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Serum level of pepsinogen significantly associated with gastric distress induced by amino-bisphosphonates

Osteoporosis International volume 22, pages 1717–1723 (2011)Cite this article

Abstract

Summary

To elucidate whether serum levels of pepsinogens are associated with the occurrence of gastrointestinal adverse events induced by amino-bisphosphonates (amino-BP), the serum levels of pepsinogen were measured in amino-BP users. Our results indicate that measurement of pepsinogen I is useful in predicting gastric distress induced by amino-BP in osteoporosis.

Introduction

To elucidate whether serum levels of pepsinogens are associated with the occurrence of gastrointestinal adverse events induced by amino-BP, the serum levels of pepsinogen I and II were measured in amino-BP users.

Methods

When the patients complained of gastric distress symptoms during the first 6 months after amino-BP use resulting in discontinuation of the drug, endoscopical examinations were performed to assess whether gastric lesions were present. A total of 223 amino-BP users were enrolled in the study, of which 47 patients refused to take the drug due to gastric distress symptoms. The remaining 176 patients did not complain of any gastric distress.

Results

Among 47 patients, eight patients showed obvious gastric lesions such as gastric or duodenal ulcers and acute gastric mucosal lesions in the endoscopical examination. The remaining 39 patients did not show any gastric lesions. The possible confounding factors, such as a Helicobactor pylori infection or concurrent use of ulcerogenic agents, did cause not affect gastric distress in amino-BP users. The serum pepsinogen I level was significantly associated with severity of the gastric lesion 46.8 ± 27.7, 60.8 ± 32.4, and 103.4 ± 49.2 ng/ml for patients without any gastric distress, with gastric distress accompanied no gastric lesions, and with gastric distress accompanied gastric lesions, respectively.

Conclusions

ROC analysis revealed that the cutoff value of pepsinogen I for expectation of gastric regions was 76.8 ng/ml. The results clearly indicate that measurement of pepsinogen I may be useful in predicting gastric distress induced by amino-BP in osteoporosis.

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Acknowledgements

The authors wish to thank Dr. Toshitsugu Sugimoto (Department of Internal Medicine, Shimane University) for his stimulating discussions. The authors would also like to thank Mrs. Shigeyuki Ishii (Teijin Pharmaceutical Co.) and Masao Inoue (Tokyo CRO Co.) for their kind provision of information.

Conflicts of interest

Masataka Shiraki received honorarium for the lectures from the pharmaceutical companies, which distributed amino bisphosphonate. No other conflict of interest exists.

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Affiliations

  1. Research Institute and Practice for Involutional Diseases, Nagano, Japan

    M. Shiraki & Y. Yamazaki

  2. Public Health Research Foundation, Tokyo, Japan

    T. Kuroda

  3. Division of Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital, Kyoto, Japan

    S. Tanaka

  4. Department of Endoscopy and Digestive diseases, Aizawa Hospital, Nagano, Japan

    K. Miyata

  5. 1610-1, Meisei, Misato, Azumino City, Nagano Prefecture, 399-8101, Japan

    M. Shiraki

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  1. M. Shiraki
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  2. Y. Yamazaki
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  3. T. Kuroda
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  4. S. Tanaka
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  5. K. Miyata
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Correspondence to M. Shiraki.

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Shiraki, M., Yamazaki, Y., Kuroda, T. et al. Serum level of pepsinogen significantly associated with gastric distress induced by amino-bisphosphonates. Osteoporos Int 22, 1717–1723 (2011). https://doi.org/10.1007/s00198-010-1374-3

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Keywords

  • Amino-bisphosphonates
  • Gastrointestinal adverse event
  • Osteoporosis
  • Pepsinogen