Health, Medical, Research, Science

An alternative to statins for those at risk of heart disease…

ALN-PCS CUTS ‘BAD’ CHOLESTEROL

For those patients unable to take statins, a new type of cholesterol-lowering drug could help those at risk of heart disease, new research has revealed.

The treatment referred to as ‘ALN-PCS’ cuts the levels of ‘bad’ cholesterol by more than half – a reduction similar to statins.

Experimental findings from the first tests in humans do show the potential benefits of an agent that works in a different way to statins. The drug blocks production of a protein that destroys receptors that normally clear harmful LDL cholesterol from the bloodstream.

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The first trial has involved 32 volunteers with high LDL (or ‘bad ‘cholesterol). People from this group were then randomly assigned to receive either an injection of ALN-PCS or a saline placebo.

A single dose of the drug cut LDL levels by as much as 57 per cent. The research findings have been published in the medical journal, The Lancet. The researchers suggest that the bigger the dose, the greater reduction in LDL.

Kevin Fitzgerald, a trial investigator from Alnylam Pharmaceuticals, was integral to developing the new treatment. He says the drug – which would likely be developed in tablet form – could be used for the one in five heart disease patients intolerant or resistant to statins, or even to enhance their effects.

ALN-PCS works by blocking the production of the cholesterol regulator PCSK9 – a protein that destroys low-density lipoprotein (LDL) receptors that normally clear LDL cholesterol from the blood.

Genetic research has shown previously that mutations’ resulting in a rise in PCSK9 activity does lead to a major increase in LDL cholesterol. This contributes to the build-up of plaque inside blood vessels, while genetic variants that cause a reduction in PCSK9 activity are known to lower cholesterol dramatically.

The 32 volunteers selected for the trial, aged between 18 and 65 years old, were deemed to have raised cholesterol levels ranging from between mild to moderate. The volunteers were randomly assigned to receive injections containing one of six doses of ALN-PCS, or saline.

For those given the highest dose of ALN-PCS, LDL cholesterol dropped up to 57 per cent – with an average of 40 per cent overall – compared with the results from those who had taken the saline placebo.

Professor Peter Weissberg is medical director at the British Heart Foundation. He said:

… People with extremely high cholesterol are at increased risk of a heart attack and this approach could offer new hope for those who are resistant to statins.

… These initial results add to growing evidence that blocking the action of a certain protein can dramatically lower ‘bad’ LDL cholesterol.

… More research is now needed to confirm this approach is both safe and effective at preventing heart attacks in the long term before it becomes widely available.

According to further research in the United States, statins may also help keep the mouth as well as the heart healthy. Significantly reduced levels of inflammation associated with gum disease were found in patients taking statin pills for heart conditions.

Dr Ahmed Tawakol, the study leader, and from the Harvard Medical School, said gum and heart disease were often ‘co-existing inflammatory conditions’ and that their chemical biologies ‘may be intertwined’.

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Health, Medical, Research

Statins can weaken muscles and joints…

New research warns that taking statins will make you more likely to be diagnosed with muscle pain, joint disease and injuries.

Researchers found a 20 per cent increased risk of muscle problems in those patients on the cholesterol-lowering drugs compared with those not taking them.

The risk is deemed to be relatively small but it is important because millions of older patients with heart conditions take statins and their use may eventually widen to include healthy younger people.

Statins are the most widely prescribed drugs in Britain. The number of patients taking them is estimated to be as high as 8 million. There have been persistent complaints about side effects such as muscle pain and weakness.

The most serious adverse reaction of taking statins is myopathy, and affects around one in every 1,000 users. The reactions include muscle pain, tenderness and weakness. This condition can progress to rhabdomyolysis, a complete breakdown of muscle cells that can lead to kidney failure and death.

In some patients muscle weakness may persist even after stopping the drugs. And a British Heart Foundation survey found that one in three patients prescribed statin drugs doesn’t take them, partly because of the side effects.

The latest study carried out in the United States investigated the scale of illnesses linked to statins, including muscle weakness, muscle cramps and tendon diseases.

Researchers based at the Veterans Association in North Texas, Dallas, used data from the US military health care system.

Patients were divided into two equal groups: 6,967 who used statins for at least 90 days in 2005, and 6,967 non-users.

A report published by JAMA internal medicine says that statin patients were almost 20 per cent more likely than non-users to have a diagnosis of a musculo-skeletal disease, a 13 per cent higher risk of dislocation, strain or sprain, and slightly higher risk of muscle pain.

But statin users were no more at risk of joint-diseases such as osteoarthritis than non-users. The report states: ‘To our knowledge, this is the first study to show statin use is associated with an increased likelihood of diagnoses of musculoskeletal conditions, joint diseases and injuries.’ (sic)

Calls have been growing for healthy over-50s to take statins, not just those at extra risk of a heart attack. The researchers also said that any significant effect on general health, however small, needs to be carefully considered. These findings are concerning because starting statin therapy at a young age for primary prevention of cardiovascular diseases has been widely advocated.

Warnings from statin drug manufacturers’ include muscle pain and weakness, memory loss, fatigue, sleep disturbances, sexual dysfunction and depression. There is also a higher risk of developing diabetes.

Scientists in the UK say the study shows a very small impact of statins, increasing the risk of musculoskeletal disorders overall from 85 per cent in those not on statins to 87 per cent on a statin.

The Royal Pharmaceutical Society fears that more patients might stop taking the drugs. Citing that the UK has some five million people taking statins to prevent heart attacks and strokes, the Society says that if 1 per cent of these patients stop taking their statins due to concerns about muscle pains we will see at least 2,000 more heart attacks and strokes over the next ten years as a result, but avoid only 1,000 musculoskeletal problems. The Society also points out that musculoskeletal disorders occur commonly and are rarely due to taking statins.

It is argued, too, that statins save lives when used in the right type of patient – generally those at higher risk of stroke or heart attack because of other medical problems. With statins the benefits are hidden because many people who otherwise would have had a heart attack today were prevented from having a cardiac arrest because of the taking of these drugs. Doctors point out that the side effects of statins are often all too obvious, and this biases many people against a life-saving tablet.

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