which point PPIs were reinstituted at the dose that had originally alleviated the subjects' symptoms. The primary outcome was the proportion of subjects in whom step-down was successful, defined as no recurrence of reflux-type symptoms on single-dose PPI.

Results: A total of 117 subjects enrolled in the study; all were followed to the primary endpoint. 79.5% did not report recurrent symptoms of heartburn or acid regurgitation during the 6 months after step-down to single-dose PPI. Logistic regression revealed that longer duration of PPI use before study enrollment was associated with greater likelihood of symptom recurrence with step-down. Although quality of life was not significantly altered, dyspepsia (excluding reflux-type symptoms) increased. Overall costs of management were reduced.

Conclusions: The majority of patients rendered asymptomatic on greater than single-dose PPI might be subsequently stepped-down to single-dose therapy without recurrence of reflux-type symptoms. This intervention can decrease management costs without adversely affecting quality of life.

Publication types

  • Clinical Trial
  • Comparative Study
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Adult
  • Aged
  • Aged, 80 and over
  • Cohort Studies
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Female
  • Follow-Up Studies
  • Gastroesophageal Reflux / diagnosis
  • Gastroesophageal Reflux / drug therapy*
  • Heartburn / diagnosis
  • Heartburn / drug therapy*
  • Humans
  • Lansoprazole
  • Logistic Models
  • Male
  • Middle Aged
  • Multivariate Analysis
  • Omeprazole / administration & dosage
  • Omeprazole / analogs & derivatives
  • Patient Satisfaction
  • Probability
  • Prospective Studies
  • Proton Pump Inhibitors*
  • Proton Pumps / therapeutic use*
  • Quality of Life*
  • Risk Assessment
  • Severity of Illness Index
  • Treatment Outcome


  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Proton Pump Inhibitors
  • Proton Pumps
  • Lansoprazole
  • Omeprazole