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1.
Medicine (Baltimore) ; 98(51): e18471, 2019 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-31861026

RESUMEN

This study aimed to compare the Hamilton anxiety rating/Hamilton depression rating (HAMA/HAMD) scale scores and blood pressure (BP) goal achievement associated with the use of valsartan-amlodipine single-pill combinations (SPCs) versus valsartan and amlodipine combination in adult hypertensive patients.A total of 476 hypertensive patients were randomly assigned into the SPC (valsartan-amlodipine) and control (valsartan and amlodipine combination) groups. All patients had an uncontrolled BP (160-179/100-109 mm Hg). BP goal was <140/90 mm Hg. Cox proportional hazards regression analysis was used to analyze the likelihood of HAMA/HAMD scales, SPCs, control group, and daily dosage number. Kaplan-Meier analysis was used to estimate the rates of BP goal achievement over time among the 2 groups.A total of 476 patients were included in the study, and 439 patients completed the follow-up and received the index drug therapy. There was a significant difference in BP between the 2 groups on days 28, 42, and 56. Patients who received SPCs had a significantly higher rate of BP goal achievement over time (P = .000). The average HAMD scores in the SPC and control groups were 5.54 and 5.49 and 6.06 and 6.21 on days 28 and 56, respectively. The average HAMA scores in the SPC and control groups were 7.41 and 7.13 and 7.90 and 8.01 on days 28 and 56, respectively. The means of HAMD and HAMA scores were 5.826 and 7.614, respectively. The higher the HAMA/HAMD scores, the lower was the BP goal achievement. The number of drugs taken by the patients was associated with the HAMA and HAMD scores. There was no significant difference between HAMA scores of patients taking 1 tablet daily (7.22 ±â€Š1.885) and those taking two-tablets daily (7.38 ±â€Š1.953) (P = .408). However, when these scores were compared to those of patients taking 4 tablets daily (8.08 ±â€Š2.285), a significant difference was observed (P = .000, P = .000).Hypertensive patients treated with valsartan-amlodipine SPCs were significantly more likely to achieve BP goal and have lesser HAMA/HAMD scores compared to patients treated with valsartan and amlodipine combination.


Asunto(s)
Combinación Amlodipino y Valsartán/uso terapéutico , Antihipertensivos/administración & dosificación , Ansiedad/prevención & control , Depresión/prevención & control , Hipertensión/tratamiento farmacológico , Combinación Amlodipino y Valsartán/farmacología , Presión Sanguínea/efectos de los fármacos , Femenino , Humanos , Hipertensión/psicología , Masculino , Persona de Mediana Edad , Estudios Retrospectivos
2.
Medicine (Baltimore) ; 98(26): e16264, 2019 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-31261595

RESUMEN

BACKGROUND: Clinical researchers found that Amlodipine besylate and Valsartan (ABVS) can effectively treat mild to moderate hypertension (MMH). However, no study has systematically investigated its efficacy and safety for patients with MMH. Thus, present study will systematically assess the efficacy and safety of ABVS for patients with MMH. METHODS: MEDICINE, Cochrane Library, EMBASE, Ovid, PsycINFO, Web of Science, Allied and Complementary Medicine Database, and China National Knowledge Infrastructure will be searched for literatures related to the topic from inception to the present without language limitations. All randomized controlled trials that assess the efficacy and safety of ABVS for patients with MMH will be considered for inclusion. Two researchers will independently select study, extract data, and assess risk of bias for all eligible studies. RESULTS: The primary outcome includes the change of seated diastolic blood pressure. The secondary outcomes consist of the change of seated systolic blood pressure, health-related quality of life, and the tolerability. CONCLUSIONS: The results of this study will summarize the latest evidence on ABVS for the treatment of MMH. ETHICS AND DISSEMINATION: This study does not need ethical approval, because it will not use individual data. The results of this study are expected to be published at peer-reviewed journals. PROSPERO REGISTRATION NUMBER: PROSPERO CRD42019133123.


Asunto(s)
Combinación Amlodipino y Valsartán/uso terapéutico , Antihipertensivos/uso terapéutico , Hipertensión/tratamiento farmacológico , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de Investigación , Índice de Severidad de la Enfermedad , Revisiones Sistemáticas como Asunto
3.
High Blood Press Cardiovasc Prev ; 25(4): 407-413, 2018 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-30390203

RESUMEN

INTRODUCTION: Although hypertensive drugs may have the same effect on peripheral blood pressure, they vary in their effect on central blood pressure and its indices. AIM: To evaluate efficacy of fixed-dose combination of amlodipine 10 mg/valsartan 160 mg versus nebivolol 5 mg/valsartan 160 mg in grade 2 or more hypertensive patients assessed by peripheral and central blood pressure. METHODS: A prospective, open label, randomized study done in the outpatient cardiology clinic at Beni-Suef University Hospital. A total of 137 patients continued the study; group I (n = 75) received Amlodipine 10 mg/Valsartan 160 mg (A/V) and group II (n = 62) received Nebivolol 5 mg/Valsartan 160 mg (N/V). Peripheral, central blood pressure and its indices were measured at baseline, after 6 and 12 weeks. RESULTS: The two combinations reduced peripheral and central BP (P < 0.0001) after 6 and 12 weeks. A/V combination significantly reduces central Pulse Pressure (PP) after 6 and 12 weeks (- 8.53 ± 13.80 and - 10.17 ± 11.29 (P < 0.0001) respectively), while N/V showed its efficacy in reducing central PP after 12 weeks (- 7.03 ± 13.10, P = 0.005). A/V combination was more effective in reducing Pulse Wave Velocity (PWV) after 6 and 12 weeks; P < 0.0001 vs P = 0.004. After 6 weeks, N/V was more effective in reducing Augmentation Index (AIx) (- 6.00 ± 10.94 (P = 0.002) vs. - 3.44 ± 9.80 (P = 0.026)) while after 12 weeks A/V did not show any significance (P = 0.085). CONCLUSIONS: Both treatment groups lowered patients' peripheral, central blood pressure after 6 and 12 week of treatment, but Amlodipine/Valsartan combination was more effective. Both treatments exerted different effects on central indices.


Asunto(s)
Combinación Amlodipino y Valsartán/uso terapéutico , Antihipertensivos/uso terapéutico , Presión Sanguínea/efectos de los fármacos , Hipertensión/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , Combinación Amlodipino y Valsartán/efectos adversos , Antihipertensivos/efectos adversos , Egipto , Femenino , Humanos , Hipertensión/diagnóstico , Hipertensión/fisiopatología , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Factores de Tiempo , Resultado del Tratamiento
4.
Medicine (Baltimore) ; 96(26): e7172, 2017 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-28658108

RESUMEN

High blood pressure (BP) is a major risk factor associated with stroke in China. This is a subanalysis of patients from the China Status II study, aimed to evaluate the effectiveness and safety of valsartan/amlodipine (Val/Aml) single-pill combination (SPC) in hypertensive patients with different stroke subtypes (hemorrhagic, ischemic, or mixed).China Status II was a multicenter, postmarketing, prospective observational study in hypertensive patients uncontrolled on monotherapy. The study was an 8-week open-label treatment period with 2 4-week follow-ups. Change in BP from baseline to weeks 4 and 8, BP control rate, and response rate at weeks 4 and 8, and safety of 8-week treatment with Val/Aml (80/5 mg) were assessed.A total of 565 hypertensive patients with different types of stroke were analyzed in this China Status II substudy. Significant mean sitting systolic/diastolic BP (MSSBP/MSDBP) reductions from baseline to week 8 were observed across all stroke subtypes (P < .0001). At week 8, percentages of patients achieving MSSBP response (≥20 mm Hg reduction from baseline) were 76.3%, 74.4%, and 85.7%, MSDBP response (≥10 mm Hg reduction from baseline) were 67.8%, 65.9%, and 64.3%, and BP control (<140/90 mm Hg) were 74.6%, 80.5%, and 92.9%, in the hemorrhagic, ischemic, and mixed stroke subgroups, respectively. Adverse events (AEs) and serious AEs were reported in 5 patients (1%) and 1 patient (0.2%), respectively, in the ischemic stroke subgroup, while no AEs were reported in hemorrhagic and mixed stroke subgroups.Val/Aml SPC was effective in hypertensive patients with different stroke subtypes and was well tolerated.


Asunto(s)
Combinación Amlodipino y Valsartán/uso terapéutico , Antihipertensivos/uso terapéutico , Hipertensión/complicaciones , Hipertensión/tratamiento farmacológico , Accidente Cerebrovascular/complicaciones , Anciano , Combinación Amlodipino y Valsartán/efectos adversos , Antihipertensivos/efectos adversos , Presión Sanguínea/efectos de los fármacos , China , Comorbilidad , Femenino , Estudios de Seguimiento , Humanos , Masculino , Estudios Prospectivos , Accidente Cerebrovascular/tratamiento farmacológico , Resultado del Tratamiento
6.
J Cardiovasc Pharmacol ; 66(5): 497-503, 2015 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-26248276

RESUMEN

Obesity is a major global health concern and is associated with hypertension. However, there is a lack of studies evaluating the effectiveness of valsartan/amlodipine single-pill combination in Chinese hypertensive patients with excess body weight uncontrolled by monotherapy. To evaluate this effectiveness and its association with obese categories, we performed a prespecified subanalysis and a post hoc analysis of patients from China status II study. In this subanalysis, 11,289 and 11,182 patients stratified by body mass index (BMI) and waist circumference (WC), respectively, were included. Significant mean sitting systolic and diastolic blood pressure (BP) reductions from baseline were observed at week 8 across all BMI and WC subgroups (P < 0.001). The percentages of patients achieving BP control were 65.2%, 62.8%, and 64.5% (men 64.5% and women 64.4%) in the overweight, obesity, and abdominal obesity subgroups, respectively. The positive association between BP control and obese categories could only be found in subgroups stratified by BMI other than WC. Our study demonstrated the effectiveness of valsartan/amlodipine single-pill combination in Chinese hypertensive patients with excess body weight uncontrolled by monotherapy, and its effectiveness was better associated with BMI than WC.


Asunto(s)
Combinación Amlodipino y Valsartán/uso terapéutico , Bloqueadores del Receptor Tipo 1 de Angiotensina II/uso terapéutico , Antihipertensivos/uso terapéutico , Presión Sanguínea/efectos de los fármacos , Bloqueadores de los Canales de Calcio/uso terapéutico , Hipertensión/tratamiento farmacológico , Sobrepeso/complicaciones , Adolescente , Adulto , Anciano , Combinación Amlodipino y Valsartán/efectos adversos , Bloqueadores del Receptor Tipo 1 de Angiotensina II/efectos adversos , Índice de Masa Corporal , Bloqueadores de los Canales de Calcio/efectos adversos , China , Femenino , Humanos , Hipertensión/complicaciones , Hipertensión/diagnóstico , Hipertensión/fisiopatología , Masculino , Persona de Mediana Edad , Sobrepeso/diagnóstico , Sobrepeso/fisiopatología , Estudios Prospectivos , Factores de Tiempo , Resultado del Tratamiento , Circunferencia de la Cintura , Adulto Joven
9.
J Hypertens ; 33(2): 401-11, 2015 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-25380149

RESUMEN

OBJECTIVES: An international double-blind, parallel-group, randomized controlled trial was performed to determine the efficacy and safety of a new first-line strategy in mild to moderate hypertension based on a single-pill combination of perindopril/amlodipine versus a validated stepped-care strategy (initiation with valsartan monotherapy, up-titrating to valsartan/amlodipine after 2 months). METHODS: At inclusion, patients received perindopril/amlodipine 3.5/2.5 mg or valsartan 80 mg. At 1, 2, and 3 months, patients were up-titrated if they had uncontrolled hypertension (≥140/90 mmHg). The up-titration steps were: perindopril/amlodipine 7/5 mg, 14/10 mg, and 14/10 mg + indapamide sustained release 1.5 mg; or valsartan 160 mg, valsartan/amlodipine 160/5 mg, and 160/10 mg. The two groups were similar at baseline (55.5 years, 53% men, blood pressure 163.5/100.2 mmHg); 881 perindopril/amlodipine and 876 valsartan/amlodipine patients were analyzed for efficacy. RESULTS: After 1 month, the rate of controlled hypertension was 33% with perindopril/amlodipine versus 27% with valsartan/amlodipine (estimate of difference, +6.1%; P = 0.005); this between-strategy difference remained significant at every visit (P < 0.05). After 3 months, blood pressure was 137.8 ±â€Š12.4/83.3 ±â€Š8.7 and 139.7 ±â€Š13.3/84.8 ±â€Š9.0 mmHg, respectively, with greater reductions from baseline with perindopril/amlodipine (primary endpoint -2.0/-1.5 mmHg; both P < 0.001). Similar results were observed at all other visits (all P ≤ 0.001). The safety of the two strategies was equivalent. CONCLUSIONS: The three-step strategy of initiation with single-pill perindopril/amlodipine produces greater reductions in blood pressure, and better and quicker rates of control of hypertension. This can be expected to be associated with benefits beyond blood pressure control, notably improved compliance and better cardioprotection.


Asunto(s)
Combinación Amlodipino y Valsartán/uso terapéutico , Amlodipino/uso terapéutico , Antihipertensivos/administración & dosificación , Hipertensión/tratamiento farmacológico , Perindopril/uso terapéutico , Adulto , Anciano , Presión Sanguínea/efectos de los fármacos , Método Doble Ciego , Combinación de Medicamentos , Quimioterapia Combinada , Femenino , Humanos , Indapamida/administración & dosificación , Masculino , Persona de Mediana Edad , Valsartán/administración & dosificación
10.
Adv Ther ; 31(7): 762-75, 2014 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-24985411

RESUMEN

INTRODUCTION: Single-pill combination (SPC) therapy of two drugs is recommended by international guidelines, including the Chinese guidelines (2010), for the treatment of hypertension in high-risk patients who require marked blood pressure (BP) reductions. Real-world data on the efficacy and safety of valsartan/amlodipine (Val/Aml) SPC are scarce. The present study is the first observational study in China to evaluate the efficacy (primary endpoint) and safety of Val/Aml (80/5 mg) SPC in Chinese patients with hypertension whose BP was not adequately controlled by monotherapy in a real-world setting. METHODS: This prospective, multicenter, open-label, post-marketing observational study included 11,422 Chinese adults (≥18 years) with essential hypertension from 238 sites of 29 provinces who were prescribed once-daily Val/Aml (80/5 mg) SPC. Patients were treated for 8 weeks. The primary efficacy variable of the study included changes in mean sitting systolic BP (MSSBP) and mean diastolic BP (MSDBP) from baseline to week 8 (end point). The secondary efficacy variable of the study included BP control rate and response rate at week 4 and 8. Safety assessments included recording and measurement of all adverse events (AEs) and vital signs in the safety population. RESULTS: A significant reduction of 27.1 mmHg in MSSBP (159.6 vs. 132.5 mmHg; P < 0.0001) and 15.2 mmHg in MSDBP (95.6 vs. 80.4 mmHg; P < 0.0001) from baseline was observed at week 8. The BP-lowering efficacy of Val/Aml SPC was independent of age and comorbidities. BP control of <140/90 mmHg was achieved in 76.8% (n = 8,692) of the patients. The most frequently reported AEs were dizziness (0.2%), headache (0.2%), upper respiratory tract infection (0.2%), and edema (0.2%). Only three serious AEs were reported and they were not drug-related. CONCLUSION: This is the first evidence-based real-world data in Chinese hypertensive patients which demonstrate the efficacy and safety of Val/Aml (80/5 mg) SPC.


Asunto(s)
Combinación Amlodipino y Valsartán/uso terapéutico , Antihipertensivos/uso terapéutico , Hipertensión/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , Combinación Amlodipino y Valsartán/administración & dosificación , Combinación Amlodipino y Valsartán/efectos adversos , Antihipertensivos/administración & dosificación , Antihipertensivos/efectos adversos , Grupo de Ascendencia Continental Asiática , Presión Sanguínea/efectos de los fármacos , China , Método Doble Ciego , Combinación de Medicamentos , Edema/inducido químicamente , Femenino , Cefalea/inducido químicamente , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos
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