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   2020| January-March  | Volume 11 | Issue 1  
    Online since September 12, 2020

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Critical review and analysis of approval of favipiravir for restricted emergency use in mild-to-moderate COVID-19
Arunkumar Radhakrishnan, Ruckmani Arunachalam, Abinaya Elango
January-March 2020, 11(1):1-7
The Central Drugs Standard Control Organization, the Indian drug regulatory agency, granted accelerated approval to Glenmark Pharmaceuticals to market favipiravir in mild-to-moderate COVID-19 on June 19, 2020, for restricted use. The patients should sign informed consent before receiving favipiravir. Subsequently, Glenmark Pharmaceuticals issued a press release on June 20, 2020, stating that it was a landmark development for COVID-19 patients in India and the approval was backed by strong clinical evidence supporting the use of favipiravir in COVID-19. The authors carefully reviewed the press release issued by Glenmark Pharmaceuticals, product information, and informed consent form available with FabiFlu® (Glenmark's favipiravir brand) and public notice issued by the Drugs Controller General of India. They have gone through the regulatory requirements of emergency approvals in India and the USA, WHO's clinical trial synopsis for assessing efficacy of anti-COVID drugs and emergency use authorization granted to remdesivir in the USA. They critically analyzed the efficacy data presented in favor of favipiravir in this due process. Based on the review and analysis, the authors consider that the two crucial publications quoted in the product information, Chen et al. (2020) and Cai et al. (2020), do not provide convincing evidence for the efficacy of favipiravir. The entire clinical data presented in the press release and product information do not offer undisputed support for the efficacy of favipiravir in mild-to-moderate COVID-19. Moreover, it is the right time to take policy decision and frame guidelines on how to handle emergency approvals for medicinal products in grave situations such as the COVID-19 pandemic, in India.
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Effect of nebivolol on microalbuminuria in hypertensive patients with or without type 2 diabetes mellitus
Padma Latha Merugu, Thrilok Chander Bingi
January-March 2020, 11(1):13-18
Objective: To evaluate the effect of nebivolol on microalbuminuria (MA) in hypertensive patients with or without type 2 diabetes mellitus. Materials and Methods: This was an open-label, prospective study. Drug naive patients with stage I hypertension with or without type 2 DM with MA (urine albumin: creatinine ratio [UACR] between 30–300 mg/g) were enrolled in the study and were started on nebivolol 5 mg orally once daily. Efficacy parameters UACR, blood pressure (BP) were measured at baseline and 24 weeks. Paired t-test was used to analyze efficacy endpoints. P < 0.05 was considered to be statistically significant. Results: A total of 30 participants completed the study. Participants who received nebivolol showed a significant decrease in mean UACR, systolic BP, and diastolic BP at 24 weeks compared to baseline (P < 0.001). No participant discontinued the study because of adverse events. Conclusion: Nebivolol has a favorable effect on MA in addition to its antihypertensive effect in hypertensive patients. Further studies with large samples are required to characterize this effect of nebivolol on clinical outcomes.
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Hospital based intensive medication safety monitoring; an observational prospective study in a north Indian private tertiary care teaching institute
Vidushi Sharma, Pramil Tiwari, Mithesh Rathod
January-March 2020, 11(1):19-24
Objective: To identify and characterize adverse drug reactions (ADRs) in patients admitted in intensive care units and wards of a private tertiary care hospital. Materials and Methods: This prospective, observational study was conducted on inpatients. During their hospital stay, whenever a new symptom unrelated to disease or change in laboratory values was observed; ADR was identified using World Health Organisation's definition and recorded in the patient's case sheet. ADRs were classified based on Naranjo's probability scale, Modified Hartwig's criteria of severity and Schumock–Thornton preventability scale. Further, ADRs were analyzed in terms of age, gender, organ system involved, number of medications, and length of stay. Results: Of the 1000 study patients, 35 patients developed 43 ADRs (reported incidence: 3.5%). Twenty-seven patients developed one ADR, while eight patients developed 2 ADRs each. Anti-infective drugs were suspected to have caused the majority (44%) of the ADRs. The most affected organ systems were the gastrointestinal system (44%) and hematological system (26%). On the causality scale, 81.39% ADRs were probably related to suspected medications. About 91% ADRs were probably preventable and 58% ADRs were moderately severe. Number of patients with ADRs was significantly more (P < 0.05) in patients (51.42%) prescribed >11 medications. Further, the number of patients with ADRs was significantly more (P < 0.05) among patients (80%) with a longer stay (>6 days); suggesting, polypharmacy and length of patient's stay as important contributors to developing ADRs. Conclusion: Medication use is majorly associated with the occurrence of ADRs in inpatients. Such surveys on a larger scale would be a useful effort in making medication use safer.
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Ubrogepant: The first gepant to pass food and drug administration for acute migraine
Sivagourounadin Kiruthika, Rajendran Priyadharsini
January-March 2020, 11(1):33-34
Migraine is one of the most common and disabling forms of primary headache disorders. It is characterized by the presence of unilateral pulsatile headache associated commonly with nausea, vomiting, photophobia, and phonophobia lasting for about 4–72 h. Currently, nonsteroidal anti-inflammatory drugs, ergot alkaloids, and triptans are the most commonly used drugs to abort an acute attack of migraine. Management of acute migraine is becoming a challenging task to physicians and patients due to several drawbacks faced with the use of aforementioned drugs. This lacuna is being filled up by developing drugs against novel targets such as calcitonin gene-related peptide (CGRP) and pituitary adenylate cyclase-activating peptide. In December 2019, the US Food and Drug Administration (FDA) approved ubrogepant for the treatment of acute migraine with or without aura in adults. Ubrogepant belongs to a new class of drugs called “Gepants” which are small molecules targeted against the CGRP receptor. The recommended initial dose is 50 mg or 100 mg orally. It follows first-order kinetics and is metabolized to a major extent by CYP3A4-mediated mechanisms. Compared to placebo, ubrogepant causes significant and rapid freedom from headache, pain and absence of migraine-associated most bothersome symptoms. Nausea, vomiting, and dry mouth are some of its common adverse effects. Ubrogepant with advantages such as good oral bioavailability, lack of vasoconstrictor action, and lack of hepatotoxicity might emerge as a promising drug for terminating an acute attack of migraine in the future. However, long-term clinical studies are needed to ascertain its safety profile.
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The effects of a single preanesthetic dose of dexmedetomidine on propofol induction, hemodynamics, and cardiovascular parameters
Padmini Vishwanath, Rammoorthi Rao, Sunil Baikadi Vasudevarao
January-March 2020, 11(1):8-12
Objective: To find out the dose of propofol consumption for induction and also the variation in hemodynamics following single-dose dexmedetomidine premedication. Methods: A total of 60 American Society of Anesthesiologists Class 1 and 2 patients aged between 18 and 80 years, posted for elective surgeries were randomized into two groups: Group C – premedication with 2 mcg/kg fentanyl and Group D – premedication with 1 mcg/kg dexmedetomidine + 2 mcg/kg fentanyl. Both groups were preloaded with 10 ml/kg crystalloid solution. The parameters measured were propofol requirements, heart rate (HR), mean arterial pressure (MAP), cardiac index (CI), cardiac output (CO), and stroke volume variation (SVV). Results: Propofol requirements were 26.6% lesser in Group D (P < 0.001). In Group C, HR was significantly low at baseline (P = 0.008), induction (P = 0.006), and at intubation (P = 0.001) in Group D. Cardiovascular parameters such as MAP (P = 0.007), CI (P = 0.038), and CO (P = 0.021) were significantly lower in Group D compared to Group C only at baseline. There were no differences at any other point during the study. SVV was noted to be significantly lower (P = 0.018) in Group D only at intubation. Conclusion: Dexmedetomidine decreases the requirements of propofol for induction and also attenuates the hemodynamic response to intubation. Cardiovascular parameters such as MAP, CI, and CO were significantly lower in Group D only at baseline. Hemodynamic stability is mainly attributed to adequate preloading and less propofol requirement in the dexmedetomidine group.
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A rare toxicity to chemotherapy
Dilip Harindran Vallathol, Neeharika Alapati, Sailaja Kagita, Raghunadharao Digumarti
January-March 2020, 11(1):28-29
The use of chemotherapy is often limited by toxic side-effects caused to healthy cells. In general, most chemotherapy treatments cause DNA damage or stop cells in mitosis, targeting both cancer and healthy cells. Life-threatening toxicities of chemotherapies can occur with varying frequency depending on the agent suspected and underlying patient risk factors. Post-chemotherapy fatal toxicity is comparatively rare. They occur mostly after high-dose chemotherapy. Pharmacogenomics is a potential and growing field of research that can help in the individualization of therapy based on responses and toxicity. We report a case of a young man with a carcinoma of the right upper alveolus. He was started on weekly chemoradiation with low-dose cisplatinum. After the second cycle, he developed persistent pancytopenia, which never recovered after 3 weeks of admission in the hospital for supportive care. This case highlights the importance of pharmacogenomics in medical oncology. It can also help in counseling the patient and relatives, especially when there is a high degree of suspicion of an elevated amount of toxicities. There has been considerable research into pharmacogenomics in the past decade, and functional genomic approaches are likely to be used in future as an important resource for the prediction of clinical outcome.
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Ecthyma gangrenosum-Source reduction along with empirical antibiotics and wound care helps to treat serious infections
A Ramya, M Manoj Kumar Raja, E Bhavya, K Vivekananadan
January-March 2020, 11(1):30-32
Ecthyma gangrenosum (Eg) is a cutaneous necrotic lesion that is mostly seen in immunocompromised patients. It reflects a severe sepsis, possibly caused by Pseudomonas aeruginosa, an aerobic Gram-negative opportunistic pathogen that has a high risk of associated mortality in cases where the infection is systemic. These skin lesions may be seen on admission or can develop later. The recognition of Eg lesions permits the earliest possible introduction of the most effective antimicrobial therapy, which is a key prognostic factor for survival. A 52-year-old male patient admitted to the surgery department presented a sepsis associated green color pus discharge with pain and swelling. An empiric antibiotic therapy was prescribed. Five days after admission, pus culture was positive for Pseudomonas aeruginosa. As a result, the decision was made to continue the antibiotic therapy. Empiric therapy leads to granulation tissue formation. Eg can be treated with simple antibiotic therapy.
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Evaluation of the effect of temperature on the potency of isophane insulin in a rat model
Deepasree Sukumaran, Aruldhas Blessed Winston, Margaret Shanthi, Aniket Kumar
January-March 2020, 11(1):25-27
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