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1.
Eur Heart J ; 31(4): 480-8, 2010 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-20097702

RESUMEN

AIMS: Co-primary objectives were to evaluate dalcetrapib (JTT-705/RO4607381), which targets cholesteryl ester transfer protein (CETP), effects on high-density lipoprotein cholesterol (HDL-C) in participants with coronary heart disease or risk equivalents and to evaluate potential changes in mesenteric lymph nodes. METHODS AND RESULTS: Double-blind trial with participants randomized (2:1) to dalcetrapib 900 mg/day (higher than 600 mg phase III dose) or placebo, both with atorvastatin, for 24 weeks (n = 135; one without post-baseline efficacy data was excluded from intent-to-treat population); a subset continued for 24-week extension (n = 77). Lipid changes and safety parameters were assessed. Mesenteric lymph nodes were evaluated by magnetic resonance imaging. Dalcetrapib increased HDL-C (33.4%, Week 24; 33.8%, Week 48), decreased CETP activity (-53.5%, Week 24; -56.5%, Week 48), and increased apolipoprotein A-I (11.4%, Week 24; 16.4%, Week 48). Dalcetrapib showed no clinically relevant differences vs. placebo in adverse events, laboratory parameters including aldosterone, electrocardiograms, and vital signs including blood pressure (BP). Dalcetrapib had no measurable, clinically relevant effect on lymph node size. CONCLUSION: Dalcetrapib 900 mg administered for up to 48 weeks showed no clinically relevant changes in lymph nodes, BP, or other safety parameters. Dalcetrapib effectively increased HDL-C over 48 weeks of treatment.


Asunto(s)
Anticolesterolemiantes/administración & dosificación , Proteínas de Transferencia de Ésteres de Colesterol/antagonistas & inhibidores , Enfermedad Coronaria/tratamiento farmacológico , Compuestos de Sulfhidrilo/administración & dosificación , Adolescente , Adulto , Anciano , Amidas , Anticolesterolemiantes/efectos adversos , HDL-Colesterol/metabolismo , Enfermedad Coronaria/sangre , Método Doble Ciego , Esquema de Medicación , Ésteres , Femenino , Humanos , Enfermedades Linfáticas/inducido químicamente , Masculino , Mesenterio , Persona de Mediana Edad , Compuestos de Sulfhidrilo/efectos adversos , Resultado del Tratamiento , Adulto Joven
2.
Clin Drug Investig ; 30(1): 51-61, 2010.
Artículo en Inglés | MEDLINE | ID: mdl-19995098

RESUMEN

BACKGROUND AND OBJECTIVES: Long-term (>1 year) safety and efficacy studies of combination lipid therapy are lacking. This year 2 study evaluated fenofibric acid 135 mg in combination with moderate-dose statin (rosuvastatin 20 mg, simvastatin 40 mg or atorvastatin 40 mg) in patients with mixed dyslipidaemia. METHODS: This was a phase 3, open-label, year 2 extension study in patients who had completed one of three double-blind, 12-week, controlled studies and the subsequent open-label, year 1 extension study. Patients in this study had mixed dyslipidaemia (high-density lipoprotein cholesterol [HDL-C] <40 mg/dL [<1.02 mmol/L] for men or <50 mg/dL [<1.28 mmol/L] for women, triglycerides [TG] > or =150 mg/dL [> or =1.69 mmol/L], and low-density lipoprotein cholesterol [LDL-C] > or =130 mg/dL [> or =3.37 mmol/L]) at the start of the controlled study, and had completed the year 1 extension study. Treatment was once-daily oral coadministration of fenofibric acid 135 mg and moderate-dose statin (rosuvastatin 20 mg, simvastatin 40 mg or atorvastatin 40 mg), and was identical to the treatment received in the year 1 study. The year 2 population safety data were summarized for the entire duration of fenofibric acid + statin therapy. Efficacy data were summarized by combination therapy group, as well as pooled across combination therapies, and summarized across the controlled and open-label studies. RESULTS: Of the 310 patients enrolled into the year 2 study, 287 (93%) completed therapy. The mean cumulative exposure to combination therapy was 743 days across the studies. Adverse event rates were similar for all three combination therapy groups. No deaths or treatment-related serious adverse events occurred. The incidence of discontinuation due to adverse events was 2.9% overall. Rhabdomyolysis was not reported in any group. Overall, fenofibric acid + moderate-dose statin for > or =2 years resulted in sustained improvements in HDL-C (+17.4%), TG (-46.4%) and LDL-C (-40.4%). CONCLUSIONS: This long-term study demonstrated that fenofibric acid + moderate-dose statin was generally well tolerated with no new or unexpected safety concerns, and resulted in comprehensive and sustained lipid improvements in patients with mixed dyslipidaemia.


Asunto(s)
Dislipidemias/tratamiento farmacológico , Fenofibrato/análogos & derivados , Inhibidores de Hidroximetilglutaril-CoA Reductasas/administración & dosificación , Adulto , Anciano , Atorvastatina , HDL-Colesterol/sangre , VLDL-Colesterol/sangre , Método Doble Ciego , Quimioterapia Combinada , Dislipidemias/sangre , Femenino , Fenofibrato/administración & dosificación , Fluorobencenos/administración & dosificación , Ácidos Heptanoicos/administración & dosificación , Humanos , Masculino , Persona de Mediana Edad , Pirimidinas/administración & dosificación , Pirroles/administración & dosificación , Rosuvastatina Cálcica , Simvastatina/administración & dosificación , Sulfonamidas/administración & dosificación
3.
PLoS One ; 13(5): e0196900, 2018.
Artículo en Inglés | MEDLINE | ID: mdl-29795579

RESUMEN

Epidemiological transitions are occurring throughout Africa. To inform public health programs and policies, longitudinal cohorts investigating non-communicable diseases are needed. However, loss-to-follow up is a major problem. In preparation for a longitudinal study, we conducted a randomized controlled trial to test communication-based retention strategies (message content and delivery methods) among a pilot cohort of South African healthcare workers (n = 1536; median age = 36; women = 1270). Two messaging formats across three delivery modes were tested. Response rates were analyzed by intervention, survey return date and method using chi-square tests and univariate logistic regression. Sixty-seven of 238 (17.4%) control group participants and 238 of 1152 (24.6%) intervention group participants were retained (OR 1.54: CI 1.15-2.07; P = 0.004). Odds of being retained were 1.68 times greater for participants who received regular contact and themed messages compared to control (CI 1.22-2.32; P = 0.001). Neither health status nor clinical condition affected response rates (P>0.05). Time-to-first contact did not impact response rates (P>0.05). Message content and delivery method influenced response rates compared to the control, however no difference was found between intervention groups. Although greater retention is required for valid cohort studies, these findings are the first to quantitatively assess retention factors in Africa.


Asunto(s)
Cooperación del Paciente/estadística & datos numéricos , Selección de Paciente , Encuestas y Cuestionarios , Envío de Mensajes de Texto/estadística & datos numéricos , Adulto , Femenino , Personal de Salud , Estado de Salud , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Cooperación del Paciente/psicología , Prohibitinas , Sudáfrica
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