Translational pharmacology: role and its impact

Translational Pharmacology is a newly evolved branch as an extension of clinical pharmacology. Translational Pharmacology aims to move the results of the molecular pharmacological research to the patient level, which is focussed on developing the new drug that correlates with the patient needs. The basic objective is to study the changing trends from experimental to clinical pharmacology. It also helps to gather data from the preclinical studies, so as to have accurate and effective dosing in the critical clinical trials. Thus, we can conclude that Translational Pharmacology tries to bridge the gap between the basic molecular research studies in pharmacology to the clinical trials. This also reduces the time and economic burden on research. Thus, it helps in translating the knowledge from the basic animal studies to the bedside patient studies

A study on management of type 2 diabetic patients with complications

Background: Diabetes is a major public health problem both in developing and non-developing countries across the world. It is a chronic disease, which in long term causes several complications resulting in poly pharmacy for its management. Hence, this study was determined to analyze the drug utilization pattern for the management of type 2 diabetes with complications.Methods: A prospective, observational and non-interventional study was carried out in 100 diabetic patients with one or other complications admitted in medicine wards at Dhiraj Hospital. Patients who signed informed consent form were only included in the study. All the data were recorded from patients’ case files and analyzed.Results: Result of total 100 patients, maximum number 52 (52%) were falling in group of 61-70 kg and only 2 (2%) in 81-90 kg. Out of 100 diabetic patients, 40 (40%) were managed with insulin in addition to oral antidiabetic agents, 37 (37%) were managed with only Oral Hypoglycemic Agents (OHA) and 23 (23%) were managed with only insulin. The most commonly prescribed oral antidiabetic group of drug was Biguanides in 60 (60%) and most prescribed insulin was short acting Insulin in 40 (40%) patients.Conclusions: The diabetic patients are more prone to cardiovascular and other complications leading to a co morbid condition. The poly pharmacy is likely to occur in diabetic patients suffering with secondary complications. Therefore, intense blood sugar control with proper education can prevent the co morbid state and finally helps in reducing the economic burden

A study on management of hypertension in patients with type 2 diabetes mellitus in tertiary care teaching rural hospital

Background: This study was aimed to analyze the drug utilization pattern in the management of hypertension in diabetic patients.Methods: A prospective, observational and non interventional study was conducted in 100 diabetic hypertensive patients admitted in medicine wards at Dhiraj Hospital. Patients who signed informed consent form were only included in the study. All the data were recorded from patients’ case files and analyzed.Results: Of enrolled 100 patients, 69 (69%) were male and 31 (31%) were female and maximum number of the patients (42%) were found in the age group of 51-60 years. Out of 100 admitted patients, 75% patients were treated with single antihypertensive agent, 20% were treated with combination of two antihypertensive agents while only 5% were administered more than two antihypertensive agents. As a single antihypertensive agent, most commonly prescribed was ACE inhibitors (32%), Calcium Channel Blockers (23%), Angiotensin Receptor Blockers (12%) and β1 blockers (8%).Conclusions: There was poor awareness among the patients regarding control of hypertension, regular follow up, medication adherence etc. However, two third of diabetic patients had achieved blood pressure target control and ACE inhibitor remained first choice of drug for hypertension in diabetes in this study

Biologics and biosimilars: role in modern pharmacotherapy and importance of pharmacovigilance

Biologics are highly sensitive large molecules with complex structure, difficult to characterize and reproduce, derived from living cells; used for treatment, diagnosis or prevention of disease. Examples are therapeutic hormones, vaccines, monoclonal antibodies etc. Biologicals are beneficial in the management of several health conditions which were once upon a time difficult to manage like cancer, multiple sclerosis, Alzheimer’s disease, rheumatoid arthritis, diabetes etc. Biosimilars are proteins that are similar to innovator biologics but not the same as they differ slightly in structure however with no clinically significant difference. Biosimilars are not the exact replicas of originator biologic and are therefore not generics. Biosimilars for their approval are not required to undergo intense clinical trials as innovator biologic but are required to produce data that demonstrates its similarity to an original biologic in terms of clinical efficacy and safety. However, manufactures of both the biologics and biosimilars are required to submit pharmacovigilance and risk management plans as part of their application. Marketing authorization for biosimilars was for the first time framed by EMA along with the guidelines for developing them. As biologics and biosimilars are derived proteins they have immunogenic potential and risk of adverse events which cautions their use. Pharmacovigilance is needed to ensure that adverse events are quickly detected, reported and attributed to the correct product and manufacturer. Regulations are implemented to improve identification and traceability of biologics. Automatic substitution should not be permitted for biologicals.

Counterfeit drugs in India: significance and impact on pharmacovigilance

Counterfeit drugs have emerged as a major global problem. This issue has been brought to the centre of the Indian media due to the death of 15 women attending a sterilization camp in Chhattisgarh. India’s pharmaceutical industry exports drugs worth 15 billion dollars, which means a high prevalence of counterfeiting in India’s drug industry has global repercussions. However, accurate figures on the extent of counterfeit drugs in India are not available. The scientific literature as well as media reports often quotes figures of 10-35%, though studies done by the Indian Government dispute this. Counterfeit drug numbers have been known to be under represented by Governments due to fear of undermining their economy and health systems. On the other hand, rival companies in other countries may have an incentive to over hype India’s counterfeit problem to dent India’s growing status as the leading global supplier of generic medicines. Lack of clear definitions and differences between laws of countries further complicate reporting. A high prevalence of counterfeit drugs has a large impact on both health and economic indicators. Additionally, counterfeit drugs provide significant challenges to Pharmacovigilance programmes. Hence, here we discuss the significance of use of counterfeit drugs in India and challenges faced by Pharmacovigilance due to the extensive use of counterfeit drugs

Translational pharmacology: role and its impact

Translational Pharmacology is a newly evolved branch as an extension of clinical pharmacology. Translational Pharmacology aims to move the results of the molecular pharmacological research to the patient level, which is focussed on developing the new drug that correlates with the patient needs. The basic objective is to study the changing trends from experimental to clinical pharmacology. It also helps to gather data from the preclinical studies, so as to have accurate and effective dosing in the critical clinical trials. Thus, we can conclude that Translational Pharmacology tries to bridge the gap between the basic molecular research studies in pharmacology to the clinical trials. This also reduces the time and economic burden on research. Thus, it helps in translating the knowledge from the basic animal studies to the bedside patient studies

Pharmacological Overview for Therapy of Gout and Hyperuricemia

Hyperuricemia & gout are disease conditions marked by over production and reduced excretion of uric acid. These conditions are linked with unhealthy lifestyle, Hypertension, Diabetes Mellitus, Metabolic syndrome, Cardiovascular & Chronic renal disease. Thus controlling & monitoring uric acid level becomes important. Development in the technology have led to greater insights into the pathophysiology of gout & hyperuricemia. Now we have a better understanding of involvement of interleukin 1β in inflammatory process of gout. Thus with better understanding newer therapeutic targets are being explored for treatment of gout & hyperuricemia. The armamentarium of drugs being used in therapy of acute gout here been expanded with recent addition by interleukin-1 inhibitors especially for refractory patients and patients with comorbidities.  As these new therapies are evolving we need to focus on improving the use of Allopurinol through patient education and training of physicians in order to minimize development of Allopurinol hypersensitivity syndrome (AHS). Further pretesting of Human leukocyte Antigen- B ( HLA-B*5801*) should be considered in Asian population. Febuxostat being critically new drug needs cautious approach, proper education of patients and Adverse Drug Reaction (ADR) reporting. With entry of Pegloticase there is a new class of drug added for treating hyperuricemia.&nbsp