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Statins do not commonly cause muscle pain, research suggests
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LONDON - Taking statins does not commonly cause muscle pain, new research suggests.
Prescribed for the prevention of cardiovascular disease, there has been widespread concern the cholesterol-lowering drugs may frequently cause muscle pain or weakness.
Experts suggest this pain can either cause patients to stop taking the medication or discourage them from taking it in the first place, meaning they could miss out on the benefit of it lowering their risk of heart attack or stroke.
A new study looked at patient data to analyse the risk of muscle pain caused by statins in more detail than ever before, and found this is low and does not outweigh the benefits of statin therapy.
Professor Colin Baigent, director of the Medical Research Council Population Health Research Unit at the University of Oxford, and joint lead author of the study, said: “These findings suggest that if a patient on statins reports muscle pain, then it should first be assumed that the symptoms are not due to the statin and are most likely due to other causes.
“Statin therapy should continue until other potential causes have been explored.
“Additionally, in light of our analysis, we believe there is a need to revise the information in the medication label for statins to clarify that most muscle pain experienced during statin therapy is not due to the statins.”
Statins are one of the most commonly prescribed drugs in the UK, with up to eight million people taking them.
The NHS website lists muscle pain and one of the most common side effects.
But researchers say there needs to be a discussion about how this message can be changed.
Prof Baigent said: “Drug regulators around the world are concerned to keep patients safe.
“And up until now they’ve thought that doing that is best served by having these warnings about the possibility of muscle pain.
“What we’ve shown is actually that that’s not the best way to serve patients because patients take that information, and the moment they develop muscle pain, they suspect the statin and that leads many of them to stop the statin, which actually puts them in harm’s way.
“And so we’ve got to try and change the balance of that, and work with the regulators to do a better job of communicating the risks.”
An analysis of data from 155,000 patients from 23 trials of statin therapy found that when a patient reports muscle symptoms whilst taking a statin, there is a less than 10% chance the pain is caused by the drug.
It also suggests that the small increased risk of muscle symptoms was mostly observed within the first year of treatment.
After the first year there was no significant increase in the risk of reporting muscle pain.
The researchers highlight that the risk of muscle symptoms caused by statins should be considered alongside the cardiovascular benefits of the therapy.
Given the findings, they are calling for a review of the recommended strategies for managing muscle pain during statin use, and for the information in the labels for the drug to be revised.
Dr Christina Reith, senior clinical research fellow at Oxford Population Health and joint lead author of the study, said: “We hope that these results will help doctors and patients to make informed decisions about whether to start or remain on statin therapy, bearing in mind its known significant benefits in reducing the risk of cardiovascular disease.”
The study found that, among 19 clinical trials which also involved people being given a placebo, 27.1% of patients who were given statins (16,835/62,028) reported muscle pain or weakness, compared to 26.6% of those who were given the placebo.
After the first year of treatment, there was no significant difference in reports of muscle pain or weakness between those given statins and those given the placebo, the study found.
The researchers stress that if patients experience muscle symptoms, they should tell their doctor, and they acknowledge that in very rare cases the drug can cause quite serious muscle damage.
Professor Sir Nilesh Samani, medical director at the British Heart Foundation, which co-funded the study said: “This accumulation of data from many clinical trials provides a clear picture that while statins are associated with a small increase in risk of muscle pains or weakness, they do not cause the majority of muscle pain symptoms commonly associated with them.
“It reinforces the evidence that statins are safe, which should provide reassurance to the many people taking, or considering taking, these lifesaving drugs that have been proven to protect against heart attacks and strokes.”
This study is presented at the European Society of Cardiology Congress 2022, and published in The Lancet.
Conjoined twins with fused brains successfully separated
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By LAURA PARNABY
LONDON - Brazilian twins who were joined at the head have been successfully separated with the help of a British neurosurgeon.
Bernardo and Arthur Lima, who were born with fused brains, underwent several operations in Rio de Janeiro, with the direction of Great Ormond Street Hospital paediatric surgeon Noor ul Owase Jeelani.
The three-year-olds had seven surgical procedures, involving more than 27 hours of operating time in the final operation alone, and almost 100 medical staff.
It was one of the most complex separation processes ever completed, according to the charity which funded it and which Mr Jeelani founded in 2018 – Gemini Untwined.
Surgeons in London and Rio spent months trialling techniques using virtual reality projections of the twins based on CT and MRI scans – something Mr Jeelani described as “space-age stuff”.
He said that, for the first time in the world, surgeons in separate countries wore headsets and operated in the same “virtual reality room” together.
Speaking about the VR aspect of the surgery, Mr Jeelani told the PA news agency: “It’s just wonderful, it’s really great to see the anatomy and do the surgery before you actually put the children at any risk.
“You can imagine how reassuring that is for the surgeons.
“In some ways these operations are considered the hardest of our time, and to do it in virtual reality was just really man-on-Mars stuff.”
He said that previously unsuccessful attempts to separate the boys meant their anatomy was complicated by scar tissue, and he was “really apprehensive” about the risky procedure.
Mr Jeelani said he was “absolutely shattered” after the 27-hour operation, where he took only four 15-minute breaks for food and water, but it was “wonderful” to see the family feeling “over the moon” afterwards.
“There were a lot of tears and hugs,” he said. “It was wonderful to be able to help them on this journey.”
He added that, as with all conjoined twins after separation, the boys’ blood pressures and heart rates were “through the roof” – until they were reunited four days later and touched hands.
Mr Jeelani said they were recovering well.
He added that his charity has fast become a “global repository for knowledge and experience” of separation surgery, and he hopes it will serve as a model for a “global health service” providing expert care in other rare diseases.
“The idea behind the charity was to create a global health service for super-rare cases to try and improve results for these kids,” he said.
“The model of what we have done, I think, can and should be replicated for other super-rare conditions.”
This was Mr Jeelani’s sixth separation procedure with Gemini Untwined, after previously operating on twins from Pakistan, Sudan, Israel, and Turkey.
He led the procedure alongside Dr Gabriel Mufarrej, head of paediatric surgery at Instituto Estadual do Cerebro Paulo Niemeyer in Brazil.
Dr Mufarrej said the hospital where he works has been caring for the boys for two-and-a-half years, and their separation will be “life-changing”.
He said: “Since the parents of the boys came from their home in the Roraima region to Rio to seek our help two-and-a-half years ago, they had become part of our family here in the hospital.
“We are delighted that the surgery went so well and the boys and their family have had such a life-changing outcome.”
As Bernardo and Arthur are almost four years old, they are also the oldest craniopagus twins with a fused brain to have been separated.
According to Gemini figures, one in 60,000 births result in conjoined twins, and only 5% of these are joined at the head – known as craniopagus children.
It is estimated that 50 such sets of twins are born around the world every year.
Of them, it is thought only 15 survive beyond the first 30 days of life.
With current technologies, which the charity aims to make more accessible, approximately half of these cases would be candidates for successful surgical separation.
Morning exposure to deep red light improves declining eyesight, study suggests
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LONDON - Three minutes of morning exposure to deep red light can improve declining eyesight, new research has suggested.
Scientists wanted to look at what effect a single three-minute exposure would have while also using much lower energy levels than their previous studies.
Building on separate University College London (UCL) research in flies, the team also compared morning exposure to afternoon exposure.
According to the new study, on average there was a 17% improvement in participants’ colour contrast vision when exposed to three minutes of 670 nanometre (long wavelength) deep red light in the morning.
The researchers found this single exposure lasted for at least a week.
However, when the same test was conducted in the afternoon, no improvement was seen.
Scientists say their findings mark a breakthrough for eye health and should lead to affordable home-based eye therapies, helping the millions of people globally with naturally declining vision.
Lead author Professor Glen Jeffery, from the UCL Institute of Ophthalmology, said: “We demonstrate that one single exposure to long wave deep red light in the morning can significantly improve declining vision, which is a major health and wellbeing issue, affecting millions of people globally.
“This simple intervention applied at the population level would significantly impact on quality of life as people age and would likely result in reduced social costs that arise from problems associated with reduced vision.”
All participants were aged between 34 and 70, had no eye disease, completed a questionnaire regarding eye health prior to testing, and had normal colour vision (cone function).
This was assessed using a Chroma Test – identifying coloured letters that had very low contrast and appeared increasingly blurred, a process called colour contrast.
Using a provided LED torch-like device all 20 participants (13 female and 7 male) were exposed to three minutes of 670nm deep red light in the morning between 8am and 9am.
Three hours after exposure their colour vision was tested again, and 10 of the participants were also tested one week after exposure.
A few months on from the first test, six of the 20 participants conducted the same test in the afternoon, between 12pm to 1pm.
But when they had their colour vision tested again, it showed no improvement.
Prof Jeffery said: “Using a simple LED device once a week recharges the energy system that has declined in the retina cells, rather like re-charging a battery.
“And morning exposure is absolutely key to achieving improvements in declining vision: as we have previously seen in flies, mitochondria have shifting work patterns and do not respond in the same way to light in the afternoon – this study confirms this.”
The research, funded by the Biotechnology and Biological Sciences Research Council, and Sight Research UK, is published in Scientific Reports.
US approves first new Alzheimer’s drug in 20 years
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MATTHEW PERRONE
WASHINGTON - US government health officials approved the first new drug for Alzheimer’s disease in nearly 20 years, disregarding warnings from independent advisers that the much-debated treatment has not been shown to help slow the brain-destroying disease.
The Food and Drug Administration said it granted approval to the drug developed by Biogen for patients with Alzheimer’s disease.
It is the only drug that US regulators have said can likely treat the underlying disease, rather than manage symptoms like anxiety and insomnia.
The decision, which could impact millions of people and their families, is certain to spark disagreements among physicians, medical researchers and patient groups.
It also has far-reaching implications for the standards used to evaluate experimental therapies, including those that show only incremental benefits.
The new drug, which Biogen developed with Japan’s Eisai Co, did not reverse mental decline, only slowing it in one study.
The drug, Aducanumab, is given as an infusion every four weeks.
The FDA is requiring the drugmaker to conduct a follow-up study to confirm the drug’s benefits for patients.
If the study fails to show effectiveness, the FDA could pull the drug from the market, though the agency rarely does so.
Biogen did not immediately disclose the price, though analysts have estimated the drug could cost between 30,000 and 50,000 US dollars for a year’s worth of treatment.
A preliminary analysis by one group found that the drug would need to be priced 2,500 to 8,300 US dollars per year to be a good value based on the “small overall health gains” suggested by company studies.
The non-profit Institute for Clinical and Economic Review added that “any price is too high” if the drug’s benefit is not confirmed in follow-up studies.
Alzheimer’s gradually attacks areas of the brain needed for memory, reasoning, communication and basic daily tasks.
In the final stages of the disease, those afflicted lose the ability to swallow.
The global burden of the disease, the most common cause of dementia, is only expected to grow as millions more baby boomers progress further into their 60s and 70s.
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