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  1. Article: Review of Satralizumab for Neuromyelitis Optica Spectrum Disorder: A New Biologic Agent Targeting the Interleukin-6 Receptor.

    Meher, Bikash R / Mohanty, Rashmi R / Dash, Ashish

    Cureus

    2024  Volume 16, Issue 2, Page(s) e55100

    Abstract: Currently, three monoclonal antibodies (MABs) have received regulatory approval from the federal agency, the United States Food and Drug Administration (USFDA), for the medical management of neuromyelitis optica spectrum disorder (NMOSD). Satralizumab ... ...

    Abstract Currently, three monoclonal antibodies (MABs) have received regulatory approval from the federal agency, the United States Food and Drug Administration (USFDA), for the medical management of neuromyelitis optica spectrum disorder (NMOSD). Satralizumab was the third approved therapy after MABs like eculizumab and inebilizumab for NMOSD, an uncommon but severe enfeebling autoimmune neurological disease. Satralizumab, a humanized monoclonal antibody, exerts its action in NMOSD by acting against cytokine interleukin-6 (IL-6), a foremost mediator in the pathological process of NMOSD. Two pivotal clinical trials carried out in NMOSD patients had established that satralizumab significantly decreased the rate of relapse in patients suffering from NMOSD as opposed to placebo. The trials also demonstrated that satralizumab is relatively safe. Thus, satralizumab provides an efficacious and safe treatment option for this rare, disabling central nervous system (CNS) disease. Our review aimed to elucidate the pharmacological characteristics of satralizumab and illustrate the available evidence regarding its safety and efficacy in patients with NMOSD.
    Language English
    Publishing date 2024-02-27
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 2747273-5
    ISSN 2168-8184
    ISSN 2168-8184
    DOI 10.7759/cureus.55100
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Indication-specific pricing of drugs: a utopian idea, a pragmatic proposition or unrealistic in economically constrained settings?

    Meher, Bikash R / Padhy, Biswa M

    Tropical doctor

    2020  Volume 50, Issue 2, Page(s) 157–159

    Abstract: The concept of indication-specific pricing (ISP) of drugs means that the cost of a drug will vary depending on the reasons for its use. ISP is a novel concept and its beneficial or detrimental effects are unknown. Experience from richer countries ... ...

    Abstract The concept of indication-specific pricing (ISP) of drugs means that the cost of a drug will vary depending on the reasons for its use. ISP is a novel concept and its beneficial or detrimental effects are unknown. Experience from richer countries suggests that it is fraught with many administrative, ethical and regulatory challenges. It seems, though, that prices of some drugs have been set using this model. The barriers, real and potential, to the implementation of ISP in low- and middle-income countries are discussed. Implementation of ISP is impractical in such environments because of the large impoverished population, low frequency of health insurance, generally poor health infrastructure, lack of regulatory oversight, and the fact that most healthcare expenditure is borne personally.
    MeSH term(s) Costs and Cost Analysis ; Developing Countries/economics ; Drug Costs/legislation & jurisprudence ; Drug Costs/standards ; Humans ; Pharmaceutical Preparations/economics ; Poverty/economics
    Chemical Substances Pharmaceutical Preparations
    Language English
    Publishing date 2020-02-09
    Publishing country England
    Document type Journal Article
    ZDB-ID 193169-6
    ISSN 1758-1133 ; 0049-4755
    ISSN (online) 1758-1133
    ISSN 0049-4755
    DOI 10.1177/0049475520903644
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article: Comparison of Efficacy and Safety of Azilsartan and Amlodipine Combination Versus Telmisartan and Amlodipine Combination in Hypertensive Patients: A Non-inferiority Trial.

    Dash, Ashish / Meher, Bikash R / Padhy, Biswa M / Mohanty, Rashmi R / Tripathy, Amruta

    Cureus

    2023  Volume 15, Issue 3, Page(s) e35865

    Abstract: Introduction Hypertension (HTN) is one of the most common conditions encountered in daily practice in hospitals. Combination therapy is mostly initiated in the management of HTN when target blood pressure is not achieved with monotherapy. There are few ... ...

    Abstract Introduction Hypertension (HTN) is one of the most common conditions encountered in daily practice in hospitals. Combination therapy is mostly initiated in the management of HTN when target blood pressure is not achieved with monotherapy. There are few studies comparing the antihypertensive effect of a combination of azilsartan and amlodipine with a combination of amlodipine and other angiotensin receptor blockers (ARBs), however, the results are contradictory. The objective of this study was to compare the efficacy and safety of the azilsartan and amlodipine combination versus the telmisartan and amlodipine combination in hypertensive patients. Methods The present study was a prospective, randomized, active-controlled, open-label, parallel-group clinical trial. Hypertensive patients were randomized into two groups of 25 patients each. Baseline evaluations of systolic blood pressure (SBP), diastolic blood pressure (DBP), and high-sensitivity troponin I (hsTnI) were done. Patients were reassessed after 12 weeks of drug therapy with azilsartan 40 mg and amlodipine 5 mg combination or telmisartan 40 mg once daily (QD) and amlodipine 5 mg combination QD. Results The response rate (defined as a reduction of more than 20 mm Hg in SBP or 10 mm Hg in DBP or both from baseline at 12 weeks) for HTN in the test group and control groups was found to be 88% and 96% respectively. The response rate of the azilsartan amlodipine group was found to be non-inferior to the telmisartan amlodipine group (odds ratio, OR, 0.31, p = 0.61) at the end of 12 weeks of drug therapy. At 12 weeks of follow-up, there was a significant decrease in SBP (p < 0.001), DBP (p < 0.001), and hsTnI levels (p < 0.001) in both groups from baseline values. However, differences between the test and control groups for blood pressure and hsTnI were found to be not statistically significant at 12 weeks of follow-up. The most commonly reported adverse effect in both groups was headache. Conclusion Azilsartan amlodipine combination had an 88% response rate, which was non-inferior to the telmisartan and amlodipine combination. Biomarkers such as hsTnI showed a significant decrease in both groups after 12 weeks of follow-up. However, there was no significant difference between the two groups.
    Language English
    Publishing date 2023-03-07
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2747273-5
    ISSN 2168-8184
    ISSN 2168-8184
    DOI 10.7759/cureus.35865
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article: Comparative Study of the Effects of Azilsartan and Telmisartan on Insulin Resistance and Metabolic Biomarkers in Essential Hypertension Associated With Type 2 Diabetes Mellitus.

    Meher, Bikash R / Mohanty, Rashmi R / Sahoo, Jyoti P / Jena, Monalisa / Srinivasan, Anand / Padhy, Biswa M

    Cureus

    2022  Volume 14, Issue 2, Page(s) e22301

    Abstract: Introduction The complex interplay between the autonomic nervous system, renin-angiotensin-aldosterone system (RAAS), and immunity contributes to the pathogenesis of hypertension in diabetes mellitus. The objective of this study was to investigate and ... ...

    Abstract Introduction The complex interplay between the autonomic nervous system, renin-angiotensin-aldosterone system (RAAS), and immunity contributes to the pathogenesis of hypertension in diabetes mellitus. The objective of this study was to investigate and compare the effect of azilsartan and telmisartan on insulin resistance and metabolic biomarkers in patients with both hypertension and type 2 diabetes mellitus. Methods The present study was a prospective, randomized, active-controlled, open-label, parallel-group clinical trial. Patients with grade I or II essential hypertension with type 2 diabetes mellitus were randomized into two groups of 25 patients each. Baseline evaluation of homeostasis model assessment-insulin resistance (HOMA-IR), plasma glucose, insulin, leptin and adiponectin levels, and systolic and diastolic blood pressure (SBP and DBP) of patients was done. Patients were reassessed after 12 weeks of drug therapy with azilsartan 40 mg OD (once daily) or telmisartan 40 mg OD. Results The mean changes in HOMA-IR from the baseline at the end of 12 weeks of treatment were 0.15 (-0.64, 0.94.52) in the azilsartan group and 0.32 (-0.61, 1.26) in the telmisartan group. The mean difference in the changes from the baseline in HOMA-IR between the two groups was 0.3 (-0.87, 1.48), which was not statistically significant. No statistically significant changes were observed between the two groups in metabolic biomarkers (leptin: -0.84, CI: -4.83 to 3.14, and adiponectin: -0.12, CI: -0.62 to 0.37). Systolic (SBP) and diastolic blood pressure (DBP) decreased at the end of the 12-week treatment in both the groups; however, there was no significant difference between the two groups (SBP: -2.6, CI: -10.35 to 5.1, and DBP: -3.0, CI: -7.7 to 1.7). Conclusion Neither azilsartan nor telmisartan had any significant effects on insulin resistance and metabolic biomarkers after 12 weeks of drug therapy in hypertension patients associated with type 2 diabetes mellitus. However, they showed a comparable antihypertensive effect. The adverse effects observed were mild in nature, and their incidence was comparable between the two groups.
    Language English
    Publishing date 2022-02-16
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2747273-5
    ISSN 2168-8184
    ISSN 2168-8184
    DOI 10.7759/cureus.22301
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article: Biosimilars in India; Current Status and Future Perspectives.

    Meher, Bikash R / Balan, Sakthi / Mohanty, Rashmi R / Jena, Monalisa / Das, Smita

    Journal of pharmacy & bioallied sciences

    2018  Volume 11, Issue 1, Page(s) 12–15

    Abstract: Many key biologics are scheduled to lose their patent by the year 2020, which will provide the opportunity to other biopharmaceutical companies to develop the similar biologics. Biosimilar or similar biologic used has increased in the recent year ... ...

    Abstract Many key biologics are scheduled to lose their patent by the year 2020, which will provide the opportunity to other biopharmaceutical companies to develop the similar biologics. Biosimilar or similar biologic used has increased in the recent year following the approval of the first biosimilar in early 2000. India is one of the leading manufacturers of similar biologics. India has developed a new guideline in 2012 for the pre- and post-marketing approval of similar biologics.
    Language English
    Publishing date 2018-10-04
    Publishing country India
    Document type Journal Article ; Review
    ZDB-ID 2573569-X
    ISSN 0975-7406 ; 0976-4879
    ISSN (online) 0975-7406
    ISSN 0976-4879
    DOI 10.4103/jpbs.JPBS_167_18
    Database MEDical Literature Analysis and Retrieval System OnLINE

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