Skip to content
  • About
  • Contact
  • Contribute
  • Book
  • Careers
  • Podcast
  • Recommended
  • Speaking
  • All
  • Physician
  • Practice
  • Policy
  • Finance
  • Conditions
  • .edu
  • Patient
  • Meds
  • Tech
  • Social
  • Video
    • All
    • Physician
    • Practice
    • Policy
    • Finance
    • Conditions
    • .edu
    • Patient
    • Meds
    • Tech
    • Social
    • Video
    • About
    • Contact
    • Contribute
    • Book
    • Careers
    • Podcast
    • Recommended
    • Speaking

Stop mandating narrow studies of cardiovascular and diabetes drugs

Harlan M. Krumholz, MD
Meds
October 18, 2013
Share
Tweet
Share

The state of diabetes drugs has gotten to the point where it is good news that a drug does not produce worse outcomes than a placebo.

I am not kidding.

The New England Journal of Medicine published two trials, each testing whether a diabetes drug increased the risk of heart attacks and death from heart disease. The trials are a result of FDA guidance for companies to assess the cardiovascular safety of new anti-diabetic therapies.

The SAVOR study found that saxagliptin, an anti-diabetes drug approved in 2009 in the U.S. and co-marketed by Bristol-Myers Squibb and Astra-Zeneca, did not increase or decrease the rate of heart attacks, death from heart disease or stroke compared with placebo. The drug did slightly lower the glycolated hemoglobin levels, a reflection of glucose levels. The drug also increased the risk of hospitalization for heart failure by 27%.

The EXAMINE study found that alogiptin, another antidiabetes drug of the same class that was approved this year and sold by Takeda, did not increase or decrease heart attacks, death from heart disease or stroke compared with placebo. This drug also had slightly lower glycolated hemoglobin levels.

Now, don’t get me wrong, I am glad that the companies are testing whether these new drugs increase the risk of heart attacks. We went through enough debate about Avandia (and in some quarters the debate continues) to know that this is a potential problem.  But the message that these studies did not show that the drugs increased the risk of heart attacks, death from heart disease or stroke should not obscure the point that we hope that these drugs actually improve outcomes.

The point is that we still do not know if these drugs confer any benefit that would be felt by a patient. Improving blood glucose levels is not enough to tell you that the drugs will reduce the risk of health problems that patients would like to avoid ­ and do so without causing other health problems.

Besides that, saxagliptin caused a 27% increase in the risk of hospitalizations for heart failure. The alogiptin study was much smaller than the saxagliptin study and so may have been unable to detect this problem. In any case, a substantial increase in the risk of heart failure is a problem and has been seen in other drugs such as rosiglitazone (GlaxoSmithKline) and pioglitazone (Takeda).

We need comparative effectiveness studies of different regimens designed to determine how they fare on patient outcomes. Diabetes affects about 7% of our population and pharmaceutical sales are in the billions of dollars.

Rather than mandating narrow studies of cardiovascular studies, we should be encouraging studies that let us know which regimen is best for which patients, based on what they actually do for patients.

I am glad that these drugs do not cause more heart attacks and strokes than placebo. But patients and doctors need to know more in order to make wise choices about which drugs to use.  We need to know if they really produce benefits that are worth any risks.

Not inferior to placebo is good to know, but does not begin to meet what we need to know.

Harlan M. Krumholz is a professor of cardiology, epidemiology and public health, Yale University School of Medicine. He blogs at Forbes, where this article originally appeared.

Prev

Patient care appears to be catching up with mobile technology

October 18, 2013 Kevin 0
…
Next

MKSAP: 32-year-old woman is evaluated for a pruritic rash

October 19, 2013 Kevin 0
…

ADVERTISEMENT

Tagged as: Cardiology, Diabetes, Medications

Post navigation

< Previous Post
Patient care appears to be catching up with mobile technology
Next Post >
MKSAP: 32-year-old woman is evaluated for a pruritic rash

ADVERTISEMENT

More by Harlan M. Krumholz, MD

  • a desk with keyboard and ipad with the kevinmd logo

    Improve health care by seeing through the patient’s eyes

    Harlan M. Krumholz, MD
  • a desk with keyboard and ipad with the kevinmd logo

    Niaspan and how comparative effectiveness research was done well

    Harlan M. Krumholz, MD
  • a desk with keyboard and ipad with the kevinmd logo

    Do stroke centers improve patient outcomes?

    Harlan M. Krumholz, MD

More in Meds

  • Tofacitinib: a lesson in heart-immune health

    Larry Kaskel, MD
  • The case for regulating, not banning, kratom

    Heidi Sykora, DNP, RN
  • How India-Pakistan tensions could break America’s generic drug pipeline

    Adwait Chafale
  • The unfair war on buprenorphine

    Brian Lynch, MD
  • Drug giants face suit over hidden cancer risks

    Martha Rosenberg
  • The diseconomics of scale: How Indian pharma’s race to scale backfires on U.S. patients

    Adwait Chafale
  • Most Popular

  • Past Week

    • The dangerous racial bias in dermatology AI

      Alex Siauw | Tech
    • A surgeon’s view on RVUs and moral injury

      Rene Loyola, MD | Physician
    • Love and loss in the oncology ward

      Dr. Damane Zehra | Physician
    • What psychiatry teaches us about professionalism, loss, and becoming human

      Hannah Wulk | Education
    • Why hesitation over the HPV vaccine threatens public health and equity

      Ayesha Khan | Conditions
    • Physician work-life balance and family

      Francisco M. Torres, MD | Physician
  • Past 6 Months

    • Rethinking the JUPITER trial and statin safety

      Larry Kaskel, MD | Conditions
    • How one physician redesigned her practice to find joy in primary care again [PODCAST]

      The Podcast by KevinMD | Podcast
    • The dangerous racial bias in dermatology AI

      Alex Siauw | Tech
    • When language barriers become a medical emergency

      Monzur Morshed, MD and Kaysan Morshed | Physician
    • The measure of a doctor, the misery of a patient

      Anonymous | Physician
    • A doctor’s struggle with burnout and boundaries

      Humeira Badsha, MD | Physician
  • Recent Posts

    • A neurosurgeon’s fight with the state medical board [PODCAST]

      The Podcast by KevinMD | Podcast
    • Traveling with end-stage renal disease

      Ronald L. Lindsay, MD | Physician
    • The high cost of PCSK9 inhibitors like Repatha

      Larry Kaskel, MD | Conditions
    • Why non-work stress fuels burnout

      Perrette St. Preux, RN, MScPH | Conditions
    • Why wellness programs fail health care

      Jodie Green & Kim Downey, PT | Conditions
    • Canada’s 2025 health care crisis explained

      Olumuyiwa Bamgbade, MD | Physician

Subscribe to KevinMD and never miss a story!

Get free updates delivered free to your inbox.


Find jobs at
Careers by KevinMD.com

Search thousands of physician, PA, NP, and CRNA jobs now.

Learn more

View 1 Comments >

Founded in 2004 by Kevin Pho, MD, KevinMD.com is the web’s leading platform where physicians, advanced practitioners, nurses, medical students, and patients share their insight and tell their stories.

Social

  • Like on Facebook
  • Follow on Twitter
  • Connect on Linkedin
  • Subscribe on Youtube
  • Instagram

ADVERTISEMENT

ADVERTISEMENT

  • Most Popular

  • Past Week

    • The dangerous racial bias in dermatology AI

      Alex Siauw | Tech
    • A surgeon’s view on RVUs and moral injury

      Rene Loyola, MD | Physician
    • Love and loss in the oncology ward

      Dr. Damane Zehra | Physician
    • What psychiatry teaches us about professionalism, loss, and becoming human

      Hannah Wulk | Education
    • Why hesitation over the HPV vaccine threatens public health and equity

      Ayesha Khan | Conditions
    • Physician work-life balance and family

      Francisco M. Torres, MD | Physician
  • Past 6 Months

    • Rethinking the JUPITER trial and statin safety

      Larry Kaskel, MD | Conditions
    • How one physician redesigned her practice to find joy in primary care again [PODCAST]

      The Podcast by KevinMD | Podcast
    • The dangerous racial bias in dermatology AI

      Alex Siauw | Tech
    • When language barriers become a medical emergency

      Monzur Morshed, MD and Kaysan Morshed | Physician
    • The measure of a doctor, the misery of a patient

      Anonymous | Physician
    • A doctor’s struggle with burnout and boundaries

      Humeira Badsha, MD | Physician
  • Recent Posts

    • A neurosurgeon’s fight with the state medical board [PODCAST]

      The Podcast by KevinMD | Podcast
    • Traveling with end-stage renal disease

      Ronald L. Lindsay, MD | Physician
    • The high cost of PCSK9 inhibitors like Repatha

      Larry Kaskel, MD | Conditions
    • Why non-work stress fuels burnout

      Perrette St. Preux, RN, MScPH | Conditions
    • Why wellness programs fail health care

      Jodie Green & Kim Downey, PT | Conditions
    • Canada’s 2025 health care crisis explained

      Olumuyiwa Bamgbade, MD | Physician

MedPage Today Professional

An Everyday Health Property Medpage Today
  • Terms of Use | Disclaimer
  • Privacy Policy
  • DMCA Policy
All Content © KevinMD, LLC
Site by Outthink Group

Stop mandating narrow studies of cardiovascular and diabetes drugs
1 comments

Comments are moderated before they are published. Please read the comment policy.

Loading Comments...