Skip to main content
SpringerLink
Log in

Methodological and Regulatory Considerations for Updated Guidance on the Pressor Effects of Drugs

  • Analytical Report
  • Published:
Therapeutic Innovation & Regulatory Science Aims and scope Submit manuscript

Abstract

Elevated blood pressure increases the risk of adverse cardiovascular events and death. Accordingly, characterizing the off-target blood pressure effects of drugs is an important component of regulatory benefit-risk assessment and post-marketing clinical decision-making. The U.S. Food and Drug Administration (FDA) released draft guidance in May 2018 outlining these considerations and seeking discussion regarding opportunities to improve or reassess methods and analytical techniques to measure and interpret the pressor effects of drugs. Toward this effort, the Duke-Margolis Center for Health Policy—under a cooperative agreement with the FDA—convened a public workshop to bring the stakeholder community together to discuss these opportunities. The following are summary statements and recommendations discussed at the workshop to improve blood pressure assessment throughout the product lifecycle, from development and regulatory review to clinical care.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Notes

  1. Considerations and recommendations in this article reflect discussion at the workshop, but do not necessarily represent consensus recommendations.

References

  1. Evaluating the Pressor Effects of Drugs & Ambulatory Blood Pressure Monitoring Studies. Duke-Margolis Center for Health Policy. https://healthpolicy.duke.edu/events/evaluating-pressor-effects-drugs-ambulatory-blood-pressure-monitoring-studies. February 4, 2019.

  2. Assessment of Pressor Effects of Drugs: Guidance for Industry (Draft Guidance). U.S. Food and Drug Administration; May 30, 2018.

  3. Mancia G, Omboni S, Parati G, Ravogli A, Villani A, Zanchetti A. Lack of placebo effect on ambulatory blood pressure. Am J Hypertens. 1995;8(3):311–5.

    Article  CAS  Google Scholar 

  4. Johannesen L. Design of Efficient Ambulatory Blood Pressure Monitoring Studies. Talk presented at: Evaluating the Pressor Effects of Drugs & Ambulatory Blood Pressure Monitoring Studies; February 4, 2019; Washington, DC.

  5. O'Brien E, Parati G, Stergiou G, et al. European Society of Hypertension position paper on ambulatory blood pressure monitoring. J Hypertens. 2013;31(9):1731–68.

    Article  CAS  Google Scholar 

  6. Townsend RR, Mahfoud F, Kandzari DE, et al. Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications (SPYRAL HTN-OFF MED): a randomised, sham-controlled, proof-of-concept trial. Lancet. 2017;390(10108):2160–70.

    Article  Google Scholar 

  7. D'Agostino RB Sr, Vasan RS, Pencina MJ, et al. General cardiovascular risk profile for use in primary care: the Framingham Heart Study. Circulation. 2008;117(6):743–53.

    Article  Google Scholar 

Download references

Acknowledgement

The authors thank Rick Turner for his review of the manuscript.

Funding

Funding in-part from a cooperative agreement with the U.S. Food and Drug Administration.

Author information

Authors and Affiliations

  1. Robert J. Margolis, MD, Center for Health Policy, Duke University, 1201 Pennsylvania Ave NW Suite 500, Washington, DC, 20004, USA

    Nicholas R. Harrison

  2. Stanford University, Stanford, CA, USA

    Philip T. Sager

  3. Duke University Medical Center, Durham, NC, USA

    Mitchell W. Krucoff

  4. State University of New York Downstate Medical Center, Brooklyn, NY, USA

    Michael A. Weber

  5. Pat and Jim Calhoun Cardiology Center, University of Connecticut School of Medicine, Farmington, CT, USA

    William B. White

Authors
  1. Nicholas R. Harrison
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Philip T. Sager
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Mitchell W. Krucoff
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Michael A. Weber
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. William B. White
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Nicholas R. Harrison.

Ethics declarations

Conflict of interest

No conflicts of interest.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Harrison, N.R., Sager, P.T., Krucoff, M.W. et al. Methodological and Regulatory Considerations for Updated Guidance on the Pressor Effects of Drugs. Ther Innov Regul Sci 54, 1473–1476 (2020). https://doi.org/10.1007/s43441-020-00174-8

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s43441-020-00174-8

Keywords

Search

Navigation