Pumping Marvellous

New Novartis Heart Failure Drug

Novartis is a leading Pharmaceutical company who has developed a potential new drug to focus on acute Heart Failure. You will see a lot more activity from device and pharma companies in the future on new drugs and treatments. This is all to do with the size of the market opportunities that exist around preventing hospital admissions and re-admissions. Anyway enjoy the commentary and if you don’t understand it see it as a positive step towards helping heart failure patients.

Novartis a pharma company based in Basle, Switzerland said the drug, serelaxin, reduced shortness of breath for up to five days using one measure, but results weren’t significant, using another, which looked at a shorter time frame.

However the trial was deemed successful because only one of the main study goals had to be met. Serelaxin was given to patients upon hospitalization via a 48-hour infusion. The study failed to show that it kept patients alive or out of hospital longer than the standard treatment, meaning that it failed a secondary study goal to demonstrate the drug’s working. It did, however, show a reduction of 37% in all-cause mortality compared with placebo at the end of six months. The drug was also shown to improve a measure of kidney function, doctors said. Side effects were balanced between treatment groups, suggesting the drug is safe.

Results from the study were good enough to give Novartis the confidence to start talks with health regulators in Europe and the U.S. as it hopes to file the drug for approval next year, Dr. Ameet Nathwani, a cardiologist and global business franchise head critical care at Novartis said “It is the first time in acute heart failure that a drug showed a reduction in mortality.”

Novartis sponsored the study, which involved 1,161 patients. It was to be presented at the American Heart Association conference Tuesday in Los Angeles and published in an upcoming issue of medical journal The Lancet. Novartis said the drug was well tolerated, with side effects such as low blood pressure generally comparable to placebo.

A treatment for acute heart failure would fill an important unmet medical need.

“While we have good medications at hand which can improve the symptoms and the prognosis of patients with chronic heart failure, there is currently no good treatment if the situation becomes suddenly worse,” said Dr. Pascal Meier, a cardiologist and assistant professor adjunct at Yale Medical School. Current treatments merely ease the symptoms, without addressing the condition. “New treatment options for these patients are urgently needed,” said Dr. Meier, who wasn’t involved in the study.

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All pumped up with Omecamtiv Mercabil

I know this is a bit technical but a new drug has just been through small Phase II clinical trials  with some . The new drug is called Omecamtiv Mercabil and has been developed by a new drug company called Cytokinetics and is licensed to Amgen as reported in the Lancet.

It targets the motor proteins that cause muscle contraction and prolongs the action of the left ventricle of the heart, which pumps blood around the body. Rather than make the heart beat more often like current medicines, omecamtiv mercabil makes the heart muscles contract for longer, which increases the volume of blood the heart pumps with each stroke without increasing the amount of energy used.  That means it should not exhaust the heart, which can occur with currently-used inotropic agents.

The Phase II trial compared the intravenously-administered drug to placebo in 45 heart failure patients with impaired function of the left ventricle, who were also taking background therapy with ACE inhibitors and beta blockers. Omecamtiv mercabil increased left ventricular ejection time and stroke volume compared to control, alongside a small reduction in heart rate, suggesting that the hearts were working more effectively and efficiently.

According to Professor John Cleland of the University of Hull in the UK heart failure affects around 10 million people in the EU alone  who led the trial. “This is a totally new concept,” said Prof Cleland. “We need to see whether the improvements in cardiac function translate into real benefits for patients, in terms of their symptoms and quality of life, and whether it can impact on mortality and morbidity.”

Another Phase IIb trial should start next year, and if successful the drug could be on the market within the next three to four years, said Prof. Cleland. Cytokinetics is also developing oral formulation of omecamtiv mercabil, but this is unlikely to be ready to submit for approval for five years or more.

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Wireless Heart Implant

USA

A wireless sensor developed by Atlanta-based CardioMEMS reduced the number of hospitalisations in patients with heart failure by 39 percent. The tiny implant monitors fluid pressure in the pulmonary artery and transmits the data wirelessly to physicians, who can adjust patients’ medications accordingly.

Researchers say the sensor may significantly lower health-care costs and improve quality of life for people with congestive heart failure. The device is one of several prototypes being developed by CardioMEMS and other medical implant companies to provide continuous, personalized wireless monitors for such patients.

“I think the study shows this kind of device is incredibly useful in improving outcomes in patients and directing therapy,” says Marc Jay Semigran, medical director of the Mass General Heart Failure and Cardiac Transplant Program, who was not involved in the study.

Hospitals admit 1.1 million adults each year in the US for congestive heart failure, a condition in which pressure builds up in the circulatory system and the heart fails to pump blood adequately to the rest of the body. The American Heart Association estimates that the chronic condition costs the health-care system in the US $29 billion per year. CardioMEMS aims to reduce that figure by providing an accurate way to continuously monitor patients after they’ve left the hospital which makes sense considering the readmission rates for CHF are around 1 in 4.

The device is implanted in the pulmonary artery, an area that carries a low risk of clotting. It is smaller than other implants under development because it does not require a battery or a wire to take pressure readings. Two metal loops hold it to the sides of the artery, and a pressure transducer records the flow of fluids through the blood vessel. The sensor is powered externally by a receiver built into a pillow. When a patient lies on the pillow, the sensor is activated to take measurements and send them wirelessly to a computer, where physicians can review the data.

In a large six-month clinical trial published this month in the Lancet, 550 patients from 64 centers across the United States were equipped with the device and instructed to take readings once a day. Patients were divided into two groups. The first took medication instructions from physicians who monitored the sensor data. The second took instructions from physicians who relied on traditional indicators like weight and blood pressure. Over the six months, patients in the first group experienced 39 percent fewer hospitalizations than those in the second.

Today, physicians often assess pulmonary pressure when initially evaluating a patient, but they do so far less frequently in follow-up evaluation. That’s because the measurement requires doctors to snake a catheter into a patient’s heart and inflate a balloon. However, fluid pressure changes by the day, and monitoring those fluctuations continuously is essential to treating heart failure effectively.

“Over the years, we found that pressures go up long before patients develop symptoms and call a doctor to say they’re sick,” says Philip Adamson, director of the Heart Failure Institute at Oklahoma Heart Hospital, the principal investigator in the CardioMEMS clinical trial. “By utilizing the pressure sensor information, we’re given the ability to make changes in medications long before patients bring themselves to the doctor, and that’s how we reduced hospitalizations.”

Over the past few years, several companies have jockeyed to be first on the market with a continuous pressure-sensing cardiac implant. In 2007, Medtronic failed to get FDA approval for its sensor, a stopwatch-size, battery-powered implant wired to the heart. The device reduced hospitalisations by 22 percent, but FDA regulators did not consider that worth the risks associated with implanting it. Researchers also found that the wire connecting the sensor to the heart degraded over time.

CardioMEMS is currently seeking approval for its sensor from the U.S. Food and Drug Administration and has submitted results from the clinical study for FDA review. In the next two or three years, the company plans to integrate the sensor’s receiver into a patient’s cell phone, which will be able to instantly read pressure data and upload it for both physicians and patients to review.