{"title":"Efficacy, safety, and cost-effectiveness of biosimilars of bevacizumab in näive patients with diabetic macular edema.","authors":"Shalini Virani,Akshay Bhatiwal,Parveen Rewri","doi":"10.4103/ijp.ijp_58_24","DOIUrl":"https://doi.org/10.4103/ijp.ijp_58_24","url":null,"abstract":"OBJECTIVESAnti-vascular endothelial growth factor (VEGF) therapy restores retinal architecture and enhances vision in diabetic macular edema (DME). Bevacizumab is an off-label anti-VEGF drug that effectively treats DME. The safety and efficacy of bevacizumab biosimilars, which are more affordable than the original medication, still need to be established. This study aimed to assess the cost-effectiveness, efficacy, and safety of biosimilars for treating patients with naïve DME across various price ranges that are accessible in the Indian market.MATERIALS AND METHODSTwo biosimilars, BevaciRelTM (Reliance Life Sciences Pvt. Ltd.) and ZyBev (Cadila Healthcare Limited), were compared to their original, Avastin (Roche Products [India] Pvt. Ltd.), in a randomized, control study. Three end-notes were used to assess safety and efficacy: persistence, improvement, and adverse events. Cost-effective analysis was carried out using a decision-tree analysis model.RESULTSThis study included 69 (59%) men and 54 (41%) women with naïve DME. The cohort had an average log MAR visual acuity of 0.87 ± 0.22, and the central retinal thickness at baseline on OCT was 398.5 ± 37.61 μm. The visual acuity showed a similar improvement, and there was a decrease in central retinal thickness as observed on OCT across the groups. The incremental cost-effectiveness ratio was 10.8.CONCLUSIONSThe biosimilars of bevacizumab are safe and efficacious in treating DME in a cost-effective manner.","PeriodicalId":13490,"journal":{"name":"Indian Journal of Pharmacology","volume":"185 1","pages":"248-252"},"PeriodicalIF":2.4,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142226236","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Mugundan Uma Maheshwari, Muhasaparur Ganesan Rajanandh
{"title":"From antiviral to anticancer: Exploring efavirenz's potential against breast cancer.","authors":"Mugundan Uma Maheshwari, Muhasaparur Ganesan Rajanandh","doi":"10.4103/ijp.ijp_332_24","DOIUrl":"10.4103/ijp.ijp_332_24","url":null,"abstract":"","PeriodicalId":13490,"journal":{"name":"Indian Journal of Pharmacology","volume":"56 5","pages":"361-362"},"PeriodicalIF":1.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11698294/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142835575","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Metformin-induced eyelid myokymia.","authors":"Marya Ahsan, Deba Jalal Nizami","doi":"10.4103/ijp.ijp_284_24","DOIUrl":"10.4103/ijp.ijp_284_24","url":null,"abstract":"<p><strong>Abstract: </strong>Metformin, an insulin-sensitizer, is used in the treatment of polycystic ovarian syndrome (PCOS) in obese women as it helps in weight loss and regularizes the menstrual cycle. However, impaired absorption of Vitamin B12 due to metformin has also been hypothesized. Here, we report the case of a 39-year-old woman prescribed metformin for PCOS, presenting with an unusual symptom of eyelid myokymia. She developed distressing unilateral eyelid twitching, not responsive to conservative management or oral methylcobalamin. She was a nonsmoker, nonalcoholic, and nor caffeine-abuser. Other confounding factors such as stress, sleep deprivation, or eye strain were not evident. The only significant finding was borderline low Vitamin B12 levels. The symptoms subsided on discontinuation of metformin and reappeared when metformin was reintroduced. Although eyelid myokymia is a self-limiting benign condition, it can also be triggered by drugs and affect the quality of life. Practitioners should monitor Vitamin B12 levels during metformin therapy to prevent adverse effects.</p>","PeriodicalId":13490,"journal":{"name":"Indian Journal of Pharmacology","volume":"56 5","pages":"358-360"},"PeriodicalIF":1.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11698286/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142835581","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The role of very low-dose prophylaxis in severe hemophilia patients.","authors":"Sunita Aggarwal, Anshul Tomar, Kapil Kumar, Ankitesh Kumar, Suresh Kumar, Sandeep Garg, Naresh Kumar, Sudipta Nandi","doi":"10.4103/ijp.ijp_333_24","DOIUrl":"10.4103/ijp.ijp_333_24","url":null,"abstract":"<p><strong>Introduction: </strong>Very low-dose prophylaxis of antihemophilic factor (AHF) in hemophilia involves administration of minimal amounts of clotting factor concentrates, typically below standard doses, to maintain baseline levels and reduce bleeding episodes. This method uses smaller, more frequent doses to balance bleeding prevention and cost-effectiveness. Close monitoring ensures adequate protection while avoiding overtreatment, offering a tailored, cost-effective approach to improve the quality of life (QoL) of the hemophiliacs.</p><p><strong>Aim: </strong>The study aims to study the bleeding risks in patients with severe hemophilia who are on very low-dose AHF prophylaxis. It also seeks to assess the annual consumption of AHF in the hemophiliacs. In addition, the research will determine the QoL in both groups using the social functioning (SF)-36 questionnaire,evaluate patient compliance with the prophylactic regimen, and check functional disability using the Functional Independence Score in Hemophilia (FISH).</p><p><strong>Materials and methods: </strong>The patients selected for the study were diagnosed with cases of hemophilia and were planned for any surgical procedure. The study was a cross-sectional study lasting 12 months. Patients over 13 years were included and patients with any other bleeding tendencies were excluded from the study.</p><p><strong>Results: </strong>The differences found in the study, were significant in terms of annual bleed rate (ABR), amount of AHF consumed, SF-36, and FISH scores.</p><p><strong>Conclusion: </strong>Our study found that very low-dose prophylaxis significantly reduced the ABR in hemophilia patients. Functional independence worsened in the control group but remained stable in the test group, which showed significant improvements in SF-36 domains. The test group had no inhibitor development and showed a decline in severe bleeds, proving the efficacy and superiority of low-dose prophylaxis over on-demand therapy.</p>","PeriodicalId":13490,"journal":{"name":"Indian Journal of Pharmacology","volume":"56 5","pages":"312-316"},"PeriodicalIF":1.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11698291/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142835612","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Photosensitive dermatitis caused by nintedanib in a patient of chronic fibrosing interstitial lung disease already on pirfenidone.","authors":"Aurelia Goyal, Sharang Gupta, Dimple Chopra","doi":"10.4103/ijp.ijp_371_24","DOIUrl":"10.4103/ijp.ijp_371_24","url":null,"abstract":"","PeriodicalId":13490,"journal":{"name":"Indian Journal of Pharmacology","volume":"56 5","pages":"367-368"},"PeriodicalIF":1.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11698289/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142835608","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Razia Abdul Rasheed, G Venkatraman, S Vijayalakshmi, T A R Raja, G Senthil, P Renugadevi
{"title":"Effect of glimepiride versus teneligliptin in combination with metformin in type 2 diabetes mellitus patients.","authors":"Razia Abdul Rasheed, G Venkatraman, S Vijayalakshmi, T A R Raja, G Senthil, P Renugadevi","doi":"10.4103/ijp.ijp_107_24","DOIUrl":"10.4103/ijp.ijp_107_24","url":null,"abstract":"<p><strong>Background: </strong>Long-term metabolic disease type 2 diabetes mellitus (T2DM) is distinguished by elevated blood glucose, insulin resistance, and drought of insulin with dyslipidemia. Oral hypoglycemic agents lower blood glucose levels as well as prevent both short-term and long-term complications such as micro/macrovascular atherosclerosis, chronic kidney diseases, and chronic heart disease. This study aims to compare the effect of glimepiride versus teneligliptin in combination with metformin in T2DM patients attending a tertiary care hospital.</p><p><strong>Materials and methods: </strong>This prospective, randomized, open-label study was initiated in a tertiary care hospital after obtaining IEC approval. Written informed consent was obtained. The sample size was calculated using \"Statistics and sample size software.\" Ninety-seven patients satisfying the inclusion criteria were assigned to two groups using simple randomization with allocation 1:1. Group A received metformin + glimepiride while Group B received metformin + teneligliptin for 12 weeks. Fasting blood sugar (FBS), postprandial blood sugar (PPBS), glycated hemoglobin (HbA1c), and lipid profile were recorded at the baseline and at the end of 12 weeks. This study was conducted for 1 year. Data were analyzed using SPSS version 23.0 software.</p><p><strong>Results: </strong>Out of 97 participants (Group A: 48 and Group B: 49), Group A showed a higher reduction in FBS (48.18 ± 9.64) whereas Group B showed 72.53 ± 5.01, 1.74 ± 0.42 of change in PPBS and HbA1c after 12 weeks.</p><p><strong>Conclusion: </strong>The study found that combining metformin with teneligliptin was better tolerated and improved glycemic control and lipid profile compared to metformin plus glimepiride.</p>","PeriodicalId":13490,"journal":{"name":"Indian Journal of Pharmacology","volume":"56 5","pages":"317-321"},"PeriodicalIF":1.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11698296/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142835497","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Muhammad Momin Khan, Kundan Kumar Maheshwari, Maisam Ali Rajput, Farina Fatima Siddiqui
{"title":"Piperacillin-tazobactam and nephrotoxicity: Myth busted?","authors":"Muhammad Momin Khan, Kundan Kumar Maheshwari, Maisam Ali Rajput, Farina Fatima Siddiqui","doi":"10.4103/ijp.ijp_113_24","DOIUrl":"10.4103/ijp.ijp_113_24","url":null,"abstract":"","PeriodicalId":13490,"journal":{"name":"Indian Journal of Pharmacology","volume":"56 5","pages":"363-364"},"PeriodicalIF":1.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11698290/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142835609","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rishi Kumar, Jai Prakash, Shashi Bhushan, Akash Deep Rawat, R S Ray, Rajeev Singh Raghuvanshi
{"title":"Training and education in pharmacovigilance: The experience from the Pharmacovigilance Programme of India.","authors":"Rishi Kumar, Jai Prakash, Shashi Bhushan, Akash Deep Rawat, R S Ray, Rajeev Singh Raghuvanshi","doi":"10.4103/ijp.ijp_638_22","DOIUrl":"10.4103/ijp.ijp_638_22","url":null,"abstract":"<p><strong>Abstract: </strong>For a robust Pharmacovigilance system in a country, training of healthcare professionals is of utmost importance. The training is the integral part of continual improvement in any quality management system. The present article describes the different training modules and experience from the Pharmacovigilance Programme of India (PvPI) and emphasizes that if training and education elements with special reference to pharmacovigilance are implemented for all concerned stakeholders in a healthcare system, the efficiency of deliverables will be improved and objectives of the organization can easily be achieved. The PvPI has been putting its best efforts to train healthcare professionals in pharmacovigilance and it has achieved new heights in establishing best practices for the other countries to follow for the development of pharmacovigilance system in their respective countries or regions. The aim of this article is to suggest how capacity building in a pharmacovigilance system can help low- and middle-income countries in area of pharmacovigilance. The authors tried to conceptualize the process and implementation of the training program under PvPI.</p>","PeriodicalId":13490,"journal":{"name":"Indian Journal of Pharmacology","volume":"56 5","pages":"348-357"},"PeriodicalIF":1.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11698288/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142835613","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Cardioprotective effect of S-adenosyl L-methionine due to antioxidant and anti-inflammatory properties on isoproterenol-induced chronic heart failure in Wistar rats.","authors":"Sharmila Vinayak Jalgaonkar, Raakhi Tripathi, Komal Gorakshanath Kurhade, Pradeep Chaudhari, Bhabani Shankar Mohanty, Pradeep Vaideeswar","doi":"10.4103/ijp.ijp_407_24","DOIUrl":"10.4103/ijp.ijp_407_24","url":null,"abstract":"<p><strong>Objectives: </strong>The development and progression of chronic heart failure (CHF), hypertrophy, and remodeling strongly correlate with myocardial inflammation and oxidative stress. S-adenosylmethionine (SAMe), available as a dietary supplement, exerts anti-inflammatory and antioxidant effects. Previous reports show that by regulating angiogenesis and fibrosis, S-adenosyl-L-methionine improves ventricular remodeling. The study objectives were to investigate the cardioprotective effect of SAMe in isoproterenol (ISO)-induced CHF and explore the anti-inflammatory and antioxidant properties of SAMe in this model.</p><p><strong>Methodology: </strong>After animal ethics permission, CHF was induced using ISO of 10 mg/kg for 14 consecutive days in 24 Wistar rats. There were four groups of six rats in each group: Sham Control, Disease Control (DC), ISO + SAMe 100 mg, and ISO + SAMe 200 mg. The variables assessed were heart to body weight ratio (HW/BW mg/g), bio-distribution of Flourine 18-Fluorodeoxyglucose (18F-FDG) in heart tissue, tumor necrosis factor-α (TNF-α) and glutathione (GSH) levels in heart tissue, histopathology, and positron emission tomography imaging.</p><p><strong>Results: </strong>SAMe in ISO-induced CHF animals showed a significant decrease in the HW/BW compared to DC group (P < 0.001). 18F-FDG uptake was significantly reduced by SAMe in CHF-induced rats compared to DC rats for both doses (P < 0.001). SAMe showed significantly better values of both TNF-α and GSH than the DC group in both doses (P < 0.001). SAMe in both doses showed multifocal necrosis with scarring and minimal inflammatory cells.</p><p><strong>Conclusion: </strong>SAMe exerts a cardioprotective effect on ISO-induced CHF in rats because of its antioxidant and anti-inflammatory properties.</p>","PeriodicalId":13490,"journal":{"name":"Indian Journal of Pharmacology","volume":"56 5","pages":"335-341"},"PeriodicalIF":1.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11698293/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142835496","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}