Benefit of initial dual-therapy on stroke prevention in Chinese hypertensive patients: a real world cohort study.

AIMS: Studies have shown that combination anti-hypertensive therapy is superior to mono-therapy in blood pressure control and prevention of cardiovascular events. However, whether such advantage exists in the prevention of stroke in Chinese hypertensive patients remains unclear. This study aimed to compare the impact of initial combination versus mono-therapy on stroke events in a large cohort of Chinese hypertensive patients. METHODS AND RESULTS: Hypertensive patients with uncontrolled blood pressure and without a history of stroke were screened from the Shanghai Community-dwelling Hypertensive Population Follow-up Database. Based on the initial treatment, individuals were divided into an initial mono-therapy group and initial dual combination group. Patients were followed for 42 months. 32,682 and 4,926 patients were included in the initial mono- and dual-therapy group. The achieved target blood pressure control rates of mono vs. combination groups at 6, 12, 24, and 42 months of follow-up, were 59.47% vs. 60.05%, 78.23% vs. 77.06%, 85.51% vs. 84.02%, and 86.90% vs. 85.44%, respectively. Their corresponding incidence densities of stroke were 0.792 vs. 0.489, 1.49 vs. 1.15, 2.79 vs. 2.38, and 4.25 vs. 4.32 (cases per 100 person-year), respectively. The 6-month incidence of stroke in dual-therapy group was significantly lower than mono-therapy group (adjusted HR 0.64; 95% CI: 0.30-0.93). However, no significant group differences in the incidence density were observed at 12, 24, and 42 months. CONCLUSIONS: Our study demonstrates that, for patients with uncontrolled hypertension, initial dual therapy is more effective in the prevention of stroke during the first 6 months of treatment, but not thereafter. Combination antihypertensive therapy may be a beneficial initial strategy for early stroke prevention.

The prognostic value of long-term visit-to-visit blood pressure variability on stroke in real-world practice: a dynamic cohort study in a large representative sample of Chinese hypertensive population.

BACKGROUND: The prognostic significance of long-term visit-to-visit blood pressure variability (BPV) has not yet been validated in "real world" hypertensive patients. The aim of the current study is to explore the prognostic value of BPV on stroke in hypertensive patients. METHODS: This was a dynamic prospective cohort study based on electronic medical records in Shanghai, China. Hypertensive patients (N=122,636) without history of stroke at baseline, were followed up from 2005 to 2011. The cohort comprised of 4522 stroke patients and 118,114 non-stroke patients during a mean follow-up duration of 48 months. BPV was measured by standard deviation (SD) and the coefficient of variation (CV) of blood pressure. RESULTS: The visit-to-visit variability of both systolic blood pressure (SBP) and diastolic blood pressure (DBP) was independently associated with the occurrence of stroke [SD: the hazard ratios (95% confidence intervals) of SBP and DBP were 1.042 (1.021 to 1.064) and 1.052 (1.040 to 1.065); CV: the hazard ratios (95% confidence intervals) of SBP and DBP were 1.183 (1.010 to 1.356) and 1.151 (1.005 to 1.317), respectively]. The hazard ratio values increased along with an increase of the BPV levels of SBP and DBP. The increment effect remained significant after controlling the blood pressure control status of subjects. CONCLUSIONS: Increased BPV of both SBP and DBP, independent of the average blood pressure, is a predictor of stroke among community hypertensive patients in real-world clinical practice. The risk of stroke increased along with increased BPV. Stabilizing BPV might be a therapeutic target in hypertension.

[A meta-analysis of preventing bone mineral loss in patients with endometriosis treated by gonadotrophin-releasing hormone analogues with add-back therapy].

OBJECTIVE: To evaluate the role and efficacy of preventing bone mineral loss in patients with endometriosis treated by gonadotrophin-releasing hormone analogues (GnRH-a) combined with add-back therapy. METHODS: Prospective, randomized controlled studies of the use of GnRHa with add-back therapy in treatment of endometriosis were enrolled in this study from Medline, Embase, Cochrane library, China National Knowledge Internet (CNKI), Chinese Biological Medicine Disk (CBM) and Data Base of Wanfang.After quality assessment and data extraction, meta-analysis were conducted in the change of BMD, reproductive hormone (E2) and visual pain score(VAS) by Stata 11.0 software. RESULTS: A total of 785 patients from 13 randomized controlled trail (RCT) studies enrolled in this study after exclude no following up, poor quality and repeat published studies.377 patients were in group of GnRH-a with add-back treatment and 408 patients were in group of GnRna alone.The findinds were showed in meta-analysis: (1) there was a significant difference in percentage change of bone mineral density (BMD) between two groups, the add-back therapy was more effective in prevention of bone loss which was (SMD = 0.223, 95%CI:0.003 to 0.443, P = 0.047). (2) There was no significant difference in the level of reproductive hormone between two groups (SMD = -0.053, 95% CI:-0.479 to 0.373, P = 0.807). (3) There was also no significant difference in the visual pain score between the two groups (SMD = -0.157, 95% CI: -0.474 to 0.160, P = 0.332). CONCLUSIONS: GnRH-a with add-back therapy have been shown to be more effective in preventing loss of BMD than GnRH-a treatment alone.However, the long term effect of preventing BMD should be studied.

[The effect of pitavastatin on blood glucose and its efficacy in diabetic patients with hypercholesterolemia].

OBJECTIVE: To evaluate the effect of pitavastatin on blood glucose in patients with hypercholesterolemia, and to investigate the efficacy of pitavastatin in diabetic patients combined with hypercholesterolemia. METHOD: This study was a 12-week, multi-center, open-label, without parallel-group comparison, phase IV clinical trail. RESULTS: Contrasting to baseline, the prevalences at week 4 and 12 post-treatment of abnormal fasting plasma glucose (FPG) and glycosylated hemoglobin A1c (HbA1c) (FPG: 14.2%vs 14.1% and 11.0%; HbA1c: 14.3% vs 15.1% and 16.1%) in the safety set subjects without diabetes mellitus (DM), as well as in those with DM but not taking glucose-lowering drugs (FPG: 7/7 vs 4/7 and 5/7; HbA1c: 5/5 vs 4/4 and 5/5) had no significant changes (all P values > 0.05). Contrasting to baseline, the levels of TC [(6.51 ± 0.94) mmol/L vs (5.12 ± 0.93) mmol/L and (4.54 ± 1.00) mmol/L], LDL-C [(4.11 ± 0.79) mmol/L vs (3.02 ± 0.81) mmol/L and (2.51 ± 0.70) mmol/L] and TG [2.10 (1.53, 2.54) mmol/L vs 1.62 (1.26, 2.00) mmol/L and 1.35 (1.10, 1.86) mmol/L]at week 4 and 12 post-treatment in the per protocol set 55 subjects with DM were significantly reduced (all P values < 0.05); 33.3% of subjects at high risk and 10.0% of subjects at very high risk had achieved a TC target value; 55.6% of subjects at high risk and 40.0% of subjects at very high risk had achieved a LDL-C target value. CONCLUSION: Pitavastatin has a safe effect on blood glucose and it could be used to treat diabetic patients combined with hypercholesterolemia in China.

[Effect and risk factors of pitavastatin on high sensitivity C-reactive protein in patients with hypercholesterolemia: a multilevel models analysis].

OBJECTIVE: To evaluate the effect of pitavastatin on high sensitivity C-reactive protein (hsCRP) in patients with hypercholesterolemia, and determine risk factors for the effect. METHODS: This study was a 12-week, multicenter, open-label, without parallel-group comparison, phase IV clinical trail. RESULTS: There were 330 subjects in the per protocol set. Contrast to the baseline, the average levels of hsCRP in all of subjects and the group without a history of receiving previous statin medication at week 12 post-treatment decreased respectively 26.4% (1.20 mg/L vs 1.68 mg/L) and 27.5% (1.21 mg/L vs 1.97 mg/L, all P < 0.05). The results of multilevel models indicated that the average levels of hsCRP reduced with the passage of treatment time, the time-varying rate of per-visit was 0.97 mg/L (95% confidence interval 0.96 - 0.98). Controlled individual background covariates, the model predicted that pulse pressure and white blood cell count on the baseline had the significant positive effects on hsCRP (P < 0.01). CONCLUSIONS: Pitavastatin decreases hsCRP in patients with hypercholesterolemia. The main risk factors for the effect are pulse pressure and white blood cell count on the baseline.

[Safety and efficacy of pitavastatin in patients with hypercholesterolemia: a multicenter study].

OBJECTIVE: To evaluate the safety and efficacy of pitavastatin in patients with hypercholesterolemia in China under conditions of extensive usage. METHODS: This was a 12-week, multicenter, open-label, without parallel-group comparison, phase IV clinical trial. RESULTS: There were 427 subjects in the safety set. The adverse events mainly included vomiting, myalgia and the elevations of aspartate transaminase (AST), alanine transaminase (ALT) and creatine kinase (CK), etc. The incidence of drug-related adverse events was 4.22%. There were no significant differences between pre-exposure and post-exposure average levels of renal function indicators and blood routine examination item (all P > 0.05). None of them had a high AST/ALT value, i.e. > 3 times upper limits of normal (ULN), or had a high CK value, i.e. > 10 times ULN. There were 397 subjects in the per protocol set. At week 12 post-treatment, the blood levels of total cholesterol and low density lipoprotein cholesterol (LDL-C) in subjects without previous treatment decreased 24.6% and 31.0% respectively, that of high density lipoprotein cholesterol (HDL-C) in subjects with HDL-C < 1.04 mmol/L increased 60.1% while that of triglyceride (TG) in subjects with TG > 1.70 mmol/L decreased 22.5% (P < 0.05). And 207 (92.3%) subjects were at a low risk, 46 (76.1%) subjects at an intermediate risk, 134 (47.8%) subjects at a high risk and 10 (40.0%) of subjects at a very high risk had achieved a LDL-C target value; the LDL-C goal achievement rate after switching from previous medication to pitavastatin was significant higher than that of pre-switching. CONCLUSION: Pitavastatin demonstrates positive safety and efficacy. It may be used for the treatment of patients with hypercholesterolemia in China.

[Again review of research design and statistical methods of Chinese Journal of Cardiology].

OBJECTIVE: To re-evaluate and compare the research design and the use of statistical methods in Chinese Journal of Cardiology. METHOD: Summary the research design and statistical methods in all of the original papers in Chinese Journal of Cardiology all over the year of 2011, and compared the result with the evaluation of 2008. RESULTS: (1) There is no difference in the distribution of the design of researches of between the two volumes. Compared with the early volume, the use of survival regression and non-parameter test are increased, while decreased in the proportion of articles with no statistical analysis. (2) The proportions of articles in the later volume are significant lower than the former, such as 6(4%) with flaws in designs, 5(3%) with flaws in the expressions, 9(5%) with the incomplete of analysis. (3) The rate of correction of variance analysis has been increased, so as the multi-group comparisons and the test of normality. The error rate of usage has been decreased form 17% to 25% without significance in statistics due to the ignorance of the test of homogeneity of variance. CONCLUSION: Many improvements showed in Chinese Journal of Cardiology such as the regulation of the design and statistics. The homogeneity of variance should be paid more attention in the further application.

[Relevance of cardiovascular disease risk and abnormal ankle brachial index in hypertensive patients:a multicentre study].

OBJECTIVE: To evaluate the relevance of cardiovascular disease (CVD) risk and abnormal ankle brachial index (ABI) in high-risk and very high-risk hypertensive patients and explore the strategies of prevention and treatment for peripheral arterial disease according to the CVD risk. METHODS: Between December 2008 and May 2009, the cross-sectional study investigated the prevalence of abnormal ABI (ABI < 0.90) in 2674 community-dwelling, hypertensive patients, aged ≥ 40 years old, without coronary heart disease, stroke/transient ischemic attack or known arteriosclerosis, from 18 centers in China. The relevant data were acquired through history, physical examination, laboratory examinations and other diagnostic tests. RESULTS: The number of subjects available for the full-analysis set was 2615. There was a rising prevalence of abnormal ABI with the advancing age in high-risk hypertensive patients and very high-risk ones (P < 0.001). Compared with the high-risk group, the 60 years (1.3% vs 5.1%) and 70 years (4.1% vs 10.5%) age sub-groups of the very high-risk group had a significantly higher prevalence of abnormal ABI (P < 0.05). After adjusting for such factors as investigational center, target organ damage, CVD risk and demographics, an unconditional Logistic regression model revealed that CVD risk was positively correlated with abnormal ABI (odds ratio 1.874, 95% confidence interval 1.153 - 3.045, P = 0.0112). A very high-risk hypertensive patient was 1.874 times more likely than a high-risk one to have an abnormal ABI. CONCLUSION: A high-risk hypertensive patient with a higher CVD risk is more prone to have an abnormal ABI. Among the high-risk hypertensive patients in the 60 years and 70 years age sub-groups, such a positive correlation is especially pronounced.