| Objective:Acute coronary syndrome(ACS) is a kind of diseases that has the highest prevalence and mortality worldwide, takes up most of medical resources, and spends most of money. Statins can reduce the risk of cardiovascular disease and take many benefits in patients with coronary heart disease(CHD) through various mechanisms which make them to be the key part of secondary prevention in patients with CHD. Compared with the western patients, Chinese ACS patients have different age range and combined diseases, behavior and baseline lipid levels. Therefore, western lipid control guideline does not apply to Chinese patients. With the proceeding of aging process and the reality that majority of Chinese ACS patients combined with diabetes mellitus, the study of statins in elderly patients with unstable angina pectoris complicated with diabetes mellitus is imperative. Pitavastatin than other statins in clinical application of late, lack of related research. This study compared the efficacy and safety of the different doses pitavastatin in the patients of senile unstable angina with diabetes.Method1 objectPatients(age>60, n=233) with unstable angina pectoris combined with diabetes mellitus were randomly assigned and treated with moderate-dose(2mg/d, n=17) and double-dose pitavastatin(4mg/d, n=116) for one year. And The level of serum lipids, high sensitive C-reactive protein(Hs-CRP) and homocysteine(HCY) were recorded. The primary end points were emergency percutaneous coronary intervention(PCI) or coronary artery bypass surgery after 30 days of pitavastatin treatment, cardiac death and nonfatal acute myocardial infarction. And the adverse drug reactions were the elevation of alanine aminotransferase, aspartate aminotransferase, creatine kinase(>3 times of normal limit), cognitive changes and nerve injury and r habdom- yolysis.2 statistical methodscontinuous variables recorded as mean standard deviation, non normally distributed variables recorded as median and quartile range, classification variables recorded as percentage. Evaluation of baseline data were, normal distribution of continuous variables with the t test, the non normal distribution of variables using the Wilcoxon rank sum test. The relationship between the events of pitavastatin therapy and clinical endpoints were analyzed using Cox regression model. P < 0.05 was considered statistically difference. All the data were analyzed by SPSS 15 software.Results:Baseline level of age, gender, body mass index, diastolic blood pressure and medication history were nearly identical in moderate- and double-dose pitavastatin groups(P>0.05). And no statistically significant differences in baseline lipid level including triglyceride(TG, 1.79 mmol/L Vs. 1.77 mmol/L), low density lipoprotein(LDL, 2.94 mmol/L Vs. 2.91 mmol/L), high- sensitivity C-reactive protein(Hs-CRP, 7.84 mg/L Vs.7.99 mg/L), and homocysteine(HCY, 8.78 mmol/L Vs.9.02 mmol/L) were detected between groups(P>0.05). After two months of treatment, LDL cholesterol level declined 30.0%(2.06±0.84mmol/L) in moderate-dose and 29.3%(2.01±0.71mmol/L) in double-dose pitavastatin groups, respectively, but there was no statistical significance between groups(P>0.05). In one year follow-up, LDL level in double-dose group was down-regulated about 8.5%(0.16 mmol/L) compared with moderate-dose group(P<0.05). And there was no significant difference in TG levels between groups in 2 months, 6 months and 1 year follow-up(P>0.05). Similarly, the effects of down-regulation on TC and up-regulation on HDL were identical between two groups(P>0.05). Hs-CRP levels declined significantly in both groups(5.14±3.78 mg/L Vs. 4.75±3.31 mg/L, P>0.05). Likely, HCY level declined to 4.23±2.49 mmol/Land 4.56±1.97 mmol/L in moderate-dose and double-dose pitavastatin groups(P>0.05), respectively. In 1-year follow-up, primary end point events occurred in 15(12.8%) patients in moderate-dose group and in 16(13.8%) patients in double-dose group. But no significant between-group difference in primary end point event was detected(Log Rank and Breslow method, P>0.05). The elevation of liver enzyme were found in 10.2%(12/117) and 9.5%(11/116), and creatine kinase elevation were found in 2.6%(3/117) and 0.9%(1/116) in these two groups(P>0.05), respectively. Malignant events including cognitive changes, nerve damages, and rhabdomyolysis were not occurred in these two groups.Conclusion:For elderly patients with unstable angina pectoris complic- ated with diabetes mellitus, double-dose pitavastatin significantly reduces the serum LDL level(8.5%), but don’t bring significant adverse reaction. Therefore,, intensive treatment of pitavastatin is efficacy and safety. |
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