American Journal of Cardiovascular Drugs

, Volume 17, Issue 6, pp 465–474 | Cite as

Angioedema Among Hypertensive Patients Treated with Aliskiren or Other Antihypertensive Medications in the United States

  • Raymond G. Schlienger
  • Jonathan R. Korn
  • Elizabeth Wehler
  • Sandra Lopez Leon
  • Jason Yeaw
Original Research Article

Abstract

Background

A non-interventional study suggested that use of angiotensin-converting enzyme inhibitors (ACEIs) or aliskiren was associated with an angioedema risk three times that of beta-blockers (BBs).

Objective

The aim was to assess angioedema incidence rates (IRs) and the relative angioedema risk of aliskiren compared to other antihypertensive drugs (AHDs).

Methods

A cohort study in hypertensive patients with an AHD prescription between 2007 and 2012 was conducted using data from the US PharMetrics Plus™ claims database. Angioedema was identified using the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9CM) code 995.1. Additionally, a nested case–control analysis was conducted to assess the relative angioedema risk of aliskiren or other AHDs versus BBs.

Results

A total of 3,090,114 patients were included (aliskiren n = 30,720). There were 15,744 angioedema events (IR 2.28/1000 person-years; 95% confidence interval (CI) 2.24–2.32). Aliskiren IRs were: any aliskiren 2.58 (2.08–3.17), aliskiren monotherapy 1.71 (0.74–3.37), aliskiren fixed-dose combination (FDC) 1.27 (0.41–2.96), and aliskiren free-standing combination (FSC) 2.93 (2.31–3.66). The case–control analysis included 15,100 angioedema cases and 60,400 controls; the angioedema risk for both aliskiren monotherapy and FDC was not significantly different from BBs [adjusted odds ratio (adjOR) 0.99 (95% CI 0.45–2.20) and 1.06 (0.40–2.76)]; aliskiren FSC was associated with an increased angioedema risk [adjOR 3.29 (2.42–4.48)], mainly driven by concomitant ACEI use [adjOR 7.03 (4.10–12.05)].

Conclusions

The IR and risk of angioedema in patients with aliskiren monotherapy or FDC are comparable to BBs. The higher IR and risk of angioedema identified in the aliskiren FSC group may largely be driven by the concomitant use of ACEIs.

Notes

Compliance with Ethical Standards

Funding

This study was funded by Novartis Pharma AG. Salil Budhiraja, Novartis Healthcare Pvt. Ltd., Hyderabad, India provided medical writing support for this manuscript.

Conflict of interest

RGS and SLL are paid employees of Novartis Pharma; they 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. JRK, EW, and JY have no conflicts of interest.

Supplementary material

40256_2017_242_MOESM1_ESM.docx (30 kb)
Supplementary material 1 (DOCX 30 kb)
40256_2017_242_MOESM2_ESM.docx (18 kb)
Supplementary material 2 (DOCX 17 kb)

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Copyright information

© Springer International Publishing AG 2017

Authors and Affiliations

  • Raymond G. Schlienger
    • 1
  • Jonathan R. Korn
    • 2
  • Elizabeth Wehler
    • 2
  • Sandra Lopez Leon
    • 3
  • Jason Yeaw
    • 4
  1. 1.Quantitative Safety and EpidemiologyNovartis Pharma AGBaselSwitzerland
  2. 2.Health Economics and Outcomes ResearchQuintiles IMSPlymouth MeetingUSA
  3. 3.Quantitative Safety and EpidemiologyNovartis Pharmaceuticals CorporationEast HanoverUSA
  4. 4.Health Economics and Outcomes ResearchQuintiles IMSSan FranciscoUSA

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