Why a new drug can supplement statins in reducing heart attacks and strokes

WHAT DOES THE STUDY SAY?

What did the recent study show? The study of 13,970 statin-intolerant people, published in the New England Journal of Medicine. showed that the drug lowered the levels of LDL cholesterol by 21 per cent as compared to a placebo without any therapeutic benefit. A follow-up of an average three years showed that the drug reduced the primary outcome – a composite of deaths due to heart conditions, heart attack, stroke, or revascularisation procedures to open up blocked vessels – by 13 per cent as compared to the placebo. When the researchers looked at the outcomes separately, they found that Bempedoic Acid reduced heart attacks by 23 per cent as compared to placebo and revascularisation procedures by 19 per cent.

WHAT DO CARDIOLOGISTS SAY?

“We have already had the drug in India for almost a year now — and we knew what it was supposed to do — but this large scale study gives us the data to show that it effectively reduces the risk of cardiovascular diseases. Around 10 per cent of the people who need statins cannot use them because of the muscle pain, but this medicine has now shown to effectively reduce LDL levels without these pains,” says Dr SC Manchanda, senior cardiologist from Sir Ganga Ram hospital.

“Statins are the leader among blood cholesterol reducing drugs, having proved their efficacy in reducing the risk of heart attacks and strokes, both among those who already experienced such an event and among those at a high risk of having such an event. The cardiovascular protection benefit comes both from reduction of the LDL cholesterol and stabilising effect on atherosclerotic plaques in blood vessels. However, studies in different countries have reported that between 10-30 per cent of people on statins report disabling muscle aches, which lead to discontinuation of treatment. While statin enthusiasts initially dismissed this as unrelated to statin use, several studies have now confirmed that this is indeed a true statin effect,” says Prof K Srinath Reddy, distinguished professor, Public Health Foundation of India (PHFI).

HOW THE NEW DRUG CAN BE A PART OF COMBINATION THERAPY

Explaining the study, he adds, “The recent study, demonstrating that Bempedoic Acid provides cardiovascular protection, through blood cholesterol reduction, offers an alternate pathway for gaining cardiovascular protection without experiencing severe muscle pains. This drug acts on a liver enzyme to reduce LDL cholesterol in blood and does not affect the skeletal muscles. In the clinical trial, it reduced blood cholesterol by 21 per cent, risk of heart attacks by 23 per cent and the need for a coronary revascularisation procedure by 19 per cent. The only side effect of note was a slightly higher incidence of gout in those taking the drug (3.1 per cent) compared to the placebo group (2.1 per cent). This is due to a build up of uric acid in the blood and can be prevented by diet or drugs. While statins remain the mainstay of cardiovascular disease prevention through cholesterol reduction, Bempedoic Acid offers a way to extend that protection even to persons who do not tolerate statins.”

Concurs Dr Manchanda. “The drug can be extremely useful for combination therapy in a huge proportion of people who are unable to bring down the LDL levels to the desired levels using statins alone. The maximal benefit from statins is only 50 per cent, meaning it will reduce the LDL level of a patient coming in with 180 mg/dL to only 90mg/dL at best. But in patients with very high risk, such as those who have already undergone an angioplasty (stenting) but still have high cholesterol levels, achieving the recommendation of 30 to 50 mg/dL is not possible with statin alone. Combining statins with Bempedoic Acid or another drug like Ezetimibe can help in achieving the targets,” says he.

“Besides there is a maximum dosage of statin that a person can tolerate or there are people who can only tolerate lower dose statins. In such cases, combination therapy can help,” he adds.

Dr Manchanda says that although new, the drug is not very expensive: “The other alternative available so far was something called PCSK9 Inhibitors. But, it never took off in India mainly for two reasons – it is expensive and it is an injectable to be taken every 15 days.” In contrast, he says, Bempedoic Acid is an oral pill of 180 mg to be taken once a day and not very expensive. “It is a good addition to the armamentarium for the treatment of cardiac patients,” said Dr Manchanda.

HOW DOES BEMPEDOIC ACID WORK?

Unlike statins, Bempedoic acid works by drawing out the plaque-forming LDL only from the liver, thereby not acting on muscles or causing muscle pains. The study found that the drug can increase serum creatinine levels and uric acid a little. “Until now, there have not been any drugs designed specifically for statin-intolerant patients,” said lead author of the study, Dr Steve Nissen from Cleveland Clinic, in a release.

“While statins remain the cornerstone of risk reduction in patients with elevated LDL cholesterol, this is a major step forward for a population who need statins but suffer troublesome side-effects,” he added.