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A comparison of the quality of hypertension management in primary care between Shanghai and Shenzhen: a cohort study of 3196 patients.
Li, H, Wei, X, Wong, MC, Yang, N, Wong, SY, Lao, X, Griffiths, SM
Medicine. 2015;(5):e455
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Abstract
Strong primary care is in urgent need for the management and control of hypertension. This study aimed to compare the quality of hypertensive care delivered by community health centers (CHCs) in Shanghai and Shenzhen. Multistage random sampling method was used to select 4 CHCs in each city as study settings. A cohort of hypertensive patients under the hypertensive management program in the CHCs was selected from the electronic information system by using a systematic random sampling method. Binary logistic regression models were constructed for comparison between the 2 cities. A total of 3196 patients' records were assessed. The proportions of hypertensive patients who received advice on smoking cessation (33.8 vs 7.7%, P < 0.001), increasing physical activity (52.4 vs 16.8%, P < 0.001), low-sodium diet (72.0 vs 64.1%, P < 0.001), and regular follow-up (37.8 vs 8.6%, P < 0.001) were higher in Shenzhen than in Shanghai. However, the drug treatment rate in Shenzhen was lower than that in Shanghai (74.2 vs 95.2%, P < 0.001). The hypertension control rate in Shenzhen was lower than that in Shanghai (76.3 vs 83.2%, P < 0.001). Better performance in the process of hypertensive care in terms of increasing physical activity advice, low-sodium diet advice, regular follow-up, and drug prescription was associated with a higher rate of hypertension control. The study indicates that primary care is effective in managing hypertension irrespective of management and operation models of CHCs in urban China. Our study suggests that improvements in the process of hypertensive care may lead to better hypertension control.
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MARCH2: comparative assessment of therapeutic effects of acarbose and metformin in newly diagnosed type 2 diabetes patients.
Wang, G, Liu, J, Yang, N, Gao, X, Fan, H, Xu, Y, Yang, W
PloS one. 2014;(8):e105698
Abstract
BACKGROUND The data of MARCH (Metformin and AcaRbose in Chinese as the initial Hypoglycaemic treatment) trial demonstrated that acarbose and metformin have similar efficacy as initial therapy for hemoglobin A1c (HbA1c) reduction in Chinese patients with newly diagnosed type 2 diabetes. We investigated whether the therapeutic efficacy was diversified under different body mass index (BMI) status. METHODS All 784 subjects were divided into normal-weight group (BMI<24 kg/m2), overweight group (BMI 24-28 kg/m2) and obese group (BMI≥28 kg/m2). Patients were assigned to 48 weeks of therapy with acarbose or metformin, respectively. The clinical trial registry number was ChiCTR-TRC-08000231. RESULTS The reduction of HbA1c levels and the proportion of patients with HbA1c of 6.5% or less were similar in the three groups after acarbose and metformin treatment. In overweight group, fasting blood glucose (FBG) after metformin treatment showed greater decline compared to acarbose group at 48 weeks [-1.73 (-1.99 to -1.46) vs. -1.37 (-1.61 to -1.12), P<0.05), however the decrease of 2 h post-challenge blood glucose (PBG) after acarbose treatment at 48 weeks was bigger compared to metformin group [-3.34 (-3.83 to-2.84) vs. -2.35 (-2.85 to -1.85), P<0.01]. Both acarbose and metformin treatment resulted in a significant decrease in waist circumference, hip circumference, weight and BMI in the three groups (all P<0.05). CONCLUSION Acarbose and metformin decreased HbA1c levels similarly regardless of BMI status of Chinese type 2 diabetic patients. Acarbose and metformin resulted in a significant and modest improvement of anthropometric parametres in different BMI status. Thus, acarbose treatment may contribute a similar effect on plasma glucose control compared to metformin, even in obesity patients. TRIAL REGISTRATION ChiCTR.org ChiCTR-TRC-08000231.
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The relative bioavailability and fasting pharmacokinetics of three formulations of olmesartan medoxomil 20-mg capsules and tablets in healthy Chinese male volunteers: An open-label, randomized-sequence, single-dose, three-way crossover study.
Li, KY, Liang, JP, Hu, BQ, Qiu, Y, Luo, CH, Jiang, Y, Lin, XP, Yang, N
Clinical therapeutics. 2010;(9):1674-80
Abstract
BACKGROUND Olmesartan medoxomil is an angiotensin II-receptor antagonist used in the treatment of hypertension. It is a prodrug and is converted to the pharmacologically active compound on de-esterification by arylesterase in the gastrointestinal tract. OBJECTIVE This study investigated the relative bioavailability and fasting pharmacokinetic properties of olmesartan after single doses of a 20-mg test tablet, a 20-mg test capsule, and a commercially available 20-mg reference tablet in healthy Chinese male volunteers. The study was conducted to satisfy Chinese State Food and Drug Administration regulatory requirements for approval of a generic formulation of olmesartan medoxomil. METHODS This study had an open-label, randomized-sequence, single-dose, 3-treatment, 3-period crossover design. Healthy volunteers were randomly assigned in a 1:1:1 ratio to receive a single 20-mg dose of the test tablet, test capsule, or reference tablet, each administered after a 12-hour overnight fast, followed by a 1-week washout period and administration of the alternate formulation. Blood samples were obtained at baseline and at 0.5, 1, 1.5,2,2.5,3,4,6,8,12,24,36, and 48 hours after dosing. Tolerability was assessed based on vital signs and laboratory values obtained before and after administration of study drug. The formulations were assumed to be bioequivalent if the 90% CIs for the log-transformed ratios of C(max), AUC(0-t), and AUC(0-∞) were within the predetermined equivalence range (70%-143% for C(max); 80%-125% for AUC(0-t) and AUC(0-∞)), as established by the Chinese State Food and Drug Administration. RESULTS Twenty-one healthy male subjects (mean age, 21 years [range, 18-25 years]; weight, 62.1 kg [range, 54.0-80.0 kg]) were enrolled in and completed the study. No period or sequence effect was observed. The mean AUC(0-∞) values for the test tablet, test capsule, and reference tablet were 3993 (1070), 3567 (850), and 3849 (872) ng/mL/h, respectively. The 90% CIs for the log-transformed ratios of test tablet to reference tablet for C(max), AUC(0-48), and AUC(0-∞) were 103.9 to 124.9, 94.0 to 111.5, and 94.4 to 111.7, respectively (all, P = NS). The corresponding 90% CIs for the log-transformed ratios of test capsule to reference tablet were 90.8 to 109.2, 84.9 to 107.9, and 85.1 to 100.7 (all, P = NS). Ten adverse events were reported during the study; 7 subjects complained of pain during blood sampling, and 3 had a blocked venous catheter. No treatment-related adverse events were reported or observed. CONCLUSIONS In this single-dose crossover study in healthy Chinese male volunteers, the test and reference formulations of olmesartan medoxomil 20-mg capsules and tablets met the regulatory criteria for assuming bioequivalence. The 3 formulations were well tolerated.