Current Issue : January - March Volume : 2016 Issue Number : 1 Articles : 8 Articles
Background\nAchieving adequate antimalarial drug exposure is essential for curing malaria. Day 7 blood or plasma lumefantrine concentrations provide a simple measure of drug exposure that correlates well with artemether-lumefantrine efficacy. However, the ââ?¬Ë?therapeuticââ?¬â?¢ day 7 lumefantrine concentration threshold needs to be defined better, particularly for important patient and parasite sub-populations.\n\nMethods\nThe WorldWide Antimalarial Resistance Network (WWARN) conducted a large pooled analysis of individual pharmacokinetic-pharmacodynamic data from patients treated with artemether-lumefantrine for uncomplicated Plasmodium falciparum malaria, to define therapeutic day 7 lumefantrine concentrations and identify patient factors that substantially alter these concentrations. A systematic review of PubMed, Embase, Google Scholar, ClinicalTrials.gov and conference proceedings identified all relevant studies. Risk of bias in individual studies was evaluated based on study design, methodology and missing data.\n\nResults\nOf 31 studies identified through a systematic review, 26 studies were shared with WWARN and 21 studies with 2,787 patients were included. Recrudescence was associated with low day 7 lumefantrine concentrations (HR 1.59 (95 % CI 1.36 to 1.85) per halving of day 7 concentrations) and high baseline parasitemia (HR 1.87 (95 % CI 1.22 to 2.87) per 10-fold increase). Adjusted for mg/kg dose, day 7 concentrations were lowest in very young children (<3 years), among whom underweight-for-age children had 23 % (95 % CI âË?â??1 to 41 %) lower concentrations than adequately nourished children of the same age and 53 % (95 % CI 37 to 65 %) lower concentrations than adults. Day 7 lumefantrine concentrations were 44 % (95 % CI 38 to 49 %) lower following unsupervised treatment. The highest risk of recrudescence was observed in areas of emerging artemisinin resistance and very low transmission intensity. For all other populations studied, day 7 concentrations ââ?°Â¥200 ng/ml were associated with >98 % cure rates (if parasitemia <135,000/Ã?¼L).\n\nConclusions\nCurrent artemether-lumefantrine dosing recommendations achieve day 7 lumefantrine concentrations ââ?°Â¥200 ng/ml and high cure rates in most uncomplicated malaria patients. Three groups are at increased risk of treatment failure: very young children (particularly those underweight-for-age); patients with high parasitemias; and patients in very low transmission intensity areas with emerging parasite resistance. In these groups, adherence and treatment response should be monitored closely. Higher, more frequent, or prolonged dosage regimens should now be evaluated in very young children, particularly if malnourished, and in patients with hyperparasitemia....
Cardiovascular disorders have become leading drivers of untimely deaths almost everywhere. Such deaths are however declining globally due to effective interventions. Low dose aspirin contributes to this reduction when used appropriately through minimization of the risk of coronary heart disease and other occlusive atherosclerotic syndromes that can complicate type 2 diabetes/or hypertension. One local study published in 2004 indicated that aspirin was prescribed for 33% of patients with type 2 diabetes. Since then, aspirin prescription, as part of standard therapy for type 2 diabetes/or hypertension, has risen steadily with some studies reporting this to be 66%-88%; These figures more than double those reported in jurisdictions overseas where occlusive atherosclerotic disorders commonly complicate type 2 diabetes and/or hypertension. Even so, recent transnational data show that cardiovascular deaths linked to type 2 diabetes and or hypertension are not abating in sub-Saharan Africa as in many other regions. This can suggest that interventions in black Africa, if any, maybe less than effective in comparison to areas where health outcomes are improving. Significantly, type 2 diabetes and/or hypertension can behave differently in many black groups within Africa such that occlusive atherosclerotic disorders are less common health consequences even with rising cholesterol levels. In the case of Nigeria, the evidence of cardiovascular health benefits of aspirin, as extensively described in groups overseas, appears hard to find for local cohorts. Indeed what the available data strongly suggest is that effective control of blood pressure is a higher treatment priority for saving Nigerian lives than interventions aimed at retarding the atherosclerotic process. Given these observations, the question ought to be asked whether or not low dose aspirin in type 2 diabetes/hypertension therapies, as locally practiced, is the best way of optimizing limited resources in saving Nigerian lives. This paper examines the evidence....
India is facing the double burden of communicable and non-communicable diseases (NCDs), there is need to prevent NCDs. Women in their post-menopausal phase become vulnerable to NCDs. Objective of this study was to assess the nutritional status of pre and post menopausal women residing in Banasthali University campus area of Rajasthan state, India. The present community based study was conducted among 30 women; 15 each in pre and post menopausal phase selected from a total of 72 and 56, respectively. Body Mass Index (BMI) and Waist Hip Ratio (WHR) were determined. Serum Triglycerides (TG), High Density Lipoprotein cholesterol (HDL-C), Total cholesterol (TC) and Low Density Lipoprotein Cholesterol (LDL-C), Blood hemoglobin (Hb) and Serum iron levels were estimated along with Red cell Glutathione (RBC-GSH) and serum Thiobarbituric acid (TBARS) – the markers of oxidative stress. Energy, protein and fat intake of women were calculated using 24 hour dietary recall method. BMI and WHR showed statistically significant difference between pre and post menopausal women. No significant inter group difference was found in serum TG and HDL-C levels, whereas TC, LDL-C, hemoglobin, serum iron, Red Cell GSH and TBARS levels showed significant inter group difference in the pre and post menopausal women. Postmenopausal women seemed to have a higher risk of NCDs as per biochemical pointers of lipid, iron and oxidative stress status being significantly higher in post menopausal women vis-a-vis pre menopausal ones....
This article reviews ethical issues of consent for genetic research in relation to Latin American bio-banking practices and collaborative research projects with developed countries. There is need for ethical legal safeguards for informed consent procedures so that Bio-banks, bio-specimens and data will be used in accordance with Latin American cultural needs. The issue of national regulations for bio-banking in Latin America may help to clarify what can be done in the field of international and national research respecting subject donations....
Ensuring good participant adherence in clinical trials plays an important role in that poor adherence may jeopardize the internal\nvalidity of the trial. Improving adherence in clinical trials on traditional Chinese medicine (TCM) has long been a concern for\nChinese researchers who are conducting clinical trials. Drawing on from our past experiences in managing patient adherence in\nlarge-scale clinical trials, we identified factors that influence adherence and categorized them by sources into factors with respect\nto the trial protocol, on the part of the patients and the investigators. On this basis, we developed a series of ways to improve\nparticipants� adherence, while taking into account the characteristics of TCM trials, in the hope of providing reference for peer\nclinical researchers....
Introduction: Patients undergoing craniotomy for tumor resection often experience moderate to severe postoperative pain. Intravenous acetaminophen has been proposed as an analgesic adjunct to potentially decrease opioid requirements and incidence of nausea in these patients allowing for prompt postoperative neurological evaluations. At this time, however, there is no evidence to show that acetaminophen reduces patient pain or opioid consumption after craniotomy.\n\nMethods: A retrospective analysis of 81 patients undergoing craniotomy was done to evaluate the effect of IV acetaminophen (APAP) administration on reported pain scores, opioid usage, time in the post-anesthesia care unit (PACU), and incidence of nausea within the first 24 hours.\n\nResults: No significant differences in patient reported pain scores, opioid consumption within the first 24 hours, anti-emetic use, or time in PACU were found in patients who received intravenous acetaminophen compared to those who received opioids alone.\n\nDiscussion: Our investigation represents the first evidence looking for an effect of acetaminophen on post craniotomy pain and nausea. There are randomized and blinded trials currently in progress that will add to our knowledge on this topic. Acetaminophen is a relatively safe intervention. However, until those randomized trials are completed and reported, we cannot uniformly recommend the intraoperative administration of intravenous acetaminophen to patients undergoing craniotomy....
Introduction\nNerve growth factor plays a key role in the pathology of osteoarthritis (OA) related chronic pain. The aim of these studies was to evaluate the safety, tolerability, pharmacokinetics, and clinical response of AMG 403, a human anti-nerve growth factor monoclonal antibody, in healthy volunteers and subjects with knee OA.\n\nMethods\nTwo phase I, randomized, placebo-controlled, double-blind studies were conducted. The single-ascending dose study randomized healthy volunteers (n�=�48) 3:1 to receive AMG 403 (1, 3, 10, or 30 mg intravenously; or 10 or 30 mg subcutaneously; n�=�8 per group) or placebo. The multiple-ascending dose study randomized knee OA subjects (n�=�18) 3:1 to receive AMG 403 (3, 10, or 20 mg subcutaneously once monthly for four doses) or placebo. Safety, tolerability, and pharmacokinetics (PK) were assessed for both studies. Patient�s and physician�s disease assessments and total WOMAC score were determined in knee OA subjects.\n\nResults\nAMG 403 appeared to be well-tolerated after single and multiple doses, except for subject-reported hyperesthesia, pain, and paresthesia (mild to moderate severity). These treatment-emergent neurosensory events showed evidence of reversibility and a possible dose-dependence. Three serious adverse events were reported in AMG 403 treated subjects, but were not considered treatment related. AMG 403 PK was linear with an estimated half-life of 19.6 to 25.8 days. After multiple doses, AMG 403 PK showed modest accumulation (�2.4-fold increase) in systemic exposure. Knee OA diagnosis, body weight, and anti-drug antibody development did not appear to affect AMG 403 PK. Patient�s and physician�s disease assessments and total WOMAC score showed improvement in AMG 403 treated knee OA subjects compared with placebo.\n\nConclusions\nAMG 403 was generally safe and well-tolerated in both healthy volunteers and knee OA patients, and exhibited linear pharmacokinetics. Preliminary clinical efficacy was observed in knee OA subjects....
The adoption of the European Unionââ?¬â?¢s (EU) Cosmetics Regulationââ?¬â??which came into effect as of July 2013ââ?¬â??is significant because it was the first piece of legislation at the national or supranational level to include provisions relating specifically to the use of nanomaterials in any products. While the regulation does not change the fundamental aspects of the regulatory regime, which includes putting full responsibility for ensuring the safety of the cosmetic product on the manufacturer/importer, the provision of consumer labelling of nanomaterials suggests a shifting of responsibilities that is new for cosmetics within the EU market. Although this additional shifting of responsibilities is subtle, we argue that it is nonetheless problematic, given current uncertainties about what a ââ?¬Ë?nano labelââ?¬â?¢ actually means, in addition to doubts around the capacity to furnish the consumer with sufficient information to enable them to make a fully informed consumer choice. The aim of this article is to understand the challenge of distributing regulatory responsibilities for unknown or unquantified risks through the lens of the Cosmetics Regulation. We present and discuss data gathered in interviews with a small number of cosmetics stakeholdersincluding industry, representatives of government/regulatory agencies, NGOs/civil society and experts (in industry and dialogue)-as a means of illustrating various elements viewed by stakeholders as necessary to be able to take up responsibilities and identifying the constraining factors to doing so, i.e. regulatory challenges. The overarching aim of the article is to understand the implications of the distribution of responsibilities, as set out by the regulation, for enabling consumers to meaningfully differentiate between conventional cosmetic products and those containing nanomaterials....
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