Browsing by Author "Burgess, L. J."
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- ItemClinical trial remuneration : the patients' perspective(Health and Medical Publishing Group (HMPG), 2008) Burgess, L. J.; Sulzer, N. U.; Emanuel, S.[No abstract available]
- ItemClinical trials in South Africa : need for capacity building and training(Health and Medical Publishing Group (HMPG), 2010) Burgess, L. J.; Sulzer, N. U.
- ItemCortical lens opacities in the young patient - an indication for a lipogram?(Health & Medical Publishing Group, 2001) Meyer, D.; Maritz, F. J.; Liebenberg, P. H.; Parkin, D. P.; Burgess, L. J.Aim. To determine the characteristics and prevalence of lenticular opacification in patients with underlying dyslipidaemia. Methods. Eighty patients of both genders and all ages (18 - 90 years) were enrolled in the trial if they met the inclusion criteria for dyslipidaemia. Patients were included if their fasting serum cholesterol and triglyceride concentrations were > 5.2 mmol/1 and > 2.3 mmol/1, respectively, when measured on three separate occasions over a 1-month period. Patients were excluded if they suffered from any condition known to cause or predispose them to elevated lipid levels or lenticular opacification. Lenticular changes were assessed by means of a slit-lamp through the fully dilated pupil and other physical signs were documented subsequent to thorough physical evaluation. Results. In addition to the classic clinic signs of dyslipidaemia, 31% of patients had cortical lens opacities. Cortical opacities were twice as prevalent as Achilles tendon thickening (16.3%) in our study, the second most prevalent sign of elevated lipid levels. In the subgroup of patients aged under 50 years, 55% had lenticular opacities, predominantly cortical (80%). Conclusions. Cortical lens opacification was the most prevalent sign of dyslipidaemia and it occurred at a relatively young age in our trial population in those patients who were affected. Cortical lenticular opacification should be regarded as an indication for blood lipid profile evaluation.
- ItemFDA abandons the declaration of Helsinki : the effect on the ethics of clinical trial conduct in South Africa and other developing countries(Health and Medical Publishing Group (HMPG), 2012-12) Burgess, L. J.; Pretorius, D.Four years ago, the US Food and Drug Administration (FDA) ceased compliance with the Declaration of Helsinki (DoH) (2000 revision and all subsequent revisions) for conduct of clinical trials outside its borders. It instead ruled that compliance with the Good Clinical Practices (GCP) of the International Conference of Harmonization (ICH) is sufficient. However, the ICH-GCP guidelines do not address certain ethical requirements stipulated in the DoH, such as the use of placebos v. standard therapy, post-trial access to treatment and other benefits for participants; public disclosure of trial design; publication of trial results; and disclosure of conflicts of interest. The FDA’s adoption of less morally stringent guidelines could encourage pharmaceutical companies to take ethical short cuts. It could also have practical consequences for trial ethics in developing countries, especially where research ethics committees may not be promoting high standards of protection for participants in clinical trials, due to lack of financial and human resources. Pharmaceutical companies may also pressurise research ethics committees to relax guidelines and legislation, in order to facilitate future clinical trials in developing and emerging countries that lack the resources to conduct their own clinical research on epidemics such as HIV/ AIDS, which have devastating effects on their populations.
- ItemGCP accreditation - a worthwhile investment(Health & Medical Publishing Group, 2006) Burgess, L. J.; Sulzer, N. U.[No abstract available]
- ItemLP (a) levels and apo (a) phenotypes in urban black South African men(Health & Medical Publishing Group, 1998) Carstens, M. E.; Burgess, L. J.; Taljaard, J. J. F.Objective. To investigate the lipoprotein (a) (Lp (a)) levels and apolipoprotein (a) (apo (a)) phenotypes in a group of urban black South African men. Design. Cross-sectional design. Setting. Lead acid battery plant, East London, Eastern Cape. Participants. Blood samples from a study on the association between lead and renal failure were kindly donated for the present study and 111 of the donors participated (K Steyn - personal communication). Outcome measures. Lp (a) levels and apo (a) phenotypes. Results. Three groups were identified: those with normal (< 300 U/l), intermediate (300-700 U/l) and high (> 700 U/l) plasma Lp (a) concentrations. Nine apo (a) phenotypes and 26 combinations thereof could be discerned. Apart from the single- and double-band phenotypes described before, triple-band phenotypes were also present. As the Lp (a) values increased, the relative frequency of the single-band phenotype decreased, whereas the relative frequency of the double-band phenotype increased. The relative frequency of the triple-band phenotype was highest in the group with high Lp (a) concentrations. No correlation was evident between the size of the apo (a) isoforms and the Lp (a) concentrations. Conclusions. Raised plasma Lp (a) levels have been associated with coronary heart disease (CHD). In addition, it has been proposed that the apo (a) gene determined plasma Lp (a) concentrations. These studies were performed using plasma from white subjects. CHD is uncommon in black South Africans. The reason may be that, given the lack of relationship between the size of the apo (a) isoforms and the Lp (a) concentrations observed in the present study, factors other than the isoform size may determine the Lp (a) levels in this particular ethnic group.
- ItemPatients’ motivations for participating in cardiovascular clinical trials : a local perspective(Clinics Cardiv Publishing, 2009-08) Burgess, L. J.; Sulzer, N. U.; Hoosain, F.; Leverton, N.; Bliganut, S.; Emanuel, S.Objective: To investigate patients’ motivations for participating in cardiovascular clinical trials. Methods: Patients attending TREAD Research, located within Tygerberg Hospital, Parow, Western Cape, between January 2005 and May 2006 were approached to participate in the study. Consenting patients were given a validated questionnaire to complete in their home language. All questionnaires were anonymous and 250 consecutive patients completed the questionnaire. They provided basic demographic data and rated their response to 18 statements concerning factors that may or may not have influenced their decision to participate in a clinical trial. Results: The mean (± SD) age of subjects was 56.3 ± 10.9 years. A large percentage of the respondents were unemployed (66.5%). Access to medical care was a motivation for the majority of patients (90.5%). Ninety-six per cent of patients appreciated the regular follow up they received as trial participants; 90% of patients entered the trial to receive medication, which they could otherwise not afford. A substantial 98% of patients participated to learn more about their disease. Almost all (99%) wanted to further the scientific understanding of their condition. A reassuring 94% of subjects felt that they were not pressurised into the study; 80% of patients disagreed that participation in clinical trials was an easy way to obtain money. Conclusions: Access to medical care and making a contribution to scientific knowledge are two of the most common motivations for participation in cardiovascular clinical trials. The role of remuneration is relatively unimportant.
- ItemRandomized, placebo-controlled trial of mipomersen in patients with severe hypercholesterolemia receiving maximally tolerated lipid-lowering therapy(PLoS, 2012-11-13) McGowan, M. P.; Tardif, J. C.; Ceska, R.; Burgess, L. J.; Soran, H.; Gouni-Berthold, I.; Wagener, G.; Chasan-Taber, S.Objectives: Mipomersen, an antisense oligonucleotide targeting apolipoprotein B synthesis, significantly reduces LDL-C and other atherogenic lipoproteins in familial hypercholesterolemia when added to ongoing maximally tolerated lipid-lowering therapy. Safety and efficacy of mipomersen in patients with severe hypercholesterolemia was evaluated. Methods and Results: Randomized, double-blind, placebo-controlled, multicenter trial. Patients (n = 58) were $18 years with LDL-C $7.8 mmol/L or LDL-C $5.1 mmol/L plus CHD disease, on maximally tolerated lipid-lowering therapy that excluded apheresis. Weekly subcutaneous injections of mipomersen 200 mg (n = 39) or placebo (n = 19) were added to lipid-lowering therapy for 26 weeks. Main outcome: percent reduction in LDL-C from baseline to 2 weeks after the last dose of treatment. Mipomersen (n = 27) reduced LDL-C by 36%, from a baseline of 7.2 mmol/L, for a mean absolute reduction of 2.6 mmol/L. Conversely, mean LDL-C increased 13% in placebo (n = 18) from a baseline of 6.5 mmol/L (mipomersen vs placebo p,0.001). Mipomersen produced statistically significant (p,0.001) reductions in apolipoprotein B and lipoprotein(a), with no change in high-density lipoprotein cholesterol. Mild-to-moderate injection site reactions were the most frequently reported adverse events with mipomersen. Mild-to-moderate flu-like symptoms were reported more often with mipomersen. Alanine transaminase increase, aspartate transaminase increase, and hepatic steatosis occurred in 21%, 13% and 13% of mipomersen treated patients, respectively. Adverse events by category for the placebo and mipomersen groups respectively were: total adverse events, 16(84.2%), 39(100%); serious adverse events, 0(0%), 6(15.4%); discontinuations due to adverse events, 1(5.3%), 8(20.5%) and cardiac adverse events, 1(5.3%), 5(12.8%). Conclusion: Mipomersen significantly reduced LDL-C, apolipoprotein B, total cholesterol and non-HDL-cholesterol, and lipoprotein(a). Mounting evidence suggests it may be a potential pharmacologic option for lowering LDL-C in patients with severe hypercholesterolemia not adequately controlled using existing therapies. Future studies will explore alternative dosing schedules aimed at minimizing side effects.
- ItemA rapid screening test for pleural exudates(Health and Medical Publishing Group (HMPG), 1999-01) Burgess, L. J.; Taljaard, J. J. F.; Maritz, F. J.