Heart disease teaser drugs

  There really hasn’t been much interesting talk this year about ivabradine, a drug marketed in Europe by the French company Schweppes under the trade name Corlentor, Procoralan, for the treatment of heart failure and stable angina. It is not yet available for sale in the United States, where Amgen is advancing its commercialization. In April of this year, the FDA has granted fast-track status to ivabradine to facilitate drug development and expedited review for serious diseases. Ivabradine is an oral, specific If current blocker, the first pure heart rate lowering factor, the first selective specific If inhibitor, acting selectively on the sinus node, Ivabradine significantly slows sinus rhythm, and unlike other negative frequency drugs (such as beta-blockers and calcium antagonists), Ivabradine has no effect on intracardiac conduction, myocardial contractility or ventricular repolarization.  It is the drug that has performed nothing else but windy this year. A long SIGNIFY clinical trial was followed by not only surprising results, but also gripping and troubling events. The clinical trial studied the effects of high-dose ivabradine on up to 19,000 people with stable angina, and some serious problems arose in such a large sample (more than 12,000 people). The EMA Drug Risk Assessment Committee concluded that ivabradine should be used only when the patient’s resting heart rate is at least 70 beats per minute, and that ivabradine should only be used for alleviating the symptoms of angina and has not been shown to be beneficial in reducing the risk of cardiovascular and heart failure mortality.  Something interesting came from the SIGNIFY clinical investigators at the European Society of Cardiology meeting (ESC) in Barcelona, when at the last minute they dropped out of a planned press conference to discuss the results of the SIGNIFY clinical trial and told the ESC that the EMA had asked them to remain calm until the EMA had reached a finding. However, the EMA denied this claim and said that the EMA never asked that SIGNIFY clinical trial investigators not discuss or evaluate their trial and that investigators were free to publish a discussion of their findings.  Given the news we’ve gotten so far about Ivabradine, it’s not funny that many cardiovascular experts who have nothing to do with Amgen and Schweppes suspect that doctors really have no reason to prescribe the drug.