LCZ696: Doctors hail new drug for heart failure

Yet-unnamed drug likely to be included in new treatment guidelines
By Salma Khalik Senior Health Correspondent, The Straits Times, 4 Sep 2014

A DRUG that has yet to hit the market, and does not even have a proper name, is likely to be included in Singapore's newest heart failure treatment guidelines.

Cardiologists revising the guidelines, which are for all doctors, are in favour of including LCZ696 because of its impressive performance in a clinical trial.

The guidelines are revised every four to five years, and the latest set is expected by the end of the year.

Results of a large clinical trial, presented at the European Cardiology Congress over the weekend, show LCZ696 more than doubled survival rates compared with the best treatments available today. It also reduced hospitalisation by 21 per cent.

The congress is the leading meeting for heart professionals. This year's event - held in Spain - was attended by 30,000 delegates.

Patients who tried the drug not only felt better, but were also able to do more.

Associate Professor Carolyn Lam of the National University Heart Centre said: "There's just no doubt: It's a paradigm shift. It's better than the current gold standard, and not just by a little bit."

Swiss pharmaceutical giant Novartis plans to file for its commercial use in the United States by the end of the year and in Europe next year.

An application to the Health Sciences Authority will come shortly after. But even if approval is fast-tracked, the drug would not be available in Singapore till the latter part of next year.

Nonetheless, Dr Kenneth Ng, a cardiologist in private practice, supported its inclusion. Dr Ng is on the guidelines committee.

Another committee member, Dr David See, said he would favour recommending its use for local patients.

Doctors pointed to the clinical trial results for their enthusiasm.

Dr Ng said that although the results are from only one trial, it involved more than 8,000 patients - including 32 from Singapore - who were followed for an average of 27 months.

The failure of the heart to work properly - which can be caused by heart attacks, heart disease and high blood pressure, for instance - affects Asians at a younger age than Americans and Europeans, while many are still leading productive lives.

The average age for heart failure in the US is 70. In Europe, it is 72, but in Singapore and the rest of Asia, it is 60.

Dr See, director of heart failure at the National Heart Centre, pointed out that a major problem with such failure patients is their frequent hospitalisations. They account for about 6,000 admissions a year, and generally stay for four to five days.

The clinical trial also found that for every 36 patients treated, the need for hospitalisation drops by one.

There are different types of heart failure, and more than half the heart failure patients in Singapore could benefit from this drug.

New heart failure drug 'a breakthrough'
It more than doubles patients' survival rate and boosts their quality of life, say doctors; pills could hit market by end-2014
By Salma Khalik Senior Health Correspondent In Barcelona, The Sunday Times, 31 Aug 2014

Doctors claim a new drug for patients who have suffered heart failure can cut the number of deaths, improve their life quality and reduce the likelihood of them being readmitted to hospital.

LCZ696, made by Swiss pharmaceutical giant Novartis, could hit the market as early as the end of this year.

Trials of the pill were so successful that they were stopped prematurely in March.

The results will be released officially in Barcelona today at the European Society of Cardiology (ESC) Congress, which has attracted 29,000 participants, including many cardiologists from Singapore.

LCZ696 was able to more than double the survival of heart failure patients, compared to the best current treatment for heart failure.

Dr Milton Packer of the University of Texas Southwestern Medical Centre, who presented the results to the media yesterday, said the significantly superior drug "has created an ethical mandate for its use in all patients with chronic heart failure".

He said the new drug can reduce symptoms and physical limitations in heart failure patients so they "felt better and could do more".

The clinical trial involving more than 8,400 patients from 47 countries was started in December 2009.

By March this year it was already found to be clearly and significantly superior to the current drug enalapril - which has been in existence for the past 25 years.

The new drug has a double action - it reduces the strain on the failing heart while promoting heart muscle recovery. It also has fewer side effects.

Dr David Sim of the National Heart Centre (NHC) was the principal investigator for the Singapore arm of the trial, which involved more than 30 severe heart failure patients. He described the new drug as "a breakthrough in the treatment of heart failure".

Associate Professor Carolyn Lam of the National University Hospital, who led her institution's participation, told The Sunday Times: "Heart failure is the top cause for hospital admissions among the elderly."

Dr Sim added that nationally, heart failure accounts for about 6,000 hospitalisations a year. While the majority of patients are in their 70s and 80s, the 1,000 patients seen at the NHC are mostly about 20 years younger.

He said: "It is a debilitating disease and roughly half would die within five years of diagnosis."

Heart failure affects 26 million people worldwide with treatment costing US$108 billion (S$135 billion) a year. Hospitalisation accounts for the lion's share.

Patients with heart failure are easily exhausted, so that even short walks of 50m can make them breathless.

Because of their frequent hospital admission, they add significantly to the bed crunch that Singapore's public hospitals are facing.

Dr Packer said the new drug's effect was consistent across all ethnic groups. There were no sub-groups which did not benefit from the drug, which is taken as a pill twice a day, he said.

Novartis hopes to get approval for the drug, which has yet to be given a commercial name, in the United States by the end of this year, and in Europe by early next year.

The five-day ESC Congress is one of the top heart meetings in the world and has attracted large delegations from Japan, the United States and Australia.

* Drug's inclusion in guidelines yet to be considered

THE article, "Doctors hail new drug for heart failure" (Sept 4), reported that a new drug, LCZ696, "more than doubled survival rates compared with the best treatments available today".

The study cited in the article has since been published in full in the New England Journal Of Medicine on Sept 11.

The actual reported death rate from any cause in the LCZ696 group occurred in 17 per cent of patients, compared with 19.8 per cent in the enalapril group.

This translates to a relative survival benefit of 16 per cent (absolute benefit 2.8 per cent).

The Ministry of Health heart failure clinical practice guidelines are still in development.

The workgroup has not yet deliberated on LCZ696 and will consider all evidence when doing so.

The article's claim that the "drug (is) likely to be included in new treatment guidelines" is premature, given that the drug has not yet been licensed for use.

In general, most guidelines will not consider drugs in development for inclusion in clinical guidelines.

Bernard Kwok (Dr)
Chair, Heart Failure Clinical Practice Guidelines
Ministry of Health
ST Forum, 10 Oct 2014