A multi-center, double-blind, randomized, parallel group study to evaluate the effects of two different doses of losartan on morbidity and mortality in Chinese patients with symptomatic heart failure intolerant of angiotensin converting enzyme inhibitor treatment.

BACKGROUND: There have been no mortality/morbidity endpoint studies with losartan in Chinese heart failure patients. The objective was to evaluate the effects of high-dose vs. low-dose losartan on clinical outcomes in Chinese subjects with heart failure. METHODS: This study was a post hoc analysis of the Heart failure Endpoint evaluation of Angiotensin II Antagonist losartan (HEAAL) trial (n = 545). Chinese adults with symptomatic heart failure (New York Heart Association (NYHA) II-IV) intolerant of treatment with angiotensin converting enzyme (ACE) inhibitors were randomized to losartan 150 mg or 50 mg daily. The primary endpoint was the composite event rate of all-cause death or hospitalization for heart failure. Safety and tolerability were assessed. RESULTS: Median follow-up was 4.8 years. Baseline characteristics were generally similar to the overall HEAAL cohort. Overall, 120 (44.1%) subjects in the losartan 150 mg group and 137 (50.2%) subjects in the losartan 50 mg group died (any cause) or were hospitalized for heart failure (hazard ratio (OR) 0.807, 95%CI 0.631 - 1.031). There were no notable differences between treatment groups in the proportion of subjects with adverse experiences. CONCLUSION: The results of this post hoc analysis in Chinese subjects, although not powered to show significance, were generally consistent with the main study results, which demonstrated a significantly reduced risk of all cause death or hospitalization for heart failure with daily losartan 150 mg vs. losartan 50 mg in subjects with symptomatic heart failure and intolerance to ACE inhibitors, supporting the use of the higher dose for optimum clinical benefit.

Thromboembolic event rate in patients with persistent or paroxysmal atrial fibrillation post circumferential pulmonary vein isolation: a single center experience in China.

BACKGROUND: Pulmonary-vein isolation (PVI) is currently used for the treatment of chronic and paroxysmal atrial fibrillation and a major risk of PVI is thromboembolism. The purpose of this study was to observe embolic event rate in patients with persistent or paroxysmal atrial fibrillation (AF) undergone PVI. METHODS: Circumferential PVI (CPVI) was performed in 64 consecutive patients with persistent AF (42 men, aged (60.0 +/- 9.1) years) and in 84 consecutive patients with paroxysmal AF (53 men, aged (61.4 +/- 9.3) years). Warfarin was administrated in all patients before ablation for at least 3 weeks ((5.2 +/- 2.6) weeks) and continued for at least 3 months post ablation with international normalized ratio (INR) of 2.0 - 3.0. During CPVI, intravenous heparin was given at a dose of 5000 - 8000 U or 75 - 100 U/kg, followed by 1000 U or 12 U/kg per hour. RESULTS: In patients with persistent AF, 1 patient developed embolic event during ablation and 3 patients developed embolic events after ablation. In contrast, no thromboembolic event was observed in patients with paroxysmal AF (4/64 vs 0/84, P = 0. 033). CONCLUSION: Thromboembolic event rate related to CPVI is significantly higher in patients with persistent AF than that in patients with paroxysmal AF.

[Efficacy and safety of olmesartan medoxomil versus losartan potassium in Chinese patients with mild to moderate essential hypertension].

OBJECTIVE: To evaluate the efficacy and safety of olmesartan medoxomil compared with losartan potassium in patients with mild to moderate essential hypertension. METHOD: This is a randomized, double-blind, double-dummy, active-controlled, parallel, multi-center study. After a 2-week placebo run-in period, a total of 287 eligible subjects were randomized at 1:1 ratio to receive olmesartan medoxomil 20 mg or losartan potassium 50 mg, once daily for 8 weeks. The blood pressure was assessed after 4 weeks treatment. If the subject's seating diastolic blood pressure (SeDBP) was still >or=90 mm Hg, the dosage was doubled for another 4 weeks; for those subjects whose SeDBP was <90 mm Hg after 4-week treatment, the initial dosage remained unchanged and the treatment continued until completion of the study. RESULTS: (1) The mean trough reduction in SeDBP from baseline in olmesartan group was significantly greater than that in losartan group after 4 weeks (11.72 mm Hg vs 9.23 mm Hg, P=0.004) and 8 weeks treatment (12.94 mm Hg vs 11.01 mm Hg, P=0.035). (2) The number and percentage of responders in olmesartan group (81, 65.3%) were statistically higher than those (68, 52.7%) in losartan group (P=0.028) after 4 weeks treatment and were similar between the two groups after 8 weeks treatment (P>0.05). (3) Individual and overall trough/peak ratios of DBP and SBP in 24-hour ambulatory blood pressure monitoring were higher in olmesartan group than losartan group. The hypotensive effect of olmesartan was more durable than losartan at 24 hour interval. (4) The incidence of study drug-related adverse events (AEs) in olmesartan group (10.5%) was similar as that in losartan group (13.9%, P>0.05). Most of these AEs were mild and transient. CONCLUSION: This study shows that olmesartan medoxomil, at oral dose of 20 mg-40 mg once daily was effective and safe for hypertension treatment and the hypotensive effect was superior to losartan potassium (50 mg-100 mg once daily).

[Effects of antidepressant therapy in patients with suspected "angina pectoris" and negative coronary angiogram complicating comorbid depression].

OBJECTIVE: We observed the therapeutic effectiveness and safety of different antidepressants as well as the correlation between symptomatic improvement of depression and improvement of chest pain in patients with susceptible "angina pectoris" and negative coronary angiogram complicating comorbid depression. METHODS: In this double-blinded randomized study, a total of 123 eligible patients were allocated into three groups: (1) Group F: fluoxetine 20 mg QN (n = 41); (2) Group P: Placebo 1 tablet QN (n = 40); (3) Group F + O: fluoxetine 20 mg + olanzapine 2.5 mg QN for the former 2 weeks and only fluoxetine 20 mg QN for the latter 2 weeks (n = 42). The total therapy duration was 4 weeks. HAMD, HAMA and self-evaluation table of chest pain were obtained before therapy, at the end of 1 and 2 weeks after therapy. RESULTS: Baseline HAMD and HAMA scores and self-evaluation score of chest pain were similar among 3 groups and all scores were significantly improved post various therapies in the order of group F + O > group F > group P. The rate of score decrease were seen after 1 week treatment in group F + O and after 2 week treatment in group F. There was a significant positive correlation between the rates of self-evaluation chest pain score decrease and HAMD (r = 0.867, P < 0.001) and HAMA (r = 0.854, P < 0.001) score decreases after 4 weeks therapies (P < 0.05). During the whole course of treatment, no serious adverse reaction was found in all patients. CONCLUSION: In patients with suspected "angina pectoris" and negative coronary angiogram complicating comorbid depression, the antidepressants were safe and significantly improved the symptoms of depression and anxiety and chest pain. Low dose fluoxetine plus short term olanzapine regimen was superior to fluoxetine alone regimen in terms of stronger and quicker symptom improvement.

[Coronary resistance system in evaluation of microvascular dysfunction after intracoronary microembolization: an experimental study].

OBJECTIVE: To assess the microvascular function of coronary artery after intracoronary microembolization using coronary resistance system. METHODS: The left anterior descending coronary artery (LAD) of 10 pigs weighing 21 kg-25 kg were embolized by repetitive injection of microspheres 45 micro m in diameter through a 2.8F Tracker catheter. Intra-vascular ultrasound (IVUS) images, intracoronary Doppler and pressure signals in the middle segment of LAD were acquired by use of intracoronary ultrasound imaging catheter, Doppler flow wire and pressure wire separately. Intracoronary bolus injection of 18 micro g adenosine was administered to maximally vasodilate the coronary arterial bed through the 2.8F Tracker catheter. The resting and hyperemic signals were acquired respectively before microembolization and in different levels of microembolization. Coronary resistance system reflecting the resistance to pulsatile coronary flow was established by a self-made software of PC system. The resting and hyperemic CR parameters included average resting coronary resistance (rCR) and average minimal coronary resistance (min-CR), the first-harmonic rCR and min-CR, the first-harmonic rCR orientation and min-CR orientation, and so on. Factor analysis was performed to extract the best coronary parameter from the coronary resistance parameters. RESULTS: Factor analysis showed that the first-harmonic rCR and first-harmonic min-CR were correlated better with the first component extracted from the resting and hyperemic CR parameters than rCR and min-CR, with the correlation coefficient being 0.913 and 0.950 in the first-harmonic CR and first-harmonic min-CR respectively. No significant difference in min-CR was found between the value at the dosage of 5 x 10(4) microspheres and that before microembolization. The min-CR value increased markedly from 271 mm Hg.ml(-1).s(-1) +/- 99 mm Hg.ml(-1).s(-1) at the dosage of injecting 5 x 10(4) microspheres to 361 mm Hg.ml(-1).s(-1) +/- 158 mm Hg.ml(-1).s(-1) at the dosage of injecting 10 x 10(4) microspheres (P < 0.05). The min-CR value remained almost unchanged from the dosage of 10 x 10(4) to 15 x 10(4) microspheres. There was no significant difference concerning the first-harmonic min-CR between the value at the dosage of 5 x 10(4) microspheres and that before microembolization. Along with the increase of number of microspheres injected the min-CR value increased gradually. The min-CR value was increased significantly than that before microembolization since the number of microspheres injected surpassed 14 x 10(4). CONCLUSION: The first-harmonic min-CR reflected the coronary microvascular dysfunction in different extents of microembolization better than min-CR. The extent of coronary microvascular dysfunction wasn't linearly related to the extent of microembolization.

Cholesterol-lowering effect of a theaflavin-enriched green tea extract: a randomized controlled trial.

BACKGROUND: Tea consumption has been associated with decreased cardiovascular risk, but potential mechanisms of benefit are ill-defined. While epidemiologic studies suggest that drinking multiple cups of tea per day lowers low-density lipoprotein cholesterol (LDL-C), previous trials of tea drinking and administration of green tea extract have failed to show any impact on lipids and lipoproteins in humans. Our objective was to study the impact of a theaflavin-enriched green tea extract on the lipids and lipoproteins of subjects with mild to moderate hypercholesterolemia. METHODS: Double-blind, randomized, placebo-controlled, parallel-group trial set in outpatient clinics in 6 urban hospitals in China. A total of 240 men and women 18 years or older on a low-fat diet with mild to moderate hypercholesterolemia were randomly assigned to receive a daily capsule containing theaflavin-enriched green tea extract (375 mg) or placebo for 12 weeks. Main outcome measures were mean percentage changes in total cholesterol, LDL-C, high-density lipoprotein cholesterol (HDL-C), and triglyceride levels compared with baseline. RESULTS: After 12 weeks, the mean +/- SEM changes from baseline in total cholesterol, LDL-C, HDL-C, and triglyceride levels were -11.3% +/- 0.9% (P =.01), -16.4% +/- 1.1% (P =.01), 2.3% +/- 2.1% (P =.27), and 2.6% +/- 3.5% (P =.47), respectively, in the tea extract group. The mean levels of total cholesterol, LDL-C, HDL-C, and triglycerides did not change significantly in the placebo group. No significant adverse events were observed. CONCLUSION: The theaflavin-enriched green tea extract we studied is an effective adjunct to a low-saturated-fat diet to reduce LDL-C in hypercholesterolemic adults and is well tolerated.