The Food and Drug Administration (FDA) has just granted Serelaxin made by Novartis breakthrough designation for acute heart failure. This experimental drug, also called RLX030, has shown promising results in treating symptoms of acute heart failure (AHF) including shortness of breath, congestion and the worsening of heart failure and increasing their life-span as well. Typically patients diagnosed with AHF die within a year of hospitalization even with all the available treatments. This is important news as there has been no successful trial of any new drug or treatment for AHF that has worked in the past 20 years.
Trial of Serelaxin
In the Phase 3 trial of this drug, co-led by Professor John R. Teerlink MD, of the Section of Cardiology, San Francisco Veterans Affairs Medical Center, University of California, San Francisco, the co-lead investigator of the RELAX-AHF study1,161 patients of acute heart failure in 11 countries were either given a placebo or Serelaxin via IV apart from other standard drugs for this condition. Of the patients who received the drug, a significant number had reduced shortness of breath or dyspnea and also reduced all cause mortality risk rates by 37 percent and cardiovascular mortality risk also by 37 percent, giving patients a six month survival benefit. Reducing dyspnea was one of the endpoints of the trial and this one was successfully reached. Of the patients who received the placebo, 65 died, while those who received Serelaxin, 42 died.
The drug was well-tolerated by patients with few incidences of side effect like hypotension and gastrointestinal disturbances, which manifested in both groups of patients and were manageable.
Unfortunately, Serelaxin did not meet statistical significance on its two secondary end points that were days alive at day 60 and a composite of cardiovascular death and heart/renal-failure hospitalizations up to day 60. As such, despite its perceived and statistically significant benefits, it did not actually succeed in reducing the number of hospitalizations due to AHF, though it did reduced the number of deaths and helped patients survive longer.
How it works
Serelaxin is a recombinant form of the naturally occurring hormone relaxin-2 that is found in both men and women. In men it is thought to help sperm motility. In pregnant women, the amount of the hormone rises to support the effects of pregnancy on the body and its pressure. It relaxes the reproductive organs and the pelvis to take the stress of pregnancy and childbirth and increases blood flow without increasing blood pressure. In patients of AHF this hormone works by increasing the net output of blood from the heart and blood flow in the kidney. It also reduces organ damage caused by heart failure; it also has anti-inflammatory properties.
Statistics of AHF
Heart disease is constantly on the increase. There are many different kinds of cardiovascular ailments that are all treated differently, depending on their causative factors and patient health. With more than 15 million cases of AHF globally of which 3.5 million occur in the US and EU alone, AHF is serious especially since mortality rates are high. Overall heart disease is a leading cause of death and causes pressure on the healthcare system, costing $34.4 billion annually including cost of treatment, medical services, hospitalization and loss of productivity. While statistics say that half the people suffering from heart failure die within five years, the rates for AHF are much higher.
In fact AHF often occurs in patients without any previous history of heart disease or cardiac problems. AHF patients need urgent and immediate care in a hospital setting and their blood pressure and breathing needs to be carefully monitored. Patients are also prone to infections of various kinds, including septicemia and bacterial infections. Diabetes, high blood pressure and renal failure often aggravate and are aggravated by AHF since they have a synergestic effect on the body.
Current available treatment for AHF
AHF may appear without any warning, and without a previous history of heart problems, so it is important that the patient should be diagnosed and treated in a health care facility, preferably one that offers special cardiac care. Of course, at times heart disease is also present, but even then AHF can occur suddenly. The standard treatment for AHF includes one or a combination of:
• Morphine helps with dyspnea and restlessness
• Anti-coagulants like heparin or similar to increase blood flow
• Vasodilators that improve blood circulation
• Nitrates in the right doses relieve pulmonary congestion
• Diuretics to improve kidney function and lower blood pressure in patients with edema
• Oxygenation to relieve respiratory distress
There are some other medicines, which may be given to patients with special problems. Many of the usual heart disease medicines are not used to treat AHF. After the patient has stabilized then other medicines may be included again depending on the patients’ particular medical history and investigative tests. Beta blockers may be given to the patient once he or she has stabilized. Patients who suffer from heart failure are at greater risk of renal failure as well and may need haemodialysis if they already have kidney problems. Patients may also require circulatory assist devices to maintain blood flow.
AHF often has a complex etiology: often there are a number of different causes for heart failure. Even the reasons for AHF are poorly understood. As such, it looks like Novartis’ discovery of this new treatment that increases the life span of the patient is an exciting development in cardiac care drugs.