When Akira Endo found the first cholesterol-lowering compound in 1973, he could never have predicted the significance of his discovery.
The scientist's breakthrough would lead to the creation of statin drugs, which have saved millions of lives by reducing the risk of heart disease and stroke.
Fast forward to the present and a landmark study has confirmed these benefits in older populations.
The research, jointly led by the LKS Faculty of Medicine of the University of Hong Kong (HKUMed) and the Harvard TH Chan School of Public Health, addresses longstanding uncertainties about the use of statins in high-risk populations.
The study addresses longstanding uncertainties about the use of statins in high-risk populations.
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The robust evidence demonstrated that continuous statin therapy resulted in a substantial relative risk reduction in cardiovascular diseases (CVDs) of 21 for those aged 75–84 and 35 percent for those aged 85 or above, without any heightened safety concerns.
The pioneering study, published in the Annals of Internal Medicine, marks a significant milestone, as it provides powerful real-world evidence on statin use in the elderly population using advanced analytical methods.
Why is this significant?
While statins have been used for decades to improve lipid profiles and reduce the risk of CVDs, there is little consensus on the use of statins for primary prevention in patients aged 75 or above in the existing international clinical guidelines.
The uncertainty of statin use for this population is due in part to the underrepresentation of the elderly population in randomised controlled trials (RCTs), leaving this important clinical question unresolved in real-world practice. This study used real-world data to quantify the long-term benefits and risks associated with statin therapy in primary prevention among older adults to inform decision-making on statin initiation in this large and growing population.
The research team, led by Professor Eric Wan Yuk-fai from the Department of Family Medicine and Primary Care under the School of Clinical Medicine, and the Department of Pharmacology and Pharmacy of HKUMed, analysed the public electronic medical records from the Hospital Authority from January 2008 to December 2018 of over 80,000 older individuals in Hong Kong who had suboptimal lipid levels and high-risk conditions, such as diabetes or other risk factors for CVDs.
The study investigated the relationship between statin therapy and the risk of CVD incidence in this population with a novel analytical approach known as target trial emulation. The method incorporated the key features of RCTs in the study design for observational studies, substantially reducing the bias typically associated with traditional observational studies.
The findings indicate that the continual use of statins was linked to a 21 percent reduction in relative risk and an absolute risk reduction of five percent over five years in CVDs among people aged 75–84.
The relative risk reduction was an even more substantial 35 percent, and the absolute risk reduction after five years was 12.5 percent in those aged 85 or above. The study also found no increased risk of major adverse events, including liver dysfunction or myopathies, identified with statin use in this population.
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The study also found no increased risk of major adverse events in the older age groups
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Future implications
The study confirmed the benefits and safety of statin use for primary prevention of CVDs in the older population, which suggests that advanced age should not be a discriminatory factor for high-risk patients regarding the benefits of statin therapy.
Considering the increasing burden related to CVDs in the ageing population globally, this study provides significant evidence to support the prescription of statin therapy for the primary prevention of CVDs in this vulnerable population.
"These findings have significant implications for informing clinical decisions regarding the initiation of statin therapy for this increasingly large population group," said Professor Cindy Lam Lo-kuen, Danny D B Ho Professor in Family Medicine, Department of Family Medicine and Primary Care, School of Clinical Medicine, HKUMed. "This study also pioneered a new research method to explore many more important but unanswered clinical questions related to the care of the elderly in real-world practice."
The successful application of target trial emulation to answer this research question also sheds light on future research in geriatric medicine.
"The older population, especially very old adults, are generally underrepresented in the RCTs, leading to a lack of high-quality evidence on treatment for this specific population group," emphasised Professor Eric Wan Yuk-fai. "The innovative approach adopted in this study has the potential to generate high-quality evidence in the field of geriatric medicine, thereby advancing our understanding and improving healthcare outcomes for older populations."