Tag: clinical guidelines

Categories : Respiratory DiseasesTags :

WHO Announces Guidance Updates to Treatment of Drug-resistant TB

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The World Health Organization (WHO) Global Tuberculosis Programme has announced upcoming updates to the guidance on the treatment of drug-resistant tuberculosis (DR-TB). These updates are announced in a Rapid Communication and include shorter novel 6-month all-oral regimens for the treatment of multidrug- and rifampicin-resistant TB (MDR/RR-TB), with or without additional resistance to fluoroquinolones (pre-XDR-TB), and also an alternative 9-month all-oral regimen for the treatment of MDR/RR-TB.

The Rapid Communication is released ahead of updated WHO consolidated guidelines to come later in the year which will inform national programmes and stakeholders.

Dr Tereza Kasaeva, Director of WHO’s Global TB Programme said: “We now have more and much better treatment options for people with drug-resistant TB thanks to research generating new evidence. This is major progress compared to what was available even a few years ago, and will be of great benefit for people struggling with TB and drug-resistant TB, resulting in better outcomes, saving lives and reducing suffering.”

All patients with MDR/RR-TB, including those with additional resistance to fluoroquinolones, stand to benefit from effective all-oral treatment regimens, either shorter or longer, implemented under programmatic conditions.

The summary of the updates are as follows:

The 6-month BPaLM regimen, comprising bedaquiline, pretomanid, linezolid (600 mg) and moxifloxacin, may be used programmatically in place of 9-month or longer (>18 months) regimens, in patients (aged ≥ 15 years) with MDR/RR-TB who have not had previous exposure to bedaquiline, pretomanid and linezolid (defined as > 1 month exposure). This regimen may be used without moxifloxacin (BPaL) in the case of documented resistance to fluoroquinolones (in patients with pre-XDR-TB). Drug susceptibility testing (DST) to fluoroquinolones is strongly encouraged, but DST should not delay treatment initiation.

The 9-month, all-oral, bedaquiline-containing regimens are preferred over the longer (>18 months) regimen in adults and children with MDR/RR-TB, without previous exposure to second-line treatment (including bedaquiline), without fluoroquinolone resistance and with no extensive pulmonary TB disease or severe extrapulmonary TB. In these regimens, 2 months of linezolid (600 mg) can be used as an alternative to 4 months of ethionamide. Access to rapid DST for ruling out fluoroquinolone resistance is required before starting a patient on one of these regimens.

Patients with extensive forms of DR-TB (eg XDR-TB4) or those who are not eligible for or have failed shorter treatment regimens will benefit from an individualised longer regimen designed using the priority grouping of medicines recommended in current WHO guidelines.6

Decisions on appropriate regimens should be made according to clinical judgement and patient preference, considering results of DST, patient treatment history, risk of adverse events, and severity and site of the disease.

All treatment should be delivered under WHO-recommended standards, including patient-centred care and support, informed consent where necessary, principles of good clinical practice, active drug safety monitoring and management, and regular monitoring of patients and of drug resistance to assess regimen effectiveness.

The full details of the regimens included in the review are available in the Rapid Communication.

Source: World Health Organization

Categories : COVIDTags :

WHO Panel Recommends Paxlovid for at-Risk Mild COVID

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Pfizer’s oral antiviral Paxlovid (nirmatrelvir/ritonavir) is strongly recommended for patients with non-severe COVID with greater hospitalisation risk, such as unvaccinated, older, or immunosuppressed patients, according to a WHO Guideline Development Group writing in The BMJ. 

The experts explained that Pfizer’s Paxlovid, a comnbination of nirmatrelvir and ritonavir tablets, is likely a better choice for these patients because it may prevent more hospitalisations than the alternatives, is safer than molnupiravir, and is easier to administer than intravenous options such as remdesivir and antibody treatments. 

Use in low-risk patients is not recommended due to trivial benefits. It is also not recommended for patients with severe or critical COVID, as there are currently no trial data on nirmatrelvir/ritonavir for this group.

Their recommendation is based on new data from two randomised controlled trials with 3100 patients.

In these trials, moderate certainty evidence showed that nirmatrelvir/ritonavir reduced hospital admission (84 fewer admissions per 1000 patients), low certainty evidence suggested no important difference in mortality, and high certainty evidence suggested little or no risk of adverse effects leading to drug discontinuation.

Additionally, WHO also makes a conditional (weak) recommendation to use the antiviral drug remdesivir for patients with non-severe COVID at highest risk of hospitalisation.

This is based on new data from five randomised controlled trials involving 2700 patients and replaces a previous recommendation against treatment with remdesivir in all patients with covid-19 regardless of disease severity.

Antiviral drugs should be administered as early as possible, but this may be challenging in low- and middle-income countries, the panel noted, and also that access to these drugs is tied to COVID tests.

The emergence of resistance is also an uncertain risk, they add.

This guidance adds to previous conditional recommendations for the use of molnupiravir for high-risk patients with non-severe COVID and for the use of sotrovimab or casirivimab-imdevimab (monoclonal antibody treatments) in selected patients; and against the use of convalescent plasma, ivermectin and hydroxychloroquine in patients with COVID regardless of disease severity. For patients with severe COVID, WHO strongly recommends corticosteroids, with the addition of IL-6 receptor blockers or baricitinib.

Source: EurekAlert!

Categories : Diseases, Syndromes and ConditionsTags : 1 Comment

Atopic Dermatitis Linked to Range of Comorbid Conditions

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A comprehensive review has uncovered “clear evidence” of associations between atopic dermatitis (AD) and a range of comorbid conditions, which has informed updated clinical guidelines for AD. 

An expert panel reported on the results of a wide-ranging review in the Journal of the American Academy of Dermatology.  They found evidence linking AD to certain allergic, atopic, and immune-mediated conditions, as well as mental health problems, bone diseases, and skin infections. There is some evidence which supports associations between AD and substance use, attention deficit-hyperactivity disorder (ADHD), and some elements of metabolic syndrome. Less compelling evidence suggests AD has links to some cardiovascular conditions. There is inconclusive evidence for associations between adult AD and autism spectrum disorders, myocardial infarction, stroke, and metabolic syndrome. 

“Atopic dermatitis is one of several atopic diseases, meaning that there are internal sensitivities that can help drive the disease in the organ of choice, including asthma, allergic rhinoconjunctivitis, and food allergies, among others,” Dawn M.R. Davis, MD, co-chair of the guideline panel, told MedPage Today. “We always knew there was an association between atopic dermatitis and the other atopic diseases, but we lacked the evidence. Fortunately, because we’re getting more attention and more research is being performed in these areas, we now have data to back up our suspicions regarding the associations between atopic dermatitis and other atopic diseases.”

“Thanks to research by our colleagues, we discovered several other comorbidities that we did not expect, including skin diseases like alopecia areata and urticaria, as well as mental health conditions, including depression, anxiety, and substance use,” she continued. “We also have some evidence of associations with metabolic conditions, such as disorders of bone metabolism, and cardiovascular diseases.”

This review was conducted in concert with updating the American Academy of Dermatology clinical guideline on AD. The quantity and depth of data also warranted a separate guideline component for recognition of comorbidities associated with AD. The main goal was to increase awareness of the associations.

“The goal of this guideline is to plant a seed in the mind of providers and to empower and validate patients, so they can have a customised, individualised, robust discussion about how their particular circumstances relate to any of the risk factors,” said Dr Davis.

Key findings and statements in the guideline include:

  • The association between AD and asthma is well established, but the “atopic march” explanation remains unproven
  • “Clear evidence” of an association between AD and food allergy, but estimated prevalence of food allergy in adults with AD remains low
  • Epidemiologic studies “consistently show” an association between AD and alopecia areata, but there are limited data on severity of alopecia or treatment response
  • Analysis of four studies showed that AD doubles the odds ratio of depression though reasons for this are unclear
  • A “potential association” between AD and substance use/abuse (limited evidence)
  • Accumulating evidence suggests small associations between AD and hypertension, peripheral and coronary artery disease, congestive heart failure, and acute clinical events
  • A “small association” suggested between adult AD with obesity and dyslipidemia; however, limited data have pointed to a possible inverse association with diabetes
  • Several studies have shown associations with increased risk of osteoporosis and fracture in adults with AD, possibly linked by systemic inflammation.

“To date, research on AD-associated comorbidities has focused on identifying potential associations in epidemiologic studies,” the guideline authors wrote. “There is currently no conclusive evidence demonstrating that screening for comorbid conditions associated with AD improves patient outcomes. For the evidence of AD associations to be put into action, research is required on whether screening or management of these comorbidities among adults with AD beyond what is recommended for the general population is beneficial.”

Besides the comorbidities document, other documents will be published over two years which will address topical therapy, systemic treatment and phototherapy, and paediatric AD.

Source: MedPage Today

Categories : CancerTags :

New Guidelines for Brain Cancer Care

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Credit: National Cancer Institute

New guidelines for managing and treating brain metastases have been published in the Journal of Clinical Oncology and are set to improve care for cancer patients and extend and improve the quality of their lives.

The new guidelines come from an expert panel assembled by the American Society of Clinical Oncology (ASCO). The panel included a diverse range of top cancer doctors, as well as a patient representative.

The guidelines reflect the enormous advances in care for brain metastases  over the last few decades. In the 1970s, early attempts to develop guidelines largely emphasised steroids and whole-brain radiation therapy, without controlled, randomised studies to guide the use of surgery and chemotherapy.

Far more encompassing and far more evidence-based, the new guidelines will help doctors and patients make the best treatment decisions and achieve the best outcomes.

“When I started in this field 30 years ago, the average survival with brain metastases was 4 months, and most patients died from the brain disease. With improvements in therapies, fewer than one-quarter of patients die from the brain metastases, and some patients live years or are even cured,” said David Schiff, MD, a co-chair of the ASCO panel and the co-director of UVA Cancer Center’s Neuro-Oncology Center. “Equally importantly, the use of advanced localised radiation techniques and new targeted chemotherapies and immunotherapies have improved the quality of survival for most patients suffering from brain metastases.”

Up to 30% of cancer patients will have it spread to the brain, where it can be extremely difficult to treat. In the United States, approximately 200 000 new brain metastases are diagnosed each year.

The likelihood of a solid tumour spreading to the brain varies by cancer type, with approximately 20% of lung cancers spreading to the brain within a year after diagnosis. For patients with breast cancer, renal cell cancer or melanoma, that number is up to 7%. That is in addition to the patients found to have brain metastases at the time of their initial diagnosis.

Bringing together a diverse range of disciplines, the ASCO panel incorporated the results of more than 30 randomised trials published since 2008. The resulting guidelines cover everything from when surgery is appropriate and when and in what form radiation should be used to those circumstances in which medication alone may be employed.

The guidelines emphasise the importance of local therapies (surgery or stereotactic radiosurgery) for symptomatic brain metastases and lay out when these options are feasible. They highlight situations in which local therapy or whole brain radiotherapy can be deferred in place of chemotherapy, targeted therapy or immunotherapy depending on tumour type and molecular features. They also lay out how, in many cases, doctors can avoid the cognitive toxicity of whole brain radiotherapy by using either stereotactic radiosurgery or hippocampal-avoidant whole brain radiotherapy with the drug memantine.

“Patients with brain metastases may initially see a neurosurgeon, radiation or medical oncologist. The rigorous analysis underpinning these guidelines will provide each subspecialist a comprehensive picture of the treatment options appropriate for a given patient,” Dr Schiff said. “The result will allow patients the optimal personalised approach to maximise long-term control of brain metastases with good functional outcome.”

 Additional information is available at the ASCO website.

Source: EurekAlert!

Categories : Cardiovascular DiseaseTags :

Guidelines for Percutaneous Coronary Intervention May Need Changing

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Percutaneous coronary intervention (PCI) is often performed after a heart attack, or to alleviate symptoms of chest pressure, but a new study published in Nature questions the efficacy of the current guidelines. 

Current American Heart Association guidelines recommend that patients who undergo PCI, a minimally invasive procedure to open clogged arteries, be prescribed dual antiplatelet therapy (DAPT) to prevent blood clots, and that they continue using the combination of aspirin and a second antiplatelet medication for at least one year after the procedure with continuation of DAPT beyond one year for patients with acceptable bleeding risk.

The current guidelines are based on previous research, including the DAPT Study, a large clinical trial 10 years ago of patients undergoing PCI with a stent, that found using DAPT beyond one year after PCI decreased ischaemic events but posed a higher risk of bleeding. Since then, questions have arisen as to whether the evidence is representative of real-world populations and changing practice patterns.

To better understand whether the results of prior trials of DAPT duration are applicable today, researchers at Beth Israel Deaconess Medical Center (BIDMC) developed new analytic methods to update a previously conducted trial to better reflect contemporary practice. The findings, published in Circulation, suggest that because of improvements in stent technology and changes in the types of patients receiving stents, the risks of DAPT may now outweigh the benefits for the average patient.

“Clinical research can become outdated as practices and technologies evolve,” said corresponding author Robert W. Yeh, MD, MSc, an interventional cardiologist at BIDMC. “By extrapolating what an older trial might have shown had it been conducted today, we found that many patients who’ve received stents and are currently on combination antiplatelet therapy may actually benefit from stopping one of those antiplatelet drugs – adding to growing evidence that aspirin and drugs like it may be less useful than previously thought.”

Yeh and colleagues extrapolated the results of 5743 DAPT Study participants to national data from 568 540 patients undergoing PCI with a stent. Using new analytic methods, the team estimated a contemporary “real-world” treatment effect of 30 months versus 12 months of DAPT after coronary stent procedures. Compared to the previous trial population, contemporary registry patients had more comorbidities and were more likely to present with heart attack and receive second generation drug-eluting stents. After adjustment to represent the registry population, the researchers no longer saw a significant effect of prolonged DAPT on reducing stent thrombosis or heart attack, but increased risk of bleeding persisted.

Additionally, the team used their previously developed risk tool called the DAPT Score to stratify subgroups of patients who may or may not benefit from prolonged DAPT. They found that the projected ischemic benefits of prolonged DAPT in the subgroup of patients with DAPT score less than two disappeared, while the bleeding risk persisted. In contrast, in the subgroup of patients with DAPT score of two or greater, ischemic benefits of prolonged DAPT persisted, though were slightly attenuated, with negligible increase in bleeding.

“While patients at highest risk of ischaemic event, [a] small group of patients should likely remain on these medications, longer duration DAPT may have more limited benefits and greater harms for most,” said lead author Neel M. Butala, MD, MBA, a research fellow in the Smith Center. “These results illustrate the importance of a nuanced interpretation of clinical trials to guide clinical decision-making. The methods may be applicable across various cardiovascular conditions to help ensure that evidence is up-to-date and appropriate for real world populations.”

Source: Beth Israel Deaconess Medical Center

Categories : Cardiovascular Disease Expert OpinionTags :

‘Every Guideline We Write Is Out of Date’ Quips ESC as New Data Emerges

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Just as the European Society of Cardiology (ESC) unveiled their new guidelines for the treatment of heart failure, along came some data that the guideline’s authors hint will cause the work to be revised.

The guidelines, which appear in the European Heart Journal, state that so far, there is no treatment shown to reduce mortality and morbidity in patients with heart failure with preserved ejection fraction, however there are positive results from the EMPEROR-Preserved study showing that treatment with empagliflozin robustly reduced hospitalisation risk.

“Every guideline we write is out of date a few days after it’s published. I’m, of course, exaggerating a little bit, but guidelines are dynamic documents. They represent what we know at the time that they’re written and then new information comes out and they have to be updated, and that takes time,” Milton Packer, MD, of Baylor University Medical Center in Dallas, told MedPage Today.

“It’s a process, and we all understand that process; there is no real concept of finality here. We do the best we can with the data we have. And so these guidelines coming won’t represent the results of the EMPEROR-Preserved trial, but the next one will,” Dr Packer added.

Carlos Aguiar, MD, of Hospital Santa Cruz in Lisbon, agreed: “We also know that these new indications do need to go through the regulatory authorities, so it does take some time for the whole process to be concluded.”

“We do need to wait for those approvals also from the regulatory agencies in their reviews for physicians to be able to implement this in clinical practice,” he told MedPage Today.

However, the writers of the 2021 guideline did tweak the comprehensive algorithm for the treatment of heart failure, the highlights of which include:

  • Right heart catheterisation should be considered in patients in whom heart failure is thought to be due to constrictive pericarditis, restrictive cardiomyopathy, congenital heart disease, and high-output states. It may be considered in selected patients with heart failure with preserved left ventricular ejection fraction (LVEF) to confirm the diagnosis.
  • In patients with chronic heart failure with reduced LVEF, dapagliflozin (Farxiga) or empagliflozin are recommended to reduce hospitalisation and mortality risk. As a Class I recommendation, it is based on evidence gleaned from randomised clinical trials.
  • Vericiguat (Verquvo) may be considered in patients with New York Heart Association (NYHA) class II to IV heart failure after worsening with treatment with an angiotensin inhibitor, a beta-blocker, and a mineralocorticoid receptor antagonist, to reduce the risks of cardiovascular mortality or heart failure hospitalisation.
  • For treatment of heart failure with midrange LVEF — a change in term from “mildly reduced” ejection fraction — to reduce hospitalisation and mortality risk, the guidelines suggest a number of treatments including angiotensin inhibitors, beta-blockers, mineralocorticoid receptor antagonists, and the combination agent sacubitril/valsartan but none have strong clinical trial evidence (Class IIb)  .
  • For patients with heart failure with preserved ejection fraction, the current guidelines recommend (Class I evidence) screening for and treatment of aetiologies, as well as cardiovascular and non-cardiovascular comorbidities.
  • After hospitalisation for heart failure, the guidelines recommend (Class I evidence) that patients be carefully evaluated to exclude persistent signs of congestion before discharge and to optimise oral treatment, and that evidence-based oral medical treatment be administered before discharge. An early follow-up visit is recommended at 1 to 2 weeks after discharge to assess signs of congestion and drug tolerance, and to start and/or uptitrate evidence-based therapy.
  • The SGLT2 inhibitors canagliflozin (Invokana), dapagliflozin, empagliflozin, ertugliflozin (Steglatro), and sotagliflozin are recommended in patients with heart failure and type 2 diabetes at risk of cardiovascular events to reduce hospitalisations for heart failure, major cardiovascular events, end-stage renal dysfunction, and cardiovascular death. The SGLT2 inhibitors dapagliflozin, empagliflozin, and sotagliflozin are recommended in patients with type 2 diabetes and heart failure with reduced ejection fraction (Class I evidence). The DPP-4 inhibitor saxagliptin (Onglyza) is not recommended in patients with heart failure (Class III evidence).

Source: MedPage Today

Categories : Cardiovascular DiseaseTags :

New Guidelines for Venous Thromboembolism Released

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The American College of Chest Physicians (CHEST) have released new clinical guidelines for venous thromboembolism (VTE) management, which provide 29 recommendations on 17 Patients, Interventions, Comparators, Outcomes (PICO) questions, four of which have not been addressed previously.

The last full edition of the guideline, “Antithrombotic Therapy and Prevention of Thrombosis 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines,” was published in 2012, with an update in 2016. This guideline is the first addressing this topic, which will have regular updates as new evidence emerges according to the Living Guidelines Model of the American College of Chest Physicians.

Within the updated recommendations, the panel generated 29 guidance statements, 13 of which are graded as strong recommendations. These include:

  • In patients with acute isolated distal deep vein thrombosis (DVT) of the leg who are managed with anticoagulation, we recommend using the same anticoagulant regimen as for patients with acute proximal DVT.
  • In patients with cerebral venous sinus thrombosis, we recommend anticoagulation therapy for at least the treatment phase (first 3 months) over no anticoagulant therapy.
  • In patients with acute DVT of the leg, we recommend against the use of an inferior vena cava (IVC) filter in addition to anticoagulants.
  • In patients with thrombosis and antiphospholipid syndrome being treated with anticoagulant therapy, we suggest adjusted-dose vitamin K antagonists over direct oral anticoagulant therapy.

“These guidelines help to clarify for providers the intricacies of managing patients with VTE,” said expert panel member, Scott C Woller, MD, FCCP. “Serving as a comprehensive reference for any stage, the recommendations cover aspects from initial management through secondary prevention and risk reduction of post-thrombotic syndrome.”

The order in which PICOs and guidance statements are presented in the manuscript is intended to follow the chronology of VTE management:

  • Whether to treat
  • Interventional and adjunctive treatments
  • Initiation phase
  • Treatment phase
  • Extended phase
  • Complications of VTE

The guidance statements are mainly intended for clinicians who manage patients with VTE but could also inform researchers selecting topics for future studies. Patients and policy makers may also be informed by the guideline content.

Source: EurekAlert!