Response | Clinical | Mar 20, 2019

      Summary response to UCSF on endothelial function

      Response to the article entitled: "Vascular endothelial function is impaired by aerosol from a single IQOS HeatStick to the same extent as by cigarette smoke"
      by Pooneh Nabavizadeh1, Jingtao Liu1, Christopher M Havel2, Sharina Ibrahim3, Ronak Derakhshandeh1, Peyton Jacob III2,4, Matthew L Springer1,3,4.

      1. Cardiovascular Research Institute, University of California San Francisco, San Francisco, California, USA.; 2. Division of Clinical Pharmacology, Department of Medicine, University of California San Francisco, San Francisco, California, USA.; 3. Division of Cardiology, University of California, San Francisco, California, USA.; 4. Center for Tobacco Control Research and Education, University of California, San Francisco, California, USA.

       

      by Gizelle Baker, Patrick Picavet, Maurice Smith, Patrick Vanscheeuwijc, Emilija Veljkovic, and Manuel C. Peitsch1.

      1. PMI Research and Development, Philip Morris Products S.A., Quai Jeanrenaud 5, 2000 Neuchâtel, Switzerland.

      TIME TO READ: 1.5 MIN

      The points raised in this research letter are not new. This was originally published by the authors in a public comment to the IQOS Modified Risk Tobacco Product Application on Dec 4, 2017 (FDA-2017-D-3001-0118). A response was developed to address the issue and was incorporated into our Tobacco Products Scientific Advisory Committee material.

      A detailed review and analysis of all study data can be found on here.

      A public comment by Dr. Konstantinos Farsalinos, M.D., on November 24, 2017, can be found here.

      The totality of evidence available to-date for THS clearly demonstrates that THS presents less risk of harm and can reduce the risk of smoking related diseases including cardiovascular diseases (CVD) compared to continued smoking. The study reported by the authors provides no reliable scientific information about the effects of THS on the risk of CVD. We agree that endothelial dysfunction is an important prognostic factor in the development of atherosclerosis, hypertension, and heart failure.

      Furthermore, flow-mediated dilation (FMD) is an accepted non-invasive technique to assess endothelial function and is considered predictive of cardiovascular risk, but only when executed following a strictly standardized protocol (as published by the “International Brachial Artery Reactivity Task Force”) avoiding the ingestion of substances that affect FMD prior to measurement. In contrast, an acute change in FMD measured immediately after exposure to substances such as nicotine, as per experimental design of Nabavizadeh et al. are not predictive of cardiovascular risk. The effects observed in the study by Nabavizadeh et al. are actually expected, well-known short-term sympathomimetic effects of nicotine that are not predictive of the development of CVD in humans.

      Related Content
      Smoke-free device on a machine in laboratory.
      PMI’s studies on smoke-free products
      Learn more about our scientific assessment program and the results of our research studies on our smoke-free products.
      A scientist holds a pipette with rubber gloves.
      Research
      Discover PMI's rigorous scientific approach to smoke-free products and product assessment. Dive into our research results, peer-reviewed publications, independent research, and expert reports.
      A scientist in a white coat looking through a microscope.
      Independent research on heated tobacco products
      Over 750 independent studies on heated tobacco products. Find out how you can access them.

      PMIScience.com is operated by Philip Morris International for the purpose of publishing and disseminating scientific information about Philip Morris International’s efforts in support of its smoke-free product portfolio. This site is a global site for use by scientists, the public health and regulatory communities, and other stakeholders with an interest in tobacco policy. The purpose of this site is not advertising or marketing, nor is it directed at any specific market. It is not intended for use by consumers. New tobacco products sold in the United States are subject to FDA regulation; therefore the content of this site is not intended to make, and nor should it be construed as making, any product related claims in the United States without proper FDA authorization. ​
      ​
      Reduced Risk Products ("RRPs”) is the term we use to refer to products that present, are likely to present, or have the potential to present less risk of harm to smokers who switch to these products versus continuing smoking. PMI has a range of RRPs in various stages of development, scientific assessment and commercialization. All of our RRPs are smoke-free products that deliver nicotine with far lower quantities of harmful and potentially harmful constituents than found in cigarette smoke.