Ranked one of the best clinical decision support tools for health professionals worldwide*, BMJ Best Practice provides step-by-step guidance on diagnosis, treatment and prevention.
Updated daily using robust evidence-based methodology and expert opinion, BMJ Best Practice provides you with access to the very latest clinical information.
Your user profile grants you remote access, the ability to download the highly rated app, and the convenience of automatic activity tracking for CME/CPD purposes.
Esketamine approved in the US as the first ever monotherapy for treatment-resistant depression in adults
For the first time, the Food and Drug Administration (FDA) has approved a ketamine-related drug as a standalone treatment for adults with major depressive disorder (MDD). Esketamine nasal spray is approved for patients who have treatment-resistant depression (TRD) - defined as an inadequate response to at least two oral antidepressants.
The approval follows a multicenter randomized controlled trial which demonstrated the rapid efficacy of esketamine monotherapy. Within the first 24 hours of the initial dose, participants experienced significant improvements in their Montgomery-Asberg Depression Rating Scale (MADRS) total score, with the effects persisting for at least 4 weeks. By the fourth week, 22.5% of patients receiving esketamine had achieved remission (MADRS total score ≤12), compared to 7.6% in the placebo group.
Until now, esketamine had been approved in the US exclusively as an adjunctive therapy alongside an oral antidepressant for two indications in adults: as a treatment for TRD, and for those with MDD experiencing suicidal ideation or behavior.
This expanded indication makes esketamine accessible to individuals with TRD who are not on an antidepressant or who wish to discontinue their current one, which may help to overcome treatment barriers owing to negative experiences with oral antidepressants, such as poor tolerability.
Despite growing clinical adoption of esketamine, several questions remain. The optimal patient profile for treatment response, how long therapeutic effects might persist, and the appropriate duration of therapy all require further investigation. While no longer considered a last-resort treatment, esketamine is not a first- or second-line treatment.
Esketamine is approved only for use in an appropriate certified clinical setting under the supervision of a health care provider; typically this will mean referring to a designated treatment facility offering esketamine. A key practical consideration is the logistical and occupational commitments required of patients; for example, the need to take time away from work and to arrange necessary transport and support. The drug must be self-administered by the patient, who is supervised by a health care provider in a certified medical office, and the patient monitored for at least 2 hours because of the risk of sedation, respiratory depression, difficulty with attention, judgment and thinking (dissociation), suicidal thoughts and behaviors, and the potential for drug misuse. For these reasons, esketamine is only available via a restricted distribution program in the US.
People with poorly controlled hypertension or preexisting aneurysmal vascular disorders may be at increased risk for adverse cardiovascular or cerebrovascular effects. Esketamine is contraindicated in patients with aneurysmal vascular disease, arteriovenous malformation, or intracerebral hemorrhage.
Esketamine is available in Europe; however, it is not currently approved for monotherapy. Availability of esketamine varies according to the country of practice and relevant regulatory approval.
Guidelines recommend statins for people living with HIV to prevent cardiovascular events
People living with HIV are at greater risk of atherosclerotic cardiovascular disease (ASCVD). In order to prevent major cardiovascular events such as stroke and heart attacks, guidelines now recommend statin therapy for primary prophylaxis in people over 40 years of age who are living with HIV.
The new recommendations were informed by findings from the National Institutes of Health (NIH)-supported REPRIEVE (Randomized Trial to Prevent Vascular Events in HIV) trial, a large randomized controlled trial undertaken in people living with HIV. The trial found that pitavastatin (a moderate-intensity statin) may offset the high risk of cardiovascular disease in people living with HIV by 35%, compared to placebo, after a median follow-up of 5 years.
As a consequence of this trial, the US Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents with HIV now recommends at least moderate-intensity statin therapy for primary prophylaxis in people 40-75 years of age with HIV who have low to intermediate (<20%) 10-year ASCVD risk estimates. People with HIV who are less than 40 years of age or have a 10-year ASCVD risk estimate ≥20% should be treated as per the general population, based on evidence-based guidelines.
The British HIV Association (BHIVA) also recommends offering statin therapy to people living with HIV over the age of 40 years, regardless of their estimated ASCVD risk or lipid profile. Patients with an estimated 10-year ASCVD risk ≥5% should be prioritized for primary prophylaxis.
People living with HIV are twice as likely to develop cardiovascular disease, which may be related to the disease itself and/or the use of antiretroviral therapy (ART). The global burden has tripled over the past two decades and is responsible for 2.6 million disability-adjusted life years.
FDA approves olezarsen for the treatment of familial chylomicronemia syndrome
Olezarsen, a ligand conjugated antisense oligonucleotide targeting apo C-III, has been shown to reduce triglyceride (TG) levels by >50% and acute pancreatitis risk by >85% in patients with familial chylomicronemia syndrome (FCS). Olezarsen has been approved by the Food and Drug Administration as an adjunct to diet to reduce TG levels in adults with FCS. Note this indication is for a rare and severely affected subgroup of patients with hypertriglyceridemia only. Olezarsen is not approved in Europe as yet.
First bird flu death reported in the US outbreak; case of human infection detected in the UK
Avian influenza A(H5N1) virus is currently causing a multistate outbreak in poultry and dairy cows in the US. While outbreaks have previously been reported in poultry, this is the first time the virus has been detected in cows. Cases of human infection linked to the outbreak in dairy cows have been reported, and these cases represent the first instances of likely mammal-to-human transmission globally.
As of 31 January 2025, 67 confirmed cases of human infection associated with exposure to infected poultry or dairy cows have been reported in the US since 2024 across 10 states - California, Colorado, Iowa, Louisiana, Michigan, Missouri, Oregon, Texas, Washington, and Wisconsin.
- Of the 67 cases, 40 occurred following exposure to infected dairy cows, 23 occurred following exposure to infected poultry on poultry farms and during culling operations, 1 occurred following exposure to other animals, and 3 had an unknown exposure source. One death has been reported.
- The first case of infection in a child in the US was reported in California in November 2024. The child experienced mild symptoms and received antiviral therapy. The case was identified via influenza surveillance systems. The exposure source is currently unknown.
- The first case of severe infection in the US was reported in Louisiana in December 2024. The patient had exposure to sick and dead birds in backyard flocks. The virus was identified as belonging to clade 2.3.4.4b (D1.1 genotype), the virus currently detected in poultry and wild birds across the US. The patient died in early January 2025, and was the first person in the US to die as a result of H5N1 virus infection. No human-to-human transmission related to this case has been identified.
The Centers for Disease Control and Prevention (CDC) currently considers the public health risk to be low. Updated situation summaries are available from the CDC and are being updated regularly:
In light of the outbreak, the CDC has published interim guidelines for prevention, monitoring, and public health investigations.
Members of the public are advised to:
- Avoid exposure to sick or dead animals. If this is not possible, avoid unprotected (not using respiratory and eye protection) exposures to sick or dead animals, including wild birds, poultry, other domesticated birds, and other wild or domesticated animals (including cows).
- Avoid unprotected exposures to animal feces, litter, or materials contaminated by birds or other animals with suspected or confirmed H5N1 virus infection.
- Cook poultry, eggs, and beef to safe internal temperatures and only consume pasteurized milk and milk products.
Clinicians are advised to consider the possibility of HPAI A(H5N1) virus infection in anyone showing signs or symptoms of acute respiratory illness or conjunctivitis who has a relevant exposure history.
- People exposed to infected birds or other animals are advised to monitor themselves for new respiratory illness symptoms and/or conjunctivitis, for 10 days after their last exposure. Antiviral postexposure prophylaxis may be considered in certain people to prevent infection.
- Symptomatic people are advised to seek prompt medical care for diagnosis and treatment, and isolate themselves away from others. Oseltamivir is the recommended first-line antiviral treatment.
A confirmed case of H5N1 virus infection has also been reported in the UK in the West Midlands region.
- The person acquired the infection on a farm after close prolonged contact with a large number of infected birds. The case was detected during routine surveillance, and no onwards transmission from the case has been reported. The birds were infected with the D1.2 genotype, a different strain to the ones currently circulating among birds and mammals in the US. Only a small number of cases have occurred in the UK prior to this case. The risk to the wider public is considered to be very low.
Sporadic human cases of HPAI A(H5N1) infection have been reported globally since 1997, with a case fatality rate of approximately 50% in reported cases. Most human infections have occurred after unprotected exposure to sick or dead infected poultry. There has been no evidence of sustained human-to-human transmission in any country, and limited nonsustained human-to-human transmission has not been reported since 2007.
The highest ranking* CDS app
Access clinical information anywhere, even offline, with our award-winning app.
Whether you’re on the ward, at home, or studying, the BMJ Best Practice app gives you trusted decision support information in an instant. The app is provided for free to those who have a personal subscription to BMJ Best Practice or have access provided by their institution.
* As of 24 July 2023
It’s no understatement to say that this app (and the website) is responsible for getting me through medical school. Nowhere else can you get such succinct and relevant summaries and treatment algorithms.
BMJ Best Practice app user