ABSTRACT
Background: This comparative efficacy quantification research between metformin monotherapy and metformin combination therapy, and the subsequent systematic review, along with a consecutive meta-analysis of the different as well as wide-ranged study literature on oral hypoglycemic application rationality of metformin pharmacotherapeutics were performed, for a better comprehension of multicenter maintenance of rational pharmacotherapeutic aspects in the regular antidiabetic mono- and combination therapies prescribed to the new Type II diabetic patients. Aim and Objective: This clinical research study was conducted with the objective for a comparative quantitative evidence-based chronopharmacological efficacy research between metformin monotherapy and metformin combination therapy, and a systematic review, along with an accompanying meta-analysis, on the application rationalities of metformin pharmacotherapeutics. Materials and Methods: In this comparative quantitative evidence-based chronopharmacological efficacy research study, 100 patients suffering from newly detected early moderate grade Type II diabetes mellitus, were allotted into Group A consisting of 50 patients and Group B consisting of 50 patients. The Group A patients were prescribed the anti-diabetic treatment of orally administered metformin 500 mg, to be taken once daily for a span of 30 days, as metformin 1st line (only) monotherapy. The Group B patients were prescribed an oral hypoglycemic drug other than metformin, as 1st line anti-diabetic treatment, for the 1st 30 days, and then these Group B patients were gradually transferred to oral metformin combination therapy with another oral hypoglycemic drug, as metformin 2nd line (only) combination therapy, for the next 30 days. The derived study findings of comparative percentage efficacy quantification were statistically analyzed, on the basis of comparison between both the deduced results, for obtaining the comparative quantitative evidence-based chronopharmacological efficacy between metformin monotherapy and metformin combination therapy. Systematic review as well as meta-analysis is clinical research methods, comprising of a detailed, systematic and interpretative method of collecting, assessing and synthesizing the various medical evidences, to elaborate the research solution to a well-defined research question, in the form of a well-structured qualitative research review as well as quantitative analytical interpretations. Results: In this study, it was derived that the evidence-based chronopharmacological comparative percentage efficacy quantification of anti-diabetic metformin treatment showed 53% of percentage efficacy, when metformin was administered as 1st line (only) monotherapy, and 47% of percentage efficacy, when metformin was administered as 2nd line (only) combination therapy, with other oral hypoglycaemic drugs, prescribed in diabetes mellitus type II treatment regimens. The systematic review as well as meta-analysis in this study deduced 2482 refined, and also relevant, medical research database records, from total 3211 medical research database records, with a comprehensive qualitative and quantitative research database analyses. Conclusions: In this study, it was concluded that there was a slightly greater pharmacological efficacy of metformin 1st line (only) monotherapy than metformin 2nd line (only) combination therapy. The systematic review as well as meta-analysis derived a refined and conclusive medical research analysis, which was qualitatively synthesised, along with quantitative interpretations, on the various application rationalities of metformin pharmacotherapeutics.
ABSTRACT
Background: The anti-diabetic mono- as well as combination pharmacotherapy with metformin, for the routine healthcare treatment of type II diabetic patients, is sufficiently efficacious, with an adequately safe glycemic stabilization rate. This pharmacotherapeutic property of metformin has resulted in metformin being a widely used first-line oral hypoglycemic drug, among different types of diabetic patients. Aims and Objectives: The objective of this mixed-method research study was an analytical quantification clinical research, and an observational descriptive qualitative pharmacological research analysis, on the pharmacovigilance assessments of metformin. Materials and Methods: This study procedure was a was a multivariate, observational, descriptive, retrospective, qualitative, pharmacological research analysis study, and, a multivariate, multicenter, analytical quantification of global clinical research study literature databases on pharmacovigilance assessments of metformin, among type II anti-diabetic patients. A multivariate evidence-based pharmacological research study was done, for a comparative quantification analysis between the qualitative pharmacovigilance studies on metformin monotherapy and combination therapies, and the quantitative pharmacovigilance studies on metformin monotherapy and combination therapies, conducted within a span of the past 5 years. This study was conducted, by recording, calculating, statistically deriving the percentage of the differential quantitative analysis, retrieved from the medical study literature database, along with a statistical interpretative analysis and the subsequent graphical representation of the deduced study results. Results: In this mixed method quantitative and qualitative research study, it was deduced from these study results, that slightly more qualitative pharmacovigilance assessment studies, that is 53%, were conducted on metformin monotherapy and combination therapies, than quantitative pharmacovigilance assessment studies, that is 47%, on metformin monotherapy and combination therapies; and both were analyzed with evidence-based details. Conclusion: This research study provided a comprehensive pharmacovigilance assessment of metformin monotherapy and combination therapies.
ABSTRACT
Background: Anaemia is a global health concern, associated with increased maternal and perinatal mortality, preterm delivery, low birth weight, extreme fatigue and impaired immune system; and controlled by oral haematinics; with a rise in haemoglobin concentration. The objective was to examine the various aspects of pharmacoepidemiology and pharmacohaemovigilance of oral haematinics, among the anaemic women population, in rural India.Methods: This was a multi-centre, retrospective, observational and analytical study of the hospital medical records of 250 anaemic patients, who were allocated into group A of 125 patients within 15-21 years and group B of 125 patients within 22-35 years. The patients were prescribed oral haematinics, containing 60 mg of elemental iron, thrice daily, with meals. The various aspects of pharmacoepidemiology and pharmacohaemovigilance of ferrous ascorbate, ferrous sulphate, ferrous fumarate and ferric ammonium citrate, including patients’ demographic characteristics, anaemic symptoms assessment, prescription patterns, and safety assessment, on 1st, 2nd, 3rd months and follow-up visits, were recorded and thoroughly analysed..Results: In groups A and B, the demographic characteristics of the patients were comparable; ferrous ascorbate was the most commonly prescribed oral haematinic, followed by ferrous sulphate, ferrous fumarate and ferric ammonium citrate, which controlled mild to moderate iron deficiency anaemia, with a gradual significant rise in haemoglobin concentration, in the successive 3 months; and adverse effects were observed to be statistically non-significant in either group.Conclusions: The different aspects of pharmacoepidemiology and pharmacohaemovigilance in the study established that the oral haematinics were reasonably beneficial and safe among the anaemic women population, in rural India.
ABSTRACT
Background: Arformoterol, the (R, R) enantiomer of the racemic (R, R / S, S) diastereomer, formoterol, is a short and long acting ?2 agonist bronchodilator. Levosalbutamol, the (R, R) enantiomer of racemic diastereomer (R, R / S, S) salbutamol, has a greater affinity for the ?2 receptor. Occupation of ?2 receptors by agonists result in the activation of the Gs-adenylyl cyclase-cAMP-PKA pathway, followed by phosphorylative events leading to bronchial smooth muscle relaxation. The aim of this pharmacoepidemiological study was to analyse the prescription patterns, and prescription content analysis, of arformoterol, levosalbutamol, formoterol or salbutamol, in non-severe asthma exacerbation in tertiary care hospitals, not needing hospitalization.Methods: It was a multi-centre, retrospective, observational and analytical study of 100 asthmatic patients’ hospital medical records, treated with 3 doses of arformoterol, levosalbutamol, formoterol or salbutamol nebulization, followed by peak expiratory flow rates (PEFR) measurement at the baseline and 6 minutes, after each dose; along with adverse effects recording. The number of prescriptions of 100 patients was recorded, the percentage of prescriptions was calculated, and the prescription content analysis was done.Results: PEFR of the patients showed significant increase after the first, second and third doses of bronchodilator nebulisation, with negligible adverse effects. Salbutamol was most commonly prescribed (45 prescriptions, 45%), followed by levosalbutamol (35 prescriptions, 35%), formoterol (15 prescriptions, 15%) and arformoterol (5 prescriptions, 5%). All aspects of prescription content analysis showed 100% completeness.Conclusions: Arformoterol was more effective, but equally safe, as compared to levosalbutamol, formoterol and salbutamol. Prescription frequency of salbutamol was followed by levosalbutamol, formoterol and arformoterol. Prescription content analyses showed 100% completeness.