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1.
N Engl J Med ; 380(25): 2429-2439, 2019 06 20.
Artículo en Inglés | MEDLINE | ID: mdl-30883050

RESUMEN

BACKGROUND: The prevalence of hypertension among black African patients is high, and these patients usually need two or more medications for blood-pressure control. However, the most effective two-drug combination that is currently available for blood-pressure control in these patients has not been established. METHODS: In this randomized, single-blind, three-group trial conducted in six countries in sub-Saharan Africa, we randomly assigned 728 black patients with uncontrolled hypertension (≥140/90 mm Hg while the patient was not being treated or was taking only one antihypertensive drug) to receive a daily regimen of 5 mg of amlodipine plus 12.5 mg of hydrochlorothiazide, 5 mg of amlodipine plus 4 mg of perindopril, or 4 mg of perindopril plus 12.5 mg of hydrochlorothiazide for 2 months. Doses were then doubled (10 and 25 mg, 10 and 8 mg, and 8 and 25 mg, respectively) for an additional 4 months. The primary end point was the change in the 24-hour ambulatory systolic blood pressure between baseline and 6 months. RESULTS: The mean age of the patients was 51 years, and 63% were women. Among the 621 patients who underwent 24-hour blood-pressure monitoring at baseline and at 6 months, those receiving amlodipine plus hydrochlorothiazide and those receiving amlodipine plus perindopril had a lower 24-hour ambulatory systolic blood pressure than those receiving perindopril plus hydrochlorothiazide (between-group difference in the change from baseline, -3.14 mm Hg; 95% confidence interval [CI], -5.90 to -0.38; P = 0.03; and -3.00 mm Hg; 95% CI, -5.8 to -0.20; P = 0.04, respectively). The difference between the group receiving amlodipine plus hydrochlorothiazide and the group receiving amlodipine plus perindopril was -0.14 mm Hg (95% CI, -2.90 to 2.61; P=0.92). Similar differential effects on office and ambulatory diastolic blood pressures, along with blood-pressure control and response rates, were apparent among the three groups. CONCLUSIONS: These findings suggest that in black patients in sub-Saharan Africa, amlodipine plus either hydrochlorothiazide or perindopril was more effective than perindopril plus hydrochlorothiazide at lowering blood pressure at 6 months. (Funded by GlaxoSmithKline Africa Noncommunicable Disease Open Lab; CREOLE ClinicalTrials.gov number, NCT02742467.).


Asunto(s)
Amlodipino/administración & dosificación , Antihipertensivos/administración & dosificación , Hidroclorotiazida/administración & dosificación , Hipertensión/tratamiento farmacológico , Perindopril/administración & dosificación , Adulto , África del Sur del Sahara , Anciano , Amlodipino/efectos adversos , Antihipertensivos/efectos adversos , Población Negra , Presión Sanguínea/efectos de los fármacos , Combinación de Medicamentos , Quimioterapia Combinada , Femenino , Humanos , Hidroclorotiazida/efectos adversos , Hipertensión/etnología , Modelos Logísticos , Masculino , Persona de Mediana Edad , Perindopril/efectos adversos , Método Simple Ciego
2.
Support Care Cancer ; 27(7): 2591-2598, 2019 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-30456720

RESUMEN

PURPOSE: Breast cancer is the most frequently diagnosed cancer and leading cause of cancer death among women, representing a considerable public health burden in South Africa and other low-middle income countries. Short- and long-term complications of these treatments include shoulder morbidities such as pain, decreased range of motion, tightness, weakness, pain, numbness and lymphoedema and may be present for up to 6 years post-treatment. An understanding of baseline demographic and clinical risk factors can guide rehabilitation and management strategies for high-risk patients. The aims of this study were to quantify the burden of shoulder pain and disability in a tertiary academic hospital in Cape Town, South Africa, and identify potential risk factors for the development of shoulder morbidity. METHODS: This study was a cross-sectional analysis of the prevalence of shoulder pain and dysfunction in women attending their post-treatment annual follow-up visit for unilateral breast carcinoma. RESULTS: Three in four patients reported a presence of any pain or disability while only 9% experienced severe pain and disability. Multivariable ordinal logistic regression analysis identified race, side, axillary surgery, chemotherapy and age as significant predictors of pain and chemotherapy a significant predictor of disability. CONCLUSION: The substantial burden of shoulder morbidity in this population represents a significant public health burden. The use of identified clinical and demographic characteristics may guide in the development of survivorship programmes incorporating surveillance and management of these high-risk patients.


Asunto(s)
Neoplasias de la Mama/epidemiología , Neoplasias de la Mama/cirugía , Dolor de Hombro/epidemiología , Adulto , Anciano , Anciano de 80 o más Años , Axila/patología , Linfedema del Cáncer de Mama/epidemiología , Linfedema del Cáncer de Mama/fisiopatología , Neoplasias de la Mama/fisiopatología , Estudios Transversales , Femenino , Humanos , Persona de Mediana Edad , Morbilidad , Prevalencia , Hombro/fisiopatología , Dolor de Hombro/etiología , Dolor de Hombro/fisiopatología , Sudáfrica/epidemiología
3.
Am Heart J ; 202: 5-12, 2018 08.
Artículo en Inglés | MEDLINE | ID: mdl-29800784

RESUMEN

BACKGROUND: Current hypertension guidelines recommend the use of combination therapy as first-line treatment or early in the management of hypertensive patients. Although there are many possible combinations of blood pressure(BP)-lowering therapies, the best combination for the black population is still a subject of debate because no large randomized controlled trials have been conducted in this group to compare the efficacy of different combination therapies to address this issue. METHODS: The comparison of 3 combination therapies in lowering BP in the black Africans (CREOLE) study is a randomized single-blind trial that will compare the efficacy of amlodipine plus hydrochlorothiazide versus amlodipine plus perindopril and versus perindopril plus hydrochlorothiazide in blacks residing in sub-Saharan Africa (SSA). Seven hundred two patients aged 30-79 years with a sitting systolic BP of 140 mm Hg and above, and less than 160 mm Hg on antihypertensive monotherapy, or sitting systolic BP of 150 mm Hg and above, and less than 180 mm Hg on no treatment, will be centrally randomized into any of the 3 arms (234 into each arm). The CREOLE study is taking place in 10 sites in SSA, and the primary outcome measure is change in ambulatory systolic BP from baseline to 6 months. The first patient was randomized in June 2017, and the trial will be concluded by 2019. CONCLUSIONS: The CREOLE trial will provide unique information as to the most efficacious 2-drug combination in blacks residing in SSA and thereby inform the development of clinical guidelines for the treatment of hypertension in this subregion.


Asunto(s)
Amlodipino/uso terapéutico , Antihipertensivos/uso terapéutico , Población Negra , Hidroclorotiazida/uso terapéutico , Hipertensión/tratamiento farmacológico , Hipertensión/etnología , Perindopril/uso terapéutico , Adulto , África del Sur del Sahara , Anciano , Combinación de Medicamentos , Quimioterapia Combinada , Femenino , Humanos , Masculino , Persona de Mediana Edad , Proyectos de Investigación , Método Simple Ciego
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