布地奈德缓释胶囊美国获批减少IgA肾病蛋白尿

On December 16, 2021 (Stockholm, Sweden), Calliditas announced that the U.S. FDA has accelerated the approval of budesonide extended-release capsules (Budesonid) to reduce proteinuria (usually urine protein to creatinine ratio (UPCR) ≥1.5g/g1) in adult patients with primary immunoglobulin A nephropathy (IgA nephropathy) who are at risk of rapid progression. It is the first and only drug in the world approved by the FDA to specifically treat this indication. Primary IgA nephropathy (IgAN) is the most common chronic glomerular disease in the world, and most patients are young people. About 20% to 40% of patients develop end-stage renal disease within 10 to 20 years after diagnosis.

Hilde et al. observed 16 IgAN patients using budesonide sustained-release capsules, taking 8 mg daily for 6 months, and followed up for 3 months. The efficacy of the treatment was observed by monitoring changes in 24-hour urine albumin excretion, serum creatinine, and estimated glomerular filtration rate (eGFR). They found that the median urinary albumin excretion decreased by 23% relatively during the treatment period, while the pretreatment value ranged from 0.3 to 6.0 g/24 h. The median peak value of urinary albumin dropped by 40% 2 months after discontinuation of treatment; during treatment, serum creatinine dropped by 6%, and eGFR increased by about 8%, and no major side effects related to corticosteroids were observed. Therefore, it is believed that intestinal budesonide acting on the ileocecal region can reduce urinary albumin and serum creatinine to improve renal function.

Found in the experiment were dizziness, abdominal pain, respiratory tract infection, nausea, flatulence, pain, headache, back pain, indigestion, vomiting, fatigue, etc. Finally, the editor of Medical Companion Travel hopes that patients who are currently using budesonide sustained-release capsules can follow the doctor's instructions. Only in this way can the effect of the drug itself be maximized.

Note: The above information comes from the Internet and is compiled and edited by Medical Companion Travel (please correct me if there are any errors or omissions). It is only to provide information on the latest drugs on the market in the world and help Chinese patients understand the latest international new drug trends. It is only for internal discussion among medical staff and does not serve as any basis for medication. For specific medication guidelines, please consult the attending physician.