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Incidence of Ischemic Colitis in Treated, Commercially Insured Hypertensive Adults: A Cohort Study of US Health Claims Data

  • Original Research Article
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A Commentary to this article was published on 14 March 2015

Abstract

Background

Ischemic colitis (IC) incidence rates (IRs) among treated hypertensive patients are poorly understood, and existing literature on the subject is sparse. Antihypertensive drugs may raise the risk of developing IC. Novel antihypertensive agents—such as the direct renin inhibitor aliskiren—have not been assessed for IC risk.

Objectives

The aims of this study were to evaluate (1) the IRs of probable IC (pIC) in treated hypertensive adults, with a focus on aliskiren-treated patients; (2) the antihypertensive therapies used; and (3) the IRs of pIC in non-hypertensive adults.

Methods

This study selected hypertensive and non-hypertensive patients (N = 2,356,226 each) from a US health plan claims database. pIC was defined as diagnosis of IC within 3 months after colonoscopy, recto-sigmoidoscopy, or colectomy. IRs were calculated per 100,000 person-years (PYs) with 95 % confidence intervals (CIs) and stratified by antihypertensive regimen.

Results

IRs of pIC in hypertensive and non-hypertensive subjects were 18.6 (95 % CI 17.6–19.8) and 4.0 (95 % CI 3.4–4.7), respectively. The non-hypertensive cohort consisted of younger patients who may have been less prone to developing IC. The overall (i.e., all antihypertensive regimens combined) monotherapy IR per 100,000 PYs was 17.5 (95 % CI 16.2–18.8), the overall dual-combination regimen IR per 100,000 PYs was 19.5 (95 % CI 17.37–21.83), and the overall triple-plus combination regimen IR per 100,000 PYs was 27.7 (95 % CI 22.72–33.38).

Conclusion

Study results indicate that the treated hypertensive patients may have a higher risk of pIC compared with non-hypertensive populations. The quantity of antihypertensive agents prescribed may contribute to IC more than treatment duration.

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Acknowledgments

D.M. Hines, C.B. McGuiness, and C. Makin are paid employees of IMS Health, Plymouth Meeting, PA, USA. R.G. Schlienger is a paid employee of Novartis Pharma AG, Basel, Switzerland. Novartis Pharma AG sponsored the study and had input into the study design, interpretation of the data, writing of the report, and the decision to submit the paper for publication. The sponsor was not involved in data collection or analysis. Data extraction and analysis were provided by Shawn Hallinan. Editorial support was provided by Katharine Hendrix.

Ethical considerations

This manuscript does not contain data from a clinical study. In compliance with the Health Insurance Portability and Accountability Act (HIPAA), patient data included in the analysis are de-identified; thus, this study was exempt from Institutional Review Board review.

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Authors and Affiliations

  1. IMS Health, RWE-HEOR, One IMS Drive, Plymouth Meeting, PA, 19462, USA

    Dionne Mayhew Hines, Catherine Balderston McGuiness & Charles Makin

  2. Novartis Pharma AG, Quantitative Safety and Epidemiology, Drug Safety and Epidemiology, Lichtstrasse 35, 4056, Basel, Switzerland

    Raymond Gilles Schlienger

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  1. Dionne Mayhew Hines
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Correspondence to Dionne Mayhew Hines.

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Hines, D.M., McGuiness, C.B., Schlienger, R.G. et al. Incidence of Ischemic Colitis in Treated, Commercially Insured Hypertensive Adults: A Cohort Study of US Health Claims Data. Am J Cardiovasc Drugs 15, 135–149 (2015). https://doi.org/10.1007/s40256-014-0101-4

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