Medical Research Council of South Africa

KwaZulu Natal, South Africa

Medical Research Council of South Africa

KwaZulu Natal, South Africa

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Sliwa K.,University of Cape Town | Sliwa K.,University of Witwatersrand | Sliwa K.,Medical Research Council of South Africa | Gersh B.J.,Rochester College | And 2 more authors.
Circulation | Year: 2016

Africa is a continent characterized by marked ethnic, sociodemographic, and economic diversity, with profound changes in many regions over the past 2 decades. This diversity has an impact on cardiovascular disease presentation and outcomes. Within Africa and within the individual countries, one can find regions having predominantly communicable diseases such as rheumatic heart disease, tuberculous pericarditis, or cardiomyopathy and others having a marked increase in noncommunicable disease such as hypertension and hypertensive heart disease. Ischemic heart disease remains rare in most countries. Difficulties in the planning and implementation of effective health care in most African countries are compounded by a paucity of studies and a low rate of investment in research and data acquisition. The fiduciary responsibilities of companies working in Africa should include the effective and efficient use of natural resources to promote the overall health of populations. © 2016 American Heart Association, Inc.


Cuchel M.,University of Pennsylvania | Meagher E.A.,University of Pennsylvania | Theron H.D.T.,Netcare Private Hospital | Blom D.J.,University of Cape Town | And 16 more authors.
The Lancet | Year: 2013

Background Patients with homozygous familial hypercholesterolaemia respond inadequately to existing drugs. We aimed to assess the effi cacy and safety of the microsomal triglyceride transfer protein inhibitor lomitapide in adults with this disease. Methods We did a single-arm, open-label, phase 3 study of lomitapide for treatment of patients with homozygous familial hypercholesterolemia. Current lipid lowering therapy was maintained from 6 weeks before baseline through to at least week 26. Lomitapide dose was escalated on the basis of safety and tolerability from 5 mg to a maximum of 60 mg a day. The primary endpoint was mean percent change in levels of LDL cholesterol from baseline to week 26, after which patients remained on lomitapide through to week 78 for safety assessment. Percent change from baseline to week 26 was assessed with a mixed linear model. Findings 29 men and women with homozygous familial hypercholesterolaemia, aged 18 years or older, were recruited from 11 centres in four countries (USA, Canada, South Africa, and Italy). 23 of 29 enrolled patients completed both the effi cacy phase (26 weeks) and the full study (78 weeks). The median dose of lomitapide was 40 mg a day. LDL cholesterol was reduced by 50% (95% CI -62 to -39) from baseline (mean 8·7 mmol/L [SD 2·9]) to week 26 (4·3 mmol/L [2·5]; p<0·0001). Levels of LDL cholesterol were lower than 2·6 mmol/L in eight patients at 26 weeks. Concentrations of LDL cholesterol remained reduced by 44% (95% CI -57 to -31; p<0·0001) at week 56 and 38% (-52 to -24; p<0·0001) at week 78. Gastrointestinal symptoms were the most common adverse event. Four patients had aminotransaminase levels of more than fi ve times the upper limit of normal, which resolved after dose reduction or temporary interruption of lomitapide. No patient permanently discontinued treatment because of liver abnormalities. Interpretation Our study suggests that treatment with lomitapide could be a valuable drug in the management of homozygous familial hypercholesterolaemia. Funding FDA Offi ce of the Orphan Product Development, Aegerion Pharmaceuticals.


Glenton C.,Sintef | Lewin S.,Norwegian Knowledge Center for the Health Services | Lewin S.,Medical Research Council of South Africa | Scheel I.B.,Sintef
Implementation Science | Year: 2011

Background: Qualitative research is used increasingly alongside trials of complex interventions to explore processes, contextual factors, or intervention characteristics that may have influenced trial outcomes. Qualitative research conducted alongside trials can also be used to shed light on the results of systematic reviews of effectiveness by looking for factors that can help explain heterogeneous results across trials. In a Cochrane review on the effects of using lay health workers on maternal and child health and infectious disease control, we identified 82 trials. These trials showed promising benefits but results were heterogeneous.Objective: To use qualitative studies conducted alongside these trials to explore factors and processes that might have influenced intervention outcomes.Methods: We attempted to identify qualitative research carried out alongside the trials by contacting trial authors, checking papers for references to qualitative research, searching Pubmed for related studies, and carrying out citation searches. For those qualitative studies that we included, we extracted information regarding study objective, data collection and analysis methods, and key themes and categories.Results: For 52 (63%) of the trials, we found no qualitative research that had been conducted alongside the trials. For 16 (20%) trials, some form of qualitative data collection had been done but was unavailable or had been done before the trial. For 14 (17%) trials, qualitative research had been done during or shortly after the trial, although descriptions of qualitative methods and results were often sparse. Most of these 14 studies aimed to elicit trial participants' perspectives and experiences of the intervention. A common theme was participants' appreciation of the lay health workers' shared circumstances, for instance with regard to social background or experience of the health condition. In six studies, researchers explored the experiences of the lay health workers themselves. Issues included the importance of regular supervision and health professionals' support or lack of support.Conclusions: Qualitative studies carried out alongside trials of complex interventions could offer opportunities to authors of systematic reviews of effectiveness wishing to understand the heterogeneity of trial results. For interventions of lay health worker programmes at least, too few such studies exist at present for these opportunities to be realised. © 2011 Glenton et al; licensee BioMed Central Ltd.


Cuchel M.,University of Pennsylvania | Blom D.J.,University of Cape Town | Blom D.J.,Medical Research Council of South Africa | Averna M.R.,University of Palermo
Atherosclerosis Supplements | Year: 2014

The microsomal triglyceride transfer protein (MTP) inhibitor lomitapide is a licenced adjunct to a low-fat diet and other lipid-lowering medication, with or without low-density lipoprotein apheresis, for the treatment of adults with homozygous familial hypercholesterolaemia (HoFH). In a recently published phase 3 study, patients with HoFH received lomitapide in addition to maximally tolerated lipid-lowering therapy. Treatment with lomitapide resulted in a mean approximate 50% reduction in LDL-C levels after 26 weeks compared with baseline levels (p<0.0001). This decrease in LDL-C was maintained at Weeks 56 and 78 (44% [p<0.0001] and 38% [p=0.0001], respectively). This paper offers clinical perspectives based on selected case histories of patients participating in the phase 3 lomitapide study. These cases provide illustrative examples of the efficacy of lomitapide, with or without apheresis, and show that the effective management of adverse effects can enable patients to remain on effective treatment. © 2014 Elsevier Ireland Ltd.


Potterton J.,University of Witwatersrand | Stewart A.,University of Witwatersrand | Cooper P.,University of Witwatersrand | Becker P.,Medical Research Council of South Africa
Developmental Medicine and Child Neurology | Year: 2010

Aims: The human immunodeficiency virus (HIV) potentially causes a significant encephalopathy and resultant developmental delay in infected children. The aim of this study was to determine whether a home-based intervention programme could have an impact on the neurodevelopmental status of children infected with HIV. Method: A longitudinal, randomized, controlled trial was conducted. A total of 122 children aged less than 2 years 6 months were assigned to either a comparison or an experimental group. Children in the experimental group were given a home stimulation programme that was updated every 3 months. The home programme included activities to promote motor, cognitive, and speech and language development. Children in the comparison group received no developmental intervention. Children were assessed by a blinded assessor at baseline, 6 months, and 12 months using the Bayley Scales of Infant Development, 2nd edition. Results: The children in this study came from poor socioeconomic backgrounds and their nutritional status was suboptimal. The experimental group included 60 children (30 males, 30 females) with a mean age of 18 months (SD 8.1mo). The comparison group included 62 children (32 males, 30 females) with a mean age 19 months (SD 8.2mo). Cognitive and motor development were severely affected at baseline, with 52% of the children having severe cognitive delay and 72% having severe motor delay at baseline. Children in the experimental group showed significantly greater improvement in cognitive (p=0.010) and motor (p=0.020) development over time than children in the comparison group. Interpretation: A home stimulation programme taught to the caregiver can significantly improve cognitive and motor development in young children infected with HIV. © The Authors. Journal compilation © Mac Keith Press 2009.


Patent
University of Witwatersrand and Medical Research Council Of South Africa | Date: 2011-07-15

This invention relates to biomaterials, said biomaterials for use in methods to control and/or induce bone growth. Particularly, the invention relates to macroporous calcium phosphate biomaterials pre-loaded with certain amounts of osteoclastic activity inhibitors for use in methods to control and/or induce bone growth in primates.


Patent
University of Witwatersrand and Medical Research Council Of South Africa | Date: 2015-08-19

An osteogenic device for use in a method of treating cancer in a mammal is provided. The osteogenic device comprises a carrier matrix, and an effective concentration of transforming growth factor beta 3 (TGF-3) of at least 5g per 100 mg of carrier matrix, the device being for implantation, preferably by injection directly into neoplastic primary and/or metastatic secondary masses, causing direct transformation of the neoplastic mass into bone thus facilitating its surgical debridement.


Patent
University of Witwatersrand and Medical Research Council Of South Africa | Date: 2013-03-18

This invention relates to biomaterials, said biomaterials for use in methods to control and/or induce bone growth. Particularly, the invention relates to macroporous calcium phosphate biomaterials pre-loaded with certain amounts of osteoclastic activity inhibitors for use in methods to control and/or induce bone growth in primates.


Loveday M.,Medical Research Council of South Africa | Zweigenthal V.,University of Cape Town
Tropical Medicine and International Health | Year: 2011

Objectives To identify key obstacles to operational integration of TB and HIV services and to suggest strategies to promote integration in the prevention, treatment and care of patients with TB and HIV. Methods This is a health systems research case study of operational integration of TB and HIV in South Africa. Peer-reviewed and grey literature together with the experiences of the authors were used to identify key obstacles to integration in service implementation practices and community-level care. Relevant legislation, policies and guidelines were analysed to determine whether they facilitated or undermined the integration of TB and HIV services. Results Obstacles to integration exist at contextual and epidemiological levels as well as at intervention design and implementation levels. Importantly, integration at an operational level is undermined by fundamentally different principles underpinning the design of TB and HIV programmes and national policies and legislation which mitigate against integration. Conclusion South Africa has an opportunity to effect changes that will facilitate TB/HIV integration and improve care for all those infected with TB, HIV or both conditions. An analytic approach necessary to understand the obstacles to and ensure effective strategies facilitating integration is required. This needs to be followed by mobilisation of clinical and health systems expertise, health infrastructure, commitment and experience in creative and appropriate ways for the variety of health care settings. © 2011 Blackwell Publishing Ltd.


Matzopoulos R.,University of Cape Town | Matzopoulos R.,Medical Research Council of South Africa | Myers J.E.,University of Cape Town
Aggression and Violent Behavior | Year: 2014

In August 2013, the Western Cape Government adopted an Integrated Provincial Violence Prevention Policy Framework initiated by the provincial Department of Health in response to the unusually high incidence of, and health burden arising from, interpersonal violence. The policy framework encompasses a more comprehensive intersectoral approach to the prevention of violence than the traditional criminal justice and security-centred approach typically promoted in South Africa as the conventional wisdom. It aims to bring coherence and clarity to the government's objectives in the field of violence prevention by way of a whole-of-government approach encompassing all sectors. The Policy Framework attempts to balance short-term evidence-based interventions, such as reducing the availability and harmful use of alcohol, with longer term interventions that require the state and all citizens to take active responsibility in addressing more holistically the complex social norms that support violence. It is consonant with a "whole-of-society" approach current in the South African polity to policy formulation and implementation, and is underpinned by the public health-centred guidelines set out by the international Global Campaign for the Prevention of Violence. The policy framework supports evidence-based approaches for violence prevention and a review and consultation process aimed at aligning existing performance priorities and deliverables across departments. One year after its adoption we review the uptake of this policy and reflect on some of its early successes as well as barriers to its implementation. We identify early resistance arising from its conflict with intra-departmental priorities, the impact of competing policies and directives, and we propose a research agenda to support its uptake. © 2014 Elsevier Ltd.

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