ABSTRACT
Objective To assess the efficacy and safety of fluvastatin sodium extended-release tablets (fluvastatin XL) 80 mg once daily compared to fluvastatin sodium immediate-release capsules (fluvastatin IR) 40 mg twice daily in Chinese hyperlipidemic patients with moderate or high cardiovascular risk.Methods In this multi-center,randomized,double-blind,double-dummy,active-controlled,parallel-group study,after 6-week open-label treatment with fluvastatin IR 40 mg once daily,patients who did not reach their lipid goals were randomized to 12-week double-blind treatment with fluvastatin XL 80 mg once daily or fluvastatin IR 40 mg twice daily.Results (1) There were 218 patients enrolled in each group.At the study endpoint,no statistical difference was found in the mean percent change from baseline for LDL-C with-8.69％ [from (3.504 ±0.060) mmol/L to (3.153 ±0.065) mmol/L] in the fluvastatin XL group and-7.89％ [from (3.491 ±0.050) mmol/L to (3.181 ±0.060) mmol/L] in the fluvastatin IR group (P ＞ 0.05).The 95％ CI for difference between the two groups in adjusted mean percent change from baseline was (-4.70％-3.09％),which was within the pre-specified non-inferiority margin.In the fluvastatin XL group,the proportion of patients with moderate cardiovascular(CV) risk and high CV risk achieving their LDL-C treatment goals at endpoint was 50.0％ and 31.5％ respectively,while the proportion was 42.5％ and 24.5％ respectively in the fluvastatin IR group.No significant difference was found between the two groups in the proportion of patients who reached their lipid goals and the changes from baseline with other lipid parameters.(2)Similar safety profiles were observed in the two treatment groups,with 21.1％ adverse event (AE) (8.3％ study-drug related AE) in the fluvastatin XL group and 17.0％ AE (6.3％ study-drug related AE) in the fluvastatin IR group.Conclusion The efficacy of fluvastatin XL 80 mg once daily is comparable to fluvastatin IR 40 mg twice daily in Chinese hyperlipidemic patients with moderate or high cardiovascular risk and both treatments are safe and well-tolerated.
ABSTRACT
Objective To study the relationship between blood cell count and cardiac events in acute ST elevation myocardial infarction patients treated with reperfusion in the early stage. Methods In this study, we assigned 151 patients to whom reperfusion therapy had been delivered within 3 hours of STEMI symptom into two groups:primary percutaneous cor-onary intervention group and thrombolysis therapy group. Differences of cardiac events and white blood cell count in these two groups were analyzed in the first 4 days. Results In the second day and the forth day, cardiac events rate and white blood cell count were significantly lower in the primary percutaneous coronary intervention group than those in the thromboly-sis therapy group (P＜0.05). In the second day, white blood cell count has a positive correlation with cardiac events rate (r=0.226, P＜0.05). Conclusion Primary percutaneous coronary intervention decreased blood cell count and cardiac events rate. In patients with acute myocardial infarction, increasing white blood cell was related to cardiac events in the near future.
ABSTRACT
ObjectiveTo explore the value of combined echocardiography and brain natriuretic peptide (BNP) levels in acute pulmonary embolism (APE) treated by thrombolysis.Methods Echocardiography,pulmonary ventilation-perfusion imaging and plasma BNP levels were performed before thrombolysis and 24 - 48 h after thrombolysis in 31 patients with diagnosis of APE and signs of right ventricular pressure overload.Results Twenty-six patients with thrombolysis effective,after thrombolysis,the pulmonary artery systolic pressure decreased from (57.3 ± 18.2)mm Hg to (40.4 ± 15.4)mm Hg (P= 0.003) ,the right ventricular diastolic diameter reduced from (40.6 ± 6.1)mm to (35.4 ± 6.0)mm (P ＜0.01) ,the pulmonary artery diameter reduced from (27.2 ± 4.9)mm to (22.5 ± 4.4)mm (P = 0.004) ,the left ventricular diastolic diameter increased from (42.4 ± 7.2)mm to (43.1 ± 6.9)mm (P = 0.42),septal contradiction were reduced from 20 cases to 10 cases (P = 0.02),plasma BNP levels decreased from (278.8 ± 43.3)ng/L to (119.1 ± 40.4)ng/L (P = 0.000 01).Five patients with thrombolysis ineffective,there were no significant changes before and after thrombolytic therapy in the parameters of echocardiography,however,plasma BNP levels increased from (431.8 ± 57.7) ng/L to (496.4 ± 70.3) ng/L(P = 0.03).Plasma BNP levels and pulmonary artery systolic pressure had a better relationship(r = 0.62,P ＜0.01).Conclusions The pulmonary perfusion and right ventricular function in patients with APE can be rapidly improved by thrombolytic therapy.Combined echocardiography and the BNP levels is a sensitive index in the hemodynamic changes of thrombolytic therapy,and can evaluate the treatment accurately.