ObjectivesInadequate glycemic control amongst patients with Type 2 diabetes mellitus (T2DM) indicates a major public health problem and a significant risk factor for the progression and complications caused by diabetes. Glycemic control is the main therapeutic objective for the prevention of organ damage and other complications arising from diabetes.MethodsThis was a retrospective observational study of T2DM patients with complications, who were aged 40 years and older. The study was conducted retrospectively on medical records (in-patient and out-patient) obtained from a South Indian teaching hospital, Manipal, India. The patients included in the study had fasting blood sugar, postprandial blood sugar and HbA1c measured at least twice during follow-ups the previous year. Patients’ HbA1c levels were categorized into good control ≤7% (≤53mmol/mol), and poor control >7% (>53mmol/mol), and patients’ characteristics were analyzed.ResultsA total of 657 patients were included in the study. The mean age was 59.67 (SD = 9.617) years, with 152 (23.1%) females and 505 (76.9%) males, and 514 (78.2%) patients had poor glycemic control. Most of the patients were on insulin mono-therapy [n = 271 (42.1%)], about a third of the patients were on combination therapy that included an oral hypoglycemic agent and insulin [n = 236 (36.6%)]. Patients with a history of more than 10 years of diabetes [n = 293 (44.6%)], had a family history of diabetes [n = 256 (39%)] and obesity [n = 95 (14.5%)], all had poor glycemic control.ConclusionThis present study indicated a significant association of gender (female), age, high-density lipoprotein level, duration of diabetes and type of medication, with poor glycemic control in T2DM patients that had secondary medical complications.
The present study is mainly aimed at delivering a drug into the brain via the intranasal route using a liposomal formulation. For this purpose, rivastigmine, which is used in the management of Alzheimer's disease, was selected as a model drug. Conventional liposomes were formulated by the lipid layer hydration method using cholesterol and soya lecithin as lipid components. The concentration of rivastigmine in brain and plasma after intranasal liposomes, free drug and per oral administration was studied in rat models. A significantly higher level of drug was found in the brain with intranasal liposomes of rivastigmine compared to the intranasal free drug and the oral route. Intranasal liposomes had a longer half-life in the brain than intranasally or orally administered free drug. Delivering rivastigmine liposomes through the intranasal route for the treatment of Alzheimer's disease might be a new approach to the management of this condition.
In India, very few reports on the cost of adverse drug reactions (ADRs) are available. There is a need to study this aspect of health care in order to understand the economic burden imposed by ADRs. The aim of the current work was to study the costs associated with documented ADRs in a tertiary care teaching hospital. This study was conducted in medical wards of a south Indian tertiary care teaching hospital over a 6-month period. The study protocol was assessed and approved by the institutional ethics committee. A total of 317 ADRs from 246 patients were identified during the study period. The present study used an intensive monitoring method to detect ADRs and assessed an incidence of 32.7% adverse reactions in the monitored group. The causality, severity, predictability, and preventability of the documented ADRs were assessed. The total cost to the hospital due to ADRs was found to be Rs. 1,567,397 (US$36 451). The average cost per patient hospitalized with an ADR was Rs. 4,945 (US$115). The cost per reaction was found to be higher in the Indian context, as the per capita annual expenditure on health in this country is around US$109.
The overall user opinion of content and legibility of the leaflets was good. Pictogram-based patient information leaflets can be considered an effective educational tool for HD patients.
Our findings suggest that the UGT1A6 (552A>C) genetic polymorphism plays a significant role in the steady state concentration of valproic acid, and it thereby has an impact on the toxicity of the valproic acid used in the patients with epilepsy.
Rifampin (RF) is metabolized in the liver into an active metabolite 25-desacetylrifampin and excreted almost equally via biliary and renal routes. Various influx and efflux transporters influence RF disposition during hepatic uptake and biliary excretion. Evidence has also shown that Vitamin D deficiency (VDD) and Vitamin D receptor (VDR) polymorphisms are associated with tuberculosis (TB). Hence, genetic polymorphisms of metabolizing enzymes, drug transporters and/or their transcriptional regulators and VDR and its pathway regulators may affect the pharmacokinetics of RF. In this narrative review, we aim to identify literature that has explored the influence of single nucleotide polymorphisms (SNPs) of genes encoding drug transporters and their transcriptional regulators (SLCO1B1, ABCB1, PXR and CAR), metabolizing enzymes (CES1, CES2 and AADAC) and VDR and its pathway regulators (VDR, CYP27B1 and CYP24A1) on plasma RF concentrations in TB patients on antitubercular therapy. Available reports to date have shown that there is a lack of any association of ABCB1, PXR, CAR, CES1 and AADAC genetic variants with plasma concentrations of RF. Further evidence is required from a more comprehensive exploration of the association of SLCO1B1, CES2 and Vitamin D pathway gene variants with RF pharmacokinetics in distinct ethnic groups and a larger population to reach conclusive information.
The objective of our study was to evaluate the effect of adherence patterns on the sample size and power of a clinical trial. Simulations from a population pharmacokinetic/pharmacodynamic (PK/PD) model linked to an adherence model were used. Four types of drug characteristics, such as long (~35 hours) and short (~12 hours) half‐life in combination with earlier or delayed time to reach steady‐state PD end points were studied. Adherence patterns were simulated using Markov chains. Our results clearly demonstrate the significant impact of varying levels and patterns of nonadherence on the sample size and power of a study. For drugs with short half‐lives the evidence to support efficacy could be diluted by various patterns of nonadherence that would make its efficacy indistinguishable from the response to placebo. Prospectively utilizing clinical trial simulations with thorough incorporation of various adherence patterns would provide valuable information when designing a trial.
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