BACKGROUND AND AIMS:Saroglitazar magnesium, a dual PPAR α/γ agonist, is approved in India for the treatment of non-alcoholic fatty liver disease (NAFLD), now known as metabolic dysfunction-associated steatotic liver disease (MASLD). While controlled trials with saroglitazar have demonstrated improvements in hepatic and metabolic parameters in patients with MASLD, real-world data in populations with diverse metabolic comorbidities remain limited. METHODS:This is an ongoing, prospective, single-arm, multicenter, real-world, phase 4 study evaluating the effectiveness and safety of saroglitazar 4 mg once daily in patients with MASLD. The current interim analysis includes 500 patients who completed 24 weeks of treatment. Changes in liver stiffness measurement (LSM), hepatic steatosis (CAP and UAP), glycemic control, lipid profile, liver enzymes and non-invasive fibrosis scores were assessed. Safety was evaluated based on treatment-emergent adverse events (TEAEs). This was a non-protocol-defined, exploratory interim analysis; all statistical inferences are descriptive and p-values are nominal. RESULTS:At baseline, the mean age was 45.7 ± 11.6 years, weight 81.0 ± 13.6 kg, body mass index (BMI) 29.9 ± 4.7 kg/m2 and 42% had obesity. After 24 weeks of treatment, mean LSM ± SD decreased from 10.1 ± 3.2 kPa to 8.0 ± 3.2 kPa (-20.7%, p < 0.001) and CAP decreased by 20.3 dB/m (p < 0.001). ALT levels reduced by 33.6% (p < 0.001) and HbA1c by 4.8% (p < 0.001). Improvements were also observed in lipid profile and fibrosis scores (FIB-4, FAST, APRI, ALERT). A total of 68 patients (13.6%) reported TEAEs, the majority of which were mild (85.5%) and unrelated to the study drug. No deaths were reported. CONCLUSIONS:In this interim real-world analysis, saroglitazar 4 mg was associated with improvements in liver stiffness, hepatic steatosis, metabolic parameters and non-invasive fibrosis markers in patients with MASLD. The treatment was generally well tolerated. These findings warrant further confirmation upon completion of the 52-week analysis. IMPACT AND IMPLICATIONS:Saroglitazar 4 mg for 24 weeks was associated with improvements in surrogate markers of liver injury, steatosis, glycaemic control and lipid metabolism, with good tolerability. These interim real-world findings support further evaluation in the planned 52-week analysis. CLINICAL TRIAL NUMBER:CTRI/2023/05/053326 [Registered on: 31/05/2023].
Abstract Objective Influenza-like illness (ILI) is characterized by the sudden onset of systemic and respiratory symptoms such as fever, fatigue and myalgia, requiring prompt management. Anas barbariae 200K, a homeopathic medicinal product, is traditionally used to relieve flu-like symptoms. This study aimed to evaluate its efficacy in alleviating ILI symptoms within 72 hours. Secondary outcomes assessed symptoms relief, adverse effects, functional outcomes, compliance, and participant and investigator satisfaction. Methods This prospective, randomized, double-blind, placebo-controlled multicenter superiority trial with two parallel groups was conducted in primary care in India in 2021. Children (6–12 years) and adults (18–65 years) with ILI symptoms for less than 24 hours were randomized to receive either Anas barbariae 200K (Oscillococcinum®) or placebo. Treatment was given three times daily for three days. The primary endpoint was the proportion of participants with alleviation of ILI symptoms within 72 hours following the initiation of treatment. Results A total of 707 participants received Anas barbariae 200K (n = 352) or placebo (n = 355). Within 72 hours, the Anas barbaria e 200K group showed significantly greater symptom relief than the placebo group (74% vs. 44.5%; p < 0.0001). Secondary endpoints also favored Anas barbariae 200K group, including faster symptom alleviation (46.7 vs. 67.3 hours; p < 0.0001) and shorter median time, estimated by KM analysis, to return to daily activities (4.0 vs . 6.0 days; p < 0.0001). No serious adverse events were reported. Conclusion Anas barbariae 200K significantly alleviated ILI symptoms within 72 hours, with improvements that were both statistically and clinically significant. Significant benefits were also observed across secondary outcomes, with no safety signal identified. This study showed that Anas barbariae 200K could be an effective and well-tolerated treatment for ILI symptoms. Trial registration Clinical Trials Registry of India, CTRI : 2021/02/031250, registered on February 12, 2021.
Although percutaneous nephrolithotomy (PCNL) has been performed for decades and has gone through many refinements, there are still concerns regarding its more widespread utilization because of the long learning curve and the potential risk of severe complications. Many technical details are not included in the guidelines because of their nature and research protocol.To achieve an expert consensus viewpoint on PCNL indications, preoperative patient preparation, surgical strategy, management and prevention of severe complications, postoperative management, and follow-up.An international panel of experts from the Urolithiasis Section of the European Association of Urology, International Alliance of Urolithiasis, and other urology associations was enrolled, and a prospectively conducted study, incorporating literature review, discussion on research gaps (RGs), and questionnaires and following data analysis, was performed to reach a consensus on PCNL.The expert panel consisted of 36 specialists in PCNL from 20 countries all around the world. A consensus on PCNL was developed. The expert panel was not as large as expected, and the discussion on RGs did not bring in more supportive evidence in the present consensus.Adequate preoperative preparation, especially elimination of urinary tract infection prior to PCNL, accurate puncture with guidance of fluoroscopy and/or ultrasonography or a combination, keeping a low intrarenal pressure, and shortening of operation time during PCNL are important technical requirements to ensure safety and efficiency in PCNL.Percutaneous nephrolithotomy (PCNL) has been a well-established procedure for the management of upper urinary tract stones. However, according to an expert panel consensus, core technical aspects, as well as the urologist's experience, are critical to the safety and effectiveness of PCNL.
