Category: The Lancet

The CardioMEMS’ heart failure pressure measurement system

By Steven Greer, MD

The CardioMEMS’ heart failure pressure measurement system will be evaluated by Read more »

Serelaxin to treat acute heart failure

The FDA granted Novartis the coveted “Breakthrough” status for drug serelaxin to treat acute heart failure. If approved, it will be the first drug in decades to address AHF. Also, early data suggest that serelaxin might have a survival benefit, which would be unprecedented.

To learn more, we interviewed Gregg Fonarow, MD, Director, Ahmanson-UCLA Cardiomyopathy Center and Co-Chief of Clinical Cardiology. He discusses the strengths and weaknesses of the Phase 3 trial upon which the FDA based the decision to grant Breakthrough status.

Matthews Chacko, MD: Renal denervation to treat HTN

December 29, 2010

Many medical devices cause a far greater clinical impact than pharmaceutical therapies such as statins and chemotherapies. For example, ICDs have a dramatic life-saving capability, but for only a small portion of the patients receiving an ICD. Likewise, coronary stents improvement survival in patients with acute MI, but merely alleviate angina in most other patients.

A new device, unknown to most doctors, currently being investigated in Australia, Europe, and South America, could confer the most dramatic clinical benefit to the largest group of patients in the history of medical devices. That device is the Ardian renal artery/nerve ablation catheter to treat essential hypertension, recently acquired by Medtronic.

Medications to treat high blood pressure deliver tens of billions in revenue to the pharmaceutical companies, yet the magnitude of effect is just a few millimeters of mercury reduction in hypertension. In a small, but well designed, trial of the Ardian device, improvements in blood pressure of the magnitude of 30 mmHg were seen in almost all patients. If these data hold up, and safety concerns do not arise, this device would turn the hypertension market upside down, to the dismay of Big Pharma. Total medical costs could be reduced as well if damage to the kidneys, eyes, and hearts of millions of patients are avoided.

Matthews Chacko, MD, Director of Peripheral Vascular Intervention at Johns Hopkins, discusses this device, the data in The Lancet, and his thoughts on safety and efficacy.


Gordon Guyatt, MD: Update on the problem of clinical trials being stopped early to inflate efficacy of drugs

Gordon Guyatt, MD, epidemiologist, internist, and biostatistician at McMaster University updates us on the progress being made against the problem of clinical trials being stopped early to inflate efficacy of drugs. Since our first coverage of the topic two years ago, the FDA, the Cochrane group, and other agencies have implemented changes in policy.  Dr. Guyatt discusses the Crestor JUPITER trial as an example of a trial that was stopped early and inflated efficacy.


Paul Richardson, MD: Current Therapies for Multiple Myeloma

Interviewed by Steven Greer, MD

Dr. Paul Richardson, Clinical Director of the Multiple Myeloma Center at Harvard’s Dana-Farber Cancer Institute gives an overview of the current standard of care for patients with multiple myeloma


Paul Richardson, MD: Three-drug regimen for multiple myeloma

Dr. Paul Richardson of Harvard’s Dana-Farber Cancer Institute reviews the recent Lancet article by Cavo, et al, that was the first randomized controlled trial to compare three-drug regimen (bortezomib plus thalidomide plus dexamethasone) to just thalidomide/dexamethasone. The complete response rates and progression free survival were significantly better in the three drug arm.


Limitations of The Lancet papers espousing the cancer risk reduction of daily aspirin

March 21, 2012 By Dr. Kausik Ray from St. George’s University in London

Here are my thoughts on The recent Lancet papers that uses meta-analysis to study whether daily aspiring reduces the risk of cancers. I think the editorial was very good and I concur with the conclusions. There were methodological limitations:

1) The meta analyses conducted included data on about 36 000 people and about 360,000 person years of follow-up (FU). However, they excluded the two largest trials which had cancer incidence as a prespecified endpoint (the Women’s Health study and the Physicians Health study). We included those in our paper and had data on 102,000 people and 700,000 person years of FU.

2) That being said, the present data provide mechanistic insights into the potential role of aspirin. The fact that benefit on cancer incidence with low dose appears after 3 years fits with what we understand about cancer neogensis and the fact that in the second paper there were favorable effects on cancer metastases provide supportive data for a potential role for aspirin.

3) The data do not tell us much about who to treat or the risk benefits, as you need to treat about 189 people for 10 years or 1890 people for 1 year to prevent 1 new cancer. In contrast for every 219 people treated for 5 years there’s one extra major non cerebral bleed, or 1095 people/year. So the risk benefit, on average, is 2 extra bleeds per incident cancer prevented. Remember these do not capture intracerebral bleeds, retinal bleeds hospital admissions etc as cancer incidence is collected in cancer registry and is more reliable than collecting bleeding data after trial follow up has finished. The data that bleeding declines and aspirin is protective against bleeds >5 years is biologically implausible. The implication is if you treat whole populations and more bleed especially early they come off drug so the NNT (i.e. those who stay on drug) to prevent one event will become even higher.

4) The studies published add considerably to our understanding, but guidelines should not change on the basis of these for general populations. We need the results of ongoing studies which accurately record cancer incidence and document non-trivial bleeds over extended follow up to determine net benefit. Beyond that we need at an individual level to determine who is at high absolute risk of bleeding and who is at high absolute risk of cancer to determine on a personalized level whether the treatment is suitable. (e.g. those with a high bleeding risk score versus a low risk score for cancer would not be individuals the medical community should perhaps offer this treatment to.)

Ongoing trials will help clarify matters, and what the present study adds is the possibility that in a few years time, if we correctly identify risk versus benefit, we might use aspirin for the primary prevention of cancer rather than vascular disease.

The following is or previous interview with Dr. Ray on the bleeding risks of aspirin.

Lon Schneider, MD: New criteria to diagnose Alzheimer’s Disease

Lon Schneider, MD, Director of USC’s Alzheimer’s Center, discusses the new lexicon to discuss prodromal Alzheimer’s and the new biomarkers to diagnose AD decades sooner than current methods. These new methods promise to expedite clinical trials and drug development, but pose challenges for the current day clinician.

The risk of diabetes associated with statin drugs

Produced and interviewed by Steven Greer, MD

The statin drug Crestor, made by AstraZeneca, recently received an expanded label indication from the FDA to include patients with normal cholesterol levels. At the same time, new studies indicate that statins increase the risk of diabetes by 9%. For low-heart-risk patients, the risk-benefit analysis might not support statins.

Naveed Sattar, MD PhD, author of the Lancet paper highlighting the diabetes risk, spoke with The HCC. He reviewed his findings and posed some possible biological mechanisms of action to explain how statins could causes diabetes. Other drugs, such as antipsychotics, are well known to cause diabetes.

Update: An article in Arch Int Med found similar results. In a female population studied, use of statins was associated with a 40% increase in diabetes.

More setbacks for Bydureon (exenatide)

October 29, 2010

In Part 2 of the Weekly Summary show, Jay Skyler, MD, leads the discussion about the surprise setbacks to approval for the diabetes drug Bydureon (long-acting exenatide) to be marketed by Eli Lilly and Amylin Pharmaceuticals. After answering the data required in the first Complete Response letter from the FDA, the agency issued another CR letter asking for more data on QT-prolongation.

Topics discussed include:

  • Was the FDA influenced by the Avandia saga?
  • The details of what is now requested about the extra QT data
  • Is the drug industry going to shy away from new diabetes drugs given the burdensome FDA requirements?

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