Physicochemical equivalence of generic antihypertensive medicines (EQUIMEDS): protocol for a quality of medicines assessment.

BACKGROUND: Prevention and optimal management of hypertension in the general population is paramount to the achievement of the World Heart Federation (WHF) goal of reducing premature cardiovascular disease (CVD) mortality by 25% by the year 2025 and widespread access to good quality antihypertensive medicines is a critical component for achieving the goal. Despite research and evidence relating to other medicines such as antimalarials and antibiotics, there is very little known about the quality of generic antihypertensive medicines in low-income and middle-income countries. The aim of this study was to determine the physicochemical equivalence (percentage of active pharmaceutical ingredient, API) of generic antihypertensive medicines available in the retail market of a developing country. METHODS: An observational design will be adopted, which includes literature search, landscape assessment, collection and analysis of medicine samples. To determine physicochemical equivalence, a multistage sampling process will be used, including (1) identification of the 2 most commonly prescribed classes of antihypertensive medicines prescribed in Nigeria; (2) identification of a random sample of 10 generics from within each of the 2 most commonly prescribed classes; (3) a geographical representative sampling process to identify a random sample of 24 retail outlets in Nigeria; (4) representative sample purchasing, processing to assess the quality of medicines, storage and transport; and (5) assessment of the physical and chemical equivalence of the collected samples compared to the API in the relevant class. In total, 20 samples from each of 24 pharmacies will be tested (total of 480 samples). DISCUSSION: Availability of and access to quality antihypertensive medicines globally is therefore a vital strategy needed to achieve the WHF 25×25 targets. However, there is currently a scarcity of knowledge about the quality of antihypertensive medicines available in developing countries. Such information is important for enforcing and for ensuring the quality of antihypertensive medicines

Prevalence and determinants of obesity - a cross-sectional study of an adult Northern Nigerian population

<p>Abstract</p> <p>Background</p> <p>Obesity is assuming an epidemic dimension globally. It is important to appreciate factors associated with the disease so that a holistic approach can be taken in tackling the rising burden. The objective of this study was to determine the prevalence of overweight and obesity and the factors independently associated with obesity in an urban Nigerian population.</p> <p>Methods</p> <p>A cross-sectional study of 300 healthy adult subjects was conducted in the urban city of Katsina, northern Nigeria. Relevant sociodemographic and clinical information were obtained. Screening for obesity was done using the Body Mass Index while relevant laboratory investigations were conducted. Univariate and multivariate logistic regression analyses were performed to determine the predictors of obesity.</p> <p>Results</p> <p>Overweight and obesity was found in 53.3% and 21.0% respectively with a significantly higher prevalence in females compared to males (overweight: 62.0% vs 41.9%, p < 0.001; obesity: 29.8% vs 9.3%, p < 0.001). In univariate analysis, the odds of obesity were higher in women and in the presence of hypertension, hypercholesterolaemia and hyperuricaemia. However, in multivariate analysis, factors independently associated with obesity were female sex (OR 6.119, 95% CI 2.705-13.842, p < 0.001), hypercholesterolaemia (OR 2.138, 95% CI 1.109-4.119, p = 0.023) and hyperuricaemia (OR 2.906, 95% CI 1.444-5.847, p = 0.003).</p> <p>Conclusion</p> <p>There is a high prevalence of obesity in northern Nigeria and women are significantly more affected. The high prevalence is independently associated with female sex, hypercholesterolaemia and hyperuricaemia. Public health education is urgently needed in order to reduce this burden and prevent other non-communicable cardiovascular disorders.</p

Gender differences in clinical characteristics and outcome of acute heart failure in sub-Saharan Africa: results of the THESUS-HF study

Background: The impact of gender on the clinical characteristics, risk factors, co-morbidities, etiology, treatment and outcome of acute heart failure in sub-Saharan Africa has not been described before. The aim of this study was to evaluate the sex diffe rences in acute heart failure in sub-Saharan Africa using the data from The sub-Saharan Africa Survey of Heart Failure (THESUS-HF). Methods and results: 1,006 subjects were recruited into this prospective multicenter, international observational heart failure survey. The mean age of total population was 52.4 years (54.0 years for men and 50.7 years for women). The men were significantly older (p = 0.0045). Men also presented in poorer NYHA functional class (III and IV), p = 0.0364). Cigarette smoking and high blood pressure were significantly commoner in men (17.3 vs. 2.6 % and 60.0 vs. 51.0 % respectively). On the other hand, atrial fibrillation and valvular heart disease were significantly more frequent in women. The mean hemoglobin concentration was lower in women compared to men (11.7 vs. 12.6 g/dl, p ≤ 0.0001), while the blood urea and creatinine levels were higher in men (p \u3c 0.0001). LV systolic dysfunctional was also seen more in men. Men also had higher E/A ratio indicating higher LV filling pressure. Outcomes were similar in both sexes. Conclusions: Although the outcome of patients admitted for AHF in sub-Saharan regions is similar in men and women, some gender differences are apparent suggesting that in men more emphasis should be put on modifiable life risk factors, while in women prevention of rheumatic heart diseases and improved nutrition should be addressed vigorously

Modifiable cardiovascular risk factors among apparently healthy adult Nigerian population - a cross sectional study

<p>Abstract</p> <p>Background</p> <p>Cardiovascular disease (CVD) remains a major cause of morbidity and a leading contributor to mortality worldwide. Over the next 2 decades, it is projected that there will be a rise in CVD mortality rates in the developing countries, linked to demographic changes and progressive urbanization. Nigeria has witnessed tremendous socio-economic changes and rural-urban migration which have led to the emergence of non-communicable diseases. We set out to determine the prevalence of modifiable CVD risk factors among apparently healthy adult Nigerians. This is a descriptive cross-sectional study carried out at Katsina, northwestern Nigeria from March to May 2006. Subjects for the study were recruited consecutively from local residents, hospital staff and relations of in-patients of the Federal Medical Centre, Katsina using convenience sampling. Socio-demographic information, anthropometric measurements and blood pressure were obtained from the subjects in a standardized manner. Venous samples were collected for necessary investigations and analyzed at the hospital central laboratory.</p> <p>Findings</p> <p>Three hundred subjects (129 males and 171 females) with a mean age of 37.6 ± 10.6 (range 18-75) years were studied. Prevalence of the modifiable cardiovascular risk factors screened for were as follows: generalized obesity 21.3% (males 10.9%, females 29.2%, p < 0.05), truncal obesity 43.7% (males 12.4%, females 67.3%, p < 0.05), hypertension 25.7% (males 27.9, females 24%, p > 0.05), type 2 diabetes mellitus 5.3% (males 5.4%, females 5.3%, p > 0.05), hypercholesterolaemia 28.3% (males 23.3%, females 32.2%, p < 0.05), elevated LDL-cholesterol 25.7% (males 28%, females 24%, p > 0.05), low HDL-cholesterol 59.3% (males 51.9%, females 65%, p < 0.05), hypertriglyceridaemia 15% (males 16.3%, females 14%, p > 0.05) and metabolic syndrome 22% (males 10.9%, females 30.4%, p < 0.05).</p> <p>Conclusions</p> <p>We found high prevalence of CVD risk factors among apparently healthy adult Nigerians. In order to reduce this high prevalence and prevent subsequent cardiovascular events, encouragement of a healthy lifestyle is suggested.</p

Search for the standard model Higgs boson in the H to ZZ to 2l 2nu channel in pp collisions at sqrt(s) = 7 TeV

A search for the standard model Higgs boson in the H to ZZ to 2l 2nu decay channel, where l = e or mu, in pp collisions at a center-of-mass energy of 7 TeV is presented. The data were collected at the LHC, with the CMS detector, and correspond to an integrated luminosity of 4.6 inverse femtobarns. No significant excess is observed above the background expectation, and upper limits are set on the Higgs boson production cross section. The presence of the standard model Higgs boson with a mass in the 270-440 GeV range is excluded at 95% confidence level.Comment: Submitted to JHE

Combined search for the quarks of a sequential fourth generation

Results are presented from a search for a fourth generation of quarks produced singly or in pairs in a data set corresponding to an integrated luminosity of 5 inverse femtobarns recorded by the CMS experiment at the LHC in 2011. A novel strategy has been developed for a combined search for quarks of the up and down type in decay channels with at least one isolated muon or electron. Limits on the mass of the fourth-generation quarks and the relevant Cabibbo-Kobayashi-Maskawa matrix elements are derived in the context of a simple extension of the standard model with a sequential fourth generation of fermions. The existence of mass-degenerate fourth-generation quarks with masses below 685 GeV is excluded at 95% confidence level for minimal off-diagonal mixing between the third- and the fourth-generation quarks. With a mass difference of 25 GeV between the quark masses, the obtained limit on the masses of the fourth-generation quarks shifts by about +/- 20 GeV. These results significantly reduce the allowed parameter space for a fourth generation of fermions.Comment: Replaced with published version. Added journal reference and DO

Clinical Outcomes in 3343 Children and Adults with Rheumatic Heart Disease from 14 Low and Middle Income Countries: 2-Year Follow-up of the Global Rheumatic Heart Disease Registry (the REMEDY study)

Background: There are few contemporary data on the mortality and morbidity associated with rheumatic heart disease or information on their predictors. We report the 2-year follow-up of individuals with rheumatic heart disease from 14 low- and middle-income countries in Africa and Asia. Methods: Between January 2010 and November 2012, we enrolled 3343 patients from 25 centers in 14 countries and followed them for 2 years to assess mortality, congestive heart failure, stroke or transient ischemic attack, recurrent acute rheumatic fever, and infective endocarditis. Results: Vital status at 24 months was known for 2960 (88.5%) patients. Two-thirds were female. Although patients were young (median age, 28 years; interquartile range, 18–40), the 2-year case fatality rate was high (500 deaths, 16.9%). Mortality rate was 116.3/1000 patient-years in the first year and 65.4/1000 patient-years in the second year. Median age at death was 28.7 years. Independent predictors of death were severe valve disease (hazard ratio [HR], 2.36; 95% confidence interval [CI], 1.80–3.11), congestive heart failure (HR, 2.16; 95% CI, 1.70–2.72), New York Heart Association functional class III/IV (HR, 1.67; 95% CI, 1.32–2.10), atrial fibrillation (HR, 1.40; 95% CI, 1.10–1.78), and older age (HR, 1.02; 95% CI, 1.01–1.02 per year increase) at enrollment. Postprimary education (HR, 0.67; 95% CI, 0.54–0.85) and female sex (HR, 0.65; 95% CI, 0.52–0.80) were associated with lower risk of death. Two hundred and four (6.9%) patients had new congestive heart failure (incidence, 38.42/1000 patient-years), 46 (1.6%) had a stroke or transient ischemic attack (8.45/1000 patient-years), 19 (0.6%) had recurrent acute rheumatic fever (3.49/1000 patient-years), and 20 (0.7%) had infective endocarditis (3.65/1000 patient-years). Previous stroke and older age were independent predictors of stroke/transient ischemic attack or systemic embolism. Patients from low- and lower-middle–income countries had significantly higher age- and sex-adjusted mortality than patients from upper-middle–income countries. Valve surgery was significantly more common in upper-middle–income than in lower-middle– or low-income countries. Conclusions: Patients with clinical rheumatic heart disease have high mortality and morbidity despite being young; those from low- and lower-middle–income countries had a poorer prognosis associated with advanced disease and low education. Programs focused on early detection and the treatment of clinical rheumatic heart disease are required to improve outcomes. </jats:sec

Performance of CMS muon reconstruction in pp collision events at sqrt(s) = 7 TeV

The performance of muon reconstruction, identification, and triggering in CMS has been studied using 40 inverse picobarns of data collected in pp collisions at sqrt(s) = 7 TeV at the LHC in 2010. A few benchmark sets of selection criteria covering a wide range of physics analysis needs have been examined. For all considered selections, the efficiency to reconstruct and identify a muon with a transverse momentum pT larger than a few GeV is above 95% over the whole region of pseudorapidity covered by the CMS muon system, abs(eta) < 2.4, while the probability to misidentify a hadron as a muon is well below 1%. The efficiency to trigger on single muons with pT above a few GeV is higher than 90% over the full eta range, and typically substantially better. The overall momentum scale is measured to a precision of 0.2% with muons from Z decays. The transverse momentum resolution varies from 1% to 6% depending on pseudorapidity for muons with pT below 100 GeV and, using cosmic rays, it is shown to be better than 10% in the central region up to pT = 1 TeV. Observed distributions of all quantities are well reproduced by the Monte Carlo simulation.Comment: Replaced with published version. Added journal reference and DO

Performance of CMS muon reconstruction in pp collision events at sqrt(s) = 7 TeV

The performance of muon reconstruction, identification, and triggering in CMS has been studied using 40 inverse picobarns of data collected in pp collisions at sqrt(s) = 7 TeV at the LHC in 2010. A few benchmark sets of selection criteria covering a wide range of physics analysis needs have been examined. For all considered selections, the efficiency to reconstruct and identify a muon with a transverse momentum pT larger than a few GeV is above 95% over the whole region of pseudorapidity covered by the CMS muon system, abs(eta) < 2.4, while the probability to misidentify a hadron as a muon is well below 1%. The efficiency to trigger on single muons with pT above a few GeV is higher than 90% over the full eta range, and typically substantially better. The overall momentum scale is measured to a precision of 0.2% with muons from Z decays. The transverse momentum resolution varies from 1% to 6% depending on pseudorapidity for muons with pT below 100 GeV and, using cosmic rays, it is shown to be better than 10% in the central region up to pT = 1 TeV. Observed distributions of all quantities are well reproduced by the Monte Carlo simulation.Comment: Replaced with published version. Added journal reference and DO