New findings from a post hoc analysis of the phase 3 HARBOR trial indicate a greater proportion of eyes with 

neovascular age-related macular degeneration (nAMD)

 treated with ranibizumab maintained or gained visual acuity at subretinal fluid (SRF) resolution.

The data from the analyses report approximately 9% of eyes lost vision during SRF resolution and these eyes had reduced final visual acuity gains at 12 and 24 months.

“Further analyses are warranted to investigate potential underlying factors and discuss the treatment implications if confirmed,” wrote study author Manuel J. Amador-Patarroyo, MD, Medical Director, Medical Affairs Ophthalmology, Genentech.

The objective of Amador-Patarroyo and colleagues’ analysis was to determine the effects of SRF resolution on visual acuity in nAMD using eyes from the HARBOR trial. The HARBOR trial was a double-masked, randomized, active treatment–controlled trial of ranibizumab carried out from January 2020 to July 2021.

It included treatment-naive patients with nAMD and active subfoveal choroidal neovascularization, for a total of 1,097 patients. Then, multiple intervention arms were pooled for the analysis if SRF was present at baseline and intraretinal fluid/SRF resolved during the study, based on spectral-domain optical coherence tomography (OCT), for a total of 349 patients.

The intervention was three monthly loading doses followed by intravitreal injections of 0.5-mg or 2.0-mg ranibizumab administered monthly or pro re nata over 24 months. Main outcomes for the analysis consisted of the mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) between the month before SRF resolution and the month of SRF resolution detection.

Additionally, visual outcomes at months 12 and 24 were analyzed in eyes without SRF recurrence after SRF resolution. The proportion of patients who lost ≤4 letters were considered as vision gainers or maintainers and those who lost ≥5 letters were considered as vision losers. 

Out of the 349 patients, 32 (9%) were observed to have lost ≥5 ETDRS letters (mean, -9.9 letters [95% CI, -12.0 to –7.9]) and 317 (91%) of the eyes gained or maintained BCVA (mean, 6.1 letters [95% CI, 5.3 to 6.8]) between the month before SRF resolution and the month of SRF resolution.

Investigators noted no differences in baseline ocular characteristics between patients groups. Among the eyes without SRF recurrence after SRF resolution (64%; 224 of 349), eyes that lost ≥5 ETDRS letters had reduced visual outcome gains from baseline to month 12 versus those that gained or maintained letters (1.4 vs. 12.9 letters), as well as at month 24 (0.0 vs. 12.6 letters).

The abstract, “Subretinal Fluid Resolution and Visual Acuity in Patients with Neovascular Age-Related Macular Degeneration: A HARBOR Post Hoc Analysis,” was published in 

Articles

A post-hoc analysis of the HARBOR trial suggest a greater proportion of ranibizumab-treated eyes with nAMD gained/maintained visual acuity at SRF resolution. 

Eyes with nAMD Treated with Ranibizumab Maintained Visual Acuity at SRF Resolution

Dietary exclusion of common food allergens could provide improvement to 

 disease severity, pruritus and sleep health among affected patients. However, the impact may not be substantial.

In a systematic review of clinical trials gauging the benefit of dietary eliminations for the treatment of atopic dermatitis, a team of US investigators observed slight improved measures of eczema severity and symptomatic outcomes among patients with mild to moderate disease. The findings—which investigators wrote did not include sufficient data on the risks of such dietary changes—were relatively unsupportive of the practice for patients with the allergy-borne skin disease.

Led by Paul Oykhman, MD, MSc, of the Division of Clinical Immunology and Allergy in the Department of Medicine at McMaster University, investigators conducted a systematic review and meta-analysis observing the benefits and harms of dietary elimination in the treatment of atopic dermatitis. They highlighted the perceived drivers of disease activity that help draw eczema’s complex pathophysiological relationship to other atopic diseases like food allergy: skin barrier dysfunction, immune disregulation and microbial dysbiosis.

“Use of dietary elimination (excluding potential food allergens) as an effective treatment option for atopic dermatitis has resulted in divided views given growing evidence of other factors driving atopic dermatitis that are unrelated to food,” they wrote. “Moreover, multiple harms of prolonged and nonspecific food allergen elimination are increasingly recognized.”

Such harms include a risk of worsened eczema area or severity, development of immunoglobulin E (IgE)-mediated allergy to foods that patients may exclude, and nutrition deficiencies.

Their review included randomized-controlled and observational trials available across 5 databases through January 2022. Eligible research for analysis focused on comparisons of dietary elimination versus control for the treatment of atopic dermatitis. Oykhman and colleagues conducted a random-effects meta-analysis of disease outcomes in patients.

Their analysis included 10 randomized controlled trials including 599 patients; the baseline median of study mean age was 1.5 years old, and median of study mean SCOring Atopic Dermatitis index was 20.7.

In comparison of control (defined as no dietary elimination), investigators observed a low-certainty evidence supporting slight eczema benefit, per SCOring metric improvement of a minimally important ≥8.7 points, in patients who underwent dietary elimination—50% versus 41%, a risk difference of 9 percentage points (95% CI, 0 - 17).

Investigators additionally observed slight improvements in daytime itch score and sleeplessness among patients who underwent dietary elimination. No benefit per elimination strategy—including empiric versus testing-guided—nor food-specific sensitization were observed.

What’s more, the team noted the review data lacked sufficient evidence to interpret the harms of elimination diets that have been previously understood in such patient populations. However, they wrote that indirect evidence suggested an increased risk of IgE-mediated food allergy among those who underwent elimination diets.

“Dietary elimination may lead to a slight, potentially unimportant improvement in eczema severity, pruritus, and sleeplessness in patients with mild to moderate atopic dermatitis,” they concluded. “This must be balanced against potential risks for indiscriminate elimination diets including developing IgE-mediated food allergy and withholding more effective treatment options for atopic dermatitis.”

Dietary Elimination for the Treatment of Atopic Dermatitis: A Systematic Review and Meta-Analysis

The Journal of Allergy and Clinical Immunology: In Practice.

Though avoidance of common food allergens is a popular practice among patients with atopic dermatitis, clinical trial evidence doesn't support its benefit compared to its risks.

Dietary Eliminations May Not Significantly Benefit Pediatric Eczema

Increased antibiotic use to treat patients with acute upper respiratory infections puts patients at a risk of developing various 

A team, led by Harris Carmichael, MD, Division of Primary Care and Population Health, Stanford University School of Medicine, estimated adverse events by only measuring comparatively severe events that require subsequent clinical evaluation.

Current guidelines recommend avoiding antibiotics for several acute upper respiratory infections to reduce the risk of adverse events in absence of a likely benefit.

However, it is unknown what the extent of harm is from these antibiotics and prior estimates finding a number needed to harm between 8-10 generally rely on patient-reported adverse events of any severity. A better understanding could inform patient-centered decision-making.

In the study, the investigators constructed a retrospective cohort that analyzed 51 million patient encounters and determined the adjusted odds ratio of clinically detectable adverse events following antibiotic use compared with events among unexposed individuals with acute upper respiratory infections using logistic regression models.

The investigators sought outcomes on adverse events including candidiasis, diarrhea, 

 infection (CDI), and a composite outcome.

The results show 62.4% of the populations were treated with an antibiotic during an acute upper respiratory infection encounter. There were adverse events of diarrhea (aOR, 1.24) observed in 54,279 patients in the antibiotic-exposed group, 46,936 for candidiasis (aOR, 1.61) in the same group. The number needed to harm was 3126 and 1975, respectively. 

The observed events of CDI in the exposed group was 30,133, with an adjusted odds ratio of isolated CDI of 1.07 and an aOR of combined adverse events of 1.30. This resulted in a number needed to harm of 17,695 and 1150 respectively.

The investigators also found that female patients were more likely to be diagnosed with any adverse event.

The overall rate of adverse events caused by antibiotics was 5.7 additional cases of CDI per 100,000 outpatient prescriptions following an upper respiratory tract infection.

“Despite higher [number needed to harm] than previous methods of analysis, we find substantial iatrogenic harm associated with prescribing antibiotics in [acute upper respiratory infections],” the authors wrote.

Earlier this year, investigators found research on pediatric patients with 

 infections (CDI) could ultimately result in future studies identifying risk factors within the pediatric population.

A team, led by Danilo Buonsenso, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario A, examined certain characteristics and risk factors for pediatric patients hospitalized with C difficile infections.

In the 5-year, retrospective study, the investigators examined 359 patients at 2 referral centers in Rome between January 2014 and December 2018. Of the 359 patients who were tested for C difficile infections, 87 were positive and 272 were negative.

The investigators found pediatric patients with CDI had a higher number of previous-day hospital admissions (

 = 0.001), and total hospital admissions (

In addition, patients with chronic comorbidities frequently tested positive for C difficile (66.7% vs. 33.3%).

The investigators also found proton pump inhibitors and antibiotic use was linked to C difficile infections (

However, among specific antibiotics, only fluoroquinolone use was significantly associated with C difficile infections.

Pediatric patients with CDI were also more likely exposed to antibiotics during hospitalization.

Clostridium difficile and other adverse events from overprescribed antibiotics for acute upper respiratory infection

The results show female patients were more likely to be diagnosed with any adverse event. 

Antibiotics to Treat Upper Respiratory Infections Increase Risk of C Difficile Infections

New research suggests that oxidative stress may help to induce 

, and that damage-associated molecular pattern (DAMP) levels in both serum and skin may be used as biomarkers to indicate activity and 

The study was led by Jingying Wang, MD, of the Affiliated Hospital of Southwest Medical University’s Department of Dermatology in China. 

Wang and colleagues note that recently, some studies have reported that under adverse stimulus conditions, including oxidative stress, cells released DAMPs and promoted autoimmune disease onset through the induction of sterile inflammation and later leading to to vitiligo.

The investigators noted that “a number of DAMPs are found at high levels extracellularly in vitiligo, enhancing inflammatory responses that contribute to disease progression. These DAMPs include high mobility group box 1, heat shock protein 70, S100B proteins, adenosine triphosphate, the IL family, antimicrobial peptides and other biomolecules.”

Wang and colleagues stated that epidermal melanocytes are uniquely vulnerable to oxidative stress thanks to their pro-oxidant status during the synthesis of melanin. This results in damage to melanocytes and the production of self-antigen, which led to their decision to conduct the study for further exploration.

The investigators gathered and assessed published research on the topics of DAMPs, vitiligo, and oxidative stress, found through database searches using such sources as MEDLINE, PubMed, and Embase. Through the data they were able to obtain, the researchers were able to come up with several key findings regarding the effects of DAMPs on vitiligo pathogenesis.

The investigators made several important findings from their research, the first of which being that HMGB1 worsens vitiligo by impacting melanocyte survival. Some of their research noted that hydrogen peroxide (H2O2) stimulation led to translocation of HMGB1 and release from melanocytes.

The research team also noted the effects of Hsp70, with diffuse and intense expression of Hsp70 patterns being observed in vitiligo skin more so than in healthy skin. They pointed out that, generally, increased levels of S100B were also found to be closely related to vitiligo, adding that their precise molecular mechanisms needed more research.

The expression of IL-33 and ST2 was found to have expanded within skin lesions, with vitiligo patients having increased serum IL-33.

Additionally, recent studies cited had observed abnormal LL37 expression in a series of skin diseases including rosacea, psoriasis, and atopic dermatitis. Due to some research reporting that average blood LL37 levels for vitiligo patients were greater than control arm levels, the investigators added that LL37 could contribute to 

“DAMP levels in serum and skin may be used as biomarkers to indicate vitiligo activity and prognosis,” they wrote. “Targeted therapies, incorporating HMGB1, Hsp70, and IL-15 could significantly improve disease etiology. Thus, novel strategies could be identified for vitiligo treatment by targeting DAMPs.”

Damage-associated molecular patterns in vitiligo: igniter fuse from oxidative stress to melanocyte loss

In a recent study, DAMPs were found to play a major role in deteriorating vitiligo conditions by initiating host defenses against signals of danger.

Study Suggests Vitiligo Induced by Damage-Associated Molecular Patterns from Oxidative Stress

Research on the sleep health and associations of chronic stressors and symptoms of 

 in older adults has yielded conflicting results. And while the overall prevalence of stress increased during the COVID-19 pandemic, not much is understood about chronic stressors in this population or how these stressors have impacted sleep health.

This study aimed to expand the understanding by assessing any associations between chronic stress and insomnia symptoms during the first year of the pandemic. Wan-Chin Kuo, PhD, RN, School of Nursing, University of Wisconsin-Madison, and investigators performed an analysis focused on the sleep health of aging adults. 

Investigators noted the substantial economic impact that insomnia has had on the US healthcare system with estimates placing the yearly cost of direct and indirect treatment expenditures at $100 billion. This includes healthcare utilization, medications, and risk of accidents due to insomnia, which is the most prevalent sleep disorder.

Looking for Links Between Insomnia and Stress

The cross-sectional analysis implemented early-release COVID-19 data collected from the Health and Retirement Study which included more than 37,000 older individuals. Investigators isolated and examined information regarding chronic stressors and insomnia symptoms in 2021 adults over the age of 55. 

Insomnia was defined as difficulty initiating or maintaining sleep in the context of adequate opportunities to sleep that led to daytime consequences. The Jenkins Sleep Questionnaire (JSQ) rated symptom frequency with a 3-point Likert-type scale (0 = rarely or never, 1 = sometimes, and 2 = most of the time) and consisted of 4 screening questions: 

How often do you have trouble falling asleep?

How often do you have trouble with waking up during the night?

How often do you have trouble with waking up too early and not being able to fall asleep again?

How often do you feel really rested when you wake up in the morning?

If a symptom was reported as "sometimes" or "most of the time" it was considered a current experience of insomnia. 

Individuals used a similar numeric scale (0 = did not occur; 1 = not upsetting; 2 = somewhat upsetting; and 3 = very upsetting) to report the occurences of stressors present within the previous 12 months which aligned with the first year of the pandemic for this study. The 8-item chronic stressors scale (CSS-8) was used to measure individuals' subjective experience of chronic stressors across 8 areas of life:

Findings revealed that self-health issues, family-health issues, and financial stress were the leading co-occurences in older adults during the beginning of the pandemic. 

Those with frequent experiences of co-occuring stressors were much more likely (91%) to have difficulty falling asleep. This group was also more likely to have issues staying asleep (40%), but investigators noted that the association wasn't as strong after adjusting for health risk factors and COVID-19 concerns.

"Frequent stress co-occurrence plays an important role linking chronic stress to insomnia symptoms in an aging population," investigators concluded. "Ongoing research is needed to examine the lingering effects of frequent stress co-occurrence on older adults' sleep health in the post COVID-19 era."

Linking chronic stress to insomnia symptoms in older adults: The role of stress co-occurrence during the pandemic

Findings revealed that self-health issues, family-health issues, and financial stress were the leading co-occurrences in older adults during the beginning of the pandemic. 

Study Evaluates Link Between Chronic Stress and Insomnia in Aging Population

Elbasvir-grazoprevir treatment results in high rates of sustained virologic response (SVR), as well as drops in alcohol use and increases in quality of life for patients with chronic hepatitis C virus (HCV) infections.

A team, led by Jean-Pierra Bronowicki, Hépato-gastroentérologie, CHRU Nancy, INSERM 1256, Université de Lorraine, Nancy, CHRU Vandoeuvre les Nancy, assessed the real-life effectiveness of elbasvir-grazoprevir therapy in the general population and among subgroups with a high hepatitis C virus prevalence in France.

There is a well-established efficacy and safety profile of elbasvir-grazoprevir, with data from more than 10 clinical trials available.However, the characteristics of patients treated in routine clinical practice could differ.

In the multicenter, prospective, observational Zephyr study, the investigators analyzed the use and effectiveness of elbasvir-grazoprevir in current practice for 467 patients with chronic HCV. The results are based on data for adult patients who received at least 1 dose of the treatment between December 2017 and June 2019 in 67 hospitals and clinics in France. The mean age of patients was 55.7 years.

The investigators balanced gender among the patient population and designed a treatment plan to monitor patients for 48 weeks after the end of treatment.

Data was collected from medical records that were closest to the treatment initiation and prespecified follow-up time points, as well as from the routine interviews during the consultations.

The majority of patients (89.5%) were treatment-naïve and infected with genotype 1b (70.4%).

Of the 75 patients with HCV Gt1a genotype, 56% had HCV RNA ≥ 800,000 IU/ml, while 24.2% of the entire patient population had stage F3-F4 fibrosis.

The investigators also conducted a subgroup analysis among 110 migrants (23.6%) and found `5.3% (n = 58) were using opioid agonist treatment, including individuals who inject drugs, 6.8% (n = 30) with chronic kidney disease stages 3–5, 1.9% (n = 9) with an inherited blood disorder, and 0.9% (n = 4) coinfected with HIV.

The remaining 58.7% (n = 269) of the study were included in the general population subgroup analysis.

Sustained virologic response was reached by 98% of the study at 12 weeks following the conclusion of treatment. This remained consistent among genotype, HCV RNA values, fibrosis stage, and the subgroup of interest.

However, the rate of Alcohol Use Disorders Identification Test-Consumption and Life Habit questionnaire completion was high at each visit. The data suggested alcohol consumption was decreasing with an improvement in the quality of life.

“Using real-world evidence data on a French population representative of HCV patients, we confirmed the results obtained during EBR/GZR development program,” the authors wrote.

An observational, prospective, multicenter study on the utilization and effectiveness of elbasvir–grazoprevir treatment association for chronic hepatitis C in France (ZEPHYR study)

Sustained virologic response was reached by 98% of the study at 12 weeks following the conclusion of treatment and remained consistent among genotype, HCV RNA values, fibrosis stage, and the subgroup of interest.

High Rates of Sustained Virologic Response From Elbasvir-Grazoprevir Treatment in HCV Patients

A cross-sectional study on clinical characteristics, life quality, and condition management of 

 finds that this type of combined condition is uncommon, shows a female preponderance, and is more likely to result in joint involvement of the conditions.

The study was led by Teck Sheng Gan, MD, of the Hospital Kuala Lumpur Department of Dermatology in Malaysia. It was designed to assess psoriasis patients’ quality of life with and without LE so as to increase clinician awareness of the differing needs of these kinds of patients.

“Psoriasis patients with coexistent LE were uncommon, displayed a female preponderance, were more likely to have joint involvement, and had greater quality of life impairment than those without LE,” Gan and colleagues wrote. “LE preceded psoriasis in most of these patients, and systemic LE was the most common subtype.”

The investigators used a retrospective, cross-sectional study, with psoriasis patients included who had been added to the Malaysian Psoriasis Registry (MPR) in the period between January of 2007 and December of 2018.

The research team included data from a total of 21,735 psoriasis patients, with only 0.16% (34) of them having both LE and psoriasis. Their data on psoriasis patients was taken from the MPR at enrollment, and their data for patients with coexistent psoriasis and LE was gathered when their conditions of concomitant LE were first reported.

The MPR registry contains demographic, disease severity, comorbidity, and type-of-treatment data, in addition to other information. Patients in the registry are given the health-related quality of life (HRQoL) assessment as well as the Dermatology Life Quality Index (DLQI) questionnaire, and the DLQI was used in part for the investigators’ assessment.

The study results indicated that of the 34 coexistent cases, in 16 of them (65%) LE preceded their psoriasis. The investigators also found that psoriasis patients facing LE reported earlier ages of psoriasis onset (27.56 ± 11.51 compared to 33.31 ± 16.94 years, 

 = 0.006) as opposed to those without LE.

The research team also noted the significant female preponderance among the 34 cases, reporting the male to female ratio of 1:5.8 (

 < 0.001) for patients with both conditions compared with those without LE.

Additionally, the investigators noted that psoriasis patients with coexistent LE showed higher psoriatic arthropathy rates (26.5% versus 13.0%, 

= 0.02) and substantially higher rates of reported impairment of life quality (DLQI >10; 57.6% versus 40.3%, 

 among psoriasis patients with LE (72.7% compared to 40%). Also, they noted that hematological abnormalities (50% compared to 20%) were greater among patients with LE preceding psoriasis compared with those with psoriasis preceding LE.

Some other facts included in their study were that hydroxychloroquine had triggered psoriasis onset for 24.1% (7) of patients, and that those with LE had a higher likelihood of having been given systemic psoriasis treatment versus those without reported LE (30.3% versus 14.2%, 

“Psoriasis patients with coexistent LE in the MPR were uncommon (0.16%), displayed a female preponderance, and were more likely to have joint involvement, an earlier age of psoriasis onset and to suffer greater impairment to their quality of life compared with psoriasis patients without LE,” they wrote. “Lupus erythematosus preceded psoriasis in more than half of the patients in our cohort, and SLE was the most common subtype of LE reported.”

The study, “Clinical characteristics, management, and quality of life of psoriasis patients with coexistent lupus erythematosus: Data from the Malaysian Psoriasis Registry,” was published online in the 

International Journal of Rheumatic Diseases

In a recent study, patients with psoriasis and coexistent lupus erythematosus were analyzed regarding their clinical characteristics, condition management, and quality of life.

Psoriasis Patients with Lupus Erythematosus Skew Female, More Likely to Have Joint Involvement

Older men are getting, on average, worse 

 than older women. But they may just not know it.

Older adult men report less mean nightly sleep time and worse sleep efficiency per polysomnography tests than women, according to new longitudinal cohort data that show gender may be a greater correlate to older-age sleep health than chronic conditions like obstructive sleep apnea.

In new research findings from the Sleep Heart Health Study, a team of US investigators observed trends of decreasing sleep time and greater arousal rates among aging men and women. They additionally observed that women were more likely to report subjective measures of poor sleep than men—despite polysomnography tests indicating the opposite to be true.

An investigation team led by Mark L. Unruh, MD, MSc, of the Renal-Electrolyte Division at the University of Pittsburgh Medical Center, reviewed data from the Sleep Heart Health Study, designed to assess cardiovascular consequences and natural history of sleep-disordered breathing through a longitudinal cohort. The trial included 6441 men and women aged ≥40 years old recruited from various cardiovascular and respiratory clinical trials and cohorts, analyzed from 1995 to 1998.

Unruh and colleagues included the original participant cohort, excluding those with missing demographic or clinical characteristics relevant to their assessment. The final sample included 5407 participants. They sought to examine the extent of association between age and subjective and objective sleep quality, independent of chronic conditions.

As they explained, many studies have reported polysomnography-based sleep outcomes featuring only a small rate of “healthy” older adults, sometimes used as assessment control populations.

“These studies have examined sleep parameters in older adults without known medical or psychiatric chronic health conditions or sleep apnea, but the majority of older adults in the community have at least one chronic health condition,” Unruh and colleagues wrote. “The limited generalizability of these studies that examined only ‘healthy participants’ makes it difficult to assess the extent to which subjective and objective sleep parameters are associated with ‘usual aging.’”

Their assessment included unattended home polysomnography and sleep questionnaires completed by patients, per the 8-item Epworth Sleepiness Scale (ESS) in which scores ≥10 indicate significant sleepiness.

Of the population, 52.3% were female and approximately 83% were White. A majority of participants (61.6%) were ≥50 years old. Participants reported a mean approximate BMI of 28.3; the most common chronic conditions were hypertension, obesity, and chronic heart disease. Men were twice as likely to report sleep disordered breathing per Respiratory Disturbance Index score >15.

Sleep efficiency scores gradually decreased by age, from a mean score of 85.6 among women aged 39 - 49 years old, to 77.8 among those aged ≥80 years old; men reported similar trends. Women reported better sleep efficiency and longer mean sleep time in nearly every age category. The average amount of sleep was 20 minutes shorter for men than women across a participants lifespan.

In findings adjusted for participant race, use of hormone replacement therapy, smoking history, sleep apnea and chronic health conditions, total sleep time and adjusted sleep efficiency were still significant decremental with older age in both genders. However, investigators did not observe a link between age and sleep latency, and arousal index was significantly higher among older participants.

Among both men and women, older age was linked to significantly longer wake time after sleep onset when adjusted for race, smoking history, sleep apnea, and chronic health conditions.

In measures of self-reported sleep habits and quality, women reported greater rates of trouble falling asleep (P = .02), waking up during the night (P = .09), and not getting enough sleep (P <.001) than men for every age group. Investigators additionally observed ESS score declines and sleeping medication increases associated with older age.

“The higher prevalence of chronic health conditions, including sleep apnea, in older adults did not explain changes in sleep parameters with aging and age–sex differences in these relationships, although the age–sex differences were consistent with a meta-analysis and previous studies in smaller samples of middle-aged to older men and women,” investigators wrote.

The team concluded that the analysis of the Sleep Heart Health Study suggested a strong association between older age and each of subjective sleep issues, shorter total sleep time per polysomnography and increased arousals.

“A number of interventions have been found to improve sleep parameters in older adults, including behavioral interventions, biofeedback, management of stress and grief, and use of benzodiazepines and melatonin,” they wrote. “Although there is not a material change with older age in the weak correlation between polysomnography findings and self-report, it is important for clinicians to recognize the discordance between sleep complaints and findings from polysomnography.”

Subjective and Objective Sleep Quality and Aging in the Sleep Heart Health Study

,” was published online in Journal of the American Geriatrics Society.

Data show older men and women are getting less and less sleep. However, women are much more likely to report such issues than men, despite faring slightly better in polysomnography tests.

Older Adult Men Report Worse Sleep Health Than Women Over Time

A new analysis shows no associations between the use of 

A team, led by Le Zhang, MPH, Department of Medical Epidemiology and Biostatistics, Karolinska Institute, updated the synthesis of evidence of whether ADHD medications are linked to the risk of a broad range of cardiovascular diseases.

While ADHD medications are more commonly used now than decades ago, there remain cardiovascular safety concerns.

“While evidence from randomized clinical trials (RCTs) suggests ADHD medications are efficacious in reducing core ADHD symptoms, there are concerns about their cardiovascular safety,” the authors wrote. “As ADHD medications are sympathomimetic agents that exert dopaminergic and noradrenergic effects, increasing heart rate and blood pressure is biologically plausible.”

In the study, the investigators searched various databases up to May 1, 2022 for observational studies investigating the association between ADHD medications and risk of cardiovascular disease. The medications included stimulants and nonstimulants.

The investigators sought main outcomes of any type of cardiovascular event, including hypertension, ischemic heart disease, cerebrovascular disease, heart failure, venous thromboembolism, tachyarrhythmias, and cardiac arrest.

Overall, the team found 19 studies involving 3.9 million children, adolescent, and adult participants from 6 countries or regions. The final analysis included 14 cohort studies and the median follow-up time ranged from 0.25-9.5 years.

The results show the pooled adjusted relative risk did not show a statistically significant association between ADHD medication use and any cardiovascular disease among children and adolescents (RR, 1.18; 95% CI, 0.91-1.53), young or middle-aged adults (RR, 1.04; 95% CI, 0.43-2.48), or older adults (RR, 1.59; 95% CI, 0.62-4.05).

There were also no significant associations found based on treatments (stimulants: RR, 1.24; 95% CI, 0.84-1.83l nonstimulants: (RR, 1.22; 95% CI, 0.25-5.97).

They also found no statistically significant associations found for specific cardiovascular outcomes in relation to cardiac arrest or arrhythmias (RR, 1.60; 95% CI, 0.94-2.72), cerebrovascular diseases (RR, 0.91; 95% CI, 0.72-1.15), or myocardial infarction (RR, 1.06; 95% CI, 0.68-1.65).

Finally, the investigators did not find any associations with any cardiovascular disease in female patients (RR, 1.88; 95% CI, 0.43-8.24) or in individuals with preexisting cardiovascular disease (RR, 1.31; 95% CI, 0.80-2.16).

“This meta-analysis suggests no statistically significant association between ADHD medications and the risk of [cardiovascular disease] across age groups, although a modest risk increase could not be ruled out, especially for the risk of cardiac arrest or tachyarrhythmias,” the authors wrote. “Further investigation is warranted for the cardiovascular risk in female patients and patients with preexisting [cardiovascular disease] as well as long-term risks associated with ADHD medication use.”

Risk of Cardiovascular Diseases Associated With Medications Used in Attention-Deficit/Hyperactivity Disorder A Systematic Review and Meta-analysis

They also found no statistically significant associations found for specific cardiovascular outcomes in relation to  cardiac arrest or arrhythmias, cerebrovascular diseases, or myocardial infarction.

No Associations Between ADHD Medications, Cardiovascular Disease Risk Found

The scientific discussion surrounding the benefit of eyeglasses in SARS-CoV-2 transmission prevention has been persistent for as long as the debate around the virus’ means of transmission—droplet versus airborne—in mid-2020.

But since that time, more progress has been made to determine the latter transmission debate than the former. And a new study adds to the continued uncertainty surrounding glasses and the pandemic virus.

New data from a randomized controlled trial conducted by a team of multinational investigators indicated that wearing glasses in public settings was not associated with reduced risk of positive COVID-19 tests. However, the team considers the evidence “uncertain” given study limitations and recommended further assessment into the simplistic public health strategy.

Led by Atle Fretheim, MD, PhD, of the Centre for Epidemic Interventions Research at the Norwegian Institute of Public Health in Oslo, investigators from Noway, Switzerland, Germany and the US sought to evaluate glasses as a preventive strategy against SARS-CoV-2 infection, as well as other respiratory viruses. They noted prior research has supported the use of wearing glasses to lower risk of respiratory viruses—though these were observational, not clinical trials.

“Use of eye protective gear for infection control was proposed more than 100 years ago but has received little attention during the ongoing COVID-19 pandemic, except as part of personal protective equipment for health care workers,” they wrote. “Repurposing sunglasses for infection control could be a simple, safe, and environmentally friendly infection prevention measure.”

Fretheim and colleagues conducted the pragmatic trial in Norway from February 2 to April 24, 2022. Participants were recruited via online advertisement, requiring they were ≥18 years old, did not regularly wear glasses, had access to wearable glasses, and had not contracted COVID-19 within 6 weeks prior nor had COVID-19 symptoms at baseline.

Participants were randomized to either wearing glasses or not (control) in public over the span of 14 days. Investigators sought a primary outcome of positive COVID-19 test results reported to the country’s surveillance system, with secondary outcomes including positive COVID-19 test results and self-reported respiratory infection.

The final analysis included 3717 adults randomized to either strategy; about two-thirds (65.6%) were women and mean age was 46.9 years old. Approximately 70% of intervention participants reported wearing glasses ≥50% of the time;this group was additionally more likely to wear a face mask ≥50% of the time (39.5%) than participants in the control arm (29.7%).

Investigators observed positive COVID-19 test results among 68 (3.7%) of participants who wore glasses during the 14-day assessment, versus 65 (3.5%) of participants in the control group, indicating a relative risk (RR) increase of 10% (RR, 1.10; 95% CI, 0.75 – 1.50).

For the secondary outcome, self-reported positive test results were observed among 9.6% of the glasses arm, versus 11.5% of the control arm, indicating an relative risk reduction of 17% (RR, 0.83; 95% CI, 0.69 – 1.00). Investigators additionally observed lowered risk of respiratory infections per self-reported symptoms in the intervention group (30.8%) than control group, with a statistically significant relative risk reduction of 10% (RR, 0.90; 95% CI, 0.82 – 0.99).

However, the team highlighted trial limitations including an “inconclusive” primary endpoint result due to a wide 95% confidence interval. They also faced challenges due to less-than-expected recruitment, decreasing regional incidence of COVID-19 at the time, and alterations to national SARS-CoV-2 testing recommendations.

“The trial took place during the Norwegian winter, and the importance of transmission in public spaces may be different in other seasons or cultural settings,” they added. “The COVID-19 incidence was exceptionally high during the time of the trial. Also, the effects that the intervention had on behavior (eg, face mask use) will likely vary across contexts and populations.”

Nonetheless, Fretheim and colleagues concluded their findings did not indicate a protective effect of wearing glasses in public against SARS-CoV-2 infection. Their recommendation on the longtime public health practice is hindered by trial limitations and the conflicting outcomes.

“Any effect would probably be modest at best, but wearing glasses is simple, low burden, and low cost; has few negative consequences; and may be worth considering as 1 component in infection control, pending further studies,” they wrote.

Effect of Wearing Glasses on Risk of Infection With SARS-CoV-2 in the Community

A clinical trial from Norway showed inconclusive results, and challenges in the study design.

Can Glasses Help Prevent COVID-19? Data Remain Unsure

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