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
Pulsatile drug delivery systems are developed to deliver drug according to circadian behavior of diseases. This means that these systems will deliver drug at time when disease display it’s most morbid and mortal state within a circadian cycle (24 hrs.). The product follow a sigmoidal drug release profile characterized by a time period of no release (lag time) followed by a rapid and complete drug release. Thus drug can be delivered at right time, in right amount and at right site of action by use of such approach. The potential benefits of chronotherapeutics have been investigated and established for number of diseases like asthma, arthritis, cancer, diabetes, epilepsy, hypertension, ulcer, hypercholesterolemia etc. Various capsular, osmotic, single and multiple unit systems that are modulated by soluble or erodible polymer coatings, rupturable membranes are available in market. These systems are beneficial for diseases showing chronopharmacological behavior where night time dosing is required or for the drugs having high first pass effect or having site specific absorption in GIT, or for drugs with high risk of toxicity or tolerance. These systems also improve patient compliance by decreasing dosing frequency.