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New ADA guidelines list more than 40 recommendations related to blood pressure targets, screening and diagnosis, and overall management strategies.

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An American Red Cross discusses the importance of National Blood Donor Month and the challenges faced during the COVID-19 pandemic.

The National Blood Shortage: An Unprecedented Challenge

Uric acid levels might help forecast the risk of severe cardiovascular outcomes, including death, in 

A team, led by Yong Yang, Department of Cardiology, The Third Medical Center of PLA General Hospital, evaluated the prognostic utility of uric acid in hypertensive patients.

Much of the research regarding the association of uric acid with mortality and cardiovascular outcomes in patients with hypertension have been contradictory.

The researchers searched various databases to identify studies reporting on the association of uric acid with mortality and cardiovascular outcomes in patients with hypertension.

The researchers sought outcomes including cardiovascular or all-cause mortality, coronary artery disease (CAD), stroke, and major adverse cardiovascular events (MACEs).

Overall, they identified 11 eligible studies involving 49,800 hypertensive patients.

The pooled hazard ratio (HR) was 1.51 (95% CI, 1.12-2.02) for all-cause mortality for patients with the highest than those with reference lower group of uric acid level. The HR for this patient population was also 1.68 (95% CI, 1.28–2.20) for cardiovascular mortality, 1.31 (95% CI, 1.10–1.55) for CAD, and 1.48 (95% CI, 1.28–1.70) for MACEs.

There was no significant association between elevated uric acid level and incident stroke in this patient population.

“This meta-analysis indicates that elevated uric acid level is significantly associated with an increased risk of cardiovascular or all-cause mortality, CAD and MACEs in hypertensive patients,” the authors wrote. “Hypertensive patients with highest uric acid level exhibited a tendency for reduced risk of stroke, but the difference is not significant.”

Recently, researchers found the combination of a polypill comprising statins, multiple blood-pressure-lowering drugs, and aspiring could reduce the overall risk of developing 

Overall, the low-density lipoprotein cholesterol level was lower by approximately 19 mg per deciliter and systolic blood pressure was lower by approximately 5.8 mm Hg with the polypill and with combination therapy than with placebo.

The investigators sought primary outcomes for the polypill-alone and polypill-plus aspirin arms of the study was death from cardiovascular causes, myocardial infarction, stroke, resuscitated cardiac arrest, heart failure, or revascularization.

They also sought primary outcomes for the aspirin comparison of death from cardiovascular causes, myocardial infarction, or stroke.

The investigators found the primary outcome for the polypill comparison occurred in 126 participants (4.4%) in the polypill group and in 157 (5.5%) in the placebo group (HR, 0.79; 95% CI, 0.63-1.00).

For the aspirin group, the primary outcome occurred in 116 participants (4.1%) in the aspirin group and in 134 (4.7%) in the placebo group (HR, 0.86; 95% CI, 0.67-1.10).

For the polypill-plus aspirin combination, the primary outcome occurred in 59 individuals (4.1%) in the treatment group and in 83 (5.8%) individuals in the double-placebo group (HR, 0.69; 95% CI, 0.50-0.97).

Association of serum uric acid with mortality and cardiovascular outcomes in patients with hypertension: a meta-analysis,

Articles

There was no significant association between uric acid levels and incident stroke. 

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Uric Acid Levels Linked to Negative Cardiovascular Outcomes in Hypertensive Patients

New findings from the phase 3 NAVIGATOR trial show investigative monoclonal antibody tezepelumab is associated with reduced exacerbations and improved lung function and disease control versus placebo among patients with 

The new research, featuring patients aged 12-80 years old, show a wide-reaching effect of the thymic stromal lmphoypoietin (TSLP) inhibitor when administered subcutaneously over 1 year of care.

Investigators, led by Andrew Menzies-Gow, MD, of the Royal Brompton Hospital in London, sought to observe the efficacy and safety of the investigative drug from AstraZeneca and Amgen, following clinical trial successes showing inhibition of the asthma pathogenesis-implicated cytokine which tezepelumab targets is associated with symptomatic benefit.

Their multicenter, randomized, double-blind, placebo-controlled trial compared 210 mg tezepelumab to placebo placebo, administered subcutaneously every 4 weeks over 52 weeks of assessment. They sought a primary endpoint of annualized asthma exacerbation rate over the 52-week period. Menzies-Gow and colleagues additionally assessed their endpoint among patients with blood eosinophil counts of <300 cells/mL at baseline.

The team additionally sought secondary endpoints of tezepelumab’s effect on forced expiratory volume in 1 second (FEV1) and scores on the Asthma Control Questionnaire-6 (ACQ-6), with 0 representing no asthma impairment and 6 representing maximum impairment.

Additional assessments included the Asthma Quality of Life Questionnaire (AQLQ) ranging from 1 (maximum impairment) to 7 (no impairment), and the Asthma Symptom Diary (ASD), ranging from 0 (no symptoms) to 4 (worst possible symptoms).

Their patient population included 1061 patients aged 12-80 years old with severe, uncontrolled asthma, randomized to either tezepelumab (n = 529) or placebo (n = 532).

Patients administered therapy reported 0.93 annualized asthma exacerbation rates (95% CI, 0.80 – 1.07), versus 2.10 among placebo recipients (95% CI, 1.84 – 2.39; 

Among patients with blood eosinophil counts <300 cells/mL, annualized rate with tezepelumab was 1.02 (95% CI, 0.84 – 1.23) versus 1.73 with placebo (95% CI, 1.46 – 2.05).

Prebronchodilator FEV1improvements were greater at 52 weeks among patients administered tezepelumab versus placebo (0.23 L vs 0.09 L; difference, 0.13 L; 

 <.001). Scores on ACQ-6, AQLQ, and ASD were additionally improved among tezepelumab patients at week 52 versus placebo.

Adverse events were generally as frequent and at the same level of severity among tezepelumab- and placebo-treated patients, investigators noted.

The findings would indicate metrics of severe asthma—including exacerbations, lung function, asthma control, and quality of life—were significantly improved with 52 weeks of tezepelumab versus placebo.

“Tezepelumab simultaneously reduced blood eosinophil count and levels of FENO and IgE; these findings suggest that the drug suppresses multiple inflammatory pathways,” investigators wrote. “The effect of tezepelumab on these biomarker levels may be related to decreased interleukin-5 and interleukin-13 levels.”

American Academy of Allergy, Asthma & Immunology (AAAAI) 2021 Virtual Sessions

, Menzies-Gow discussed NAVIGATOR findings showing tezepelumab’s associated benefit in reduced hospitalization risk among treated patients with severe asthma.

At the time of the findings, he discussed the unique mechanisms of tezepelumab in treating asthma which make it among the most interesting treatment candidates in the disease space.

“The excitement around tezepelumab is really around its unique mechanism of action,” he explained. “With tezepelumab, we’re targeting TSLP—so we’re going upstream, we’re looking at one of the epithelial-derived cytokines, which really drives all the downstream inflammation.”

Fellow tezepelumab investigator Jonathan Corren, MD, a Los Angeles-based allergist, 

 year that the biologic therapy may have atopic disease treatment properties that would make it applicable to inflammatory conditions beyond asthma.

“Because the drug may have very profound effects in modifying the type 2 inflammatory response, we’ll have to examine the possibility that you can give it for shorter periods of time,” Corren explained. “But that’s not well established.”

Tezepelumab in Adults and Adolescents with Severe, Uncontrolled Asthma

The newest findings show the TSLP inhibitor is beneficial over 52 weeks in patients aged 12-80 years old.

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Tezepelumab Improves Severe Asthma Exacerbation, Disease Control in Phase 3 NAVIGATOR

The US Food and Drug Administration (FDA) has approved the first orthokeratology (ortho-k) contact lens for the management of 

The approval was granted to Johnson & Johnson Vision for their ACUVUE Abiliti Overnight Therapeutic Lenses.

Myopia, or nearsightedness, is considered one of the biggest eye health threats in the 21st century.

Over half of the world population is expected to become myopic by the year 2050, with 1 billion people expected to have high myopia.

Children under 12 years old are most vulnerable to develop high myopia, with an increased risk of eye diseases later in life.

Data show the ortho-k lenses can be safe and effective when managing myopia, according to previous 

The device is specifically designed and fitted to match a patient’s eye, using a unique corneal shape to temporarily reshape the cornea.

It is available in both spheric and toric designs, in order to correct different combinations of corneal topography, refractive errors, and other measures connected to the fitting software.

According to investigators, the software can help accurately guide an eye care professional, with a successful first fit rate of approximately 90%.

The approval includes both an overnight therapeutic lenses and overnight therapeutic lenses for astigmatism.

Data show the overnight therapeutic lenses have reduced the axial elongation of the eye in children with myopia by 0.28 mm on average, over a 2-year period.

 Xiao-Yu Song, MD, PhD, Global Head of Research & Development at Johnson & Johnson Vision, said the decision marked an “important milestone” in benefiting eye health in patients with myopia.

“We look forward to supporting parents and eye care professionals in their care of children with comprehensive resources, starting with Abiliti Overnight Therapeutic Lenses, and continuing with additional products and services to address the progression of myopia,” said Song in a 

Moshe Mendelson, OD, FIAO, an optometrist with Johnson & Johnson Vision, went on to call the increasing prevalence of myopia in children an “epidemic.”

“For too long we have relied on increasing the prescription of glasses for children, while having few resources to address the underlying disease and help change this worrying trajectory of eye health,” Mendelson said. “The FDA approval of Abiliti Overnight will provide eye care professionals and parents with more options to manage myopia.”

The ortho-k lenses are expected to be available in the US by the end of the year. 

The ortho-k lenses are fitted to a patient's eye using a corneal shape to temporarily reshape the cornea. 

Ophthalmology

FDA Approves Orthokeratology Contact Lenses For Myopia Management

 from a phase 3 trial testing finerenone as an addition to standard of care treatment in patients with chronic kidney disease and type 2 diabetes.

The company announced researchers have met the primary endpoint in the FIGARO-DKD study showing finerenone significantly reduced the composite risk of time to first occurrence of cardiovascular death or non-fatal cardiovascular events including myocardial infarction, stroke, or hospitalization for heart failure.

Finerenone is an investigational, non-steroidal, selective mineralocorticoid receptor antagonist (MRA). The treatment has shown promise in reducing the harmful effects of mineralocorticoid receptor (MR) overactivation, a known driver of kidney and cardiovascular damage through inflammatory and fibrotic processes.

In comparison to the FIDELIO-DKD trial—also a phase 3 study testing finerenone in this patient population, the FIGARO-DKD study included a higher proportion of patients with earlier stage chronic kidney disease and type 2 diabetes.

In the randomized, double-blind, placebo-controlled, parallel-group, event-driven study, 7400 patients with chronic kidney disease and type 2 diabetes across a broad range of disease severity were randomized to receive either finerenone or placebo across more than 1000 sites in 47 countries. Patients received either finerenone 10 mg or 20 mg orally once daily or placebo in addition to the standard of care treatment of blood glucose lowering therapies and maximum tolerated dose of the guideline directed therapies angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin II receptor blockers (ARBs).

“Up to 40 percent of people with type 2 diabetes develop chronic kidney disease, and they are at high risk of experiencing cardiovascular events, as well as progressing to kidney failure,”said Prof. Luis M. Ruilope, Professor at the Public Health and Preventative Medicine department of the Autonoma University and co-principal investigator of the FIGARO-DKD trial, in a 

. “The FIGARO-DKD study delivers important insights into the potential effects on cardiovascular outcomes of finerenone in the management of people with chronic kidney disease and type 2 diabetes.”

Bayer has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) based on the data from the Fidelio-DKD study, which was presented at the American Society of Nephrology’s (ASN) Kidney Week Reimagined 2020. The data from the FIGARO-DKD study will be presented during an upcoming scientific meeting.

The FDA granted Fast Track designation for the treatment in 2015.

Bayer has submitted a New Drug Application for the mineralocorticoid receptor antagonist. 

Nephrology

Endocrinology

Diabetes

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New Data Positive for Finerenone as a Kidney Disease, Diabetes Treatment

New research may give clinicians a better understanding of the unmet needs of biologically-naïve patients with 

A team, led by Romina di Giuseppe, Kompetenznetz Darmerkrankungen, characterized the profile of Crohn’s disease or ulcerative colitis biologic-naïve patients starting a new therapy with vedolizumab or TNFα-antagonists, baseline disease activity predictors, and the perception of the quality of life.

In the VEDOIBD-Study, the researchers compared vedolizumab with other biologics as induction and maintenance therapies for Crohn’s disease (n = 627) and ulcerative colitis (n = 546) enrolled from IBD-experienced centers in Germany.

For biologic-naïve patients—vedolizumab (n = 397) and anti-TNF (n = 359)—the researchers analyzed disease severity and perception of quality of life predictors with logistic regression.

A first biological therapy with vedolizumab was considered for older Crohn’s disease when compared to biologicals-naïve anti-TNF patients, including those with a less complicated, but longer disease course and a history of comorbidities. There were no differences in unmet needs observed among the ulcerative colitis patient group.

The presence of extra-intestinal manifestations in biologic-naïve anti-TNF patients with Crohn’s disease (OR, 3.83; 95% CI, 1.69-8.68), as well as both biologic-naïve patient groups with ulcerative colitis, stool frequency (OR, 2.00; 95% CI, 1.25–3.19); OR, 1.82; 95% CI, 1.10–3.02), respectively) and rectal bleeding (OR, 2.24; 95% CI, 1.20–4.18); OR, 1.92; 95% CI, 1.19–3.11), respectively) emerged as the most important predictors of disease severity. This was significantly linked to a worse perception of quality of life.

“This study highlights the existence of unmet medical needs of patients with CD or UC, for whom a new biological therapy is planned as part of the VEDOIBD-Study, which considerably impacts their HRQoL,” the authors wrote.

remission was significantly more common in patients who continued treatment with infliximab, compared to those who discontinued treatment.

The use of anti-tumor necrosis factor (TNF) agents is common in the treatment of refractory UC, but the long-term use of anti-TNF therapy can increase the risk of malignancy or infection.

No previous study trial has evaluated the safety of anti-TNF agent discontinuation in patients with UC in remission.

Of the 122 patients screened, a total of 95 were randomly assigned to the infliximab-continued group (n = 48) and the infliximab-discontinued group (n = 47). The final analysis included 92 patients, with 46 in each group.

In the infliximab-continued group, 37 of 46 patients (80.4%) were in remission at week 48.

In the infliximab-discontinued group, 25 of 46 patients (54.3%) were in remission at week 48.

Adverse events were found in 8 (17%) patients in the infliximab-continued group, including a patient who experienced an infusion reaction. This is compared to 6 (13%) in the infliximab-discontinued group, with 2 patients experiencing psoriatic skin lesions.

Profile of patients with inflammatory bowel disease in conjunction with unmet needs and decision-making for choosing a new biologic therapy: a baseline analysis of the VEDOIBD-Study

International Journal of Colorectal Disease

The presence of extra-intestinal manifestations in biologic-naïve anti-TNF patients with Crohn’s disease was a predictor of disease severity.

Ulcerative Colitis

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, IBS and IBD, Crohn's disease, and more.

Researchers Explore Unmet Needs for IBD Patients

The therapy was generally well-tolerated and offered substantial pain relief in patients.

Rheumatology

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Osteoarthritis

Intra-Articular FX201 Gene Therapy Shows Promise for Osteoarthritis

A new study compares patients self-reported outcomes after depot or daily sublingual buprenorphine treatment, including satisfaction and burden rates. 



Opioid-induced Constipation

Pain

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Patients Report High Satisfaction with Depot Buprenorphine Treatment for Opioid Dependence

The majority of adverse effects reported were considered mild. 

Hepatitis C

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Direct-Acting Antivirals Effective Against HCV Following Liver Transplant Surgery

While obesity is less common in pediatric sickle cell patients, BMI may impact airway resistance in this population.


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Rare Disease Report®

BMI Strongly Correlates with Airway Resistance in Children with Sickle Cell 

The smart pen cap system is associated with real-time hypoglycemia alerts and insulin dose recommendations. 

FDA Grants Clearance to Smart Insulin Pen Caps for Diabetes

A new study presented at ASGCT found that patients with indications of hemostatic efficacy experienced few adverse effects with gene therapy treatment BAY 2599023. 

Conference

In-Human Gene Therapy BAY 2599023 Effective in Patients with Severe Hemophilia 

More than 3000 people per day in India have died of COVID-19 since April 28.

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EU Prioritizing Pfizer-BioNTech COVID-19 Vaccine

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Meredith McCormack, MD discusses consequences of high air pollution levels in the United States found in the 2021 American Lung Association State of the Air Report. 

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Addressing the Harmful Effects of Air Pollution on At-Risk Communities 

Early results from the MOMENTUM study show that treated patients experienced fewer vaso-occlusive episodes and related hospital admissions. 


ARU-1801 Gene Therapy for Sickle Cell Associated with Improved Clinical Outcomes

More than 40% of the treatment arm of the placebo-controlled trial achieved a complete renal response.

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Latest Clinical News

Uric Acid Levels Linked to Negative Cardiovascular Outcomes in Hypertensive Patients

Tezepelumab Improves Severe Asthma Exacerbation, Disease Control in Phase 3 NAVIGATOR

FDA Approves Orthokeratology Contact Lenses For Myopia Management

New Data Positive for Finerenone as a Kidney Disease, Diabetes Treatment

Researchers Explore Unmet Needs for IBD Patients