A multivariate comparative clinical pharmacotherapeutic efficacy and chronopharmacovigilance assessment study of ofloxacin, one of the commonplace, TGFβ1 inducing and telomerase impairing fluoroquinolones, in treating acute gastroenteritis, chronic obstructive pulmonary disease, new drug-sensitive tuberculosis, recurrent mixed cutaneous infections, and post-surgical refractory wound infections, among the global patients, with heterogenous pharmacogeographic and pharmacogenomic constitution

Background: Ofloxacin has an inhibitory effect on DNA gyrase, DNA topoisomerase IV and IL-1α, IL-6, IL-8, TNFa; and a superinducing effect on IL-2. Ofloxacin has profound bactericidal, anti-tubercular, anti-leprotic, anti-viral including anti-coronavirus, anti-fungal, anti-protozoal, comedolytic, anti-comedogenic, anti-inflammatory, immunomodulatory, and anti-malignant: pro-apoptotic and anti-proliferative potential, including TGFb1 targeted G2 phase cell cycle arrest and telomerase activity impairment. Objectives of the study were a comparative clinical pharmacotherapeutic efficacy and chronopharmacovigilance assessment study, of ofloxacin, one of the commonplace TGFb1 inducing and telomerase impairing fluoroquinolones, in treating heterogenous global patients, suffering from different diseases.Methods: A prospective, multivariate study of 100 patients, allotted into group A (acute gastroenteritis) =20, group B (chronic obstructive pulmonary disease) =20, group C (new drug-sensitive tuberculosis) =20, group D (recurrent mixed cutaneous infections) =20, and group E (post-surgical refractory wound infections) =20, was prescribed ofloxacin 200-400 mg twice daily, according to required prescribed regimens. A comparative pharmacotherapeutic efficacy assessment was made from the complete recovery time-periods, including the residual recovery time-periods. The chronopharmacovigilance assessment was made by adverse effects occurrence monitoring during treatment period or follow-up, with an Adverse Event Case Report Form. Results: The residual recovery time-periods, in group A=0 days, group B=2 days, group E=3 days, group D=3 days, and group C=7 days. Adverse effects were not statistically significant, with a predictable chronopharmacovigilance illustration.Conclusions: The pharmacotherapeutic efficacy of ofloxacin was more for treating group A, followed by group B, followed by group E and group D, and finally followed by group C. Ofloxacin was safe, without any pharmacogenomic or pharmacogeographic heterogeneity related fluctuation

A study on the aspects of pharmacoepidemiology and pharmacohaemovigilance of ferrous ascorbate, ferrous fumarate, ferrous sulphate and ferric ammonium citrate, among the rural anaemic women, in the Indian spectrum

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

A clinical pharmacological evidence-based analytical research study on the clinical pharmacokinetic dose-dependent correlation of oral haematinics with the obstetric and gynaecological global anaemic patients’ recovery rate

Background: The goal of iron therapy is to repair the haemoglobin deficit and replenish storage iron. Oral haematinics are the treatment of choice, due to their higher effectiveness, higher safety, higher ease of administration, higher patient compliance, better accessibility, no occurrence of nosocomial infections and lower cost. This analytical evidence-based clinical research was conducted for the molecular pharmacokinetic study of the pharmacological response and adherence of the patients to oral haematinics, in global tertiary medical care centres.Methods: 100 anaemic patients, who were treated for moderate iron-deficiency anaemia, were prescribed oral haematinics, such as, ferrous ascorbate, ferrous sulphate, ferrous fumarate and ferric ammonium citrate, containing 60 mg of elemental iron, once to thrice daily, with or after meals, according to the progress of the disease, treatment regimen scheduling, occurrence or non-occurrence of adverse drug reactions and prognosis of the patient. The pharmacokinetic dose-dependent percentage recovery rate of the patients on 1st (30th day), 2nd (60th day) and 3rd (90th day) months and follow-up (105th day) visits, was finally deduced from the patients’ recovery features of symptoms and signs, and the confirmatory laboratory investigations recordings, with the efficacy and safety evaluation findings.Results: During the oral haematinics treatment, the pharmacokinetic dose-dependent percentage recovery rate of the patients was 29% on 30th day, 62% on 60th day, 93% on 90th day and 100% on 105th day of treatment.Conclusions: All the oral haematinics treated global anaemic patients had shown 100% recovery rate in tertiary medical care centres

A rational pharmacotherapeutic study of comparative safety among topical anti-acne 1% nadifloxacin monotherapy, 0.1% adapalene monotherapy, 0.025% tretinoin monotherapy, 1% nadifloxacin and 0.1% adapalene combination therapy and 1% nadifloxacin and 0.025% tretinoin combination therapy, in mild to moderate acne vulgaris, in tertiary care hospitals

Background: Topical adapalene and tretinoin, are comedolytic, anti-comedogenic and anti-inflammatory, on RAR (α, β, γ) receptors binding. Adapalene enables quicker follicular penetration, by lesser anti-AP-1 (c-Jun, c-Fos) and no CRBPII mRNA actions, causing chemical stability, lipophilicity and less photo-lability, producing lesser photosensitivity and no skin irritation, unlike tretinoin; wherein reducible by overnight application and combination therapy, slow-release polymers or emollients, respectively. Topical nadifloxacin is bactericidal, anti-inflammatory and comedolytic, with inhibitory effect on DNA gyrase, DNA topoisomerase IV and IL-1α, IL-6, IL-8. The Global Alliance to Improve Outcomes in Acne Guidelines recommend synergistic and additive combination therapies, which enhance therapeutic efficacy and reduce adverse effects. Due to inadequacy of data, this study was conducted, to compare the safety among topical anti-acne monotherapies and combination therapies, and to easily detect any adverse effect producing component in the topical combination therapy.Methods: In this multi-centre, prospective, randomised, open-labelled, comparative study, groups A, B, C, D and E (20 patients each), applied topical 1% nadifloxacin monotherapy, 0.1% adapalene monotherapy, 0.025% tretinoin monotherapy, 1% nadifloxacin and 0.1% adapalene combination therapy and 1% nadifloxacin and 0.025% tretinoin combination therapy, respectively, over their facial mild to moderate acne lesions, once daily overnight; and adverse effects, like erythema, scaling, dryness, prutitus, burning, or stinging, were assessed on 0, 15, 30, 60, 90 days and follow-ups, by Local Irritation Scale.Results: In all 5 groups, no adverse effects were observed, with no statistically significant difference among the observations.Conclusions: The therapies were well tolerated and safe among all 5 groups

A rational pharmacotherapeutic study of the prevalent prescription patterns of delamanid, ofloxacin, levofloxacin, and bedaquiline among the multi-drug resistant tuberculosis patients in global multi-centre tertiary care hospitals

Background: Delamanid, a nitro-dihydro-imidazooxazole, is a bactericidal cell wall methoxy-mycolic and keto-mycolic acids biosynthesis inhibitor in actively replicating, dormant, and intracellular tuberculosis, and both drug-susceptible and drug-resistant strains of M. tuberculosis and M. kansasii, decreasing hydrophobicity and facilitating better bacterial drug penetration. Delamanid promotes intracellular generation of microbiocidal nitrogen oxidative intermediaries including nitric oxide, toxic even to dormant M. tuberculosis. Ofloxacin, the racemic mixture and levofloxacin, the S-or levorotatory isomer of ofloxacin, are bactericidal to M. tuberculosis, MAC, M. fortuitum, and other atypical mycobacteria, with inhibitory effect on DNA gyrase, DNA topoisomerase IV and IL-1α, IL-6, IL-8. Bedaquiline, a novel diarylquinoline, inhibits mycobacterial adenosine triphosphate synthase of M. tuberculosis, disrupting mycobacterial energy metabolism and replication. Bedaquiline’s initial bacteriostatic action is followed by a bactericidal effect after 5-7 days. The objective was to perform a rational pharmacotherapeutic study of the prevalent prescription patterns of delamanid, ofloxacin, levofloxacin, and bedaquiline, among the multi-drug resistant tuberculosis patients, in global multi-centre tertiary care hospitals.Methods: A multi-centre, retrospective, observational and analytical study of clinical prescriptions of 100 multi-drug resistant tuberculosis patients in hospitals, were performed. For 24-48 weeks, these patients had been prescribed anti-tubercular drugs, like delamanid 100 mg and ofloxacin 400 mg twice daily, levofloxacin 750 mg and bedaquiline 400 mg once daily followed by 200 mg thrice weekly, as part of MDR-TB treatment regimens. The no. of prescriptions for each drug were recorded, and the corresponding prescription rates were statistically derived in percentages. Results: Delamanid was most commonly prescribed (32 prescriptions, 32%), followed by ofloxacin (29 prescriptions, 29%), levofloxacin (24 prescriptions, 24%), and bedaquiline (15 prescriptions, 15%). The completeness of the prescription contents, the dose of drug, the duration of treatment, the instructions of medication, the frequency of drug intake, the name of the drug and the dosage form of the drug were observed in 100% of prescriptions.Conclusions: Prescription frequency of delamanid was followed by ofloxacin, levofloxacin and bedaquiline. Prescription content analyses showed 100% completeness

A global analytical molecular pharmacological study of the endocrinological pharmacotherapeutic rationale of anti-diabetic prescriptions appraisal attributes for metformin and sitagliptin, with evaluation of anti-diabetic tertiary medical healthcare patient satisfaction

Background: The inhibition of dipeptidyl peptidase-4 by anti-diabetic drugs dipeptidyl peptidase-4 inhibitors enhances hormonal activity of incretins (GLP-1, GIP, GRP), stimulates insulin release and reduces glucagon secretion, producing anti-hyperglycaemic activity among type II diabetics. The objective of this study was a global analytical molecular pharmacological study of the endocrinological rationale of anti-diabetic prescriptions appraisal attributes for metformin and sitagliptin, along with anti-diabetic tertiary medical healthcare patient satisfaction evaluation.Methods: 100 new early moderate grade type II diabetics were prescribed oral metformin 500 mg or sitagliptin 25 mg once daily for 3 months, in monotherapy, or in combination therapy, or in a mixed regimen of monotherapy and combination therapy. The patients’ endocrinological pharmacotherapeutic compliance was analysed. The number of prescriptions for metformin and sitagliptin was recorded; and prescription percentages were calculated. The completeness and molecular basis of prescription content attributes were analysed. The molecular basis of anti-diabetic pharmacotherapeutics, was analysed. The anti-diabetic tertiary medical healthcare patient satisfaction was evaluated by patient response to different attributes of anti-diabetic treatment.Results: All the patients had completed the study, with no adverse effects related drop-out, lost to follow-up or voluntarily withdrawn patients. The prescription rates of metformin was 75% (75 prescriptions), followed by sitagliptin: 25% (25 prescriptions).100% prescriptions were complete for each prescription content attribute. The molecular pharmacotherapeutic response mechanisms were significantly efficacious. All the patients were satisfied with each anti-diabetic medical healthcare attribute. Conclusions: The patient endocrinological pharmacotherapeutic compliance was significantly high. Metformin was most commonly prescribed, followed by sitagliptin. The prescription content analyses showed 100% completeness, with significant pharmacotherapeutic molecular efficacy. There was ample anti-diabetic medical healthcare satisfaction

A systematic review on metformin rational pharmacotherapeutics

This systematic review of the different and wide-ranged studies on metformin rational pharmacotherapeutics was performed, for a better comprehension of multi-centre maintenance of rational pharmacotherapeutic aspects in the regular anti-diabetic treatment prescribed to the new type II diabetic patients. This systematic review contributed 3729 refined and relevant medical records, among total 4570 records obtained from the study databases search, thus providing a refined qualitatively synthesised conclusive medical research study literature, on metformin rational pharmacotherapeutics

A pharmacoepidemiological study of prescription patterns of β2 sympathomimetic bronchodilators in exacerbation of non-severe asthma in tertiary care hospitals, not needing hospitalization

Background: Arformoterol, the (R, R) enantiomer of the racemic (R, R / S, S) diastereomer, formoterol, is a short and long acting β2 agonist bronchodilator. Levosalbutamol, the (R, R) enantiomer of racemic diastereomer (R, R / S, S) salbutamol, has a greater affinity for the β2 receptor. Occupation of β2 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

A comparative study on the pharmacovigilance scoring of causality assessment grading and staging of topical pharmacotherapy of ofloxacin 0.3% ophthalmic solution in bacterial conjunctivitis and ofloxacin 0.3% otic solution in otitis externa

Background: Topical pharmacotherapeutic modalities would minimalize systemic adverse effects. Ofloxacin, the bactericidal racemic mixture, has inhibitory effects on DNA gyrase, DNA topoisomerase IV and IL-1α, IL-6, and IL-8. This was a comparative study for pharmacovigilance scoring of causality assessment grading and staging of topical ofloxacin pharmacotherapy in bacterial conjunctivitis and otitis externa.Methods: Group A=50 bacterial conjunctivitis patients were prescribed topical ophthalmic 0.3% ofloxacin, 2 drops in each eye after every 3 hours for 2 days, and 2 drops in each eye after every 6 hours for next 5 days; and group B=50 otitis externa patients were prescribed topical otic 0.3% ofloxacin, 3 drops in each ear after every 6 hours for first 2 days, and 5 drops in each ear after every 12 hours for next 5 days. Comparative adverse drug reactions occurrence, like transient ocular burning or discomfort, ocular irritation, redness, stinging, pruritis, photophobia, ocular watering and dryness in group A, and pruritis, headache, dizziness, mild ear pain, rashes, and hypersensitivity reactions in group B, were analysed with adverse event case report forms, on days 0, 3, 5, 7, 10, 15, 30, and on follow-ups, with causality assessment scores, from adverse drug reactions grading and staging.Results: The occurrence of adverse effects were statistically non-significant, in both groups, with causality assessment scoring for group A: -11, none on average=Unlikely causality, and group B: -11, none on average= Unlikely causality.Conclusions: Topical ofloxacin therapy in group A and group B patients, were safe and tolerable; with nil causality of association of adverse drug reactions.

A rational pharmacovigilance safety appraisal of topical pefloxacin 0.3% ophthalmological drops in bacterial conjunctivitis, in global multi-centre tertiary care hospitals

Background: Pefloxacin is a newer broad-spectrum bactericidal fluoroquinolone antibiotic, with superior antibacterial activity in vivo against pathogenic ocular gram-negative and anaerobic microorganisms and better pharmacokinetic properties. The objective of this clinical research study was the rational pharmacovigilance safety appraisal of topical pefloxacin 0.3% ophthalmological drops in bacterial conjunctivitis, in global multi-centre tertiary care hospitals.Methods: The 43 bacterial conjunctivitis patients were prescribed topical pefloxacin 0.3% ophthalmological drops, 2 drops in each eye after every 3 hours for 2 days, and 2 drops in each eye after every 6 hours for next 5 days. The pharmacovigilance safety appraisal was performed by monitoring the occurrence of adverse drug reactions, like, transient ocular burning or discomfort, ocular irritation, redness, stinging, pruritis, photophobia, ocular watering and dryness, and recording in Adverse Event Case Report Forms, on days 0, 3, 5, 7, 10, 15, 30, and on further follow-ups.Results: In this study, the safety assessment showed that only 1 patient had ocular discomfort in the eye. The occurrence of adverse effects was statistically non-significant. Thus, 0.3% pefloxacin ophthalmological drops treatment was safe and tolerable, among all 43 patients.Conclusions: Therefore, pefloxacin is a safe ocular antibiotic for treating bacterial conjunctivitis, with adequate drug tolerability exhibited by the patients