Tag Archives: mortality

COVID mRNA vaccines are safe in patients with heart failure

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COVID mRNA vaccines are associated with a decreased risk of death in patients with heart failure, according to research presented at ESC Congress 2022.1 The study also found that the vaccines were not associated with an increased risk of worsening heart failure, venous thromboembolism or myocarditis in heart failure patients.

“Our results indicate that heart failure patients should be prioritised for COVID-19 vaccinations and boosters,” said study author Dr. Caroline Sindet-Pedersen of Herlev and Gentofe Hospital, Hellerup, Denmark. “COVID-19 vaccines will continue to be important for preventing morbidity and mortality in vulnerable patient populations. Thus, studies emphasising the safety of these vaccines are essential to reassure those who might be hesitant and ensure continued uptake of vaccinations.”

Patients with heart failure are at increased risk of hospitalisation, need for mechanical ventilation, and death due to COVID-19.2 Vaccination reduces the risk of serious illness from COVID-19. However, “Due to perceptions about possible cardiovascular side effects from mRNA vaccines in heart failure patients, this study examined the risk of cardiovascular complications and death associated with mRNA vaccines in a nationwide cohort of patients with heart failure,” said Dr. Sindet-Pedersen.

The study included 50,893 unvaccinated patients with heart failure in 2019 and 50,893 patients with heart failure in 2021 who were vaccinated with either of the two mRNA vaccines (BNT162B2 or mRNA-1273).3 The two groups were matched for age, sex, and duration of heart failure. The median age of participants was 74 years and 35% were women. The median duration of heart failure was 4.1 years. Participants were followed for 90 days for all-cause mortality, worsening heart failure, venous thromboembolism, and myocarditis, starting from the date of the second vaccination for the 2021 group and the same date in 2019 for the unvaccinated group.

The researchers compared the risk of adverse outcomes in the two groups, after standardising for age, sex, heart failure duration, use of heart failure medications, ischaemic heart disease, cancer, diabetes, atrial fibrillation, and admission with heart failure less than 90 days before the first date of follow up. Dr. Sindet-Pedersen explained: “Standardisation imitates a randomised trial and is a way to obtain a better causal interpretation of the results from observational studies.”

Among 101,786 heart failure patients, the researchers found that receiving an mRNA vaccine was not associated with an increased risk of worsening heart failure, myocarditis or venous thromboembolism but was associated with a decreased risk of all-cause mortality. The standardised risk of all-cause mortality within 90 days was 2.2% in the 2021 cohort (vaccinated) and 2.6% in the 2019 cohort (not vaccinated), showing a significantly lower risk for all-cause mortality in 2021 versus 2019. The standardised risk of worsening heart failure within 90 days was 1.1% in both cohorts. Similarly, no significant differences were found between groups for venous thromboembolism or myocarditis.

Dr. Sindet-Pedersen concluded: “The study suggests that there should be no concern about cardiovascular side effects from mRNA vaccines in heart failure patients. In addition, the results point to a beneficial effect of vaccination on mortality.”

 

Clinical Trials of Antibiotics on Children

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Central Licensing Authority i.e. Drugs Controller General (India) has given approval for conduct of various clinical trials of Antibiotics on children under one year of age. During the last three years, such clinical trials approved were mainly related to trials in Multi Drug Resistant Tuberculosis (MDRTB) and Tuberculosis Meningitis in children. The details of the clinical trials are registered in Clinical Trial Registry of India (CTRI), which is publicly available (www.ctri.nic.in).

Antibiotic use is a major driver of resistance. Neonates are more prone to infections and vulnerable to ineffective treatment. Sepsis remains a leading cause of mortality and morbidity, especially during the first five days of life and in low and middle-income countries (LMIC).

Antibiotics are included in Schedule H and H1 to the Drugs & Cosmetics Rules, 1945, and, therefore, cannot be sold in retail except on and in accordance with the prescription of a Registered Medical Practitioner.

Indian Council of Medical Research (ICMR) has launched a programme on Antimicrobial Stewardship, Prevention of Infection and Control (ASPIC) in 2012. Functional infection control programmes not only cut down the rates of nosocomial infections, but also reduce the volume of antibiotic consumption and are a critical part of any comprehensive strategy to contain antimicrobial resistance (AMR). Further, a red line campaign has been launched to regulate over the counter sale of Schedule H antibiotics. The campaign is aimed at discouraging unnecessary prescription and over-the-counter sale of antibiotics causing drug resistance for several critical diseases including TB, malaria, urinary tract infection and even HIV.

The Ministry of Health & Family Welfare has also launched a programme named ‘National Programme on Containment of Antimicrobial Resistance’ to address the problem of growing AMR.

The Minister of State (Health and Family Welfare), Sh Faggan Singh Kulaste stated this in a written reply in the Rajya Sabha here today.

So lonely I could die

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Social isolation, loneliness could be greater threat to public health than obesity, researchers say.

Loneliness and social isolation may represent a greater public health hazard than obesity, and their impact has been growing and will continue to grow, according to research presented at the 125th Annual Convention of the American Psychological Association.

“Being connected to others socially is widely considered a fundamental human need–crucial to both well-being and survival. Extreme examples show infants in custodial care who lack human contact fail to thrive and often die, and indeed, social isolation or solitary confinement has been used as a form of punishment,” said Julianne Holt-Lunstad, PhD, professor of psychology at Brigham Young University. “Yet an increasing portion of the U.S. population now experiences isolation regularly.”

Approximately 42.6 million adults over age 45 in the United States are estimated to be suffering from chronic loneliness, according to AARP’s Loneliness Study. In addition, the most recent U.S. census data shows more than a quarter of the population lives alone, more than half of the population is unmarried and, since the previous census, marriage rates and the number of children per household have declined.

“These trends suggest that Americans are becoming less socially connected and experiencing more loneliness,” said Holt-Lunstad.

To illustrate the influence of social isolation and loneliness on the risk for premature mortality, Holt-Lunstad presented data from two meta-analyses. The first involved 148 studies, representing more than 300,000 participants, and found that greater social connection is associated with a 50 percent reduced risk of early death. The second study, involving 70 studies representing more than 3.4 million individuals primarily from North America but also from Europe, Asia and Australia, examined the role that social isolation, loneliness or living alone might have on mortality. Researchers found that all three had a significant and equal effect on the risk of premature death, one that was equal to or exceeded the effect of other well-accepted risk factors such as obesity.

“There is robust evidence that social isolation and loneliness significantly increase risk for premature mortality, and the magnitude of the risk exceeds that of many leading health indicators,” said Holt-Lunstad. “With an increasing aging population, the effect on public health is only anticipated to increase. Indeed, many nations around the world now suggest we are facing a ‘loneliness epidemic.’ The challenge we face now is what can be done about it.”

Holt-Lunstad recommended a greater priority be placed on research and resources to tackle this public health threat from the societal to the individual level. For instance, greater emphasis could be placed on social skills training for children in schools and doctors should be encouraged to include social connectedness in medical screening, she said. Additionally, people should be preparing for retirement socially as well as financially, as many social ties are related to the workplace, she noted, adding that community planners should make sure to include shared social spaces that encourage gathering and interaction, such as recreation centers and community gardens.