In the realm of cardiovascular agents, the heart failure segment currently represents a hotspot for product development. With around 30 compounds in various stages of development, ranging from Phase I to pre-registration, drug companies recognize that this is a growing disease market. Ivabradine (Servier's Procoralan) represents one of the most recent entries into the heart failure market, having found use in both the treatment of chronic heart failure (CHF) and stable angina in Europe.
Ivabradine is a heart-rate-lowering agent that selectively inhibits the sinus node I(f) pacemaking current, thereby decreasing myocardial oxygen demand without effecting inotropism or blood pressure. Backed by sound clinical data and a fairly benign safety profile, ivabradine has enjoyed moderate use within the countries it has launched in.
In 2005, ivabradine received its label for the treatment of chronic stable angina in patients who were intolerant of or inadequately controlled by beta blockers and whose heart rate exceeded 60 beats per minute (in sinus rhythm). This indication was acquired on the back of the 10,917 patient BEAUTIFUL study. Although, ivabradine did not significantly reduce the composite primary end point of cardiovascular death, admission to hospital for acute myocardial infarction, and admission to hospital for new onset or worsening heart failure, it did significantly reduce the secondary end points of hospital admission for fatal/non-fatal myocardial infarction and coronary revascularization (See Table) (Fox K, 2008).