Editor's Choice
2024 AHA/ACC/AMSSM/HRS/PACES/SCMR Guideline for the Management of Hypertrophic Cardiomyopathy – J Am Coll Cardiol
11 May, 2024 | 14:20h | UTCIn a significant advancement for the treatment of hypertrophic cardiomyopathy (HCM), the American Heart Association and the American College of Cardiology, along with other leading societies, have released updated guidelines to optimize patient care. Here are the essential updates and recommendations for practicing physicians:
1 – Updated Diagnostic Strategies: The guideline emphasizes the use of advanced imaging techniques and genetic testing to enhance diagnostic accuracy, enabling personalized treatment approaches.
2 – Risk Assessment Tools: Revised tools for sudden cardiac death (SCD) risk assessment are detailed, aiding clinicians in making informed decisions regarding the use of implantable cardioverter-defibrillators (ICDs).
3 – Management of Obstructive HCM: New recommendations for the pharmacological treatment of symptomatic obstructive HCM include the use of disopyramide and advanced therapies such as septal reduction when initial medication does not suffice.
4 – Guidelines on Exercise and Lifestyle: The guidelines provide a nuanced approach to physical activity, recognizing the benefits while outlining the risks for patients with HCM. Detailed advice is offered on managing competitive sports involvement and other lifestyle considerations.
5 – Multidisciplinary Approach: The guidelines advocate for a team-based approach involving specialized HCM centers, ensuring patients benefit from comprehensive expertise and the latest treatment modalities.
6 – Innovations in Treatment: Highlighting new therapeutic options like myosin inhibitors, the guidelines underscore their role in managing obstructive symptoms when traditional medications are inadequate.
7 – Special Populations: Detailed sections on the management of HCM in children and pregnant women, addressing the unique challenges these groups face.
These guidelines represent a cornerstone in the evolving landscape of HCM management, embodying a commitment to enhancing outcomes and quality of life for patients through evidence-based practices and collaborative care.
Reference (link to free full-text):
RCT: KarXT (xanomeline–trospium) demonstrates significant symptom reduction in schizophrenia compared to placebo – The Lancet
11 May, 2024 | 13:42h | UTCStudy Design and Population: The EMERGENT-2 study was a randomized, double-blind, placebo-controlled, flexible-dose, 5-week phase 3 trial conducted across 22 inpatient sites in the USA. It targeted adults aged 18–65 years diagnosed with schizophrenia, exhibiting a recent exacerbation in psychotic symptoms. A total of 252 participants, each with a Positive and Negative Syndrome Scale (PANSS) score of 80 or higher and a Clinical Global Impression-Severity score of 4 or more, were enrolled and randomized equally into two groups to receive either the muscarinic receptor agonist KarXT (xanomeline–trospium) or a placebo.
Main Findings: KarXT significantly reduced the PANSS total scores from baseline to week 5, with a mean decrease of 21.2 points compared to 11.6 points in the placebo group (least squares mean difference -9.6; 95% CI -13.9 to -5.2; p<0.0001; Cohen’s d=0.61). All secondary endpoints were also met favorably for KarXT. Common adverse events for KarXT included constipation, dyspepsia, and nausea, but rates of extrapyramidal symptoms were similar between the two groups. The treatment was generally well tolerated with comparable discontinuation rates due to adverse events.
Implications for Practice: These results indicate that KarXT could represent a new class of antipsychotic treatment, diverging from traditional D2 dopamine receptor antagonists and instead leveraging muscarinic receptor activation. The promising outcomes observed in EMERGENT-2 suggest that KarXT has the potential to improve both positive and negative symptoms of schizophrenia while maintaining a favorable safety profile. Ongoing and future studies (EMERGENT-3, EMERGENT-4, and EMERGENT-5) will further elucidate the long-term efficacy and safety of KarXT.
Reference (link to abstract – $ for full-text):
Cluster Randomized Trial: Hyperangulated video laryngoscopy reduces intubation attempts in surgical patients – JAMA
11 May, 2024 | 13:39h | UTCStudy Design and Population: This cluster randomized multiple crossover clinical trial was conducted at a single U.S. academic hospital to compare the effectiveness of hyperangulated video laryngoscopy versus direct laryngoscopy in reducing the number of intubation attempts during surgery. The study involved 7,736 adult patients, aged 18 years or older, undergoing elective or emergent cardiac, thoracic, or vascular surgical procedures that required single-lumen endotracheal intubation for general anesthesia. The trial randomized two sets of 11 operating rooms on a weekly basis to use either video laryngoscopy or direct laryngoscopy for the initial intubation attempt from March 2021 to December 2022.
Main Findings: Hyperangulated video laryngoscopy significantly decreased the number of intubation attempts compared to direct laryngoscopy. Specifically, 1.7% of surgical procedures using video laryngoscopy required more than one intubation attempt versus 7.6% for direct laryngoscopy, with an estimated proportional odds ratio of 0.20 (95% CI, 0.14-0.28; P < .001). Furthermore, intubation failure was markedly lower with video laryngoscopy (0.27%) compared to direct laryngoscopy (4.0%). However, there was no significant difference in the rates of airway and dental injuries between the two methods.
Implications for Practice: The findings indicate that hyperangulated video laryngoscopy enhances initial intubation success and reduces the need for multiple intubation attempts in a variety of surgical settings. This suggests that video laryngoscopy could be considered a preferable technique for endotracheal intubation in the operating room, potentially improving patient outcomes and efficiency. Further research might explore the generalizability of these results to other medical centers and different patient populations.
Reference (link to abstract – $ for full-text):
RCT: Video laryngoscopy improves first-attempt intubation success in neonates compared to direct laryngoscopy – N Engl J Med
11 May, 2024 | 13:37h | UTCStudy Design and Population: This single-center randomized clinical trial investigated the efficacy of video laryngoscopy versus direct laryngoscopy for urgent intubation in neonates. A total of 226 neonates requiring intubation either in the delivery room or neonatal intensive care unit (NICU) were enrolled and stratified by gestational age into two groups: less than 32 weeks and 32 weeks or more. The study primarily focused on the success rate of the first intubation attempt, monitored through exhaled carbon dioxide detection.
Main Findings: The trial included 214 neonates, analyzing the success of intubation on the first attempt. Video laryngoscopy significantly outperformed direct laryngoscopy, achieving a first-attempt success rate of 74% (95% confidence interval [CI], 66 to 82) compared to 45% (95% CI, 35 to 54) in the direct laryngoscopy group. Moreover, the median number of attempts for successful intubation was lower in the video-laryngoscopy group (1 attempt, 95% CI, 1 to 1) versus the direct-laryngoscopy group (2 attempts, 95% CI, 1 to 2). Additionally, neonates in the video laryngoscopy group experienced higher median lowest oxygen saturations and heart rates during intubation.
Implications for Practice: The findings suggest that video laryngoscopy could be more effective than direct laryngoscopy for urgent neonatal intubation, particularly in increasing the likelihood of success on the first attempt. These results recommend reconsidering current intubation techniques in neonatal care settings to incorporate video laryngoscopy, potentially leading to safer and more efficient intubation processes in this vulnerable population.
Reference (link to abstract – $ for full-text):
SCCM/IDSA Updated guidelines for evaluating new fever in adult ICU patients – Crit Care Med
5 May, 2024 | 15:12h | UTCThe 2023 revision of the guidelines for assessing new-onset fever in adult ICU patients stresses rigorous diagnostic processes using the GRADE methodology. These guidelines, developed without industry funding, offer 12 recommendations and nine best-practice statements focused primarily on the accurate measurement of core body temperature and initial diagnostic evaluations geared towards identifying potential infectious causes. Central temperature monitoring is recommended when possible; otherwise, oral or rectal measurements are preferred. The utility of imaging studies and rapid diagnostic tests is highlighted, along with the selective use of biomarkers to guide the cessation of antimicrobial therapy. The guidelines underscore that most recommendations are based on weak evidence, thus highlighting the need for continued research in diagnostic methodologies and fever management in the ICU setting.
Reference (link to free full-text):
RCT: Early patching proves more effective than extended optical treatment in pediatric amblyopia management – The Lancet
5 May, 2024 | 15:00h | UTCStudy Design and Population:
The EuPatch study was a multicenter, randomized controlled trial conducted across 30 hospitals in multiple European countries, including the UK, Greece, Austria, Germany, and Switzerland. It targeted children aged 3–8 years diagnosed with amblyopia due to anisometropia, strabismus, or both, with an interocular difference ≥0.30 logMAR in best corrected visual acuity (BCVA). Participants were divided into two groups: one underwent 18 weeks of glasses use before patching (Extended Optical Treatment, EOT), and the other just 3 weeks (early patching), each supplemented with an intensive patching regimen.
Main Findings:
Out of the 334 initially randomized participants, 317 were analyzed for the primary outcome. The early patching group demonstrated a significantly higher success rate, achieving ≤0.20 logMAR interocular difference in BCVA in 67% of cases compared to 54% in the EOT group after 12 weeks of patching (p=0.019). The median follow-up times were 42 weeks for the EOT group and 27 weeks for the early patching group, with dropout rates of 14% and 6%, respectively.
Implications for Practice:
The findings suggest that early patching is superior to EOT in the management of amblyopia in children, presenting a viable option for enhancing treatment effectiveness. This study supports the potential personalization of amblyopia treatments based on the quicker onset of patching. These results could influence future guidelines and clinical practices in pediatric ophthalmology.
Reference (link to free full-text):
Systematic Review: Comparing antibiotic treatment vs. appendectomy for the initial treatment of uncomplicated appendicitis – Cochrane Library
4 May, 2024 | 13:09h | UTCStudy Design and Population:
This Cochrane review analyzed 13 randomized controlled trials involving 3,358 participants to compare the efficacy of antibiotic treatment versus appendectomy in managing uncomplicated acute appendicitis. The included studies predominantly involved adult participants and utilized broad-spectrum antibiotics, with interventions ranging from open to predominantly laparoscopic appendectomy. Data collection spanned from hospital admission to up to seven years, with studies conducted across various global regions, including Asia, Europe, and North America.
Main Findings:
The primary outcomes revealed that antibiotic treatment might slightly increase the risk of unsuccessful treatment with 76 additional unsuccessful cases per 1,000 individuals compared to surgery, though these results did not reach clinical significance. Antibiotics reduced wound infections but possibly increased the average hospital stay by half a day. About 30.7% of participants treated with antibiotics required an appendectomy within one year. Secondary outcomes showed very uncertain evidence on antibiotics’ effect on intra-abdominal abscess or reoperation rates, and a slight increase in negative appendectomy rates was observed.
Implications for Practice:
The findings suggest that while antibiotics could serve as an initial treatment to avoid surgery in two-thirds of cases annually, a significant portion may still require surgical intervention. This information is crucial for clinicians in making informed treatment decisions, particularly considering patient preferences and the risk of surgery. Further research is needed to explore long-term outcomes and identify patient subgroups that may benefit most from either treatment.
Reference (link to abstract – $ for full-text):
ACP Guidelines for the pharmacologic management of type 2 diabetes in adults – Ann Intern Med
3 May, 2024 | 14:05h | UTCThe American College of Physicians (ACP) has issued an updated guideline focusing on the pharmacological management of type 2 diabetes. This guideline reviews the efficacy and safety of new medications, including GLP-1 agonists, SGLT-2 inhibitors, and others, emphasizing a systematic evaluation using the GRADE methodology. Key recommendations advise the integration of SGLT-2 inhibitors or GLP-1 agonists with metformin and lifestyle changes for better glycemic control and reduction in mortality and major cardiovascular events. Conversely, the use of DPP-4 inhibitors in similar therapeutic contexts is not recommended due to insufficient evidence of benefit. This guideline targets healthcare providers managing nonpregnant adults with type 2 diabetes.
Reference (link to free full-text):
ACP cost-effectiveness analysis: Newer antidiabetic medications in type 2 diabetes – Ann Intern Med
3 May, 2024 | 13:57h | UTCThis systematic review evaluates the cost-effectiveness of newer antidiabetic medications for type 2 diabetes from U.S. clinical and economic perspectives. Analyzing non-industry funded cost-effectiveness analyses (CEAs) using GRADE and Drummond criteria, the study identifies varying cost per quality-adjusted life-year (QALY) values for medications such as GLP1a and SGLT2i. It concludes that while GLP1a and SGLT2i offer low value as primary therapies due to high costs, they may present intermediate value as adjunct treatments to metformin. The study highlights the methodological variability in CEAs and the influence of drug cost and effectiveness assumptions on outcomes. The results suggest cautious interpretation in clinical decision-making due to varied evidence quality and cost-effectiveness profiles among the reviewed medications.
Reference (link to free full-text):
ACP Meta-Analysis: Comparative efficacy of newer antidiabetic agents in type 2 diabetes management – Ann Intern Med
3 May, 2024 | 13:49h | UTCThis systematic review and network meta-analysis evaluates the effectiveness and safety of modern antidiabetic drugs in managing type 2 diabetes mellitus. The study analyzed 130 publications from 84 randomized controlled trials, using GRADE criteria for evidence assessment. Sodium-glucose cotransporter-2 (SGLT2) inhibitors and glucagon-like peptide-1 (GLP1) agonists demonstrated significant reductions in all-cause mortality and major adverse cardiovascular events when compared to usual care, with SGLT2 inhibitors also showing benefits in reducing chronic kidney disease progression and hospitalizations due to heart failure. In contrast, dipeptidyl peptidase-4 (DPP4) inhibitors, insulin, and tirzepatide showed no significant mortality benefits. The study identified limitations including sparse direct drug comparisons and inadequate data for certain patient subgroups. Overall, SGLT2 inhibitors and GLP1 agonists were associated with fewer serious adverse events and severe hypoglycemia compared to insulin and sulfonylureas.
Reference (link to free full-text):
Review: Key findings from the Women’s Health Initiative studies on postmenopausal interventions – JAMA
3 May, 2024 | 13:34h | UTCThe Women’s Health Initiative (WHI) studied the impact of various interventions on postmenopausal women aged 50-79, using data from 161,808 participants between 1993 and 2018. The findings suggest that hormone therapy, specifically with conjugated equine estrogens and medroxyprogesterone acetate, does not reduce the risk of cardiovascular diseases, dementia, or other chronic conditions in postmenopausal women. It is, however, effective for managing severe menopausal symptoms when initiated before age 60 in women without contraindications. The trials also concluded that universal supplementation of calcium and vitamin D does not effectively prevent fractures and should be limited to those not meeting dietary intake recommendations. Furthermore, a low-fat diet rich in fruits, vegetables, and grains did not reduce the incidence of breast or colorectal cancer, though it may decrease breast cancer mortality rates, indicating the need for further investigation.
Reference (link to free full-text for a limited period):
Clinical Trial Follow-up: Antenatal corticosteroids not associated with adverse neurodevelopmental outcomes in late preterm births – JAMA
2 May, 2024 | 23:25h | UTCStudy Design and Population:
This research involved a prospective follow-up study of a multicenter randomized clinical trial, specifically focusing on children aged 6 years or older whose birthing parents were enrolled in the Antenatal Late Preterm Steroids (ALPS) trial. The trial initially examined the impact of administering 12 milligrams of intramuscular betamethasone, given twice 24 hours apart, on late preterm infants (34-36 completed weeks). The follow-up study involved 949 children from 13 centers in the Maternal-Fetal Medicine Units (MFMU) Network, assessed for neurodevelopmental outcomes.
Main Findings:
The primary outcome measured was the General Conceptual Ability score less than 85 on the Differential Ability Scales, 2nd Edition (DAS-II). Results showed no statistically significant differences between the betamethasone group (17.1%) and the placebo group (18.5%) in achieving this score. Secondary outcomes related to motor function and social responsiveness also showed no significant differences between the groups. Sensitivity analyses further confirmed these findings, suggesting that the administration of betamethasone did not adversely affect neurodevelopmental outcomes at age 6 or older.
Implications for Practice:
These findings support the continued use of antenatal corticosteroids for improving short-term neonatal respiratory outcomes in late preterm deliveries without concern for long-term neurodevelopmental harm. Clinicians can consider these results reassuring, as the study effectively dispels earlier concerns about potential negative long-term effects related to neurodevelopment from antenatal steroid use in late preterm infants.
Reference (link to abstract – $ for full-text):
USPSTF Guideline: Biennial screening mammography recommended for women aged 40-74 to reduce breast cancer morbidity and mortality
1 May, 2024 | 21:45h | UTCStudy Design and Population:
The US Preventive Services Task Force (USPSTF) performed a systematic review and collaborated on modeling studies to evaluate the effectiveness of various mammography-based breast cancer screening strategies. This assessment included factors such as age of initiation and cessation of screening, screening intervals, modalities, and the use of supplemental imaging. The population studied consisted of cisgender women and all other persons assigned female at birth who are 40 years or older and at average risk of breast cancer.
Main Findings:
The USPSTF concludes with moderate certainty that biennial screening mammography for women aged 40 to 74 years provides a moderate net benefit in reducing the incidence of and progression to advanced breast cancer, as well as in decreasing breast cancer morbidity and mortality. However, the evidence is insufficient to assess the benefits and harms of mammography screening in women aged 75 and older, as well as the use of supplemental screening with ultrasound or MRI in women with dense breasts.
Implications for Practice:
Based on these findings, the USPSTF recommends biennial screening mammography for women aged 40 to 74 years. This recommendation aims to optimize breast cancer outcomes while considering the balance of benefits and harms of screening. There is a need for further research to clarify the benefits and risks associated with mammography in women older than 75 and for those with dense breasts considering supplemental screening.
Commentary on X (thread – click for more)
🧵 Just published: USPSTF recommends all women undergo routine #breastcancer screening every other year beginning at age 40, an update from the 2016 recommendation to start at age 50.
https://t.co/xDPK4qu7JH pic.twitter.com/3zVBMWeuKb— JAMA (@JAMA_current) April 30, 2024
Reference (link to free full-text):
RCT: Beta-blockers post myocardial infarction showed no benefit in patients with preserved ejection fraction
30 Apr, 2024 | 13:40h | UTCThis randomized, open-label clinical trial conducted across 45 centers in Sweden, Estonia, and New Zealand examined the impact of long-term beta-blocker treatment in patients with acute myocardial infarction (AMI) who had undergone coronary angiography and had a preserved left ventricular ejection fraction (LVEF ≥ 50%). The study involved 5020 patients, predominantly from Sweden, with a median follow-up of 3.5 years. Participants were randomly assigned to receive either a beta-blocker (metoprolol or bisoprolol) or no beta-blocker. The primary endpoint was a composite of death from any cause or new myocardial infarction. The results showed no significant difference in the primary endpoint between the beta-blocker group (7.9%) and the no–beta-blocker group (8.3%) with a hazard ratio of 0.96 (95% CI, 0.79 to 1.16; P=0.64). Additionally, no significant differences were observed in secondary endpoints such as death from cardiovascular causes, myocardial infarction, or hospitalizations for atrial fibrillation and heart failure. Safety endpoints were also comparable between the groups. Overall, long-term beta-blocker treatment did not confer a reduction in risk for the primary composite endpoint or improve secondary outcomes in this patient population.
Commentary on X:
Original Article: Beta-Blockers after Myocardial Infarction and Preserved Ejection Fraction (REDUCE-AMI trial) https://t.co/z1NNeAK9Mm
Editorial: Routine Beta-Blockers in Secondary Prevention — On Injured Reserve https://t.co/NzlExH0LZm #ACC24 pic.twitter.com/8Jqpj2dM6E
— NEJM (@NEJM) April 17, 2024
Reference (link to abstract – $ for full-text):
RCT: Empagliflozin does not reduce heart failure hospitalization or death post-myocardial infarction
29 Apr, 2024 | 12:39h | UTCThis randomized, placebo-controlled trial assessed empagliflozin in preventing heart failure or death in patients recently hospitalized for acute myocardial infarction. Among 6,522 patients divided evenly into empagliflozin and placebo groups, there was no significant difference in the primary outcome—a composite of heart failure hospitalization or death—after 17.9 months. The empagliflozin group saw 8.2% experiencing the primary outcome versus 9.1% in the placebo group, yielding a non-significant hazard ratio of 0.90 (95% CI, 0.76 to 1.06; P=0.21). The results indicate that empagliflozin does not effectively reduce the risk of heart failure or mortality compared to placebo in this setting.
Reference (link to abstract – $ for full-text):
RCT: Semaglutide significantly improves symptoms and weight loss in HFpEF and type 2 diabetes patients
29 Apr, 2024 | 12:36h | UTCThis randomized clinical trial evaluated the effects of semaglutide on 616 patients with obesity-related heart failure with preserved ejection fraction (HFpEF) and type 2 diabetes. Patients received weekly doses of 2.4 mg semaglutide or a placebo for 52 weeks. The study’s primary findings included a significant improvement in heart failure–related symptoms, as measured by the Kansas City Cardiomyopathy Questionnaire clinical summary score (average increase of 13.7 points in the semaglutide group versus 6.4 points in the placebo group). Additionally, semaglutide treatment resulted in a mean 9.8% reduction in body weight compared to 3.4% with placebo. Secondary outcomes also favored semaglutide, showing enhancements in 6-minute walk distance and reductions in C-reactive protein levels. Notably, semaglutide was associated with fewer serious adverse events compared to placebo.
Reference (link to abstract – $ for full-text):
Cohort Study: No increased risk of autism, ADHD, or intellectual disability from acetaminophen use in pregnancy
29 Apr, 2024 | 12:34h | UTCThis cohort study investigated the association between acetaminophen use during pregnancy and the risk of autism, ADHD, and intellectual disability in children. The study utilized a population-based sample of nearly 2.5 million Swedish children born between 1995 and 2019, with data analyzed up to 2021. Initial findings without sibling controls suggested a marginal increase in the risks of autism and ADHD. However, sibling control analyses, which help adjust for familial confounding, showed no significant associations (HR for autism and ADHD at 0.98, and intellectual disability at 1.01). These results imply that earlier observed risks might be due to unaccounted familial factors, not acetaminophen exposure.
Reference (link to abstract – $ for full-text):
Pooled Analysis: Changes in prevalence of underweight and obesity from 1990 to 2022 in 200 countries
27 Apr, 2024 | 16:02h | UTCStudy Design and Population:
This pooled analysis utilized data from 3,663 population-representative studies involving 222 million participants to assess trends in underweight, thinness, and obesity. The study separated its analysis between adults (aged ≥20 years) and school-aged children and adolescents (aged 5–19 years) across 200 countries from 1990 to 2022. Bayesian hierarchical models were employed to estimate trends in different BMI categories.
Main Findings:
The findings indicate significant geographical and demographic variations in the prevalence of underweight and obesity. While the combined prevalence of underweight and obesity decreased in a minority of countries, it increased significantly in the majority, particularly in island nations, the Middle East, and North Africa. The study also found that obesity rates have surpassed underweight rates in the vast majority of countries by 2022.
Implications for Practice:
The increasing prevalence of obesity alongside persistent underweight and thinness issues underscores the need for a dual-focused public health approach. Strategies should prioritize not only the reduction of obesity through healthy eating and physical activity but also address undernutrition by improving access to nutritious foods, especially in regions like south Asia and parts of Africa where underweight remains prevalent.
M-A Proportional increase in new-onset diabetes with different intensities of statin therapy
27 Apr, 2024 | 15:41h | UTCStudy Design and Population:
This research is a meta-analysis of individual participant data from large, long-term, randomized, double-blind controlled trials involving statins. The study encompasses 19 trials comparing statin use to placebo and four trials comparing varying intensities of statin therapy, involving a total of 154,664 participants over periods ranging from 4.3 to 4.9 years. Participants were adults enrolled in statin trials with a scheduled duration of at least two years and a participant count of at least 1000.
Main Findings:
The study revealed a dose-dependent increase in the incidence of new-onset diabetes when using statins. Participants receiving low to moderate-intensity statin therapy showed a 10% increase in new-onset diabetes annually compared to placebo, while those on high-intensity statin therapy exhibited a 36% increase. The absolute increases in new-onset diabetes were significantly influenced by the extent of HbA1c measurement. Notably, a large portion of new-onset diabetes cases occurred among participants with baseline glycaemic levels nearing the diabetes diagnostic threshold. Furthermore, the study found a moderate rise in mean glucose levels and HbA1c among those without baseline diabetes, and a significant worsening of glycemia among those with existing diabetes.
Implications for Practice:
The findings highlight a moderate, dose-dependent risk of new-onset diabetes associated with statin therapy, especially in individuals close to the diagnostic threshold for diabetes. These results should be considered in the clinical management of statin therapy, balancing the small increases in glycemia against the substantial benefits of statins in reducing cardiovascular risk. Healthcare providers should monitor glycaemic control in patients on statin therapy, particularly those prescribed high-intensity doses.
Reference (free full-text):
Cohort Study: Higher serious bleeding rates linked to diltiazem in elderly atrial fibrillation patients on anticoagulation
26 Apr, 2024 | 12:35h | UTCStudy Design and Population:
This retrospective cohort study analyzed data from 204,155 Medicare beneficiaries aged 65 years or older diagnosed with atrial fibrillation. The study focused on new users of the anticoagulants apixaban or rivaroxaban who commenced treatment with either diltiazem or metoprolol between January 2012 and November 2020, with follow-up extending up to 365 days.
Main Findings:
Patients treated with diltiazem exhibited a significantly increased risk of serious bleeding, including bleeding-related hospitalization and death, compared to those treated with metoprolol. The hazard ratio (HR) for serious bleeding events was 1.21, with a rate difference (RD) of 10.6 per 1000 person-years. Notably, the risk escalated with diltiazem doses exceeding 120 mg/day, indicating a dose-response relationship. Secondary outcomes, such as ischemic stroke or systemic embolism, did not show significant differences between the treatment groups.
Implications for Practice:
The findings suggest that in older adults with atrial fibrillation treated with apixaban or rivaroxaban, diltiazem increases the risk of serious bleeding, especially at higher doses. These results underscore the importance of cautious medication management and might influence clinical decisions regarding the choice of ventricular rate control in this population.
Reference (link to abstract – $ for full-text):
RCT: Lack of significant effect of Paxlovid (nirmatrelvir–ritonavir) on symptom alleviation in Covid-19
26 Apr, 2024 | 11:49h | UTCStudy Design and Population:
This phase 2–3 randomized clinical trial investigated the efficacy of nirmatrelvir in combination with ritonavir for treating mild-to-moderate Covid-19 in adults. Participants, both vaccinated and unvaccinated, were enrolled based on their risk factors for severe Covid-19. The study included 1296 adults who had confirmed Covid-19 with symptom onset within the past 5 days. They were randomly assigned to receive either nirmatrelvir–ritonavir or placebo every 12 hours for 5 days.
Main Findings:
The primary endpoint was the time to sustained alleviation of all targeted Covid-19 signs and symptoms. Results showed that the median time to alleviation was 12 days for the treatment group and 13 days for the placebo group, a difference that was not statistically significant (P=0.60). Hospitalizations and deaths were slightly lower in the treatment group (0.8%) compared to the placebo group (1.6%), but this difference was also not statistically significant. Adverse events were similar across both groups, with dysgeusia and diarrhea being the most common in the treatment group.
Implications for Practice:
The findings indicate that nirmatrelvir–ritonavir treatment does not significantly reduce the time to symptom alleviation for Covid-19 compared to placebo among vaccinated or unvaccinated adults. These results suggest that further research is needed to explore the potential benefits of this treatment in specific subpopulations or in combination with other interventions.
Reference (free full-text):
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RCT: Free Access to Water vs. Fasting Pre-Cesarean Reduces Vomiting and Increases Maternal Satisfaction
25 Mar, 2024 | 11:17h | UTCStudy Design and Population: This randomized controlled trial was carried out at the Obstetric Unit, Universiti Malaya Medical Center from October 2020 to May 2022. A total of 504 women scheduled for planned cesarean delivery under spinal anesthesia were randomized into two groups: 252 were allowed free access to water up until being called to the operating theater, and 252 were required to fast from midnight before the procedure. The study primarily aimed to evaluate the effects of these preoperative oral intake policies on perioperative vomiting and maternal satisfaction.
Main Findings: The results demonstrated significant benefits for the group with free access to water. Specifically, perioperative vomiting was observed in 3.6% of women with water access compared to 9.5% of those fasting, indicating a relative risk reduction. Maternal satisfaction scores were notably higher in the water access group, with median scores of 9 versus 5 for the fasting group. Additional findings included lower reports of thirst, fewer instances of preoperative intravenous hydration, reduced ketone presence in urine, and a lower average number of vasopressor doses needed. Significantly, 95.2% of participants in the water access group would recommend their regimen to a friend, compared to only 39.7% in the fasting group.
Implications for Practice: Allowing free access to water up until the time of surgery for women scheduled for cesarean delivery under spinal anesthesia significantly reduces the risk of perioperative vomiting and improves maternal satisfaction, without adversely affecting post-cesarean recovery or neonatal outcomes. These findings support revising current preoperative fasting guidelines to improve patient experience and potentially enhance clinical outcomes.
PCI vs. CABG in left main coronary disease patients with and without diabetes—a pooled analysis of 4 trials
22 Mar, 2024 | 11:41h | UTCStudy Design and Population: This research pooled individual patient data from four randomized clinical trials (SYNTAX, PRECOMBAT, NOBLE, and EXCEL), comparing percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) in 4393 patients with left main coronary artery disease. The trials included both patients with and without diabetes, allowing for a comparative analysis of outcomes based on the revascularization method and the presence of diabetes.
Main Findings: Patients with diabetes exhibited higher rates of 5-year mortality, spontaneous myocardial infarction (MI), and repeat revascularization compared to those without diabetes. However, mortality rates following PCI vs. CABG were similar in diabetic (15.3% vs. 14.1%, respectively) and non-diabetic patients (9.7% vs. 8.9%, respectively). PCI was associated with a lower risk of stroke within the first year post-operation across all patients. Notably, diabetic patients underwent higher rates of spontaneous MI and repeat revascularization after PCI compared to CABG, with a more significant absolute excess risk observed beyond the first year compared to non-diabetic patients.
Implications for Practice: For patients with left main disease deemed suitable for either PCI or CABG, diabetes status significantly influences long-term outcomes, including death and cardiovascular events. While PCI offers a lower early risk of stroke, it is associated with increased risks of spontaneous MI and repeat revascularization, particularly in diabetic patients. These findings underscore the importance of considering patient-specific factors, such as diabetes status, in choosing between PCI and CABG for left main coronary artery disease revascularization.
Reference
Prakriti Gaba et al. (2024). Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting in Patients With Left Main Disease With or Without Diabetes: Findings From a Pooled Analysis of 4 Randomized Clinical Trials. Circulation, 0. DOI: 10.1161/CIRCULATIONAHA.123.065571. Access the study here: Link