论文部分内容阅读
目的观察对于氟伐他汀钠胶囊40 mg日一次使用不能达标的稳定型心绞痛或2型糖尿病患者,剂量增加为40 mg每日两次的有效性和安全性。方法多中心、前瞻性、观察性上市后临床监测研究。该研究共纳入251例高脂血症合并稳定型心绞痛或2型糖尿病患者,这些患者经氟伐他汀钠胶囊40 mg睡前一次口服治疗至少4周后,低密度脂蛋白胆固醇(LDLC)未达标(>100 mg/dL)。经医生判断后根据临床需要将剂量增加至40 mg每日两次,共观察8周。主要疗效指标为治疗8周时LDLC水平与患者入组时即药物剂量增加前(基线)相比的变化;次要指标为第8周时LDLC的达标率、空腹甘油三酯(TG)、总胆固醇(TC)及高密度脂蛋白胆固醇(HDLC)水平与基线相比的变化以及安全性和耐受性。结果意向治疗人群(ITT)251例。氟伐他汀钠胶囊40 mg每日两次治疗终点时(第8周)ITT人群的LDLC较基线显著降低,总ITT人群、稳定型心绞痛和2型糖尿病患者LDLC较基线的降幅分别为27.3%、25.3%和28.9%(P均<0.001)。研究结束时59.4%的患者LDLC达标(<100 mg/dL),稳定型心绞痛和2型糖尿病患者的达标率分别为52.9%和67.2%。TG水平较基线显著下降,总人群、稳定型心绞痛和2型糖尿病患者分别下降17.02%、16.50%和17.78%(P均<0.001)。4例患者(1.6%)转氨酶(ALT/AST)升高>3倍正常值上限(ULN),其中3例氟伐他汀减量至40 mg每日一次后继续使用,没有患者出现肝脏症状或胆红素异常。研究过程中没有患者报告肌肉症状和/或肌酸激酶(CK)升高>5×ULN。结论对于应用氟伐他汀钠胶囊40 mg每日不达标的稳定型心绞痛或2型糖尿病患者,剂量增加至80 mg每日可以明显改善达标率,并且具有良好的安全性和耐受性。
OBJECTIVE To investigate the efficacy and safety of fluvastatin sodium capsules at 40 mg once daily for patients with stable angina or type 2 diabetes who were dosed at 40 mg twice daily. Methods Multi-center, prospective, observational, postmarketing clinical monitoring studies. The study enrolled 251 patients with hyperlipemia with stable angina or type 2 diabetes who were treated with fluvastatin sodium capsules 40 mg orally for at least 4 weeks prior to bedtime, and low-density lipoprotein cholesterol (LDLC) did not (> 100 mg / dL). After the doctor judged according to clinical need to dose increased to 40 mg twice daily for a total of 8 weeks. The primary efficacy index was the level of LDLC at 8 weeks of treatment compared with that before enrollment (baseline); the secondary outcome was the rate of LDLC at week 8, fasting triglyceride (TG), total Changes in cholesterol (TC) and high density lipoprotein cholesterol (HDLC) levels compared to baseline, as well as safety and tolerability. Results Intent to treat the population (ITT) in 251 cases. Fluvastatin sodium capsule 40 mg twice daily at the end of treatment (week 8) The LDLC was significantly lower in the ITT population than in the baseline, and the decline in LDLC was 27.3% in the total ITT population, stable angina pectoris and type 2 diabetes mellitus, respectively, 25.3% and 28.9% respectively (all P <0.001). At the end of the study, 59.4% of patients achieved LDLC compliance (<100 mg / dL), and patients with stable angina and type 2 diabetes achieved rates of 52.9% and 67.2%, respectively. TG levels decreased significantly from baseline. The total population, stable angina and type 2 diabetes patients decreased by 17.02%, 16.50% and 17.78%, respectively (all P <0.001). ALT / AST increased> 3 times the upper limit of normal (ULN) in 4 patients (1.6%), of which fluvastatin was reduced to 40 mg once daily and then continued to be used. No patient developed symptoms of liver or gallbladder Anomalies of the red. None of the patients reported muscle symptoms and / or elevated creatine kinase (CK)> 5 × ULN during the study. CONCLUSIONS: The use of fluvastatin sodium capsules 40 mg daily in patients with non-compliance with stable angina or type 2 diabetes, the dose increased to 80 mg per day can significantly improve the compliance rate, and has good safety and tolerability.