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  • Study shows antipsychotic drugs increase health risks in dementia patients

    Study shows antipsychotic drugs increase health risks in dementia patients

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    In a recent British Medical Journal study, researchers assess the adverse effects associated with the use of antipsychotic drugs in people with dementia.

    Study: Multiple adverse outcomes associated with antipsychotic use in people with dementia: population based matched cohort study. Image Credit: Fahroni / Shutterstock.com

    The role of antipsychotics in dementia management

    Individuals diagnosed with dementia undergo functional disability and progressive cognitive decline. Some common psychological and behavioral symptoms of dementia include anxiety, depression, apathy, aggression, delirium, irritability, and psychosis.

    To manage psychological and behavioral symptoms of dementia, patients are commonly treated with antipsychotics. The United Kingdom National Institute for Health and Care Excellence currently recommends the use of antipsychotics only when non-drug interventions are ineffective in alleviating behavioral and psychological symptoms of dementia. However, there has been an increase in antipsychotic use during the recent coronavirus disease 2019 (COVID-19) pandemic, which has been attributed to lockdown measures and the unavailability of non-pharmaceutical treatments.

    In the U.K., risperidone and haloperidol are the only antipsychotics that have received approval for the treatment of behavioral or psychological symptoms of dementia. In 2003, the United States Food and Drug Administration (FDA) highlighted the risks, such as stroke, transient ischaemic attack, and mortality, associated with the use of risperidone in older adults with dementia. 

    Based on multiple study reports, regulatory guidelines have been formulated in the U.K., U.S., and Europe to reduce inappropriate prescriptions of antipsychotic drugs for the treatment of behavioral and psychological symptoms of dementia. To date, few studies have provided evidence of the association between antipsychotic drug prescriptions in older adults with dementia and risks of multiple diseases, such as myocardial infarction, venous thromboembolism, ventricular arrhythmia, and acute kidney injury.

    About the study

    The current study investigated the risk of adverse outcomes associated with antipsychotics in a large cohort of adults with dementia. Some adverse outcomes considered in this study were venous thromboembolism, stroke, heart failure, ventricular arrhythmia, fracture, myocardial infarction, pneumonia, and acute kidney injury.

    Over 98% of the U.K. population is registered with National Health Service (NHS) primary care general practice. All relevant data were collected from the electronic health records held at the Clinical Practice Research Datalink (CPRD), which is associated with over 2,000 general practices. CPRD comprises the Aurum and GOLD databases, which can be considered as broadly representative of the U.K. population.

    Individuals above 50 years of age and diagnosed with dementia were recruited. Importantly, none of the study participants were under antipsychotic intervention one year before their diagnosis.

    The researchers utilized a matched cohort design, in which each patient who used antipsychotics after their initial dementia diagnosis was matched using the incidence density sampling method. This method considered up to 15 randomly selected patients who were diagnosed with dementia on the same date but were not prescribed antipsychotic drugs.

    Antipsychotics increase the risk of adverse effects in dementia patients

    Across the two cohorts, the mean age of the participants was 82.1 years. A total of 35,339 participants were prescribed an antipsychotic during the study period.

    The mean number of days between the first diagnosis of dementia and the date of a first antipsychotic prescription was 693.8 and 576.6 days for Aurum and GOLD, respectively. The most commonly prescribed antipsychotics were risperidone, haloperidol, olanzapine, and quetiapine.

    The current population-based study revealed that adults with dementia prescribed antipsychotics are at a greater risk of venous thromboembolism, myocardial infarction, stroke, heart failure, pneumonia, fracture, and acute kidney injury than non-users. This observation was based on analyzing 173,910 adults with dementia selected from both databases. 

    The increased risk of adverse outcomes was most prevalent among current and recent users of antipsychotic drugs. After 90 days of antipsychotic use, the risk of venous thromboembolism, pneumonia, acute kidney injury, and stroke was higher than non-users. However, antipsychotic drugs did not impact the risk of ventricular arrhythmia, appendicitis, and cholecystitis.

    As compared to the use of risperidone, haloperidol was significantly associated with an increased risk of pneumonia, fracture, and acute kidney injury. Although the adverse effects of haloperidol were higher than quetiapine, no significant differences were observed between risperidone and quetiapine for the risk of fracture, heart failure, and myocardial infarction. The risk of pneumonia, stroke, acute kidney injury, and venous thromboembolism was lower for quetiapine as compared to risperidone.

    Conclusions 

    The current study highlights how antipsychotic drugs affect older adults with dementia. The use of these drugs was associated with many serious adverse outcomes, such as stroke, acute kidney injury, pneumonia, venous thromboembolism, heart failure, and myocardial infarction.

    In the future, these risks must be considered, along with cerebrovascular events and mortality, while making regulatory decisions about the use of antipsychotic drugs for the treatment of dementia in older adults.

    Journal reference:

    • Mok, L. H. P., Carr, M. J., Guthrie, B., et al. (2024) Multiple adverse outcomes associated with antipsychotic use in people with dementia: population based matched cohort study. BMJ. doi:10.1136/bmj.2023.076268

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  • COVID-19 vaccine associated with reduced risk of cardiac and clot-related complications after SARS-CoV-2 infection

    COVID-19 vaccine associated with reduced risk of cardiac and clot-related complications after SARS-CoV-2 infection

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    The risk of cardiac and clot-related complications following COVID-19 is substantially reduced in people who receive the COVID-19 vaccination compared with unvaccinated individuals, reports an observational study published online in the journal Heart.

    COVID-19 vaccines proved to be highly effective in reducing the severity of acute SARS-CoV-2 infection, COVID-19-related hospital admission and death.

    And while some COVID-19 vaccines were associated with increased risk of rare but serious complications, such as blood clots and heart inflammation (myocarditis), the risk of these complications was substantially higher after SARS-CoV-2 infection.

    Some studies have suggested that vaccination could protect against these complications of COVID-19, but most did not include long-term complications and were focused on specific populations.

    To address this, researchers set out to study the association between COVID-19 vaccination and the risk of post-COVID-19 cardiac and thromboembolic complications using population data for the UK, Spain and Estonia which included 10.17 million vaccinated people and 10.39 million unvaccinated people.

    Individuals who were vaccinated received either an adenovirus-based vaccine (Oxford/AstraZeneca or Janssen) or one of the mRNA vaccines (BioNTech/Pfizer or Moderna).

    The researchers identified cases of cardiac and thromboembolic complications in the first year after SARS-CoV-2 infection and recorded them according to four post-infection time windows: 0-30, 31-90, 91-180 and 181-365 days after infection.

    A range of potentially influential factors, such as age, sex and pre-existing conditions including chronic lung disease, diabetes, heart disease and a history of blood clots were accounted for in the analysis to minimise bias.

    The results show that COVID-19 vaccination was associated with reduced risks of heart failure, venous thromboembolism (clot within the veins of a limb) and arterial thrombosis/thromboembolism (blood clot in the artery) for up to a year after SARS-CoV-2 infection.

    Reduced risk of other complications, such as ventricular arrhythmia/cardiac arrest (heart attack), myocarditis/pericarditis were also seen but only in the acute phase (first 30 days after infection).

    Compared with unvaccinated individuals, having COVID-19 vaccination was associated with reduced risks of venous thromboembolism by 78%, arterial thrombosis/thromboembolism by 47% and heart failure by 55% in the first 30 days after SARS-CoV-2 infection.

    As time progressed, the protective effects of vaccination waned, but remained at 47%, 28%, and 39% respectively at 91-180 days after infection and 50%, 38%, and 48% respectively at 181-365 days.

    This is an observational study, so can’t establish cause and effect, and the authors highlight some limitations including the inherent data quality concerns and risk of bias with use of real-world data, and potential under-reporting of post-COVID-19 complications.

    However, state-of-the-art statistical methods were used to deal with these limitations and results were consistent across all databases, which they say highlights the robustness and replicability of the findings.

    As such, they conclude, “Our analyses showed a substantial reduction of risk (42-82%) for thromboembolic and cardiac events in the acute phase of COVID-19 associated with vaccination.”

    They add, “Reduced risk in vaccinated people lasted for up to 1 year for post-COVID-19 venous thromboembolism, arterial thrombosis/thromboembolism and heart failure, but not clearly for other complications.”

    The authors suggest that the protective effects of vaccination are “consistent with known reductions in disease severity following breakthrough versus unvaccinated SARS-CoV-2 infection” and say further research is needed on the possible waning of the effect over time and on the impact of booster vaccination.

    Source:

    Journal reference:

    Mercadé-Besora, N., et al. (2024). The role of COVID-19 vaccines in preventing post-COVID-19 thromboembolic and cardiovascular complications. Heart. doi.org/10.1136/heartjnl-2023-323483.

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  • Reevaluating the role of direct oral anticoagulants in cardiovascular treatment

    Reevaluating the role of direct oral anticoagulants in cardiovascular treatment

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    Direct oral anticoagulants (DOACs) are a common treatment for patients with a wide variety of cardiovascular conditions. DOACs are the preferred treatment over vitamin K antagonists (VKAs) for many patients with atrial fibrillation or venous thromboembolism, since the latter would have a higher risk of intracranial bleeding and more complex dosing routine. However, new research suggests that DOACs should not be the first line of treatment for every patient who need to treat or prevent blood clots.

    A systematic overview from researchers at Brigham and Women’s Hospital, a founding member of Mass General Brigham, discusses the efficacy of DOACs compared to other treatment methods. This review utilized data from randomized controlled trials to compare DOACs with other treatment methods for various cardiovascular conditions. Although there is merit to using DOACs in many common conditions, the manuscript provides a robust summary of clinical trials indicating that DOACs fare worse in patients with mechanical heart valves, thrombotic antiphospholipid syndrome, atrial fibrillation associated with rheumatic heart disease, and patients with embolic stroke of unclear source. The authors also highlight clinical scenarios in which there is uncertainty, with a look toward future for better evidence generation.

    The results we reviewed here have significant implications for optimizing anticoagulation therapy and improving patient outcomes in clinical practice. There is a critical need for further research regarding why DOACs are less efficacious or safe than the standard of care in certain scenarios.”


    Behnood Bikdeli, MD, MS, of the Brigham’s Heart and Vascular Center

    Source:

    Brigham and Women’s Hospital

    Journal reference:

    Bejjani, A., et al. (2024). When Direct Oral Anticoagulants Should Not Be Standard Treatment. Journal of the American College of Cardiology. doi.org/10.1016/j.jacc.2023.10.038.

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