Internal Medicine
RCT: No Difference in Postoperative Complications Between Continuation and Discontinuation of Renin-Angiotensin System Inhibitors Before Major Surgery – JAMA
31 Aug, 2024 | 19:12h | UTCStudy Design and Population: This multicenter randomized clinical trial included 2,222 patients who had been treated with renin-angiotensin system inhibitors (RASIs) for at least 3 months and were scheduled for major noncardiac surgery at 40 hospitals in France between January 2018 and April 2023. The participants were randomly assigned to either continue RASIs until the day of surgery or to discontinue them 48 hours before surgery.
Main Findings: The trial found no significant difference in the primary outcome—a composite of all-cause mortality and major postoperative complications within 28 days—between the continuation and discontinuation groups (22% in both groups, RR 1.02, 95% CI 0.87-1.19). However, the continuation group experienced a higher incidence of intraoperative hypotension (54% vs. 41%, RR 1.31, 95% CI 1.19-1.44).
Implications for Practice: Continuation of RASIs before major noncardiac surgery does not increase the risk of postoperative mortality or major complications, but it does elevate the risk of intraoperative hypotension. Clinicians should weigh these risks when deciding whether to continue or discontinue RASIs before surgery.
RCT: Beta-Blocker Interruption Post-Myocardial Infarction Increases Cardiovascular Events Without Improving Quality of Life – N Engl J Med
31 Aug, 2024 | 19:04h | UTCStudy Design and Population: This multicenter, open-label, randomized, noninferiority trial included 3,698 patients across 49 sites in France. Participants had a history of myocardial infarction, a left ventricular ejection fraction of at least 40%, and had not experienced a cardiovascular event in the past six months. The study compared outcomes between patients who either interrupted or continued long-term beta-blocker therapy, with a minimum follow-up of one year.
Main Findings: Interruption of beta-blocker treatment resulted in a higher incidence of adverse cardiovascular events (23.8%) compared to continuation (21.1%), with a hazard ratio of 1.16 (95% CI, 1.01 to 1.33). The difference did not meet the criteria for noninferiority (P=0.44). Additionally, there was no significant improvement in quality of life among patients who discontinued beta-blockers.
Implications for Practice: The findings suggest that in patients with a history of myocardial infarction and stable cardiovascular health, continuing beta-blocker therapy is preferable to interruption. Discontinuation may increase the risk of adverse cardiovascular outcomes without offering quality of life benefits, supporting the ongoing use of beta-blockers in this population.
Meta-Analysis: High-Dose Psilocybin Shows Small Advantage Over Escitalopram for Depression – The BMJ
24 Aug, 2024 | 16:41h | UTCStudy Design and Population: This systematic review and Bayesian network meta-analysis evaluated the effectiveness of oral monotherapy with psychedelics (psilocybin, LSD, MDMA, ayahuasca) compared to escitalopram in adults with depressive symptoms. The analysis included 15 trials with psychedelics and 5 trials with escitalopram, covering a total of 811 participants in psychedelic trials and 1968 in escitalopram trials.
Main Findings: The analysis revealed that only high-dose psilocybin demonstrated a significant improvement in depressive symptoms compared to placebo when considered in the context of antidepressant trials, but the effect size was small (standardized mean difference of 0.31). High-dose psilocybin also outperformed escitalopram (10 mg and 20 mg), with a mean difference exceeding the minimal important difference. However, the placebo response was generally lower in psychedelic trials compared to antidepressant trials, suggesting potential overestimation of effect sizes in psychedelic studies.
Implications for Practice: The findings suggest that while high-dose psilocybin may offer a small advantage over escitalopram for treating depression, the overall effect size is comparable to traditional antidepressants. The results highlight the importance of considering the impact of blinding and placebo response in psychedelic trials, and suggest that improved blinding and standardized psychotherapies could help better assess the true efficacy of these treatments.
Systematic Review: Nasogastric Feeding Increases Diarrhea and Pain Compared to Nasojejunal Feeding in Acute Pancreatitis – BMC Gastroenterol
18 Aug, 2024 | 19:23h | UTCStudy Design and Population: This systematic review and meta-analysis compared the safety and efficacy of nasogastric (NG) versus nasojejunal (NJ) feeding initiated within 48 hours of hospital admission in patients with moderate to severe acute pancreatitis. The analysis included four randomized controlled trials (RCTs) involving a total of 217 patients.
Main Findings: The review found no significant difference in mortality between NG and NJ feeding groups. However, NG feeding was associated with a higher incidence of diarrhea (RR 2.75, P = 0.02) and pain (RR 2.91, P = 0.002). The risk of infection was also higher in the NG group (6.67% vs. 3.33%, P = 0.027). No significant differences were observed in the need for surgical intervention, the requirement for parenteral nutrition, or the success rates of feeding procedures.
Implications for Practice: The findings suggest that while NG feeding does not increase mortality in acute pancreatitis, it is associated with higher rates of certain complications, particularly diarrhea and pain. Clinicians should consider these risks when choosing a feeding strategy for patients with acute pancreatitis, especially within the critical early 48-hour period post-admission.
RCT: Chelation Fails to Reduce Cardiovascular Events in Post-MI Patients with Diabetes – JAMA
18 Aug, 2024 | 19:11h | UTCStudy Design and Population: This double-masked, placebo-controlled randomized clinical trial (RCT) included 959 participants aged 50 or older with diabetes and a history of myocardial infarction (MI) from 88 sites in the US and Canada. Participants were randomly assigned to receive either 40 weekly infusions of an EDTA-based chelation solution or a placebo infusion. The median follow-up period was 48 months.
Main Findings: The trial found no significant reduction in major adverse cardiovascular events (MACE) with EDTA-based chelation compared to placebo. The primary endpoint, a composite of all-cause mortality, MI, stroke, coronary revascularization, or hospitalization for unstable angina, occurred in 35.6% of the chelation group and 35.7% of the placebo group (HR, 0.93; 95% CI, 0.76-1.16; P = .53). However, chelation did reduce median blood lead levels by 61%, from 9.0 μg/L at baseline to 3.5 μg/L by the 40th infusion (P < .001).
Implications for Practice: Despite the significant reduction in blood lead levels, EDTA-based chelation did not reduce cardiovascular events in this high-risk population. These findings suggest that while chelation therapy may lower lead levels, it does not translate into cardiovascular benefits for patients with diabetes and a history of MI, challenging its use in this context.
Retrospective Cohort Study: Rheumatoid Arthritis Linked to Over 50% Increased Lung Cancer Risk, with a Three-Fold Risk in RA-Associated Interstitial Lung Disease – Arthritis Rheumatol
18 Aug, 2024 | 18:58h | UTCStudy Design and Population: This retrospective matched cohort study examined the risk of lung cancer in 72,795 patients with rheumatoid arthritis (RA) and 757 patients with RA-associated interstitial lung disease (RA-ILD) from the Veterans Health Administration database, compared with 633,937 non-RA controls. The study spanned from 2000 to 2019, with patients matched on age, gender, and enrollment year.
Main Findings: The study found that RA was associated with a 58% increase in lung cancer risk (adjusted hazard ratio [aHR] 1.58). The risk was significantly higher in RA-ILD patients, with a more than three-fold increase (aHR 3.25) compared to non-RA controls. Even among never smokers, RA patients showed a 65% increased lung cancer risk, indicating that factors beyond smoking contribute to the elevated risk.
Implications for Practice: The study underscores the significant increase in lung cancer risk among patients with RA, particularly those with RA-ILD. While this elevated risk is notable, further research is necessary to determine the most effective strategies for monitoring and managing this risk. Clinicians should be aware of these findings and consider them when evaluating the overall health and risk factors of patients with RA, especially those with additional pulmonary complications like ILD. Enhanced awareness and individualized risk assessments may help in early detection and management of lung cancer in this high-risk population.
Randomized Noninferiority Trial: Oral Vonoprazan Noninferior to IV Proton Pump Inhibitors in Preventing Rebleeding of High-Risk Peptic Ulcers – Gastroenterology
18 Aug, 2024 | 18:32h | UTCStudy Design and Population: This multicenter, randomized, open-label, noninferiority trial was conducted in Thailand across six centers, including both university and community hospitals. A total of 194 patients with high-risk peptic ulcer (PU) bleeding who had achieved successful endoscopic hemostasis were randomized to receive either vonoprazan or intravenous proton pump inhibitors (PPI). The study aimed to compare the efficacy of vonoprazan, a potassium-competitive acid blocker, with that of high-dose PPIs in preventing rebleeding.
Main Findings: The trial found that the 30-day rebleeding rate in the vonoprazan group was 7.1%, compared to 10.4% in the PPI group. This demonstrated noninferiority of vonoprazan within a 10% margin (risk difference: -3.3%, 95% CI: -11.2 to 4.7; P < .001). The 3-day and 7-day rebleeding rates were also noninferior. Secondary outcomes, including mortality rates, the need for rescue therapy, blood transfusion requirements, and length of hospital stay, were comparable between the two groups. Adverse events were similar in both groups.
Implications for Practice: Vonoprazan presents a viable alternative to intravenous PPIs for preventing rebleeding in patients with high-risk PU after endoscopic hemostasis. The availability of vonoprazan in oral form could potentially reduce hospital stays. However, further studies in multiethnic populations are needed to confirm these findings and assess the cost-effectiveness of vonoprazan in this setting.
RCT: Methotrexate Shows Modest Pain Reduction in Knee Osteoarthritis, More Research Needed – Ann Intern Med
18 Aug, 2024 | 18:01h | UTCStudy Design and Population: This multicenter, randomized, double-blind, placebo-controlled trial evaluated the effects of oral methotrexate on 207 participants with symptomatic knee osteoarthritis (KOA) who had persistent knee pain despite prior treatments. Conducted across 15 musculoskeletal clinics in the UK from June 2014 to October 2017, participants were randomly assigned to receive either methotrexate or placebo over a 12-month period.
Main Findings: At 6 months, methotrexate resulted in a modest reduction in knee pain, with a statistically significant difference of 0.79 points on the NRS compared to placebo (95% CI, 0.08 to 1.51; P = 0.030). Small but statistically significant improvements were also noted in knee stiffness and function. However, the clinical significance of these findings remains uncertain, and potential side effects of methotrexate warrant caution.
Implications for Practice: While methotrexate may offer some symptomatic relief for patients with knee osteoarthritis who do not respond to standard treatments, the modest reduction in pain and improvement in function observed in this study may not justify its routine use given the potential for significant side effects. The small magnitude of benefit suggests that methotrexate should be considered cautiously and only in select patients. Further research is necessary to confirm these findings and to better understand the risk-benefit profile of methotrexate in this population before broader clinical adoption.
Cohort Study: Long-Term Multivitamin Use Not Linked to Reduced Mortality in Over 390,000 US Adults
18 Aug, 2024 | 15:07h | UTCtudy Design and Population: This cohort study examined the association between daily multivitamin (MV) use and mortality risk using data from three large prospective cohorts in the United States. The study included 390,124 generally healthy adults with no prior history of cancer or major chronic diseases. Participants were followed for up to 27 years, with baseline MV use assessed between 1993 and 2001 and follow-up assessments from 1998 to 2004.
Main Findings: Daily MV use was not associated with a reduction in all-cause mortality. In fact, the study found a 4% higher risk of mortality among daily MV users compared to nonusers during the first half of the follow-up period (HR, 1.04; 95% CI, 1.02-1.07), although this risk was not significant in the second half. The findings were consistent across major causes of death, including heart disease, cancer, and cerebrovascular diseases.
Implications for Practice: These findings suggest that long-term MV use does not confer a mortality benefit among generally healthy adults. Healthcare providers may need to reconsider recommending MVs for longevity purposes, as the evidence does not support their efficacy in reducing mortality risk.
Updated Guidelines on Perioperative Management of Anticoagulant and Antiplatelet Therapy for Interventional Techniques – Pain Physician
18 Aug, 2024 | 14:52h | UTCIntroduction: The American Society of Interventional Pain Physicians (ASIPP) has published updated guidelines for the perioperative management of patients undergoing interventional techniques while receiving antiplatelet and anticoagulant therapy. These guidelines are essential for clinicians to balance the risk of thromboembolism against the risk of bleeding during interventional procedures.
Key Points:
1 – Risk of Thromboembolic Events:
– Thromboembolic events have a higher risk of morbidity and mortality compared to the risk of epidural hematoma. Thus, interruption of antithrombotic therapy should be carefully considered.
2 – Risk Stratification of Procedures:
– Interventional techniques are classified into three categories based on risk: low, moderate, or high. For high-risk procedures, cessation of anticoagulant or antiplatelet therapy is recommended, whereas for low to moderate-risk procedures, therapy may continue under certain conditions.
3 – Management of Direct Oral Anticoagulants (DOACs):
– DOACs such as dabigatran, apixaban, rivaroxaban, and edoxaban should generally be discontinued for 2 days before high-risk procedures and one day for moderate-risk procedures. Adjustments are needed based on renal function, specially for dabigatran.
4 – Discontinuation of Aspirin:
– For high-risk interventional procedures, discontinuation of aspirin (81 or 325 mg) is recommended 6 days before the procedure. However, for low to moderate-risk procedures, aspirin therapy may be continued or stopped for 3 days depending on individual risk factors and clinical judgment.
5 – Discontinuation of Other Antiplatelet Agents:
– Clopidogrel (Plavix) and Prasugrel (Effient): These agents should be discontinued 6 days before high-risk procedures. For low-risk procedures, these medications can be continued.
– Ticagrelor (Brilinta): Discontinue for 5 days before high-risk procedures, with consideration of patient-specific risk factors.
6 – Timing for Restarting Therapy:
– Antithrombotic therapy should typically be resumed within 12-24 hours after low to moderate-risk procedures and within 24-48 hours after high-risk procedures, depending on bleeding risk and patient status.
7 – Shared Decision-Making:
– Decisions on whether to continue or discontinue antithrombotic therapy should involve shared decision-making between the patient, the interventional pain specialist, and other treating physicians, considering all associated risks.
Conclusion: These guidelines provide a comprehensive framework for managing the delicate balance between thromboembolic and bleeding risks in patients on anticoagulant or antiplatelet therapy undergoing interventional procedures. They emphasize the importance of personalized care and multidisciplinary collaboration.
Innovative Antimicrobial Susceptibility Testing Bypasses Blood Culture, Promising Faster Sepsis Diagnosis – Nature
18 Aug, 2024 | 14:09h | UTCStudy Design and Population: This study introduces a novel ultra-rapid antimicrobial susceptibility testing (AST) method that bypasses the traditional blood culture process, potentially reducing diagnostic time by 40-60 hours. The method was evaluated using a cohort of 190 hospitalized patients in Korea with suspected sepsis, including those with blood cancers.
Main Findings: The new AST method identified bacterial species in all patients with positive blood infections, achieving a 100% match in species identification. For antimicrobial susceptibility, the method demonstrated a 94.9% categorical agreement with conventional AST methods, with a theoretical turnaround time of 13 ± 2.53 hours, significantly faster than current workflows.
Implications for Practice: This method could improve sepsis treatment by providing same-day results, potentially reducing sepsis-related mortality and the use of broad-spectrum antibiotics. However, further validation in a more diverse patient population is necessary to confirm its clinical efficacy and value.
RCT: Twice-Yearly Lenacapavir Prevents HIV Infections More Effectively Than Daily F/TAF in Women – N Engl J Med
18 Aug, 2024 | 13:56h | UTCStudy Design and Population: This phase 3, double-blind, randomized controlled trial included 5,338 adolescent girls and young women in South Africa and Uganda. Participants were assigned to receive either twice-yearly subcutaneous lenacapavir, daily oral emtricitabine–tenofovir alafenamide (F/TAF), or daily oral emtricitabine–tenofovir disoproxil fumarate (F/TDF) as an active control, with corresponding placebos.
Main Findings: Lenacapavir demonstrated superior efficacy in HIV prevention, with zero infections observed among its recipients. In contrast, the F/TAF group experienced 39 HIV infections (2.02 per 100 person-years), while the F/TDF group had 16 infections (1.69 per 100 person-years). HIV incidence was significantly lower with lenacapavir compared to background incidence and F/TDF, while no significant difference was observed between F/TAF and F/TDF.
Implications for Practice: Twice-yearly lenacapavir could be a more effective and potentially easier-to-adopt HIV prevention strategy than daily oral F/TAF in cisgender women, though considerations of injection-site reactions are necessary. This approach could improve adherence and outcomes in populations with low persistence in daily PrEP use.
CDC Updates Contraceptive Guidelines for 2024 – Centers for Disease Control and Prevention
18 Aug, 2024 | 13:51h | UTCIntroduction: The Centers for Disease Control and Prevention (CDC) has released updated recommendations in the “U.S. Selected Practice Recommendations for Contraceptive Use, 2024” and “U.S. Medical Eligibility Criteria for Contraceptive Use, 2024.” These guidelines provide healthcare providers with the latest evidence-based recommendations to support patient-centered contraceptive care, aiming to remove unnecessary barriers and ensure equitable access to contraception.
Key Points:
1 – Intrauterine Device (IUD) Placement:
– Routine use of misoprostol is not recommended for IUD placement, except in selected cases. Lidocaine (topical or paracervical block) is newly recommended to reduce patient pain during IUD placement.
2 – Bleeding Irregularities with Implants:
– Hormonal treatments and antifibrinolytic agents may improve bleeding irregularities associated with implant use, although bleeding often recurs after stopping treatment. NSAIDs and selective estrogen-receptor modulators may also be effective, with benefits persisting post-treatment.
3 – Testosterone Use and Pregnancy Risk:
– Testosterone therapy may not prevent pregnancy in transgender, gender-diverse, and nonbinary individuals with a uterus. Contraceptive counseling and services should be offered to those at risk of pregnancy who do not desire it.
4 – Self-Administration of Injectable Contraceptives:
– Subcutaneous depot medroxyprogesterone acetate (DMPA-SC) should be available for self-administration, providing an additional option for those seeking injectable contraception.
5 – Updates in Medical Eligibility Criteria:
– The 2024 guidelines include revised recommendations for patients with chronic kidney disease, updates for those who are breastfeeding, postpartum, or post-abortion, and considerations for individuals with obesity, cardiovascular conditions, and other comorbidities.
6 – Patient-Centered Counseling:
– The guidelines emphasize the importance of providing contraceptive care in a noncoercive manner, supporting the individual’s values, goals, and reproductive autonomy. Healthcare providers are encouraged to recognize and address structural inequities and avoid discrimination in contraceptive counseling.
Conclusion: These updated guidelines from the CDC are designed to support healthcare providers in delivering equitable, patient-centered contraceptive care. By removing unnecessary barriers and providing clear guidance on managing complex contraceptive issues, the recommendations aim to improve access to contraception and support informed, autonomous decision-making among patients.
Guideline Reference: Curtis, K. M., Nguyen, A. T., Tepper, N. K., et al. (2024). U.S. Selected Practice Recommendations for Contraceptive Use, 2024. MMWR Recommendations and Reports, 73(3).
Review: Prevention and Management of Device-Associated Complications in the Intensive Care Unit – The BMJ
17 Aug, 2024 | 20:04h | UTCIntroduction:
This review article, published by experts from the David Geffen School of Medicine at UCLA, focuses on the complications associated with invasive devices commonly used in the Intensive Care Unit (ICU). While these devices are essential for managing critically ill patients, they also pose significant risks, necessitating a thorough understanding of their potential complications and strategies for prevention and management.
Key Points:
1 – Central Venous Catheters (CVCs):
– CVCs are widely used in ICU patients but carry risks like vascular injury, pneumothorax, thrombosis, and infection.
– Use of real-time ultrasound guidance and careful operator technique are crucial for minimizing these risks.
– Prompt removal of unnecessary CVCs is essential to reduce the risk of complications.
2 – Arterial Catheters:
– Commonly used for hemodynamic monitoring, these catheters can lead to complications such as vascular occlusion, nerve injury, and infection.
– Ultrasound guidance is recommended to reduce the risk of complications, and catheters should be discontinued as soon as clinically feasible.
3 – Airway Devices (Endotracheal Tubes and Tracheostomies):
– Complications include laryngeal injury, tracheal stenosis, and tracheomalacia.
– Strategies to reduce these risks include minimizing intubation attempts, ensuring proper tube placement, and managing cuff pressures carefully.
4 – Extracorporeal Membrane Oxygenation (ECMO):
– ECMO is associated with significant complications, including bleeding, thromboembolic events, and neurologic injuries.
– Proper cannulation technique and vigilant monitoring are essential to mitigate these risks.
5 – Infection Control:
– Strict adherence to aseptic techniques and the use of chlorhexidine-impregnated dressings are recommended to prevent device-associated infections.
Conclusion:
This review underscores the importance of judicious use and timely removal of invasive devices in the ICU to minimize complications. Healthcare professionals must remain vigilant and employ best practices to prevent and manage these complications effectively.
Meta-Analysis: Effects of Psychological, Psychosocial, Pharmacological, Physical and Combined Treatments for Adults with a New Episode of Depression – eClinicalMedicine
17 Aug, 2024 | 19:49h | UTCStudy Design and Population: This systematic review and network meta-analysis examined 676 randomized controlled trials (RCTs) involving 105,477 participants, comparing psychological, psychosocial, pharmacological, physical, and combined treatments for adults with a new episode of unipolar depression. The study stratified interventions based on depressive symptom severity (less severe and more severe).
Main Findings: For less severe depression, group cognitive behavioral therapy (CBT) was the only treatment class that significantly improved depressive symptoms compared to treatment as usual (TAU). For more severe depression, effective interventions included combined individual CBT with antidepressants, individual behavioral therapies, and combined treatments like acupuncture or exercise with antidepressants. Notably, antidepressants alone did not show significant effects in less severe depression.
Implications for Practice: These findings suggest that group CBT may be an effective first-line treatment for less severe depression, while combined therapies, particularly those involving antidepressants and individual psychological interventions, are more effective in treating more severe depression. This evidence could guide clinical decision-making and inform updates to treatment guidelines.
Meta-Analysis: 1-Month Dual Antiplatelet Therapy Reduces Major Bleeding Without Increasing Stent Thrombosis After PCI with DES – Am J Cardiol
17 Aug, 2024 | 19:29h | UTCMain Findings: The analysis found that 1-month DAPT significantly reduced the risk of major bleeding (OR 0.66, 95% CI 0.45-0.97, p = 0.03) compared to >1-month DAPT. Additionally, there was no significant difference in stent thrombosis rates between the groups (OR 1.08, 95% CI 0.81-1.44, p = 0.60). Secondary outcomes, including all-cause mortality, cardiovascular death, myocardial infarction, stroke, and major adverse cardiovascular or cerebrovascular events were also similar between the groups.
Implications for Practice: The findings support the use of 1-month DAPT followed by aspirin or a P2Y12 receptor inhibitor as a safer alternative to longer-term DAPT in patients undergoing PCI with DES. This strategy may help reduce bleeding risks without increasing the likelihood of thrombotic events, making it a viable option for routine clinical practice, particularly in patients at high risk for bleeding.
Meta-Analysis: Long-Term Low-Carbohydrate Diets Improve Dyslipidemia but Not Glycemic Control in Type 2 Diabetes – J Diabetes Investig
17 Aug, 2024 | 19:14h | UTCStudy Design and Population: This systematic review and meta-analysis examined the impact of long-term low-carbohydrate diets (LCD) on glycemic control and other metabolic parameters in adults with type 2 diabetes. Six randomized controlled trials (RCTs) involving 524 participants were included, with intervention durations ranging from 12 to 24 months.
Main Findings: The meta-analysis found no significant difference in glycated hemoglobin (HbA1c) levels between participants on long-term LCD and those on control diets (SMD -0.11, 95% CI -0.33 to 0.11, P = 0.32). Similarly, there were no significant differences in weight loss, blood pressure, or low-density lipoprotein (LDL) cholesterol levels. However, LCDs were associated with a significant increase in high-density lipoprotein (HDL) cholesterol (SMD 0.22, 95% CI 0.04 to 0.41, P = 0.02) and a decrease in triglyceride levels (SMD -0.19; 95% CI -0.37 to -0.02; P = 0.03).
Implications for Practice: While long-term LCDs do not appear to improve glycemic control in individuals with type 2 diabetes, they may be beneficial for managing dyslipidemia, specifically by increasing HDL cholesterol and reducing triglycerides. These findings suggest that LCDs could be considered as part of a strategy for addressing cardiovascular risk factors in this population, but they should not be relied upon for glycemic management.
Study: Novel Point-of-Care hs-cTnI Test Shows High Diagnostic Accuracy and Predictive Values for Myocardial Infarction – J Am Coll Cardiol
17 Aug, 2024 | 19:00h | UTCStudy Design and Population: This international, multicenter diagnostic study assessed the clinical and analytical performance of the new high-sensitivity cardiac troponin I (hs-cTnI)-SPINCHIP point-of-care (POC) test. The study involved 1,102 adult patients presenting with acute chest discomfort in emergency departments, with myocardial infarction (MI) diagnoses adjudicated by two independent cardiologists.
Main Findings: The hs-cTnI-SPINCHIP test exhibited strong diagnostic accuracy with an area under the receiver-operating characteristic curve of 0.94, similar to established central laboratory assays. The 0/1-hour algorithm of the test identified 51% of patients as low risk for MI with a sensitivity and negative predictive value of 100%, while it confirmed MI in 27% of patients with a specificity of 90.9% and a positive predictive value of 72.9%. Consistency was observed across different sample types.
Implications for Practice: The SPINCHIP hs-cTnI POC test provides a rapid and accurate option for diagnosing MI in emergency settings, aiding quicker decision-making for ruling out or confirming MI.
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.