Less Deadly Heart

In late August, Daily Mail has published an article of a study carry out mainly by John McMurray and Milton Packer. It was presented in the European Congress of Cardiology in Barcelona, on August 30th. This research deals about the HF (Heart Failure) which is a physiological state that occurs when the heart is unable to pump sufficiently to maintain blood flow to meet the needs of the body, it occurs when the fraction ejection is less than 40% (a healthy left ventricle expels blood in valuables above 50%). This problem increases venous pressure and makes the body retain fluids. The investigation lasted 27 months and was performed in more than 8000 patients; in the trial patients were given either 200mg of LCZ696 (new medicine) twice daily (in addition to Enalapril) or only 10mg of Enalapril (current medicament) twice daily – in addition to the recommended treatment – in a bid to compare mortality and hospitalization rates.

From: New England Journal of Medicine http://www.nejm.org/doi/full/10.1056/NEJMoa1409077#t=articleBackground

In the period of the research, a total of 10,521 patients and 1,043 centers in 47 countries participated. Of the total of the patients, 2,079 didn’t fulfill requirements for randomization and 43 couldn’t participated because of some problems during the process. Finally, 4,187 patients were randomly assigned to receive LCZ696 and 4,212 to receive Enalapril for the intention-to-treat analysis. From: New England Journal of Medicine http://www.nejm.org/doi/full/10.1056/NEJMoa1409077#t=articleBackground

Enalapril (C20H28N2O5) is the normal medicament for HF and for hypertension. It is in a class of drugs called ACE inhibitors (angiotensin-converting enzyme). Enalapril works by blocking an enzyme in the body required to cause blood vessels to narrow (constrict). As a result, the blood vessels relax. This lowers blood pressure and increases the supply of blood and it makes the heart more efficient. In the other hand LCZ696 blocks AT1 (an angiotesin receptor, it has vasopressor effects and regulates aldosterone secretion) and thereby causes vasodilation and increases excretion of sodium and water by kidneys. The primary endpoint consists in reduce cardiovascular deaths or hospitalization by this injury. Enalapril reduces the hospitalizations or deaths by a 18%. LCZ696 in addition to Enalapril doubles the effect of only Enalapril, that means that there is a reduction of 20% on top of 18%, it signifies that in a group of 21 patients a patient else will get the primary endpoint. This is not the only advantage, something really important is to improve quality of life (less renal injury, less secondary effects…), that means that they feel better with the LCZ696.

Despite the explained before, there are also articles which question the effectiveness of the new treatment. One of the most common is the one which indicates that the biggest beneficiary would be the pharmaceutical company that distributes the drug, because we are talking about a common disease in world’s population, so there is  pharmaceutical interest (mainly economical) in develop alternative medicament although the health improvement won’t be too high, that means that even though that the decrease in primary endpoint was proved the pharmaceutical company will try that people perceive an even greater improvement. Other articles, without question the effectiveness in the new drug,  indicate that personal factors should be taken into account before decide which kind of treatment will be applied to the patient, in brief, there will be some patients who will be more effective the use of the new drug, and there will be others which will be continue giving their old prescription.

The new drug’s company pretends to get license next year, so the product would be available in 2015.

Original source: The differences between original and popular article are easy to see. First one has more specialized words and second one is easy to understand. Other big difference is the lacks on second one, especially in the explanation of the process, which is something understandable enough to write in this kind of article.

Personal opinion: I chose this article because I thought it was a really interesting thing because the HF it’s becoming in one of the mainly problems of public health in our environment countries and its incidence is increasing with aging. Currently cardiovascular problems are the main cause of death, so I thought that many people will be interested in this new treatment. Also at late October will take place the National Congress of Cardiology in Santiago de Compostela. This new treatment may be the leading topic.

From the webside: Palacio de congresos e de exposición de Galicia. http://www.palaciosantiago.com/evento/sec-2014-el-congreso-de-las-enfermedades-cardiovasculares/

Video of the Experts’ Discussion



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3 Responses to Less Deadly Heart

  1. Very good!. Regarding all the elements requested and stated in the instructions provided, your post it’s perfect.

    Although I’m not an specialist in heart diseases, (I’m a doctor yes, but in Biology, not specialized in human health), I use to guard against this kind of things; when I read something as “new heart drug will cut deaths by a fifth” in a media well known as a tabloid. There’s not spectacular advances in pharmacological research unless it comes from a radical different approach to a problem. It isn’t the case, but they are talking about heart failure, with millions of people having drugs daily. Lots of money. Yes, the original paper appears on New England Jouunal of Medicine an excelent peer-reviewed academic source, but it is also true that can be read at the bottom “Supported by Novartis”. You mention the Cardiology Congress in Santiago, here you have a screen-shot from their web site.

    And SO,
    It’s easy to google for critics on their study design. I recommend you to read this, because it is explained in detail what methodological aspects must be analized in a clinical trial. Pay attention to the last part, where you can read: “está apenas testando a hipótese de que o LCZ 696 (sacubritil + Valsartan máximo) é superior a enalapril meia boca”

    You can find the same critics in several NEJM reader’s comments at the bottom of the video you link (Experts’s Discussion). You can go, among many others, to “With CHF, curb your enthusiasm”, “Was the control drug comparative?”, and specially to “Significant Problems in Study Design”.

    Paula, your post is OK, but you have enough ability to go deep on this question, write something about it, and maybe explain it to your classmates.

    By the way, remember that “actual” is a false friend.

    • Paula Pais Rodríguez di:

      I have red the comments about my post and I think I have already corrected the errors I had had. I wrote a paragraph about the critics and I added a screenshot about the SEC 2014, as you had advised me.

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