Drug Safety

, Volume 20, Issue 2, pp 195–205

Safety Profile of Lansoprazole

The US Clinical Trial Experience
  • James W. Freston
  • Pamela A. Rose
  • Caren A. Heller
  • Marian Haber
  • Dennis Jennings
Original Research Article

DOI: 10.2165/00002018-199920020-00008

Cite this article as:
Freston, J.W., Rose, P.A., Heller, C.A. et al. Drug-Safety (1999) 20: 195. doi:10.2165/00002018-199920020-00008

Abstract

Objective

Lansoprazole has undergone extensive clinical evaluation for the treatment of acid-peptic diseases. The aim of this study was to define the safety profile of lansoprazole and compare it to that of other therapeutic agents evaluated in the same controlled trials.

Methods

The clinical safety profile of lansoprazole and comparative agents (placebo, ranitidine and omeprazole) was reviewed for 3281 patients who participated in short term (up to 8 weeks) and long term (up to 56 months) clinical trials conducted in the US. Adverse events, laboratory value changes and gastric biopsy changes that occurred during treatment were compared statistically for differences between treatments.

Results

The incidence of adverse events and number of patients discontinuing treatment because of adverse events was similar for lansoprazole and comparative agents. Other than elevated serum gastrin levels, a known effect of proton pump inhibitors, no trends in laboratory changes were observed. Median values for gastrin levels remained within the normal range; about 2% of patients had gastrin levels >400 pg/ml at any time, while <1% had 2 or more gastrin values >500 pg/ml. Values returned to baseline levels after therapy was discontinued. No significant changes in gastric endocrine cell growth from baseline to final visit were observed, nor was there evidence of dysplasia or neoplasia.

Conclusion

Lansoprazole is well tolerated for both short and long term treatment of acid-related disease. The tolerability of lansoprazole is comparable to that of ranitidine, omeprazole and placebo in the treatment of these diseases.

Copyright information

© Adis International Limited 1999

Authors and Affiliations

  • James W. Freston
    • 1
  • Pamela A. Rose
    • 2
  • Caren A. Heller
    • 2
  • Marian Haber
    • 3
  • Dennis Jennings
    • 2
  1. 1.Department of MedicineUniversity of Connecticut Health CenterFarmingtonUSA
  2. 2.TAP Pharmaceuticals, Inc.DeerfieldUSA
  3. 3.Department of PathologyMedical College of Pennsylvania and Hahneman UniversityPhiladelphiaUSA