The long-awaited IMPROVE-IT trial was presented last month at the American Heart Association Scientific Sessions. Here are the presentation slides:
IMPROVE-IT was a trial that tested the ability of ezetimibe (Zetia) to lower the risk of heart attacks and strokes when added to simvastatin. See Larry Husten’s background post here, and if you type “ezetimibe” in the search box on this blog or on the Gooznews blog, you will find some previous posts of mine relating to ezetimibe. I admit I was a bit surprised that the trial was positive. I was expecting it to be negative, based on the negative results of the ENHANCE trial. Still, the benefit was small, a 6.4% reduction in risk of the primary endpoint (composed of cardiovascular death, heart attack, unstable angina requiring hospitalization, coronary revascularization, and stroke). In the high-risk trial participants — all patients who had been hospitalized for acute coronary syndrome within the 10 days before randomization — this translated to a 2% absolute benefit over 7 years. Of note, there was no reduction in all-cause or cardiovascular mortality.
I only want to make a few comments now, but I intend to write more when the trial is published. First, a 6.4% reduction is risk is a very small benefit, and many people would only consider that reduction in risk meaningful in a high risk population. Second, it is regrettable that we had to wait 12 years after the drug’s approval to find out whether it improves outcomes.
Addendum, May 5, 2015: Unfortunately, the GoozNews blog is no longer up on the web. I asked Merrill Goozner what happened and he said he decided to stop paying the annual fee for the website. So the posts I wrote on ezetimibe for GoozNews are no longer up.
In past years I have attended the NPA annual conference. I didn’t make it this year, but I want to share some projects that were discussed there that I learned about from an email from Jean Silver-Isenstadt, NPA executive director.
- “Just Price” — This project would pilot methods for physicians to assess patients’ financial vulnerability; collect and publish local price data from hospitals, pharmacies, and area providers for 50-100 of the most common diagnostic procedures and treatments; and promote discussion of diagnosis and treatment costs as part of informed, shared decision-making. The publication of transparent price lists by some in the health sector would create marketplace pressure for all to be as forthcoming.
- “There’s Safety in the Conversation” — Building on the soon-to-be-released TandemHealth app, this project would support physician-patient shared decision-making based on conflict-free, evidence-based guidelines to reduce overtreatment and waste while promoting patient safety. The project would promote a model policy of safe-haven from malpractice lawsuits specifically for episodes of care in which these conversations were documented.
- “Fair Bargain” — This project would put pressure on non-profit hospitals to deliver on the community benefit required in exchange for maintaining tax-exempt status. A new robust scorecard would compare hospital expenditures, quality of community health needs assessments, and degree of consumer and physician involvement in decision-making. Public scorecards have a track record of creating transformative pressure on institutions.
The TandemHealth app is a joint project of Consumer Reports and NPA. It is designed to be used before, during and after the clinical encounter and will present evidence-based information on common medical conditions.
The following is reposted from e-patients.net.
The American Heart Association journal Circulation: Cardiovascular Quality and Outcomes has announced a new Patient or Caregiver Viewpoint section in the journal. Viewpoints will be authored by patients or their caregivers and will discuss the patient’s experience of heart disease, stroke, or other cardiovascular disease and their interactions with the healthcare system.
As Harlan Krumholz and I explain in an Editor’s Note, the editors of the journal hope that Viewpoints “will contain insights from the patient’s perspective along with suggestions on how to improve clinical care and healthcare delivery.”
The first Viewpoint, by a heart disease patient, discusses how he experienced interactions with his physicians over whether he should start a blood pressure medication and his thoughts on how physicians and patients could work together in a manner consistent with the patient’s values and goals.
Viewpoints will contain a minimum of medical jargon and will be freely accessible to the public. The journal hopes to make these articles a regular feature. If you are a patient living with or at risk of cardiovascular disease, or a friend or family member of such a patient, please consider submitting a Viewpoint. Instructions for authors are posted on the journal’s website.
I have a post up on the Assessment 2020 blog on how to increase patient involvement in medical decision making. I focus on shared decision making and argue that physicians need to develop certain competencies in order for the use of shared decision making to become routine and how certain structural changes can facilitate the process. Please read and add your comment!
I am a member of the Assessment 2020 task force of the American Board of Internal Medicine (ABIM). The task force is looking at how to improve the assessment of physicians for purposes of board certification. We are seeking to engage physicians and the public in a conversation about physician assessment, quality of care, and what skills physicians need to provide effective, safe, efficient, and patient-centered care.
We’ve started a blog and so far there are posts up by Harlan Krumholz and Richard Baron (introducing the blog), Bob Wachter (on diagnostic error), and Ben Chesluk (on teamwork). Please go take a look and let us know what you think.
Circulation: Cardiovascular Quality and Outcomes will be publishing a new series of articles called narratives, which will be written by patients or by their family, friends or caregivers.
Narratives: The purpose of this series is to further understanding of patients’ experience of cardiovascular disease. These articles will be written by patients, or by their family members, caregivers, or friends. The articles will explore the effects of illness and treatment on patients’ lives and on their relationships with family, friends, caregivers, and health care providers. They will often discuss aspects of a condition that are important to patients but may not be fully appreciated by clinicians. We are especially interested in publishing narratives that contain lessons on the strengths and weaknesses of our health care system. They may, for example, be designed to help health care providers become aware of problems in communication of information, decision making, care coordination, access, cost, timeliness, safety, equity, and quality of care.
Recently, I joined the editorial board of Circulation: Cardiovascular Quality and Outcomes, the American Heart Association journal that focuses on quality of care and outcomes research. As my readers know, I became interested in cardiovascular disease because my daughter has heterozygous familial hypercholesterolemia, a genetic disease that cause high LDL-cholesterol and can lead to premature heart disease. I wrote this perspective for the November issue on how engaged patients can help bring about positive change in health care.
SPM will be hosting a tweetchat on the 2nd and 4th Saturdays of the month. The second tweetchat will be Saturday, Sept. 28 from the floor of Stanford Medicine X, where a number of SPM members will be in attendance.
The first chat on 9/14 will focus on:
- What is participatory medicine?
- How has peer-to-peer healthcare impacted you?
Anyone interested in healthcare is invited to join in.
Go to tchat.io and plug in the hashtag #s4pm at 3pm Eastern this coming Saturday.
H/T Ileana Balcu
Addendum 9/14/13: The transcript of the 9/14 tweetchat is available here.