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INTRODUCTION:Obesity is highly prevalent in India, creating an urgent need for effective management interventions. The study hypothesizes that synthetic semaglutide has comparable safety and efficacy to the innovator drug when used in obese adults for weight management. METHODS:A phase III multicenter randomized active-controlled non-inferiority trial enrolled adults with obesity across 19 centers in India. Subjects were randomized to the test arm receiving synthetic semaglutide (Alkem Laboratories Limited) or the reference arm administered with innovator semaglutide (Wegovy®, Novo Nordisk) over 24 weeks in a 2:1 ratio. The primary efficacy endpoint was the percentage change in body weight,24 weeks post-intervention. Synthetic semaglutide was established to be non-inferior if the lower bound of the one-sided 97.5% confidence interval for the between-group difference did not exceed 4.5%. RESULTS:Of the 249 randomized participants, 246 (98.8%) completed the study. Mean percentage weight loss after 24 weeks was -14.39 ± 4.17% in the test arm and -14.61 ± 4.36% in the reference arm. The least square-mean difference was 0.15% (-0.93 to 1.24), meeting the predefined non-inferiority criterion. Weight loss >10% was achieved by 86.67% (n=143) in the test arm and 83.95% (n=68) in the reference arm (p = 0.5666), while >15% weight loss occurred in 38.79% (n=64) and 40.74% (n=33), respectively (p = 0.7683). Mean body mass index decreased by -4.93 ± 1.43 kg/m² in the test arm and -5.00 ± 1.50 kg/m² in the reference arm (p = 0.7128). Treatment-emergent adverse events were reported in 55.42% (n=92) of test-arm participants and 54.22% (n=45) of reference-arm participants. CONCLUSIONS:Test semaglutide demonstrated non-inferior efficacy, comparable safety, and similar tolerability to the innovator product.
Objectives: To evaluate real-world evidence on the clinical effectiveness and safety of faropenem in the management of upper respiratory tract infections (URTIs) in Indian paediatric patients. Methods: This multicentre, retrospective study analyzed medical records of paediatric patients (≤12 years) treated with faropenem oral suspension for URTIs. Records with complete and evaluable clinical data were included. Data collected comprised type of URTI, prescribed and actual duration of therapy, dosage and dosing frequency, laboratory parameters such as white blood cell (WBC) count and C-reactive protein (CRP) levels (where available), clinical outcomes, and adverse events. Assessments were conducted at baseline and follow-up, and results were analyzed using descriptive statistics. Results: A total of 965 records (673 males; 292 females) were evaluated, with a mean age of 7.65 ± 2.87 years. Diagnoses included undifferentiated URTI (n=648), acute otitis media (n=142), tonsillitis (n=81), pharyngitis (n=79), and acute sinusitis (n=15). The mean prescribed and actual treatment durations were 5.96 ± 1.83 and 5.87 ± 1.81 days, respectively. Faropenem was administered twice daily in 309 patients and thrice daily in 656 patients. Clinical cure was achieved in 505 patients (52.33%), while 460 (47.67%) showed improvement. Among patients with available laboratory data, elevated baseline CRP and WBC values normalized in the majority at follow-up (CRP: 88%; WBC: 84%). No major adverse events were reported. Conclusion: Faropenem demonstrated excellent real-world effectiveness and safety in paediatric URTIs. Consistent clinical improvement and normalization of inflammatory markers support its role as a well-tolerated therapeutic option in this population. Key words: Oral carbapenem, Real-world data, Clinical outcomes, Inflammatory biomarkers
Background: Neuropathic pain is a complex, chronic pain condition arising from somatosensory nervous system lesions or disease. Pregabalin and duloxetine are individually established pharmacological agents for neuropathic pain management; however, their combined efficacy as a fixed-dose combination (FDC) remains underexplored in real-world clinical settings. Objective: To retrospectively evaluate the effectiveness and safety of pregabalin–duloxetine FDC therapy in patients with neuropathic pain over a 3-month treatment period. Methods: A retrospective chart review was conducted enrolling 11,559 patients with confirmed neuropathic pain diagnoses receiving pregabalin/duloxetine FDC. Pain intensity was assessed using the Numeric Rating Scale (NRS, 0–10) and sleep interference using the Daily Sleep Interfering Rating Scale (DSIRS, 0–10) at baseline and 3 months post-treatment. Safety was evaluated by adverse drug reaction (ADR) monitoring and physician global assessment (PGA). Results: The mean NRS score decreased significantly from 6.79 ± 2.45 at baseline to 4.19 ± 2.32 post-3 months (mean reduction: 2.60 ± 3.24; p < 0.001). Similarly, DSIRS scores improved from 6.65 ± 2.38 to 4.15 ± 2.41 (mean reduction: 2.50 ± 3.31; p < 0.001). The treatment was well tolerated with 0.4% reported any ADR, predominantly mild in nature. PGA rated as Good or Excellent in 94.5% of patients. Conclusion: Pregabalin–duloxetine FDC therapy demonstrates statistically significant and clinically meaningful improvements in pain intensity and sleep quality in patients with neuropathic pain, with a favourable tolerability profile with low reported ADRs. These findings support its use as an effective therapeutic strategy in real-world clinical practice Key words: neuropathic pain, pregabalin, duloxetine, fixed-dose combination, NRS, DSIRS, retrospective analysis, RESET study
Multivitamin and mineral (MVM) supplements are dietary products that contain a combination of essential vitamins and minerals, and sometimes additional bioactive compounds. They are used to meet daily nutrient requirements, support physiological functions, and address increased nutritional needs, including in special populations. This narrative review summarizes the physiological roles, dietary sources, and deficiency symptoms of essential vitamins and minerals. Additionally, recommended dietary allowances (RDAs) and tolerable upper intake levels (ULs) of vitamins and minerals according to the Indian Council of Medical Research-National Institute of Nutrition (ICMR-NIN) are included. The review included details from various clinical studies, including randomized controlled trials, meta-analyses, and cohort studies on MVM supplementation, with special emphasis on cardiovascular, endocrine (especially diabetic mellitus), cancer, cognitive, skeletal, immune, and ocular health outcomes. It also highlights evidence in special populations such as pregnant and lactating women, infants, children, adolescents, older adults, and athletes. Furthermore, evidence related to nutraceuticals such as omega-3 fatty acids, lutein, curcumin, ginseng, brahmi, ashwagandha, and coenzyme Q10 is included. The review covers the safety and toxicity aspects of MVM supplements; however, limited evidence is available on drug-nutrient interactions. Overall, MVM supplements, along with nutraceuticals, may play a valuable role in targeted health optimization, especially in populations at risk of deficiencies. Standardized formulations, long-term safety evaluation, and integration of personalized nutrition approaches are critical to enhancing their clinical and public health impact.
This study reports the development of an enhanced liquid chromatography-tandem mass spectroscopy technique, which substantially contributes to advancements in analytical methodology. The developed method detects and quantifies four mutagenic nitrosamines N-nitroso-N-methyl-4-aminobutyric acid, N-nitrosodiethylamine, N-nitrosodiisopropylamine, and N-nitrosodibutylamine) in bempedoic acid (BA). The technique employs atmospheric pressure chemical ionization -tandem mass spectrometry, coupled with a gradient elution strategy, offering a significant advancement in the analysis of bempedoic acid. The mobile phase system comprises solvent A, which contains 0.1% formic acid in water, and solvent B, which contains 0.1% formic acid in methanol. The degassed mobile phase is pumped at a flow rate of 0.5 mL/min, while the column temperature is maintained at 40°C throughout the analytical run to ensure consistent chromatographic performance. Analytical separation was performed using an X-Bridge® Phenyl of dimension 150 × 4.6 mm, 3.5 µm high performance liquid chromatography (HPLC) column, while the detection and quantification of four nitrosamine impurities were carried out using positive-mode atmospheric pressure chemical ionization in conjunction with multiple reaction monitoring. The developed method was validated according to international council for harmonisation (ICH) guidelines to confirm its accuracy, precision, and overall reliability. The method demonstrated acceptable signal-to-noise ratios for both the limit of detection and limit of quantification, with a linear dynamic range spanning 4.42 to 106.92 ng mL- 1 and correlation coefficients exceeding 0.999 for all four nitrosamine impurities. The recoveries ranged from 83.7% to 107.4%, confirming the method’s suitability for detecting potential nitrosamine impurities in BA. It effectively supports quality control analysis, providing a reliable and robust method for the pharmaceutical and analytical chemistry fields.
