•Favipiravir is approved by some countries, including India, for COVID-19 treatment.•Favipiravir has shown rapid viral clearance and faster clinical improvement.•Various treatment recommendations ...include favipiravir for COVID-19 treatment.•Several ongoing clinical trials will further substantiate favipiravir role.
The coronavirus disease-2019 (COVID-19) outbreak all over the world has led the researchers to strive to develop drugs or vaccines to prevent or halt the progression of this ailment. To hasten the treatment process, repurposed drugs are being evaluated. Favipiravir is one such oral drug that was approved for new and reemerging pandemic influenza in Japan in 2014 and has shown potent in vitro activity against severe acute respiratory syndrome coronavirus-2. It has a wide therapeutic safety margin indicated by a wide CC50/EC50 ratio for a high dose. From the clinical studies in COVID-19, it has shown rapid viral clearance as compared to lopinavir/ritonavir (LPV/RTV) and superior recovery rate than umifenovir. Overall, favipiravir has shown promising results in clinical studies in China, Russia, and Japan, and more trials are underway in multiple countries, including USA, UK, and India. Recently, treatment guidelines from many countries and some states from India have included favipiravir in the treatment protocol. This review provides insights into the evidence-based evolving role of favipiravir in the management of COVID-19 infection with emphasis on benefits of initiating an early antiviral therapy with special focus on favipiravir, its pharmacodynamic, pharmacokinetic, in vitro, clinical data, and inclusion in the treatment protocols of COVID-19.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Background and Aim: Teneliglitpin, approved in India since 2015, is the most commonly prescribed DPP4i in India. Due to lack of evidence, this study was planned in real world setting to evaluate ...effects of teneligliptin on renal parameters and safety in Indian T2DM patients with CKD.
Methodology: TOP RENAL real world study enrolled T2DM patients with eGFR ≤60 to ≥15 ml/min/1.73m2 and were started on teneligliptin (20/40 mg OD) and continued it for next six months. Those patients prescribed any antidiabetic medication along with teneligliptin or those with change in antidiabetic prescription in the following six months were excluded.
Results: 377 patients data was collected during August'22-October'22 and grouped according to baseline eGFR (ml/min/1.73m2): G3a: 45-59 (n=102); G3b: 30-44 (n=124); G4: 15-29 (n=151). The mean age was 59.86±9.58 years and 47% were females. Renal parameters: eGFR, Sr creatinine and BUN were assessed at baseline, 3 months and 6 months. Results showed non-significant changes in eGFR (Table1), Sr. creatinine and BUN at 3 and 6 months in all three groups. No safety concerns or hypoglycemia were reported during the study.
Conclusion: Teneligliptin initiation in Indian T2DM patients with mild-severe renal impairment did not show any safety concerns and was well tolerated.
Disclosure
S. Suryawanshi: Employee; Glenmark Pharmaceuticals. V. Jadhao: Employee; Glenmark Pharmaceuticals. M. Brid: Employee; Glenmark Pharmaceuticals. S. Bhushan: None. H. V. Barkate: None.
Funding
Glenmark Pharmaceuticals Limited
•Favipiravir is an oral RNA-dependent RNA polymerase inhibitor.•Favipiravir is under investigation in many countries for the treatment of COVID-19.•We evaluated favipiravir’s efficacy and safety in ...mild-to-moderate COVID-19.•Favipiravir treatment led to significant improvement in time to clinical cure.•Favipiravir may be a safe and effective treatment in mild-to-moderate COVID-19.
To assess the efficacy and safety of favipiravir in adults with mild-to-moderate coronavirus disease 2019 (COVID-19).
In this randomized, open-label, parallel-arm, multicenter, phase 3 trial, adults (18–75 years) with RT-PCR confirmed COVID-19 and mild-to-moderate symptoms (including asymptomatic) were randomized 1:1 to oral favipiravir (day 1: 1800 mg BID and days 2−14: 800 mg BID) plus standard supportive care versus supportive care alone. The primary endpoint was time to the cessation of viral shedding; time to clinical cure was also measured.
From May 14 to July 3, 2020, 150 patients were randomized to favipiravir (n = 75) or control (n = 75). Median time to the cessation of viral shedding was 5 days (95% CI: 4 days, 7 days) versus 7 days (95% CI: 5 days, 8 days), P = 0.129, and median time to clinical cure was 3 days (95% CI: 3 days, 4 days) versus 5 days (95% CI: 4 days, 6 days), P = 0.030, for favipiravir and control, respectively. Adverse events were observed in 36% of favipiravir and 8% of control patients. One control patient died due to worsening disease.
The lack of statistical significance on the primary endpoint was confounded by limitations of the RT-PCR assay. Significant improvement in time to clinical cure suggests favipiravir may be beneficial in mild-to-moderate COVID-19.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Astaxanthin is a naturally occurring ketocarotenoid which has been found to have numerous biological functions, with its strong antioxidant property being the prominent feature. The compound has ...attracted a great amount of interest with respect to its potential utilization in the betterment of human health. In the recent past, astaxanthin has been extensively studied with respect to its possible effect on skin health, with positive results. Astaxanthin has also shown to have anti‐inflammatory, immune‐modulating, and DNA repair properties, which have further encouraged its usage to maintain skin health and tackle skin damage. In this review article, we highlight the pharmacokinetic profile of the antioxidant in brief and describe the findings of various recent published research articles which studied the effect of astaxanthin in improvement of skin health. We also mention the possible mechanisms which form the basis of the positive dermatological effects of astaxanthin and the potential indications of the antioxidant molecule in cosmetology and dermatology.
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BFBNIB, DOBA, FZAB, GIS, IJS, IZUM, KILJ, NLZOH, NUK, OILJ, PILJ, PNG, SAZU, SBCE, SBMB, UILJ, UKNU, UL, UM, UPUK
Background Chemotherapy induced nausea- vomiting (CINV) is considered as the most common, feared and most troublesome side effect of chemotherapy. NEPA (NEtupitant 300 mg + PAlonosetron 0.50 mg) is ...the first commercially available oral fixed-dose combination (FDC) of two active antiemetic agents in India. The present study was planned to evaluate the effectiveness of NEPA in the real world setting of India. Methods This was a multicentric retrospective study conducted in two centers in India. The data of all chemonaive patients, who were prescribed NEPA was analyzed. Effectiveness i.e. complete response and complete protection in controlling overall, acute and delayed phase was analyzed. Results A total of 329 patients were enrolled in the study. 260 received highly emetogenic chemotherapy (HEC) regimen and 69 received moderately emetogenic chemotherapy (MEC) regimen. Among all the enrolled patients, complete response in acute, delayed and overall phase was 93, 85.71 and 85.41% respectively; and completed protection was 88.44, 81.76 and 80.54% respectively. Those who received HEC regimen, the completed response and complete protection in overall phase was 84.61 and 79.61% respectively and those who received MEC regimen the completed response and complete control in overall phase was 84.05 and 84.05% respectively. Conclusion A single oral dose of NEPA targeting dual pathways showed effective control of nausea-vomiting in patients on the HEC and MEC regimens and had good control over nausea-vomiting in acute, delayed and overall phase of nausea-vomiting. Keywords: NEPA, India, Nausea, Vomiting, HEC, MEC
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
In advanced Renal Cell Carcinoma (aRCC), systemic therapy is the mainstay of treatment, with no or little role for surgery in these patients. Tyrosine kinase inhibitors (TKIs) and immune-oncological ...(IOs) therapies, either alone or in combination, are recommended in these patients depending on patient and tumour factors. The sequencing of therapies is critical in RCC because the choice of subsequent line therapy is heavily dependent on the response and duration of the previous treatment. There are additional barriers to RCC treatment in India. Immunotherapy is the cornerstone of treatment in ccRCC, but it is prohibitively expensive and not always reimbursed, effectively putting it out of reach for the vast majority of eligible patients in India. Furthermore, in advanced RCC (particularly the clear cell variety), Indian oncologists consider the disease burden of the patients, which is particularly dependent on the quantum of the disease load, clinical symptoms, and performance status of the patient, before deciding on treatment. There are no India-specific guidelines for clear cell RCC (ccRCC) treatment or the positioning and sequencing of molecules in the management of advanced ccRCC that take these country-specific issues into account. The current consensus article provides expert recommendations and treatment algorithms based on existing clinical evidence, which will be useful to specialists managing advanced ccRCC.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Introduction Topical minoxidil 5% is a widely used medication in the treatment of androgenetic alopecia (AGA) but is usually associated with adverse events (AE) such as scalp irritation, dryness, and ...itching. This prompted the development of nonalcoholic solutions, and cetosomal minoxidil was the most recent one. Methods Retrospective multicenter data analysis was conducted at 66 centers across India for adult AGA patients. Patients treated with either cetosomal minoxidil 5% alone (Group I) or a fixed drug combination of cetosomal minoxidil 5% and finasteride 0.1% (Group II) were analyzed for the effectiveness and safety of either formulation. The Physician Global Assessment (PGA) and Patient Global Assessment (PtGA) were used to assess each treatment's effectiveness. Safety was reported by records of AE and a product tolerability assessment with subjective cosmetic acceptability as recorded by physicians. Results Of the 261 patients, 132 were in Group I, and 129 were in Group II. At 16 weeks, in PGA, mild to moderate improvement was noted in 48% and 32% of patients in Groups I and II, respectively, whereas significant to excellent improvement was seen in 52% and 68% of patients in Groups I and II, respectively. Similar results were noted for PtGA. In Group I, 64% of patients rated the product's tolerability as excellent, and 69% reported the same in Group II. Meanwhile, 64% of patients in Group I and 74% in Group II rated the product as excellent in subjective cosmetic acceptability. Conclusions From real-world analysis, cetosomal-based minoxidil solutions were found to be effective and tolerable in AGA and could serve as therapeutic alternatives to alcoholic formulations for AGA management.
Aim
To assess the real-world effectiveness and safety of remogliflozin in the management of type 2 diabetes mellitus (T2DM) in a large uncontrolled population.
Methods
A retrospective cohort analysis ...was conducted at 1578 sites across India. Medical records of all patients who had received a remogliflozin-based regimen for a 3-month duration as per routine practice for the management of T2DM were analysed for effectiveness and safety. The efficacy assessments included mean change in HbA1c, fasting plasma glucose (FPG), postprandial plasma glucose (PPG), bodyweight, BMI, and blood pressure from baseline to 3 months. Safety assessments included incidence of adverse events reported.
Results
A total of 5452 eligible patients’ data were analysed. The mean change of HbA1c level from baseline (8.63%) to 3-month follow-up (7.68%) was − 0.95%. The mean change in FPG and PPG from baseline to the end of follow-up was − 42.4 mg/dL and − 69.1 mg/dL, respectively. A significant reduction in glycemic parameters was observed from baseline to follow-up. The overall incidence of adverse events (AEs) was about 25.9%. Genito-urinary tract infections (12.6%) were more frequently reported AEs, and no severe AEs were reported.
Conclusion
Remogliflozin etabonate was effective in improving glycemic parameters. It was well-tolerated in the real-world setting used for glycemic management of T2DM.
Background: In spite of the availability of multiple consensus statements on dermatophytosis management, different treatment approaches have been experienced in India and require more scrutiny to ...further update guidelines and improve patient care. Aim: To determine the different approaches in dermatophytosis diagnosis and management among dermatologists in India. Materials and Methods: A web-based questionnaire was created and validated by five panelists with experience of >15 years in dermatophytosis and then circulated to about 2,000 dermatologists in India in September 2021 for a real-world management scenario. Results: Out of 2,000 dermatologists, 459 responded. About half of the dermatologists (51%) routinely conduct potassium hydroxide mount (KOH) at the initiation of therapy. Similarly, about 53% of dermatologists initiate the management of dermatophytosis with combination therapy in all types of dermatophytosis for 4-6 weeks depending upon severity. Different types of combinations are being practiced, such as either two systemic and one topical, two topicals and one systemic, but the combination of one systemic and one topical (69%) is the most commonly practiced. Itraconazole (100 mg twice a day) and luliconazole are the most commonly prescribed antifungal medications. In case of non-response to routine dose of systemic anti-fungals, about 72% of dermatologists up dose them. Most of them continue these drugs for additional 1-2 weeks after clearance of the disease. Additionally, keratolytics and moisturizers are commonly prescribed. Additionally, 62% advise liver function tests (LFTs) at the initiation of therapy, whereas 72% advise monitoring adverse effects due to systemic antifungal drugs during treatment. Conclusion: Combination therapy stood out as the need of the hour in the current menace of dermatophytosis with timely monitoring of laboratory tests for adverse events due to the use of systemic antifungals for a longer duration.
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IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
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