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Nefecon Shows IgAN Benefits Regardless of Baseline eGFR
Nefecon Shows IgAN Benefits Regardless of Baseline eGFR

Medscape

time4 days ago

  • Health
  • Medscape

Nefecon Shows IgAN Benefits Regardless of Baseline eGFR

Nefecon, an oral targeted-release formulation of budesonide that targets drug release into the distal ileum, provided significant improvements in the loss of kidney function in patients with immunoglobulin A nephropathy (IgAN) at 9 months, regardless of baseline estimated glomerular filtration rate (eGFR) status, according to a new subanalysis of the phase 3 NeflgArd study. METHODOLOGY: Patients in the NeflgArd study with primary IgAN were randomly assigned to one of two groups of 182 patients each to receive either treatment with 16 mg Nefecon or placebo daily, along with supportive care with renin-angiotensin system inhibition. This was followed by a 15-month off-drug observational period allowing for continued supportive care. For the subanalysis, the patients were further stratified on the basis of eGFR deciles in relation to the overall study population, with levels above and below 38, 43, 47, 51, 55, 60, 66, 72, and 82 mL/min/1.73 m 2 . . The median eGFR overall was 55.49 mL/min/1.73 m2 and was balanced across the Nefecon and placebo groups. TAKEAWAY: The relative benefit of Nefecon in terms of eGFR was seen across most deciles and timepoints and showed a generally greater benefit in higher baseline eGFR groups (above 72 mL/min/1.73 m 2 ). ). Furthermore, the relative urine protein-creatinine ratio benefit was observed from month 9 with Nefecon vs placebo regardless of baseline eGFR, with a continued reduction to month 12, followed by a maintained treatment benefit to month 24. The eGFR benefits with Nefecon over placebo were observed among patients within the upper and lower deciles over 2 years. eGFR showed a pronounced on-treatment benefit and a delay in decline during the observation period. IN PRACTICE: 'This NefIgArd subanalysis demonstrated that the efficacy of a 9-month Nefecon treatment course in reduction of proteinuria and preservation of kidney function was independent of baseline eGFR,' said first author Jonathan Barratt, MD, of the College of Life Sciences, University of Leicester, UK. 'So, we should be confident about treating people with Nefecon across the full range of eGFR in terms of the eGFR saving we're going to see, but also the proteinuria reduction,' he added. SOURCE: The findings were reported this week at the 62nd European Renal Association (ERA) Congress 2025. DISCLOSURES: The study was funded by Calliditas Therapeutics AB. Credit Lead image: Medscape Medscape Medical News © 2025 WebMD, LLC Cite this: Nefecon Shows IgAN Benefits Regardless of Baseline eGFR - Medscape - June 06, 2025.

Budesonide ER oral tablet side effects: How to manage them
Budesonide ER oral tablet side effects: How to manage them

Medical News Today

time29-05-2025

  • General
  • Medical News Today

Budesonide ER oral tablet side effects: How to manage them

As with other drugs, budesonide can cause side effects, such as headache and nausea. If side effects of budesonide become difficult to tolerate, talk with your doctor or pharmacist. Budesonide comes as an extended-release (ER) oral tablet. ('ER' stands for extended release, which means the tablet releases the drug slowly, allowing your body to absorb it over time.) Budesonide also comes in other forms, but this article does not cover them. Read on to learn about budesonide's potential common, mild, and serious side effects. » Learn more about budesonide, including details about its uses. Budesonide can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects persist, bother you, or become severe, be sure to talk with your doctor or pharmacist. These are just a few of the more common side effects reported by people who took budesonide in clinical trials: headache nausea decreased level of cortisol abdominal pain fatigue For more information about some of these side effects, see the 'Budesonide: Managing side effects' section. Mild side effects can occur with budesonide use. This list does not include all possible mild side effects of the drug. For more information, you can refer to budesonide's prescribing information. Mild side effects that people taking budesonide have reported include: These side effects may be temporary, lasting a few days to weeks. However, if the side effects continue, bother you, or become severe, be sure to talk with your doctor or pharmacist. Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. Sharing your experience helps make medications safer for everyone by giving doctors and researchers more information about how the drug works in real life. If you develop a side effect while taking budesonide and want to tell the FDA about it, visit MedWatch or call 800-FDA-1088. For more information about some of these side effects, see the 'Budesonide: Managing side effects' section. Budesonide may cause serious side effects. The following list may not include all possible serious side effects of the drug. For more information, you can refer to budesonide's prescribing information. If you develop serious side effects while taking budesonide, call your doctor right away. If the side effects seem life threatening or you think you're having a medical emergency, immediately call 911 or your local emergency number. Serious side effects that have been reported include: Allergic reaction For some people, budesonide can cause an allergic reaction. There were no reports of this side effect in initial studies of the drug. But allergic reaction has been reported since budesonide ER oral tablets became available for use. In general, symptoms of allergic reaction can be mild or serious. Ways to manage For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They'll also let you know whether you should keep taking the medication. For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you've had a serious allergic reaction to budesonide, your doctor may recommend taking a different medication instead. While taking budesonide, you may be able to take steps to make side effects easier to manage. If you have problems with side effects that worsen or do not go away, talk with your doctor or pharmacist. They can discuss options for managing side effects or other available treatment options. Headache was a common side effect reported in studies of budesonide. Steps you can take to manage symptoms associated with this side effect include: taking over-the-counter pain medications exercising regularly using a heat or ice pack eating regular meals Nausea was a common side effect reported in studies of budesonide. Steps you can take to manage symptoms associated with this side effect include: eating or drinking ginger staying hydrated avoiding spicy foods Before taking budesonide, discuss your health history with your doctor. Budesonide may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you: Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses. Ulcerative Colitis GastroIntestinal / Gastroenterology Drugs

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