Family Medicine
RCT: Finerenone Reduces Worsening Heart Failure Events in Patients with Mildly Reduced or Preserved Ejection Fraction
6 Sep, 2024 | 22:03h | UTCStudy Design and Population: This international, double-blind, randomized clinical trial included 6,001 patients with heart failure and a left ventricular ejection fraction of 40% or greater. Patients were randomly assigned to receive either finerenone (20 mg or 40 mg daily) or placebo in addition to standard therapy, with a median follow-up period of 32 months.
Main Findings: The finerenone group experienced a 16% reduction in the composite primary outcome of worsening heart failure events and death from cardiovascular causes compared to placebo (rate ratio, 0.84; 95% CI, 0.74 to 0.95; P=0.007). Specifically, total worsening heart failure events were lower in the finerenone group (rate ratio, 0.82; 95% CI, 0.71 to 0.94; P=0.006), but cardiovascular mortality did not significantly differ between the groups (hazard ratio, 0.93; 95% CI, 0.78 to 1.11). Finerenone was linked to an increased risk of hyperkalemia.
Implications for Practice: Finerenone reduces worsening heart failure events in patients with mildly reduced or preserved ejection fraction, making it a viable addition to standard heart failure therapy. However, clinicians should monitor for hyperkalemia, a known side effect, and the lack of significant mortality benefit highlights the need for further investigation into long-term cardiovascular outcomes.
2024 ESC Guidelines for the Management of Chronic Coronary Syndromes
1 Sep, 2024 | 18:49h | UTCIntroduction: The 2024 guidelines were developed by the European Society of Cardiology (ESC) with the endorsement of the European Association for Cardio-Thoracic Surgery (EACTS). These guidelines provide updated recommendations for the management of chronic coronary syndromes (CCS), focusing on the diagnosis, treatment, and long-term care of patients with stable coronary artery disease (CAD).
Key Points:
1 – History and Risk Assessment:
– Detailed assessment of cardiovascular risk factors, medical history, and symptom characteristics is essential in patients with suspected CCS.
– Symptoms like chest pain triggered by emotional stress, dyspnea on exertion, or fatigue should be considered potential angina equivalents.
2 – Diagnostic Testing:
– Coronary Computed Tomography Angiography (CCTA): Recommended as a first-line diagnostic tool for patients with low to moderate pre-test likelihood of obstructive CAD.
– Stress Imaging: Stress echocardiography, SPECT, PET, or cardiac MRI is recommended for those with moderate to high pre-test likelihood to diagnose myocardial ischemia and estimate the risk of major adverse cardiovascular events (MACE).
3 – Revascularization Indications:
– Symptom Relief: Revascularization is recommended for patients with obstructive CAD who have significant symptoms despite optimal medical therapy.
– Prognostic Benefit: Indicated in patients with left main coronary artery disease, severe three-vessel disease, or two-vessel disease including proximal left anterior descending artery stenosis, particularly if associated with reduced left ventricular function.
– High-Risk Anatomical Features: Revascularization is advised when significant stenosis is present in patients with high-risk anatomical features identified by imaging, especially if non-invasive testing shows a large area of ischemia.
4 – Lifestyle and Risk Management:
– A comprehensive approach to cardiovascular risk reduction, including lifestyle changes (e.g., smoking cessation, diet, and physical activity) and guideline-directed medical therapy, is strongly recommended.
– Home-based cardiac rehabilitation and digital health interventions are suggested to improve long-term adherence to healthy behaviors.
5 – Antianginal and Antithrombotic Therapy:
– Tailoring antianginal therapy based on individual patient characteristics, comorbidities, and local drug availability is recommended.
– Long-term antithrombotic therapy with aspirin or clopidogrel is recommended for patients with prior myocardial infarction or revascularization.
Conclusion: The 2024 ESC guidelines emphasize a patient-centered approach, integrating advanced diagnostic tools and personalized therapeutic strategies to optimize outcomes for patients with chronic coronary syndromes. The guidelines highlight the importance of detailed risk assessment, appropriate use of diagnostic imaging, clear criteria for revascularization, and a strong focus on lifestyle interventions alongside pharmacological management.
Updated ESC Hypertension Guidelines 2024: Intensified Blood Pressure Targets and New Categories – Eur Heart J
31 Aug, 2024 | 19:54h | UTCIntroduction:
The 2024 ESC Guidelines for managing elevated blood pressure (BP) and hypertension were developed by the European Society of Cardiology (ESC) and endorsed by the European Society of Endocrinology (ESE) and the European Stroke Organisation (ESO). These guidelines introduce significant updates to BP management, including more intensive treatment targets and the introduction of a new category for “Elevated BP.”
Key Points:
1 – New Intensive BP Target: For most patients receiving BP-lowering medication, the guidelines now recommend a systolic BP treatment target range of 120-129 mmHg. This marks a significant shift from previous guidelines, which suggested a less aggressive initial target.
2 – New ‘Elevated BP’ Category: The guidelines introduce a new category, “Elevated BP,” defined as a systolic BP of 120-139 mmHg and/or diastolic BP of 70-89 mmHg. This aims to identify more patients at risk of cardiovascular events, such as heart attacks and strokes, before they meet the traditional threshold for hypertension.
3 – Pragmatic BP Management: For patients who cannot tolerate the intensive BP target, the guidelines recommend aiming for a BP that is “as low as reasonably achievable” (ALARA), particularly in frail or older individuals.
4 – Lifestyle Modifications: The guidelines emphasize lifestyle interventions, including dietary changes like potassium supplementation and new exercise recommendations, as first-line strategies for managing BP.
5 – Renal Denervation: For the first time, the guidelines include recommendations on the use of renal denervation—a procedure for patients with resistant hypertension that has not responded to standard treatments. This is not recommended as a first-line treatment but may be considered in specific high-risk cases.
Conclusion:
These new guidelines represent a major update in the management of hypertension, particularly in promoting more aggressive BP targets to reduce cardiovascular risks. The inclusion of a new BP category and recommendations for renal denervation highlight the guidelines’ focus on early intervention and advanced treatment options.
2024 ESC Guidelines for the Management of Atrial Fibrillation – Eur Heart J
31 Aug, 2024 | 19:34h | UTCIntroduction: The 2024 guidelines for the management of atrial fibrillation (AF) were developed by the European Society of Cardiology (ESC) in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS) and other specialized associations. These guidelines aim to provide evidence-based recommendations for the diagnosis, treatment, and management of AF, with a focus on improving patient outcomes through a multidisciplinary approach.
Key Points:
1 – Patient-Centered Care and Education:
– Education directed at patients, caregivers, and healthcare professionals is essential for optimizing shared decision-making. This approach ensures that treatment options are discussed openly, considering both the benefits and risks.
2 – Comorbidity and Risk Factor Management:
– Diuretics are recommended for patients with AF, heart failure (HF), and congestion to alleviate symptoms and improve AF management.
– Sodium-glucose cotransporter-2 inhibitors (SGLT2 inhibitors) are recommended for patients with AF and HF, regardless of left ventricular ejection fraction (LVEF), to reduce the risk of hospitalization and cardiovascular death.
3 – Stroke Prevention and Anticoagulation:
– Oral anticoagulation is recommended for all patients with clinical AF and elevated thromboembolic risk, particularly those with a CHA2DS2-VA score of 2 or more.
– Direct oral anticoagulants (DOACs) are preferred over vitamin K antagonists (VKAs) in eligible patients undergoing cardioversion.
4 – Rate and Rhythm Control:
– Beta-blockers, diltiazem, verapamil, or digoxin are recommended as first-choice drugs for heart rate control in patients with AF and LVEF >40%.
– Catheter ablation is recommended as a first-line treatment option in patients with paroxysmal AF to reduce symptoms and prevent AF progression.
Conclusion: The 2024 ESC guidelines emphasize a patient-centered, multidisciplinary approach to AF management, with a strong focus on the early identification and management of comorbidities and risk factors. The guidelines also advocate for the use of DOACs in stroke prevention and recommend specific strategies for rate and rhythm control to enhance patient outcomes.
Updated Guidelines for Potentially Inappropriate Medication Use in Older Adults (2023 AGS Beers Criteria®) – J Am Geriatr Soc
31 Aug, 2024 | 19:20h | UTCIntroduction:
The American Geriatrics Society (AGS) has released the 2023 update to the AGS Beers Criteria®, a critical tool for healthcare professionals aimed at improving the safety of medication prescribing in adults aged 65 and older. The guidelines identify potentially inappropriate medications (PIMs) that should generally be avoided in older adults due to the heightened risk of adverse effects.
Key Points:
1 – Anticholinergic Drugs: First-generation antihistamines (e.g., diphenhydramine) should be avoided due to their high anticholinergic activity, which can lead to confusion, dry mouth, constipation, and other serious side effects, including increased risk of falls and dementia.
2 – Nitrofurantoin: Should be avoided in individuals with a creatinine clearance less than 30 mL/min due to the risk of pulmonary toxicity, hepatotoxicity, and peripheral neuropathy.
3 – Cardiovascular Drugs: Aspirin for primary prevention of cardiovascular disease is not recommended in older adults due to the increased risk of bleeding and lack of clear benefit. Similarly, warfarin is discouraged as an initial treatment for nonvalvular atrial fibrillation or venous thromboembolism in favor of Direct Oral Anticoagulants (DOACs) unless DOACs are contraindicated.
4 – Central Nervous System (CNS) Medications: Benzodiazepines and non-benzodiazepine receptor agonist hypnotics (“Z-drugs”) are associated with increased risks of cognitive impairment, delirium, falls, fractures, and motor vehicle accidents in older adults and should generally be avoided.
5 – Antipsychotics: Should be avoided for the treatment of behavioral problems in dementia or delirium due to the increased risk of stroke and greater rates of cognitive decline and mortality unless required for specific psychiatric conditions like schizophrenia or bipolar disorder.
Conclusion:
The 2023 AGS Beers Criteria® continues to serve as an essential guide for minimizing the risks associated with medication use in older adults. It emphasizes the need for individualized care and the importance of weighing the benefits and risks of medications, particularly in vulnerable populations.
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.
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.
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.
Cohort Study: Prenatal Exposure to Buprenorphine with Naloxone Appears Safe and More Effective than Buprenorphine Alone for Neonates and Mothers – JAMA
18 Aug, 2024 | 18:06h | UTCStudy Design and Population: This population-based cohort study used healthcare data from Medicaid-insured pregnancies in the US between 2000 and 2018. The study included 8,695 pregnant individuals linked to their liveborn infants. Participants were exposed to either buprenorphine combined with naloxone or buprenorphine alone during the first trimester.
Main Findings: The study found that prenatal exposure to buprenorphine with naloxone was associated with a lower risk of neonatal abstinence syndrome (37.4% vs 55.8%) and modest reductions in neonatal intensive care unit admission (30.6% vs 34.9%) and small for gestational age (10.0% vs 12.4%) compared to buprenorphine alone. No significant differences were observed for congenital malformations, low birth weight, preterm birth, respiratory symptoms, or cesarean delivery.
Implications for Practice: These findings suggest that buprenorphine combined with naloxone is a safe and potentially preferable option for treating opioid use disorder during pregnancy, providing more flexibility in treatment choices for pregnant individuals.
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.
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).
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.
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.