GLP-1 Receptor Agonists Linked to Lower Glaucoma Risk Compared to Metformin in Type 2 Diabetes Patients: Study

USA: A recent comparative study has uncovered promising evidence that GLP-1 receptor agonists may offer significant ocular benefits over metformin for patients with type 2 diabetes, particularly in reducing the risk of glaucoma. The findings, which highlight a potential new advantage of GLP-1 receptor agonists, could influence future treatment strategies for managing diabetes-related complications.

“GLP-1 receptor agonists are linked to a substantially reduced incidence of primary open-angle glaucoma (POAG), ocular hypertension, and the requirement for first-line glaucoma treatments compared to metformin in patients with type 2 diabetes,” the researchers wrote in Ophthalmology.

Glaucoma, a leading cause of vision loss, often presents in individuals with type 2 diabetes due to various factors, including elevated intraocular pressure and poor metabolic control. Traditional treatments for diabetes primarily focus on managing blood glucose levels, with metformin being one of the most commonly prescribed medications. In the study, Iqbal Ike K Ahmed, John A. Moran Eye Center, University of Utah, Salt Lake City, USA, and colleagues compared the impact of glucagon-like peptide-1 (GLP-1) receptor agonists and metformin on the risk of primary open-angle glaucoma, ocular hypertension, and the necessity for first-line glaucoma treatments in individuals with type 2 diabetes.

For this purpose, researchers conducted a retrospective cohort study using electronic medical records (EMR) from an international health record network, spanning from May 2006 to May 2024. The study focused on patients diagnosed with type 2 diabetes mellitus (T2DM) who were treated with either GLP-1 receptor agonists or metformin. Data from 120 healthcare organizations across 17 countries were analyzed, with patient outcomes assessed at 1, 2, and 3 years.

Propensity score matching (PSM) was utilized to balance covariates such as demographics, comorbidities, and medication usage. Risk ratios (RR) were calculated to evaluate the incidence of primary open-angle glaucoma (POAG), ocular hypertension, and the need for first-line treatments, including beta-blockers, prostaglandin analogues, brimonidine, brinzolamide, dorzolamide, netarsudil, and laser trabeculoplasty.

The study revealed the following findings:

  • After PSM, both groups included 61,998 patients at the 1-year follow-up, 27,414 at the 2-year follow-up, and 14,100 at the 3-year follow-up.
  • Patients treated with GLP-1 receptor agonists had a significantly decreased risk of developing POAG compared to those on metformin at one year (RR 0.59), two years (RR 0.50), and three years (RR 0.59).
  • There were similar protective effects for ocular hypertension, with risk reductions of 56% at one year (RR 0.44), 57% at two years (RR 0.43), and 49% at three years (RR 0.51).
  • The risk of first-line therapy initiation was also lower in the GLP-1 receptor agonists group at one year (RR 0.63), two years (RR 0.71), and three years (RR 0.75).

“These findings underscore the potential eye-related benefits of GLP-1 receptor agonists and their growing importance in the clinical management of diabetic patients,” the researchers concluded.

Reference:

Muayad J, et al “Comparative effects of GLP-1 receptor agonists and metformin on glaucoma risk in type 2 diabetes patients” Ophthalmology 2024; DOI: 10.1016/j.ophtha.2024.08.023.

Powered by WPeMatico

Risk of Neonatal Adverse Outcomes Linked to Umbilical Cord pH Levels Above 7.00, suggests research

The researchers found the umbilical cord pH levels to be the single most important indicator of intrapartum fetal hypoxia and predictive of neonatal morbidity and mortality. A recent study was published in JAMA Network Open by Charlotte B. A. and colleagues. In a large population-based cohort study conducted in Denmark, it was found that even UC-pH levels higher than the traditionally defined threshold of severe acidosis were associated with increased risks of adverse neonatal outcomes. The results thus require a revision in the threshold for intensive monitoring and intervention based on UC-pH measurements.

Clinical practice is mainly oriented to umbilical cord pH as an indicator of neonatal well-being, where values below 7.00 are considered to indicate severe acidosis with heightened risks to health. Evidence supporting this threshold is inconsistent and often based on selective populations; therefore, the association may not be universal. This study assessed the association of various UC-pH levels with neonatal outcomes within a national population of full-term, singleton infants born in Denmark.

This population-based cohort study retrospectively included 340,431 liveborn, singleton, full-term infants without malformations born in Denmark from January 1, 2012, to December 31, 2018. UC-pH levels were categorized as less than 7.00, 7.00 to 7.09, 7.10 to 7.19, and 7.20 to 7.50 as the reference group. The primary outcome was a composite measure of severe adverse neonatal outcomes, directly related to neonatal death, therapeutic hypothermia, mechanical ventilation, inhaled nitric oxide treatment, and seizures. All secondary outcomes measured included Apgar score, respiratory complications, and hypoglycemia. Adjusted risk ratios and 95% confidence intervals were computed from these data.

Key Findings

  • Among the 340,431 infants included, the gestational age had a mean of 39.9 weeks, a mean birth weight of 3561 grams, and 51.3% were males.

  • More UC-pH levels below 7.20 are more common in infants with gestational ages of 40 and 41 weeks at 31.6%-33.6% compared to those of 39 weeks at 18.2%-20.2%. A higher prevalence was also associated with male infants, classified as UC-pH levels below 7.20, at 53.9%-55.4%, than it was.

  • As compared with the reference population (UC-pH 7.20 to 7.50), the severe impact of adverse outcomes was significantly greater in infants with UC-pH less than 7.00 (ARR 9.8%), between 7.00 and 7.09 (ARR 0.8%), and between 7.10 and 7.19 (ARR 0.4%). The risk for neonatal death was found to be increased only for those UC-pH levels less than 7.10.

  • Hypoglycemia was defined in 21.5% of the infants with UC-pH levels below 7.10; also, it was related with a minor increment in the needed CPAP in infants that reached levels below 7.20.

  • The findings challenge the traditional severe acidosis cut-off of UC-pH 7.00; they show that adverse outcomes are found in a dose-dependent manner, with an increasing frequency at higher pH levels. This would infer that the threshold for more frequent observation and intervention should now be reappraised in clinical practice.

This large-scale study now provides strong evidence for the fact that neonatal risks are not restricted to UC-pH levels below 7.00. Hypoglycemia, respiratory complications, and need for therapeutic interventions were some poor outcomes at UC-pH levels within the range of 7.00-7.19. The consideration of gestational age and sex differences in UC-pH is very important since they were correlated with different degrees of acidosis, something this study has pointed out. In addition, the generalizability is further strengthened by the large and unselected population. The observational nature of the study means further studies are needed to establish causality and further specify guidelines for the clinical management of UC-pH.

This study, in other words, outlines that UC-pH values above the threshold value of severe acidosis of 7.00 are related to poor neonatal outcome. Therefore, the results may suggest revision in current clinical practice regarding neonatal monitoring and intervention threshold based on UC-pH. In identification of this prominent risk above the level of UC-pH 7.00, changes in clinical protocols might help improve neonatal care and lower the incidence of unwanted neonatal outcomes.

Reference:

Andersson, C. B., Klingenberg, C., Thellesen, L., Johnsen, S. P., Kesmodel, U. S., & Petersen, J. P. (2024). Umbilical cord pH levels and neonatal morbidity and mortality. JAMA Network Open, 7(8), e2427604. https://doi.org/10.1001/jamanetworkopen.2024.27604

Powered by WPeMatico

Vision and physical disabilities during pregnancy linked to severe maternal morbidity during delivery: Study

Pregnant Women with vision or physical disabilities are at higher risk of severe maternal morbidity during childbirth suggests a study published in the O and G Open.

A study was done to estimate the risk of severe maternal morbidity (SMM) among women with disabilities compared with those without disabilities in a nationally representative sample of U.S. delivery hospitalizations. They conducted a retrospective cohort analysis using the 2016–2021 Healthcare Cost and Utilization Project’s Nationwide Inpatient Sample. We identified delivery hospitalizations and disability status using International Classification of Diseases, Tenth Revision diagnosis codes. The primary outcome was SMM, which was determined using 21 indicators specified by the Centers for Disease Control and Prevention. We used Poisson regression to estimate unadjusted and adjusted relative risks (aRRs) and 95% CIs for the association between disability status and type with SMM outcomes. RESULTS: Among 4,331,457 delivery hospitalizations, 128,413 (3.0%) were to women with disabilities. Women with disabilities had significantly higher rates of SMM compared with those without disabilities (396/10,000 deliveries vs 177/10,000 deliveries). In fully adjusted models, women with disabilities had an aRR of 1.86 (95% CI, 1.80–1.91) for one or more SMM indicators. The risk of SMM varied by disability type, with the highest risks observed for women who had vision disabilities (aRR 3.02, 95% CI, 2.70–3.38) or had physical disabilities (aRR 2.44, 95% CI, 2.34–2.55). Women with disabilities had the highest risk for other medical complications (puerperal cerebrovascular disorders and sickle cell disease with crisis), followed by other obstetric complications, respiratory complications, cardiovascular complications, acute renal failure, sepsis, and bleeding complications compared with women without disabilities. Women with disabilities have a significantly higher risk of SMM during delivery compared with those without disabilities, with the magnitude of risk varying by disability type. Efforts to reduce SMM and maternal mortality in the United States must prioritize the unique needs of this population and ensure equitable, disability-competent care for all women.

Reference:

Akobirshoev, Ilhom PhD; Vetter, Michael MA; Horner-Johnson, Willi PhD; Lomerson, Nicole MPH; Moore Simas, Tiffany A. MD, MPH; Mitra, Monika PhD. Severe Maternal Morbidity by Disability Status and Type in the United States. O&G Open 1(3):p 027, September 2024. | DOI: 10.1097/og9.0000000000000027

Keywords:

Pregnant, Women, vision, physical, disabilities, higher, risk, severe, maternal, morbidity, during, childbirth, study, Akobirshoev, Ilhom PhD; Vetter, Michael MA; Horner-Johnson, Willi PhD; Lomerson, Nicole MPH; Moore Simas, Tiffany A. MD, MPH; Mitra, Monika, O and G open

Powered by WPeMatico

Pushing kidney-stone fragments reduces stones’ recurrence, suggests study TAKE-HOME

Researchers at Medicine have found in a new study that patients who underwent the stone-moving ultrasound procedure had a 70% lower risk of such a recurrence. The Journal of Urology published the findings in August.In the instant study doctors used a handheld ultrasound device to nudge patients’ kidney-stone fragments.

As many as 50% of patients who have kidney stones removed surgically still have small fragments remaining in the kidneys afterward. Of those patients, about 25% find themselves returning for another operation within five years to remove the now-larger fragments.

“I think the main takeaways of this study are removing fragments reduces relapse and using a noninvasive, hand-held ultrasound device to help clear these kidney stone fragments,” said UW Medicine urologist Dr. Jonathan Harper, the study’s senior author.

The multisite, randomized and controlled trial was conducted from May 2015 to April 2024. Almost all of the 82 participants were from the UW Medicine or the VA Puget Sound health systems. All had stone fragments that had persisted in their kidneys for months, and their ureters were free of stones and fragments.

In the study, 40 underwent ultrasound treatment to encourage fragments to clear from the kidneys, while 42 control-group members received no such treatment.

With patients awake in a clinic office setting, doctors used a wand that generated ultrasonic pulses through the skin to move the fragments closer to the ureter, where they could be naturally expelled, sometimes with the next urination, Harper noted.

Harper and his co-lead author on the paper, urologist Dr. Mathew Sorensen, have worked on this technology and treatment for 15 years. They also use this technology, called burst wave lithotripsy, to blast larger stones into smaller pieces; those successes were published in 2022.

The pushing and breaking technologies are used with the same ultrasound platform.

Harper expressed hope that both clinical uses of the technology would become commonplace. A company, SonoMotion, is commercializing the technology, which was developed at the University of Washington, he added.

“I see a lot of potential in this It could become as common as getting your teeth cleaned. If you have a couple of small stones which could cause future problems, you make an office appointment and in 30 minutes you’re done.

“This could really revolutionize kidney stone treatment,” Harper said. 

Reference:

Mathew D. Sorensen, Barbrina Dunmire, Jeff Thiel, Bryan W. Cunitz, Barbara H. Burke, Branda J. Levchak, Christina Popchoi, Arturo E. Holmes, John C. Kucewicz, M. Kennedy Hall, Manjiri Dighe, Jessica C. Dai, Fionnuala C. Cormack, Ziyue Liu, Michael R. Bailey, Randomized Controlled Trial of Ultrasonic Propulsion–Facilitated Clearance of Residual Kidney Stone Fragments vs Observation, The Journal of Urology, https://doi.org/10.1097/JU.0000000000004186.

Powered by WPeMatico

Monthly Erenumab may induce Remission of Medication-Overuse Headache in Chronic Migraine Patients: Study

A new study by Stewart Tepper and team showed that monthly 140 mg erenumab injections in individuals with non-opioid chronic migraine and drug overuse headaches resulted in medication overuse headache remission safely and effectively within 6 months.

Acute drug misuse is prevalent in migraine patients, which includes triptans, opioids, and both combination and basic analgesics. Medication overuse headache (MOH) is a recognized secondary headache disorder according to the International Classification of Headache Disorders (ICHD-3). It is characterized by prolonged overuse of acute headache medication(s) and a clinical observation of a significant worsening of an existing headache or the emergence of a new headache type in relation to the medication overuse.

The anticalcitonin gene-related peptide (CGRP) receptor monoclonal antibody erenumab-aooe was created for adult migraine prevention and has been effective in lowering monthly migraine days. This trial was set out to evaluate the safety and effectiveness of erenumab in patients with nonopioid CM-MOH.

This randomized, parallel-group, double-blind, placebo-controlled study lasted from October 7, 2019 to November 2, 2022, at 67 centers in North America, Europe, and Australia. Adults with CM-MOH who had failed at least one preventative therapy were eligible to participate. There were 992 individuals screened, with 620 enrolled. The main endpoint was MOH remission at month 6. The secondary end goals included the decrease from baseline in mean monthly acute headache prescription days (AHMD) at month 6 and the maintenance of MOH remission throughout the DBTP. Adverse events and alterations in vital signs served as safety endpoints.

The primary analysis sample consisted of 584 nonopioid-treated subjects with an average age of 44 years, 482 of whom were female (82.5%). Baseline demographics and illness characteristics were evenly distributed across groups. At month 6, 134 patients in the erenumab 140 mg group and 117 in the erenumab 70 mg group had achieved MOH remission when compared to 102 people enrolled in the placebo group (52.6%).

The usage of AHMD was similarly decreased in the erenumab groups compared to placebo. The least squares mean shift from baseline in average monthly AHMD was -9.4 (0.4) days in the erenumab 140 mg group and -7.8 (0.4) days in the erenumab 70 mg group when compared to -6.6 (0.4) days in the placebo group. verall, erenumab was successful in achieving and maintaining high rates of MOH remission, and the amount and quality of adverse events were consistent with the established safety profile of this medication.

Reference:

Tepper, S. J., Dodick, D. W., Lanteri-Minet, M., Dolezil, D., Gil-Gouveia, R., Lucas, C., Piasecka-Stryczynska, K., Szabó, G., Mikol, D. D., Chehrenama, M., Chou, D. E., Yang, Y., & Paiva da Silva Lima, G. (2024). Efficacy and safety of erenumab for nonopioid medication overuse headache in chronic migraine: A phase 4, randomized, placebo-controlled trial. JAMA Neurology. https://doi.org/10.1001/jamaneurol.2024.3043

Powered by WPeMatico

Can MIND Diet Lower Risk of Memory Problems Later in Life?

People whose diet more closely resembles the MIND diet may have a lower risk of cognitive impairment, according to a study published in the September 18, 2024, online issue of Neurology®, the medical journal of the American Academy of Neurology. Results were similar for Black and white participants. These results do not prove that the MIND diet prevents cognitive impairment, they only show an association.

The MIND diet is a combination of the Mediterranean and DASH diets. It includes green leafy vegetables like spinach, kale and collard greens along with other vegetables. It recommends whole grains, olive oil, poultry, fish, beans and nuts. It prioritizes berries over other fruits and recommends one or more servings of fish per week.

“With the number of people with dementia increasing with the aging population, it’s critical to find changes that we can make to delay or slow down the development of cognitive problems,” said study author Russell P. Sawyer, MD, of the University of Cincinnati in Ohio and member of the American Academy of Neurology. “We were especially interested to see whether diet affects the risk of cognitive impairment in both Black and white study participants.”

The study involved 14,145 people with an average age of 64. Of participants, 70% were white and 30% were Black. They were followed for an average of 10 years.

Participants filled out a questionnaire on their diet over the past year. Researchers looked at how closely the foods people were eating matched the MIND diet.

One point was given for each of the following: three or more daily servings of whole grains; six or more weekly servings of green leafy vegetables; one or more daily servings of other vegetables; two or more weekly servings of berries; one or more weekly servings of fish; two or more weekly servings of poultry; three weekly servings of beans; five daily servings of nuts; four or fewer weekly servings of red meat; one or fewer weekly servings of fast or fried foods; one or more weekly servings of olive oil; and one or fewer tablespoons of butter or margarine daily; five or fewer weekly servings of pastries and sweets; and one glass per day of wine. The total points possible was 12.

Researchers then divided participants into three groups. The low group had an average diet score of five, the middle group had an average score of seven and the high group had an average score of nine.

Thinking and memory skills were measured at the beginning and end of the study.

During the study, cognitive impairment developed in 532 people, or 12% of 4,456 people in the low diet group; in 617 people, or 11% of 5,602 people in the middle group; and in 402 people, or 10% of the 4,086 people in the high group.

After adjusting for factors such as age, high blood pressure and diabetes, researchers found people in the high group had a 4% decreased risk of cognitive impairment compared to those in the low group.

When looking at male and female participants, researchers found a 6% decreased risk of cognitive impairment for female participants who most closely followed the diet but no decreased risk for male participants.

Researchers also looked at how quickly people’s thinking skills declined as they developed problems. They found that people who more closely followed the MIND diet declined more slowly than those who did not, and that association was stronger in Black participants than in white participants.

“These findings warrant further study, especially to examine these varying impacts among men and women and Black and white people, but it’s exciting to consider that people could make some simple changes to their diet and potentially reduce or delay their risk of cognitive issues,” said Sawyer.

A limitation of the study was it included only older Black and white people so results may not be the same for other populations.

Reference:

Russell P. Sawyer, Jessica Blair, Rhonna Shatz, Jennifer J. Manly, Suzanne E. Judd. Association of Adherence to a MIND-Style Diet With the Risk of Cognitive Impairment and Decline in the REGARDS Cohort. Neurology, 2024; 103 (8) DOI: 10.1212/WNL.0000000000209817.

Powered by WPeMatico

Minimally Invasive Procedures Effective in Reducing Pain and Improving Function in Osteoarthritis Patients: Study

Researchers have found that minimally invasive interventional procedures, namely radiofrequency ablation (RFA) and transcatheter arterial embolization (TAE), did reduce the levels of pain and improve the functionality of patients with osteoarthritis (OA) and chronic sacroiliac pain of degenerative origin. A comprehensive meta-analysis was conducted to evaluate the efficacy of such treatments on various anatomical locations by comparing RCTs and NRSI. The study was recently published in the journal Seminars in Arthritis and Rheumatism by Jacopo C. and colleagues.

PubMed and Web of Science databases were searched systematically for both RCTs and NRSI. The searched studies included patients with osteoarthritis or chronic sacroiliac pain treated with RFA or TAE. Findings were summarized according to anatomical treatment site: knee, hip, foot and ankle, shoulder, hand and wrist, and sacroiliac joints. The primary outcome assessed was the change in pain intensity score as measured by the 0–10 VAS, comparing baseline with one month, and follow-up assessments at three, six, and twelve months. Assessments of improvements in functional status were also conducted. Pooled estimates were estimated as the mean difference (MD) versus baseline, along with 95% confidence intervals (CI). For added strength, the analyses were performed separately for RCTs and NRSI.

Results

From 4,599 articles obtained, 164 met the inclusion criteria and were reviewed, and of these, 111 studies (38 RCTs and 73 NRSI) were included in the meta-analysis. Of these, one article was specific to patients with inflammatory arthritis. Significant decreases in pain intensity were seen for both RFA and TAE at all post-procedure timepoints by comparison in meta-analysis.

RCT meta-analysis: At one month post procedure:

  • Knee RFA: MD in VAS was -3.98 (-4.41 to -3.55; 21 studies).

  • Sacroiliac joints RFA: MD in VAS was -3.18 (-3.96 to -2.39; 8 studies).

NRSI meta-analysis:

  • Knee RFA: MD in VAS was -4.12 (-4.63 to -3.61; 23 studies).

  • Knee TAE: MD in VAS was -3.84 (-4.77 to -2.92; 7 studies).

  • Hip RFA: MD in VAS was -4.34 (-4.96 to -3.71; 2 studies).

  • Shoulder RFA: MD in VAS was -3.83 (-4.52 to -3.15; 3 studies).

  • Sacroiliac joints RFA: MD in VAS was -4.93 (-5.58 to -4.28; 14 studies).

Pain reduction was additional at the three, six, and twelve-month mark post-intervention. The functional status of the patients also improved at all time points assessed, thus complementing the clinical and treatment indications of these interventions.

Minimally invasive interventional procedures, like RFA and TAE, will bestow many benefits in reducing pain and improvement of the patients’ functional status with OA or chronic sacroiliac joint pain. Such findings would justify the integration of such treatments into clinical practice, especially for patients who are searching for non-surgical alternatives. Further studies would be necessary to affirm the effectiveness of such procedures within the management of inflammatory arthritis.

Reference:

Ciaffi, J., Papalexis, N., Vanni, E., Miceli, M., Faldini, C., Scotti, L., Zambon, A., Salvarani, C., Caporali, R., Facchini, G., & Ursini, F. (2024). Minimally invasive interventional procedures for osteoarthritis and inflammatory arthritis: A systematic review and meta-analysis. Seminars in Arthritis and Rheumatism, 68(152525), 152525. https://doi.org/10.1016/j.semarthrit.2024.152525

Powered by WPeMatico

High-Intensity NPPV Reduces Intubation Need in COPD Patients with Persistent Hypercapnia: JAMA

A new study published in the Journal of American Medical Association found that acute exacerbations of chronic obstructive pulmonary disease (COPD) may require less endotracheal intubation when high-intensity noninvasive positive pressure ventilation (NPPV) is used to treat persistent hypercapnia.

Due to the uncertainty around how high-intensity noninvasive positive pressure ventilation affects patients who have an acute exacerbation of chronic obstructive pulmonary disease in terms of the necessity for endotracheal intubation. Thus, this study by Zujin Luo and colleagues was to ascertain if endotracheal intubation is less necessary in patients facing an acute exacerbation of COPD and hypercapnia when high-intensity NPPV is used as opposed to low-intensity NPPV.

This randomized clinical study that took place in 30 general respiratory non-intensive care unit wards in Chinese hospitals between January 3, 2019, and January 31, 2022 following by a 90-day follow-up was on April 22, 2022. Following 6 hours of low-intensity NPPV, the patients included experienced an acute exacerbation of COPD and a Paco2 level higher than 45 mm Hg. In a 1:1 randomization, patients were assigned to either receive low-intensity NPPV with inspiratory positive airway pressure modified to obtain a tidal volume of 6 mL/kg to 10 mL/kg of anticipated body weight (n = 153) or high-intensity NPPV with inspiratory positive airway pressure adjusted to obtain a tidal volume of 10 mL/kg to 15 mL/kg of predicted body weight (n = 147).

The individuals in the low-intensity NPPV group were eligible to transition to the high-intensity NPPV group if they satisfied the predetermined requirements for endotracheal intubation. As determined by predetermined criteria, the main outcome was the requirement for endotracheal intubation while the patient was in the hospital. One of the 15 predetermined secondary outcomes was endotracheal intubation.

Following an interim study of the first 300 patients, the data and safety monitoring board and trial steering committee decided to stop the experiment, where all 300 of the patients finished the experiment. The primary outcome of satisfying prespecified criteria for the requirement for endotracheal intubation took place in 7 of 147 patients (4.8%) in the high-intensity NPPV group and 21 of 153 (13.7%) in the low-intensity NPPV group. However, the rates of endotracheal intubation were not substantially different across the groups. The high-intensity NPPV group had a higher incidence of abdominal distension than the low-intensity NPPV group. Overall, in the high-intensity NPPV group, the likelihood of patients with COPD and chronic hypercapnia meeting the requirements for endotracheal intubation was much lower.

Source:

Effect of high-intensity vs low-intensity noninvasive positive pressure ventilation on the need for endotracheal intubation in patients with an acute exacerbation of chronic obstructive pulmonary disease: The HAPPEN randomized clinical trial. (2024). JAMA. https://doi.org/10.1001/jama.2024.15815

Powered by WPeMatico

Roflumilast Cream Safe and Effective in Treatment of Atopic Dermatitis: JAMA

According to the recent study published in the Journal of American Medical Association, a new topical treatment for atopic dermatitis (AD) has been shown as a safe, effective, and well-tolerated option for patients with this chronic skin condition. This two phase 3 clinical trials, titled INTEGUMENT-1 and INTEGUMENT-2, evaluated the efficacy and safety of roflumilast cream, 0.15% and compared to a vehicle (placebo) cream, with findings suggesting significant improvement in AD symptoms after just four weeks of use.

Atopic dermatitis is a chronic inflammatory skin disorder that affects millions of people globally, causing itchy, red, and inflamed skin. Despite the prevalence of the condition, long-term treatment options remain limited, and adherence rates are often low due to side effects or lack of effectiveness. Roflumilast is a phosphodiesterase-4 (PDE4) inhibitor and has emerged as a potential alternative with its once-daily topical formulation.

In the INTEGUMENT-1 and INTEGUMENT-2 trials, a total of 1,337 patients, aged 6 and above, from the United States, Canada, and Poland were enrolled. These patients had mild to moderate AD, as determined by the Validated Global Assessment for Atopic Dermatitis to measure disease severity. These participants were randomized in a 2:1 ratio to either receive roflumilast cream, 0.15%, or vehicle cream for four weeks.

The primary outcome measured was the success rate on the Validated Investigator Global Assessment (VIGA) for Atopic Dermatitis. This required a score of 0 (clear) or 1 (almost clear) plus an improvement of at least two grades from the baseline assessment by week 4. The results found 32% of patients in the INTEGUMENT-1 trial and 28.9% in the INTEGUMENT-2 trial who used roflumilast to achieve the primary endpoint when compared to 15.2% and 12.0% of the ones using the vehicle cream, respectively. These differences were statistically significant (P < .001).

Secondary outcomes, such as reductions in the Eczema Area and Severity Index (EASI) and improvements in the Worst Itch Numeric Rating Scale, also favored roflumilast. Over 43% of patients in the INTEGUMENT-1 trial and 42% in INTEGUMENT-2 experienced at least a 75% reduction in EASI scores, a marked improvement when compared to 22% and 19.7% in the vehicle groups.

Also, roflumilast cream was well tolerated by patients. More than 95% of participants reported no irritation at the application site, and 90% noted no or only mild sensations upon use. Adverse events were rare, further strengthening its safety profile. Overall, these trials highlight roflumilast cream as a promising option for patients with mild to moderate atopic dermatitis.

Source:

Simpson, E. L., Eichenfield, L. F., Alonso-Llamazares, J., Draelos, Z. D., Ferris, L. K., Forman, S. B., Gooderham, M., Gonzalez, M. E., Hebert, A. A., Kircik, L. H., Lomaga, M., Moore, A., Papp, K. A., Prajapati, V. H., Hanna, D., Snyder, S., Krupa, D., Burnett, P., Almaraz, E., … Berk, D. R. (2024). Roflumilast Cream, 0.15%, for Atopic Dermatitis in Adults and Children. In JAMA Dermatology. American Medical Association (AMA). https://doi.org/10.1001/jamadermatol.2024.3121

Powered by WPeMatico

Osseodensification improves implant success and stability without compromising crestal bone levels, finds study

Researchers have found in a new study that Osseodensification improves osseointegration, reduces surgical trauma, and preserves bone, making it a valuable technique for implant placement in a low-density bone where poor primary implant stability is expected. The study has been published in the Journal of prosthetic Dentistry.

This systematic review and meta-analysis analyzed how implant stability and crestal bone level vary in a low-density bone in osseodensification osteotomy and conventional osteotomy. The SCOPUS, PUBMED, and Google Scholar databases were searched, along with a manual search, for articles published between January 2013 and January 2024. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed to select the studies for review. A total of 5 studies were included in this systematic review. The Joanna Briggs Institute (JBI) tools were used to conduct the risk of assessment of the included articles, and forest plots were generated for the included articles (α=.05). Results: The data were assimilated from a small sample size of 109 patients and 198 implants. The meta-analysis found that osseodensification resulted in significantly higher implant stability quotient (P<.05) values at baseline and follow-up, while the crestal bone level changes were not found to be significant (P>.05) at baseline or on follow-up visits. The osseodensification drilling protocol displayed an advantage over the conventional drilling protocol regarding higher primary stability and secondary stability, as well as bone expansion in low-density bone. No significant difference in crestal bone loss was found in either technique at baseline or at follow-up.

Reference:

Kalra J, Dhawan P, Jain N. Implant stability and crestal bone level in osseodensification and conventional drilling protocols: A systematic review and meta-analysis. J Prosthet Dent. 2024 Aug 26:S0022-3913(24)00524-9. doi: 10.1016/j.prosdent.2024.07.036. Epub ahead of print. PMID: 39191537.

Keywords:

Osseodensification, improves, implant, success, stability, compromising, crestal, bone, levels,Kalra J, Dhawan P, Jain N

Powered by WPeMatico