Archives
Meta-Analysis: Renal Denervation Modestly Reduces Blood Pressure in Uncontrolled Hypertension – J Am Heart Assoc
17 Aug, 2024 | 16:14h | UTCStudy Design and Population: This updated meta-analysis evaluated 15 randomized clinical trials, encompassing 2,581 patients, to assess the efficacy and safety of catheter-based renal denervation (RDN) in patients with uncontrolled hypertension. The trials included both patients on antihypertensive medications (ON-Med) and those off medications (OFF-Med), with comparisons made between RDN and sham or standard therapy.
Main Findings: RDN led to a modest but statistically significant reduction in blood pressure across both ON-Med and OFF-Med groups. In the OFF-Med group, 24-hour ambulatory systolic BP was reduced by 3.7 mm Hg (95% CI, -5.41 to -2.00). In the ON-Med group, the reduction was 2.23 mm Hg (95% CI, -3.56 to -0.90). Sham-controlled trials reinforced these findings, showing consistent BP reductions, thus validating the effect of RDN. However, the degree of BP reduction is modest and may be clinically limited.
Implications for Practice: While RDN appears to have a favorable safety profile and provides consistent BP reductions, the modest nature of these reductions suggests that its clinical utility may be more limited. Further research is needed to identify which patient populations might benefit the most from RDN and to optimize procedural techniques for greater efficacy.
Meta-analysis: SSRIs Significantly Reduce Symptoms but Increase Adverse Events in Premenstrual Syndrome – Cochrane Database Syst Rev
17 Aug, 2024 | 16:04h | UTCStudy Design and Population: This systematic review and meta-analysis included 34 randomized controlled trials (RCTs) involving 4,563 women diagnosed with premenstrual syndrome (PMS) or premenstrual dysphoric disorder (PMDD). The studies primarily focused on evaluating the efficacy and safety of selective serotonin reuptake inhibitors (SSRIs) compared to placebo. The trials involved a diverse population, predominantly from Western countries, with participants aged between 18 and 49 years.
Main Findings: SSRIs likely reduce overall self-rated premenstrual symptoms in women with PMS and PMDD, with a standardized mean difference (SMD) of -0.57 (95% CI: -0.72 to -0.42). Continuous SSRI administration was more effective than luteal phase administration (SMD -0.69 vs. -0.39). However, SSRIs were associated with a higher risk of adverse events, including nausea (OR 3.30), insomnia (OR 1.99), sexual dysfunction (OR 2.32), and fatigue (OR 1.52).
Implications for Practice: SSRIs are an effective treatment option for reducing premenstrual symptoms in women with PMS and PMDD, particularly when administered continuously. However, the increased risk of adverse events must be carefully considered, and patients should be monitored closely. Further research is necessary to confirm these findings and explore long-term safety.
RCT: Dietary Acid Reduction with Fruits and Vegetables Slows CKD Progression and Lowers CVD Risk in Hypertensive Patients – Am J Med
17 Aug, 2024 | 15:49h | UTCStudy Design and Population: This five-year randomized control trial included 153 hypertensive patients with macroalbuminuria and normal kidney function. Participants were randomly assigned to one of three groups: a diet rich in base-producing fruits and vegetables, oral sodium bicarbonate (NaHCO3), or Usual Care. The primary objective was to assess the effects of dietary acid reduction on chronic kidney disease (CKD) progression and cardiovascular disease (CVD) risk.
Main Findings: The study found that both fruits and vegetables and NaHCO3 slowed CKD progression compared to Usual Care, with significantly higher estimated glomerular filtration rates in the intervention groups. However, only the fruits and vegetables group showed significant reductions in systolic blood pressure, LDL cholesterol, and body mass index, leading to greater improvements in CVD risk indices.
Implications for Practice: The results support using fruits and vegetables as a foundational treatment for hypertension to reduce CKD progression and lower CVD risk, potentially with reduced reliance on pharmacological interventions.
News Release – FDA Approves First Nasal Spray for Anaphylaxis Treatment: Neffy (Epinephrine Nasal Spray) – U.S. Food and Drug Administration
17 Aug, 2024 | 15:43h | UTCThe U.S. Food and Drug Administration (FDA) has approved Neffy, the first epinephrine nasal spray for the emergency treatment of anaphylaxis and other severe allergic reactions (Type I) in both adults and pediatric patients weighing at least 30 kilograms (approximately 66 pounds). This approval introduces a non-injectable option for the rapid administration of epinephrine, which is critical in managing life-threatening allergic reactions.
Key Points for Healthcare Providers:
– Alternative to Injection: Neffy provides a new option for patients who may delay or avoid epinephrine injections due to needle phobia. This could be particularly beneficial for children and others reluctant to use injectable epinephrine.
– Efficacy and Safety: Neffy’s approval is supported by studies comparing its pharmacokinetics and pharmacodynamics to traditional epinephrine injections. These studies showed comparable blood epinephrine levels and similar physiological effects, such as increased blood pressure and heart rate.
– Administration: Neffy is a single-dose nasal spray, administered into one nostril. If symptoms do not improve or worsen, a second dose may be administered in the same nostril. Patients should still seek emergency medical care to monitor the anaphylactic reaction.
– Warnings: Certain nasal conditions, such as nasal polyps or a history of nasal surgery, may impair Neffy’s absorption. In these cases, injectable epinephrine might be a more reliable option. The product also carries typical warnings for epinephrine use, particularly in patients with coexisting conditions.
– Side Effects: Common side effects include throat irritation, nasal discomfort, headaches, and jitteriness. Healthcare professionals should discuss these with patients to ensure informed use.
Clinical Implications:
Neffy may reduce barriers to the timely treatment of anaphylaxis, potentially improving outcomes by increasing the likelihood of rapid epinephrine administration. Healthcare providers should consider Neffy as an alternative for patients who are needle-averse or have difficulty using injectable epinephrine, while also ensuring patients understand the importance of prompt medical attention following its use.
Approval Background:
Neffy was granted Fast Track designation by the FDA, emphasizing the need for an alternative to injectable epinephrine. The approval was awarded to ARS Pharmaceuticals.
Source: FDA News Release: FDA Approves First Nasal Spray for Treatment of Anaphylaxis
Randomized Phase 2 Trial: Extended-Release Ketamine Tablets Reduce Depression Scores in Treatment-Resistant Depression Without Significant Adverse Effects – Nat Med
14 Aug, 2024 | 13:30h | UTCStudy Design and Population: This phase 2 multicenter, randomized, placebo-controlled trial evaluated the efficacy and safety of extended-release ketamine tablets (R-107) in adults with treatment-resistant depression (TRD). A total of 231 patients underwent an initial open-label phase where they received 120 mg of R-107 daily for 5 days. Responders, defined by a ≥50% reduction in Montgomery–Åsberg Depression Rating Scale (MADRS) scores, were randomized to receive one of four doses of R-107 (30, 60, 120, or 180 mg) or placebo twice weekly for 12 weeks.
Main Findings: The primary endpoint, change in MADRS score at week 13, showed a significant reduction of 6.1 points in the 180 mg R-107 group compared to placebo (P = 0.019). This dose also had the lowest relapse rate (42.9%) compared to 70.6% for placebo. Secondary outcomes, including response and remission rates, were generally higher for active treatment arms but reached statistical significance only in the 120 mg dose group for treatment response. The treatment was well-tolerated, with no significant increases in blood pressure or sedation.
Implications for Practice: Extended-release ketamine tablets could be a promising treatment for TRD, offering significant symptom improvement with minimal adverse effects, particularly at higher doses. The favorable safety profile and potential for at-home administration make this formulation a convenient option for wider use, though further research is needed to confirm these findings in broader populations.
Study Shows High Prevalence of Solid Lung Nodules in Nonsmoking Adults – Radiology
14 Aug, 2024 | 13:14h | UTCStudy Design and Population: This cohort study examined the prevalence and size distribution of solid lung nodules in a nonsmoking population from the Northern Netherlands. A total of 10,431 participants aged 45 years and older, predominantly nonsmokers, were included in the Imaging in Lifelines (ImaLife) study. The study utilized low-dose chest CT scans to detect and measure lung nodules.
Main Findings: Lung nodules were present in 42% of participants, with a higher prevalence in males (47.5%) than females (37.7%). The prevalence of clinically relevant nodules (≥100 mm³) was 11.1%, and actionable nodules (≥300 mm³) were found in 2.3% of individuals. Both prevalence and nodule size increased with age, and male participants consistently showed a higher prevalence and larger nodule sizes compared to females.
Implications for Practice: While 42% of nonsmoking adults in this Northern European cohort were found to have solid lung nodules, the incidence of lung cancer within this population is notably low. This suggests that many of the clinically relevant and even actionable nodules identified in nonsmokers are likely benign. These findings highlight the need to refine nodule management strategies for individuals at low risk of lung cancer, potentially reducing unnecessary follow-up and interventions in nonsmoking populations. Future research on lung cancer outcomes in this cohort could further inform and optimize guidelines for nodule management in low-risk groups.
2024 ACC Expert Consensus Decision Pathway on Clinical Assessment, Management, and Trajectory of Patients Hospitalized With Heart Failure – J Am Coll Cardiol
14 Aug, 2024 | 12:47h | UTCIntroduction: The American College of Cardiology (ACC) has released a focused update on the 2019 Expert Consensus Decision Pathway (ECDP) for the management of patients hospitalized with heart failure (HF). This update reflects new evidence and aligns with the latest ACC/AHA/HFSA heart failure guidelines.
Key Points:
1 – SGLT Inhibitors in Hospitalization:
– The update emphasizes the use of sodium-glucose cotransporter 2 (SGLT2) inhibitors during hospitalization for heart failure, regardless of left ventricular ejection fraction (LVEF). These medications should be initiated early, provided the patient is hemodynamically stable and there are no contraindications such as type 1 diabetes or severe kidney dysfunction.
2 – Triage and Admission Criteria:
– Patients with a new diagnosis of HF with rapidly progressing symptoms, severe congestion, or higher disease complexity should generally be admitted from the emergency department (ED). Some low-risk patients may be managed in an observation unit or via Hospital at Home (HaH) programs.
3 – Daily Trajectory Review:
– The clinical trajectory of hospitalized HF patients should be reviewed daily to monitor for effective decongestion and the need for initiation of guideline-directed neurohormonal therapies. Adjustments should be made based on patient response.
4 – Neurohormonal Therapy Optimization:
– Strategies for optimizing neurohormonal therapies, including beta-blockers, angiotensin receptor/neprilysin inhibitors (ARNIs)/angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blockers (ARBs), and mineralocorticoid antagonists (MRAs), are updated. Therapy should be personalized based on patient tolerance, hemodynamics, and kidney function.
5 – Decongestion Strategies:
– The update provides enhanced guidance on diuretic therapy, including the use of dual nephron blockade and carbonic anhydrase inhibitors like acetazolamide for patients not responding adequately to loop diuretics.
6 – Palliative Care Integration:
– The role of palliative care has been highlighted, particularly for patients with worsening HF or those not responding to standard treatments. Early referral to palliative care can improve advance directive completion rates and reduce readmissions.
7 – Discharge and Follow-Up:
– Detailed discharge planning is crucial, including providing patients and caregivers with comprehensive information on medications, follow-up appointments, and the importance of adhering to the prescribed regimen. Telehealth may be utilized for post-discharge follow-up.
Conclusion: This focused update to the ACC ECDP provides essential guidance for the clinical management of patients hospitalized with heart failure. It emphasizes the early initiation of SGLT inhibitors, careful daily trajectory reviews, optimization of neurohormonal therapies, and the integration of palliative care. These updates aim to improve patient outcomes by addressing both short-term and long-term management strategies.
2024 Update to the ACC/AHA Clinical Performance and Quality Measures for Adults With Heart Failure – J Am Coll Cardiol
14 Aug, 2024 | 12:26h | UTCIntroduction:
The American Heart Association (AHA) and American College of Cardiology (ACC) have released the 2024 update to the 2020 clinical performance and quality measures for adults with heart failure. This update aligns with the latest 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure and introduces new performance and quality measures to improve patient care.
Key Points:
1 – Performance Measures (PM):
– PM-1: Guideline-Directed Medical Therapy (GDMT) at Discharge – Initiate optimal GDMT in hospitalized heart failure patients before discharge.
– PM-2: Blood Pressure Control in HFpEF – Ensure optimal blood pressure control in patients with heart failure with preserved ejection fraction (HFpEF).
– PM-3: SGLT2 Inhibitor Use in HFrEF – Prescribe sodium-glucose cotransporter-2 inhibitors for patients with heart failure with reduced ejection fraction (HFrEF).
2 – Quality Measures (QM):
– QM-1: SGLT2 Inhibitor in HFmrEF or HFpEF – Recommend SGLT2 inhibitors for patients with mildly reduced or preserved ejection fraction.
– QM-2: Social Determinants of Health – Screen and document actions addressing social determinants of health for heart failure patients.
– QM-3: Pregnancy Counseling – Provide patient-centered counseling on contraception and pregnancy risks for individuals with cardiomyopathy.
– QM-4: Continuation of GDMT in HFimpEF – Continue GDMT in patients with heart failure with improved ejection fraction (HFimpEF).
– QM-5: Optimization of GDMT before TEER – Optimize GDMT before performing transcatheter edge-to-edge repair (TEER) for chronic secondary severe mitral regurgitation.
– QM-6: Monoclonal Protein Screening for Cardiac Amyloidosis – Ensure monoclonal protein screening in patients undergoing bone scintigraphy for suspected transthyretin cardiac amyloidosis.
3 – Emphasis on Multidisciplinary Care: The guidelines highlight the importance of addressing cardiovascular disease risks, social determinants of health, and providing comprehensive patient education, particularly concerning reproductive health in women with cardiomyopathy.
4 – Exclusions: The measures exclude patients after heart transplantation or left ventricular assist device placement and allow for patient-specific exclusions when treatment is not appropriate based on clinical evidence or patient preference.
5 – No Retired Measures: The update did not retire any measures from the 2020 set, reflecting their continued relevance.
Conclusion:
The 2024 update introduces critical new performance and quality measures that reflect the latest evidence in heart failure management. These measures aim to improve patient outcomes by emphasizing guideline-directed therapies, multidisciplinary care, and consideration of social and health determinants.
Guideline Reference:
RCT: Bisoprolol Does Not Reduce COPD Exacerbations in High-Risk Patients – JAMA
14 Aug, 2024 | 12:31h | UTCStudy Design and Population: The Bisoprolol in COPD Study (BICS) was a double-blind, placebo-controlled randomized clinical trial conducted across 76 sites in the UK, including both primary and secondary care clinics. The study enrolled 515 patients with chronic obstructive pulmonary disease (COPD) who had moderate to severe airflow obstruction and a history of at least two exacerbations in the past year. Participants were randomly assigned to receive either bisoprolol (n=261) or placebo (n=258) and were followed for one year.
Main Findings: The primary outcome, the number of COPD exacerbations requiring treatment with oral corticosteroids, antibiotics, or both, did not differ significantly between the bisoprolol group (mean exacerbations, 2.03 per year) and the placebo group (mean exacerbations, 2.01 per year). The adjusted incidence rate ratio was 0.97 (95% CI, 0.84-1.13; P = .72), indicating no significant reduction in exacerbations with bisoprolol. Additionally, the rates of serious adverse events were similar between the two groups.
Implications for Practice: The findings suggest that bisoprolol does not reduce exacerbations in COPD patients at high risk and should not be recommended for this purpose. This study underscores the need for continued research into effective interventions for preventing COPD exacerbations in high-risk populations.
New AHA Guidelines for Managing Elevated Blood Pressure in Acute Care Settings – Hypertension
13 Aug, 2024 | 13:13h | UTCIntroduction:
The American Heart Association (AHA) has released a scientific statement focusing on the management of elevated blood pressure (BP) in acute care settings. This guideline addresses the significant variation in practice due to a lack of robust evidence for managing BP in such environments, particularly in emergencies or when elevated BP is asymptomatic.
Key Points:
1 – Classification of Elevated BP: Elevated BP in acute care settings is categorized into asymptomatic elevated BP and hypertensive emergency, the latter requiring immediate treatment due to acute target-organ damage.
2 – Hypertensive Emergency: Immediate treatment is necessary for patients with BP >180/110–120 mm Hg and evidence of new or worsening target-organ damage, typically using intravenous antihypertensive medications in a closely monitored environment.
3 – Asymptomatic Elevated BP: In cases where elevated BP is present without symptoms or target-organ damage, the use of antihypertensive medications should be approached cautiously. Recent studies suggest potential harm from aggressive treatment, highlighting the importance of verifying BP readings and identifying reversible causes before intervention.
4 – Proper BP Measurement: Accurate BP measurement is crucial. The guidelines stress using recently calibrated devices and following correct measurement techniques to avoid unnecessary treatment due to erroneous readings.
5 – PRN Orders: The use of “as needed” (PRN) antihypertensive medications for asymptomatic elevated BP is discouraged due to the risks of overtreatment and variability in BP control, which can lead to adverse outcomes.
6 – Treatment Thresholds: The guidelines recommend a high threshold for initiating or intensifying antihypertensive treatment in asymptomatic patients, emphasizing the need for repeated measurements and assessment of underlying causes.
7 – Post-Discharge Care: It is crucial to maintain prehospital antihypertensive regimens and avoid intensification at discharge unless clearly indicated. Effective care coordination and patient education are vital for successful transitions from hospital to home care.
Conclusion:
These guidelines represent a significant step toward standardizing BP management in acute care settings. By focusing on accurate measurement, cautious treatment of asymptomatic elevated BP, and proper follow-up, clinicians can reduce unnecessary interventions and improve patient outcomes.
Guideline Reference: Bress, A.P., et al. (2024). “The Management of Elevated Blood Pressure in the Acute Care Setting: A Scientific Statement from the American Heart Association.” Hypertension, 81–e106.
RCT: Eliminating Fasting Before Contrast-Enhanced CT in Outpatients Reduces Nausea and Vomiting Without Increasing Acute Adverse Reactions – Insights Imaging
11 Aug, 2024 | 13:41h | UTCStudy Design and Population: This single-center, randomized clinical trial was conducted in Spain with 1,103 adult outpatients undergoing non-emergency contrast-enhanced CT scans. Patients were randomized into two groups: one group fasted for at least 6 hours (control), while the other group had no food restrictions (intervention). The primary aim was to assess whether eliminating fasting affects the incidence of acute adverse reactions (AARs), such as nausea and vomiting.
Main Findings: The study found no significant difference in the overall incidence of acute adverse reactions between the fasting and non-fasting groups (3.21% vs. 2.30%; p = 0.36). However, the non-fasting group had a significantly lower incidence of nausea and vomiting (0.92% vs. 2.86%; p = 0.02). Multivariate logistic regression identified fasting, age, allergies, neurological diseases, and contrast media concentration as independent risk factors for nausea and vomiting.
Implications for Practice: The findings suggest that the traditional practice of fasting before contrast-enhanced CT scans is unnecessary and may increase the risk of nausea and vomiting. Therefore, unrestricted food intake should be allowed for most contrast-enhanced CT exams, reserving fasting only for specific imaging procedures.
Meta-Analysis: Daily Sedation Interruption Shortens PICU Stay Without Impacting Mortality or Ventilation Duration in Pediatric MV Patients – JAMA Netw Open
11 Aug, 2024 | 13:19h | UTCStudy Design and Population: This systematic review and meta-analysis included six randomized clinical trials (RCTs) involving 2,810 pediatric patients receiving mechanical ventilation (MV) in the pediatric intensive care unit (PICU). The trials compared the effects of daily sedation interruption (DSI) with continuous intravenous (IV) sedation on clinical outcomes such as MV duration and PICU length of stay.
Main Findings: The analysis found that DSI was associated with a significant reduction in the length of PICU stay (mean difference of -1.45 days, p = 0.03). However, there was no significant difference in the duration of MV between DSI and continuous sedation (mean difference of -0.93 days, p = 0.06). Additionally, there were no significant differences in total sedative doses, adverse events, or mortality between the two groups.
Implications for Practice: The findings suggest that DSI may reduce the length of PICU stay without increasing the risk of adverse events, making it a potentially valuable strategy in managing sedation for pediatric patients on MV. However, further research is needed to explore the long-term neurodevelopmental outcomes associated with DSI.
Meta-Analysis: Inhaled Antibiotics Offer Modest Reductions in Exacerbations and Quality of Life Gains in Bronchiectasis – CHEST
11 Aug, 2024 | 13:12h | UTCStudy Design and Population: This study is an updated systematic review and meta-analysis of 20 randomized controlled trials involving 3,468 adults with bronchiectasis, who were treated with inhaled antibiotics. The trials included in the analysis were selected based on criteria such as a minimum treatment duration of 4 weeks and involved patients diagnosed by CT imaging. The primary endpoint was exacerbation frequency, while secondary endpoints included severe exacerbations, bacterial load, symptoms, quality of life, and FEV1.
Main Findings: The meta-analysis found that inhaled antibiotics modestly reduced the proportion of patients experiencing exacerbations (risk ratio [RR], 0.85) and exacerbation frequency (RR, 0.78). Severe exacerbations were also decreased (RR, 0.48), and there was a slight increase in the time to the first exacerbation (hazard ratio [HR], 0.80). Additionally, quality of life showed modest improvements as measured by the Quality of Life Questionnaire-Bronchiectasis (mean difference, 2.51) and the St. George Respiratory Questionnaire (mean difference, -3.13). Bacterial load was consistently reduced, although FEV1 did not change meaningfully with treatment. The rate of adverse effects was similar to placebo (odds ratio [OR], 0.99), but antibiotic resistance appeared more likely to increase with treatment.
Implications for Practice: Inhaled antibiotics appear to be a beneficial treatment for adults with bronchiectasis, as they can reduce both exacerbation rates and severity while also improving quality of life. However, the increased risk of antibiotic resistance is a concern, indicating the need for careful patient selection and monitoring during treatment. These findings support the use of inhaled antibiotics in appropriate cases, particularly for those at high risk of exacerbations.
RCT: Nemolizumab Plus Topical Therapy Improves Skin Clearance, Itch, and Sleep in Moderate-to-Severe Atopic Dermatitis – The Lancet
11 Aug, 2024 | 12:58h | UTCStudy Design and Population: This study reports on two identical 48-week, double-blind, randomized, placebo-controlled phase 3 trials (ARCADIA 1 and ARCADIA 2) involving 1,728 adolescents and adults with moderate-to-severe atopic dermatitis and pruritus unresponsive to topical corticosteroids. Participants were randomized 2:1 to receive nemolizumab (an IL-31 receptor antagonist) or placebo, alongside background topical corticosteroids (TCS) and/or calcineurin inhibitors (TCI).
Main Findings: At week 16, nemolizumab significantly improved primary outcomes compared to placebo, with a higher proportion achieving clear or almost clear skin (IGA success) and a 75% improvement in Eczema Area and Severity Index (EASI-75). Nemolizumab also showed significant early and sustained improvements in itch and sleep. The safety profile was comparable between groups, with treatment-emergent adverse events occurring in about half of the participants.
Implications for Practice: Nemolizumab, in combination with TCS-TCI, demonstrated robust efficacy in reducing inflammation, itch, and sleep disturbances in moderate-to-severe atopic dermatitis. If approved, it could provide an important addition to current treatment options, particularly for patients inadequately managed by existing therapies.
RCT: Blinatumomab Improves Overall Survival in MRD-Negative Acute Lymphoblastic Leukemia Patients – N Engl J Med
11 Aug, 2024 | 12:53h | UTCStudy Design and Population: This phase 3 randomized clinical trial included 488 adults aged 30 to 70 with BCR::ABL1-negative B-cell precursor acute lymphoblastic leukemia (BCP-ALL) who achieved measurable residual disease (MRD)-negative remission after initial chemotherapy. The study compared the outcomes of patients receiving four cycles of blinatumomab alongside consolidation chemotherapy versus those receiving consolidation chemotherapy alone.
Main Findings: At a median follow-up of 43 months, the blinatumomab group demonstrated a significant improvement in overall survival (85% vs. 68% at 3 years) compared to the chemotherapy-only group, with a hazard ratio for death of 0.41 (95% CI, 0.23 to 0.73; P = 0.002). The 3-year relapse-free survival was also higher in the blinatumomab group (80% vs. 64%), with a hazard ratio for relapse or death of 0.53 (95% CI, 0.32 to 0.87). However, a higher incidence of neuropsychiatric events was noted in the blinatumomab group.
Implications for Practice: The addition of blinatumomab to consolidation chemotherapy significantly enhances overall and relapse-free survival in adult patients with MRD-negative BCP-ALL, suggesting its potential as a standard treatment approach for this population. Clinicians should monitor for neuropsychiatric side effects associated with blinatumomab use.
Systematic Review: Uncertain Impact of Vitamin D Supplementation During Pregnancy on Key Maternal and Neonatal Outcomes – Cochrane Database Syst Rev
11 Aug, 2024 | 12:42h | UTCStudy Design and Population: This Cochrane systematic review evaluates the effects of vitamin D supplementation alone or in combination with calcium and other vitamins/minerals during pregnancy. The analysis included 10 randomized controlled trials (RCTs) with a total of 2,313 pregnant women. The review excluded 20 studies from previous versions due to trustworthiness concerns and incorporated one new study.
Main Findings: The evidence regarding vitamin D supplementation alone was very uncertain for its impact on pre-eclampsia, gestational diabetes, preterm birth, and nephritic syndrome. There is low-certainty evidence suggesting that vitamin D may reduce the risk of severe postpartum hemorrhage and low birthweight, though the possibility of increased risk cannot be excluded. Supplementation with vitamin D plus calcium showed very uncertain effects on preterm birth and low birthweight, with no conclusive data on pre-eclampsia, gestational diabetes, or maternal adverse events. The combination of vitamin D, calcium, and other vitamins/minerals also yielded very uncertain evidence for all outcomes examined.
Implications for Practice: The current evidence does not provide strong support for routine vitamin D supplementation during pregnancy due to the low and very uncertain evidence on key outcomes. Further high-quality RCTs are needed to better understand the effects, particularly concerning maternal adverse events and neonatal health.
IDSA 2024 Guidelines for Managing Complicated Intra-abdominal Infections – Clin Infect Dis
10 Aug, 2024 | 22:10h | UTCIntroduction: The Infectious Diseases Society of America (IDSA) has updated its clinical practice guidelines for managing complicated intra-abdominal infections in adults, children, and pregnant individuals. The update focuses on risk assessment, diagnostic imaging, and microbiological evaluation, with recommendations grounded in systematic literature reviews and the GRADE approach for rating evidence.
Key Points:
1 – Risk Stratification:
– For adults with complicated intra-abdominal infections, the APACHE II score is recommended for risk stratification within 24 hours of hospital or ICU admission. The WSES Sepsis Severity Score is an acceptable alternative.
– No specific severity scoring system is recommended for pediatric patients.
2 – Diagnostic Imaging for Appendicitis:
– In non-pregnant adults, CT is suggested as the initial imaging modality for suspected acute appendicitis.
– For children, an abdominal ultrasound (US) is preferred initially, with MRI or CT recommended if the US is inconclusive.
– In pregnant individuals, US or MRI can be considered, with MRI suggested if initial US results are inconclusive.
3 – Imaging for Acute Cholecystitis and Cholangitis:
– For non-pregnant adults, US is recommended initially. If inconclusive, a CT scan is suggested.
– For pregnant individuals, US or MRI can be used, but the guidelines do not specify a preferred modality due to a knowledge gap.
4 – Blood Cultures:
– Blood cultures are recommended in adults and children with suspected intra-abdominal infections presenting with severe symptoms such as hypotension or tachypnea, especially when antibiotic-resistant organisms are a concern.
– Routine blood cultures are not recommended for patients without these risk factors.
5 – Intra-abdominal Fluid Cultures:
– In complicated intra-abdominal infections requiring source control procedures, obtaining intra-abdominal cultures is advised to guide antimicrobial therapy.
– In uncomplicated appendicitis cases, routine cultures are not recommended unless the patient is immunocompromised or complicated disease is suspected during surgery.
Conclusion: These guidelines provide evidence-based recommendations to improve the management of complicated intra-abdominal infections, emphasizing appropriate risk stratification, targeted diagnostic imaging, and the selective use of cultures to guide therapy.
Cluster RCT: AI-ECG Shows Potential to Reduce Door-to-Balloon Time and Cardiac Deaths in STEMI Patients – NEJM AI
10 Aug, 2024 | 21:57h | UTCStudy Design and Population: This open-label, cluster randomized controlled trial assessed the impact of AI-powered electrocardiogram (AI-ECG) on reducing treatment delays for ST-elevation myocardial infarction (STEMI). The study involved 43,234 patients, with an average age of 60 years, at Tri-Service General Hospital in Taiwan. Patients were randomized 1:1 into an intervention group (AI-ECG-assisted STEMI detection) or a control group receiving standard care.
Main Findings: AI-ECG significantly reduced the median door-to-balloon time for emergency department patients (82.0 vs. 96.0 minutes, P=0.002) and the ECG-to-balloon time across all settings (78.0 vs. 83.6 minutes, P=0.011). While the AI-ECG intervention did not significantly affect all-cause mortality or new-onset heart failure, it led to a notable reduction in cardiac death rates (85 vs. 116 cases; odds ratio, 0.73; P=0.029).
Implications for Practice: AI-ECG can expedite the critical time to treatment for STEMI patients, potentially reducing cardiac death. Although overall mortality remained unchanged, the reduction in cardiac deaths suggests that AI-ECG could be a valuable tool in emergency and inpatient settings to improve outcomes for STEMI patients.
Consensus Recommendations: Cardiovascular Risks in People With Narcolepsy – J Am Hear Assoc
10 Aug, 2024 | 21:48h | UTCIntroduction: The Journal of the American Heart Association recently published a consensus guideline by a panel of sleep and cardiology experts to address the heightened cardiovascular risks in individuals with narcolepsy. Given the increased prevalence of hypertension and cardiometabolic comorbidities in this population, the panel developed recommendations aimed at mitigating these risks.
Key Points:
1 – Increased Cardiovascular Risk in Narcolepsy:
– Individuals with narcolepsy, both Type 1 (NT1) and Type 2 (NT2), exhibit higher rates of cardiovascular and cardiometabolic diseases, such as hypertension, obesity, and diabetes, compared to the general population.
– The association of narcolepsy with conditions like obstructive sleep apnea (OSA) and restless legs syndrome further elevates cardiovascular risk.
2 – Monitoring and Early Detection:
– Clinicians should annually monitor blood pressure, weight, and waist circumference in patients with narcolepsy, even in the absence of existing cardiovascular disease.
– Screening for lipid levels and hemoglobin A1c is recommended, especially in patients with risk factors like hypertension, obesity, and diabetes.
3 – Lifestyle and Therapeutic Interventions:
– Patients should be educated about the link between narcolepsy and cardiovascular disease. Emphasis should be placed on maintaining optimal sleep duration, regular exercise, healthy eating, and reducing sodium intake.
– The American Heart Association’s “Life’s Essential 8” guidelines should be followed to enhance overall cardiovascular health.
4 – Medication Management:
– Narcolepsy medications, particularly stimulants and sodium oxybate, can increase cardiovascular risk. Clinicians should consider the patient’s cardiovascular profile when prescribing these treatments and explore alternatives with lower cardiovascular impact if necessary.
5 – Sodium Reduction:
– High sodium intake, from both diet and certain narcolepsy medications, is associated with increased blood pressure and cardiovascular disease. Patients should be advised to reduce sodium intake, and clinicians should consider prescribing lower-sodium alternatives when possible.
Conclusion: These expert consensus recommendations underscore the importance of proactive cardiovascular risk management in patients with narcolepsy. By implementing these guidelines, clinicians can help mitigate the long-term cardiovascular risks associated with this chronic sleep disorder.
Retrospective Study: Automated Multiorgan CT Markers Predict Diabetes and Cardiometabolic Comorbidities – Radiology
10 Aug, 2024 | 21:36h | UTCStudy Design and Population: This retrospective study analyzed data from 32,166 Korean adults (mean age, 45 years) who underwent health screenings, including fluorodeoxyglucose PET/CT scans, between 2012 and 2015. The study aimed to evaluate the predictive ability of automated CT-derived markers, such as visceral and subcutaneous fat, muscle area, bone density, liver fat, and aortic calcification, for diabetes and associated cardiometabolic conditions.
Main Findings: Visceral fat index showed the highest predictive performance for both prevalent and incident diabetes, with an AUC of 0.70 for men and 0.82 for women in cross-sectional analyses. Combining visceral fat, muscle area, liver fat, and aortic calcification improved prediction, yielding a C-index of 0.69 for men and 0.83 for women. Additionally, the study found that these CT markers were effective in identifying metabolic syndrome, fatty liver, coronary artery calcium scores >100, sarcopenia, and osteoporosis, with AUCs ranging from 0.80 to 0.95.
Implications for Practice: Automated CT-derived markers can effectively predict diabetes and multiple cardiometabolic comorbidities, surpassing traditional anthropometric measures. These findings suggest that integrating such automated assessments into routine clinical practice could enhance risk stratification and preventive care, particularly through opportunistic screening during routine CT scans.
Deep Learning Model Noninferior to Radiologists in Detecting Clinically Significant Prostate Cancer at MRI – Radiology
10 Aug, 2024 | 21:31h | UTCStudy Design and Population: This retrospective study evaluated the performance of a deep learning (DL) model for detecting clinically significant prostate cancer (csPCa) using multiparametric MRI (mpMRI) images from 5215 patients (5735 examinations) with a mean age of 66 years. The study included patients who underwent prostate MRI between January 2017 and December 2019 at a single academic institution. The DL model was trained on T2-weighted, diffusion-weighted, and contrast-enhanced MRI sequences, with pathologic diagnosis as the reference standard.
Main Findings: The DL model achieved an area under the receiver operating characteristic curve (AUC) of 0.89 on the internal test set and 0.86 on an external test set, demonstrating noninferiority to radiologists, who had AUCs of 0.89 and 0.84, respectively. Additionally, the combination of the DL model and radiologists improved diagnostic performance (AUC of 0.89). Gradient-weighted class activation maps (Grad-CAMs) effectively localized csPCa lesions, overlapping with true-positive cases in 92% of internal test set and 97% of external test set cases.
Implications for Practice: The DL model showed comparable performance to experienced radiologists in detecting csPCa at MRI, suggesting its potential to assist radiologists in improving diagnostic accuracy and reducing interobserver variability. Future research should focus on integrating the model into clinical workflows and assessing its impact on biopsy targeting.
Cross-Sectional Study: AI Model Accurately Detects Myopia, Strabismus, and Ptosis in Children Using Smartphone Photos – JAMA Netw Open
10 Aug, 2024 | 21:21h | UTCStudy Design and Population: This cross-sectional study was conducted at Shanghai Ninth People’s Hospital from October 2022 to September 2023, including 476 children diagnosed with myopia, strabismus, or ptosis. A total of 1,419 images were used to develop an AI model to detect these conditions based on mobile phone photographs.
Main Findings: The AI model demonstrated strong performance with a sensitivity of 0.84 for myopia, 0.73 for strabismus, and 0.85 for ptosis. The model achieved overall accuracies exceeding 0.80 for myopia and strabismus and 0.92 for ptosis, indicating its effectiveness in early detection of these pediatric eye conditions using only smartphone images.
Implications for Practice: The findings suggest that AI-based screening tools could enable early detection of common pediatric eye diseases at home, reducing the reliance on hospital-based screenings. This approach could facilitate timely intervention, improving visual outcomes and reducing the burden on healthcare systems.
Nested Case-Control Study: Sulfonamide Antibiotics and Cephalosporins Linked to Highest Risk of Serious Cutaneous Adverse Drug Reactions – JAMA
10 Aug, 2024 | 21:16h | UTCStudy Design and Population: This population-based, nested case-control study assessed the risk of serious cutaneous adverse drug reactions (cADRs) among older adults (66 years and above) in Ontario, Canada, who received oral antibiotics between 2002 and 2022. The study included 21,758 cases of emergency department visits or hospitalizations for serious cADRs, matched with 87,025 controls.
Main Findings: The study found that sulfonamide antibiotics (adjusted odds ratio [aOR], 2.9) and cephalosporins (aOR, 2.6) posed the highest risk of serious cADRs compared to macrolides. Nitrofurantoin, penicillins, and fluoroquinolones also showed elevated risks. Cephalosporins had the highest crude rate of cADRs (4.92 per 1,000 prescriptions).
Implications for Practice: The findings suggest that clinicians should consider the higher risks of serious cADRs associated with sulfonamide antibiotics and cephalosporins when prescribing antibiotics, opting for lower-risk alternatives when appropriate.
Erythritol Ingestion Increases Platelet Reactivity and Thrombosis Potential in Healthy Adults – Arterioscler Thromb Vasc Biol
10 Aug, 2024 | 21:11h | UTCStudy Design and Population: This interventional study evaluated the effects of erythritol versus glucose on platelet reactivity and thrombosis potential in 20 healthy volunteers, with 10 participants in each group. Researchers measured erythritol plasma levels and assessed platelet function through aggregometry and granule marker analysis both before and after ingestion of 30 g of erythritol or glucose.
Main Findings: Erythritol ingestion resulted in a more than 1000-fold increase in plasma erythritol concentration and significantly enhanced stimulus-dependent platelet aggregation and release of serotonin and CXCL4, markers of platelet activation. In contrast, glucose ingestion did not significantly alter platelet reactivity or granule marker release, highlighting erythritol’s unique pro-thrombotic effects.
Implications for Practice: These findings raise concerns regarding the safety of erythritol as a non-nutritive sweetener, particularly its potential to enhance thrombosis risk. The results suggest a need to reevaluate erythritol’s safety status and consider its impact on cardiovascular health in regulatory guidelines.
Phase 3 RCT: Butantan-DV Dengue Vaccine is Safe and Shows 67.3% Efficacy Over 3.7 Years in Participants Aged 2–59 Years – Lancet Infect Dis
10 Aug, 2024 | 20:23h | UTCStudy Design and Population: This double-blind, randomized, placebo-controlled, phase 3 trial conducted in Brazil evaluated the efficacy and safety of the Butantan-dengue vaccine (Butantan-DV) in 16,235 healthy participants aged 2–59 years. Participants, who had not previously received a dengue vaccine, were randomly assigned to receive either a single dose of Butantan-DV or a placebo and were followed up for an average of 3.7 years.
Main Findings: The study found that Butantan-DV demonstrated 67.3% efficacy against virologically confirmed dengue (VCD) caused by any dengue virus serotype, with no cases of VCD caused by DENV-3 or DENV-4. The proportions of serious adverse events were similar between the vaccine and placebo groups, indicating that the vaccine was generally well tolerated.
Implications for Practice: The results support the potential of the Butantan-DV vaccine as an effective intervention for preventing symptomatic dengue, particularly from DENV-1 and DENV-2, across a broad age range regardless of dengue serostatus. Continued development and monitoring are warranted to confirm long-term efficacy and safety.