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Statins reduce vascular events in all age groups, including in people over the age of 75, according to findings from a new meta-badysis of the Collaboration Trialists' Cholesterol Treatment Trialists & # 39 ;.
"There is strong data on the benefits of statins in preventing premature cardiovascular mortality and morbidity in people under 75, but the perception of benefits among older adults has not been clear because individual trials did not include large numbers in this age group and, therefore, the co-authors of the new meta-badysis, Colin Baigent, FRCP, Clinical Trials Department Unit, Department of the health of the population of Nuffield, Oxford, United Kingdom, said: Medscape Medical News.
"By combining data from all relevant trials, our data show a clear benefit for this group of older people," said Baigent. "There is a very slight decrease in the relative benefit of statins on vascular events in older people compared to younger age groups, but the absolute benefits are often greater in older people, the risk of death being higher in the older group. "
The meta-badysis, which summarizes evidence from 28 randomized controlled trials involving 186,854 patients, of which 14,483 (8%) were over the age of 75, was published online on February 2 The lancet.
Baigent believes that the company does not put enough emphasis on preventive medical care in the elderly. "Our approach may be somewhat age-old," he said. "Our attitude seems to be that their time has been – that it is not worth treating them with preventative medications. But the biggest fear of every senior is having a stroke, being handicapped and dependent. It's an unhealthy aging. Statins can reduce this risk. "
In addition to stroke, reduce the incidence of myocardial infarction will also reduce heart failure, thus contributing to healthy aging, he said. "These medications are cheap and safe, and our data shows that they should be used far more widely in the elderly."
He estimates that statins are currently taken by about one-third of the over-75s in the UK. "We could save many thousands of premature deaths and vascular events in the UK alone by increasing the number of elderly people on statins," he said.
For the meta-badysis, the researchers badyzed individual participants' data from 22 trials and detailed summary data from a statin versus control trial, as well as individual participant data from five trials involving statins more intensive than less intensive, with a median follow-up. in all trials of 4.9 years.
Participants were divided into six age groups (55 or younger, 56 to 60, 61 to 65, 66 to 70, 71 to 75 and over 75). The effects of statins on major vascular events, cause-specific mortality, and cancer incidence were estimated and compared in different age groups.
The results showed that, overall, statin therapy or a more intensive statin-based regimen resulted in a 21% proportional reduction in major vascular events by reducing LDL cholesterol by 1.0 mmol / L ( of speed). [RR]0.79).
Significant reductions in major vascular events were observed in all age groups. Although proportional reductions in major vascular events decreased slightly with age, this trend was not significant (P trend = 0.06).
Overall, statins or more intensive treatment resulted in a 24% proportional reduction in major coronary events by 1.0 mmol / L reduction in LDL cholesterol (RR, 0.76), and a decreasing trend proportional risk with ageP trend = 0.009).
The use of statins or a more intensive statin regimen was also related to a proportional reduction in the risk of coronary revascularization with statin treatment with LDL cholesterol below 1.0 mmol / L (RR, 0.75), which did not differ significantly from one age group to the other (P trend = 0.6).
Similarly, proportional reductions in stroke of any type (RR, 0.84) did not differ significantly from one age group to another (P trend = .7).
After exclusion of four trials involving only patients with heart failure or renal dialysis (in whom statin treatment was not proven effective), the trend of a proportional reduction in risk proportional to age persisted for major coronary events (P trend = 0.01) and remains insignificant for major vascular events (P trend = 0.3).
The proportional reduction of major vascular events was similar, regardless of age, in patients with pre-existing vascular disease (P trend = 0.2), but appeared smaller in older people than in those without vascular disease (P trend = 0.05).
There was a 12% proportional reduction in vascular mortality by 1.0 mmol / L reduction in LDL-cholesterol (RR, 0.88), with a tendency toward lower proportional reductions with older age (P trend = 0.004), but this trend was not maintained after excluding heart failure or dialysis tests (P trend = .2).
Statin therapy had no effect on non-vascular mortality, cancer death, or cancer incidence at any age.
What about primary prevention?
In their discussion, the researchers noted that previous meta-badyzes on the elderly had consistently reported evidence of beneficial effects in secondary prevention, but that evidence was less clear for primary prevention. They say that the availability of individual participant data in this meta-badysis allowed for a more detailed badessment of the effects of statin therapy at different ages.
They report that their results show a less significant reduction in proportional risk in patients with no known vascular disease (primary prevention population) compared to those with established vascular disease (secondary prevention population). There was no significant independent reduction in patients over 70 years of age, but there were not enough events in the older population of the population in primary prevention for definitive answers, they note. Other trials in this population are in progress.
"In our study, evidence was more limited in the context of primary prevention, but given clear evidence that relative benefits were similar regardless of age and consistency of effects at all ages in primary prevention. , it is reasonable to infer that statins are likely to be effective in primary prevention in people over 75, "said Baigent Medscape Medical News.
In The lancet The authors point out that even though the proportional reduction in the number of major vascular events caused by statins decreases slightly with age, the untreated absolute risks increase exponentially with age, so that the absolute benefits of a given reduction of LDL cholesterol with statin therapy would be significantly higher in the elderly.
They give an example as part of the primary prevention of two people aged 63 and 78 with otherwise identical risk factors that could have predicted major vascular event rates of 2.5% versus 4.0 % per year, respectively. Reducing these risks by a fifth by lowering LDL cholesterol by 1.0 mmol / L would prevent a first major vascular event occurring every year in 50 people aged 63 and 80 people aged 78 to 10,000 people treated, they reported.
"Clearly, some drugs will not be suitable for those who take drugs, those who interact or who have a very limited life span due to cancer or other deadly disease," added Baigent. "We also know that statins are not beneficial for heart failure patients – probably because these patients mostly die from a pump failure or sudden arrhythmia death, that statins do not. However, for many other patients in the older population, as much as – if not more – younger patients. "
"Misinformation" about adverse effects?
On the question of adverse effects of statins, Baigent believes that there has been a lot of misinformation.
"This confusion stems largely from potentially biased observational studies, which are not able to provide reliable information," he said. "The perception that statins cause troublesome problems, such as muscle pain, is just a perception." Muscle pain is very common and randomized trials have shown very clearly that the vast majority of muscle symptoms that manifest themselves in people taking the drug. "
He adds: "Evidence from randomized trials, which are unbiased and should be the only reliable source of information, indicates that statins actually cause myopathy (rarely rhabdomyolysis), a slightly increased risk of diabetes and The excess risk of all known adverse events is very low (for example, the incidence of myopathy is approximately 1 in 10,000 per year) and is far exceeded by the benefits of treatment. statins.
"Although the absolute risks of these adverse effects are higher in the elderly, the same is true for the absolute risks of vascular disease, so the overall benefit-risk balance remains strongly earnings-oriented in people over 75 years old, "concludes Baigent.
In an accompanying editorial, Bernard M.Y. Cheung, MB BChir, PhD, and Karen S.L. Lam, MD, Queen Mary Hospital, University of Hong Kong, highlight some of the limitations of the new meta-badysis.
These include the fact that patients in clinical trials are "highly selected, with less co-morbidities, less intolerance to the drug, and better adherence to treatment than the general patient population," and fully recorded and badyzed. which has limited the ability of this meta-badysis to develop knowledge about the risk of side effects for older people with statins. "
Editorialists claim that there is a need for more research on older people to enrich the evidence on the risks and benefits of statins.
They say the benefits of statins in preventing major vascular events have proven to be far greater than their risks, and the current meta-badysis, which includes older people than standard test populations, echoes to this conclusion. But they add that when statins are used in people with low cardiovascular risk, the risks and benefits must be balanced.
"The challenge for health professionals and the media is to convey the risks and benefits in a way that patients can understand, allowing them to make an informed choice," they noted.
The meta-badysis was funded by the Australian National Board of Health and Medical Research, Oxford Biomedical Research Center, the National Institute of Health Research, the Council of Medical Research from the UK and the British Heart Foundation. The disclosures for authors are listed with the article.
Lancet. Posted online 2 February 2019. Abstract, Editorial
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