| Objective: Evidence based medicine confirms that dyslipidemia is anindependent risk factor of coronary heart disease, and lipid-loweringmedication reduces cardiovascular morbidity and mortality. HMG-CoAreductase inhibitors (statins) prescribed most frequently in clinical, cansignificantly improve clinical outcome through reducing total cholesterol andlow-density lipoprotein cholesterol levels. However, low HDL-cholesterol andhigh triglyceride are also nonnegligible risk factors. Recent studies revealedthat lipoprotein(a) was also an independent risk factor of cardiovasculardisease and morbidity of coronary heart disease was positive correlated withLp(a) in postmenopausal women. Treatment with diet and statins has limiteffect to achieve the recent clinical guideline goal in postmenopausal patientswith coronary heart disease complicated by mixed hyperlipemia, especially byhyperlipoproteinemia (a). Up to now, effect of reducing Lp(a) levels by statinsremains controversial. Nicotinic acid has been shown to restrain coronaryheart disease progress and reduce incidence of cardiovascular eventssignificantly by its overall and special lipid-lowering effect. Nicotinic acid isconfirmed to be the unique medicine which can reduce Lp(a) levels at present.With the appearance of sustained release technique, adverse effect incidencehas decreased. Although combination of statins and nicotinic acid is a perfectchoice theoretically, the safety has not been very clear. So we performed thisstudy in order to investigate clinical effect and safety of niaspan plusrosuvastatin in postmenopausal patients with coronary heart diseasecomplicated by hyperlipoproteinemia (a).Methods: Fifty statin-na ve women (aged48–86years) with coronaryheart disease complicated by hyperlipoproteinemia (a)(according to including (criteria) needed drug intervention and admission were enrolled in The ThirdHospital of Hebei Medical University. All the patients were new diagnosedand the menopause years were among2-35. The treatment strategies wereapplied at the basic diseases except thiazides, adrenocortical hormone and anyother drugs which can influence lipid. The including criteria contains mono-ormulti-coronary vessel stenosis≥50%by coronary angiography duringadmission. A total of50patients were randomized into niaspan plusrosuvastatin group (n=25) and rosuvastatin group (n=25). Niaspan plusrosuvastatin group patients were administrated of rosuvastatin10mg/d andNiaspan (500mg/d for4weeks and if CK were normal, increased to1000mg/d) for12weeks. Rosuvastatin patients were administrated of onlyrosuvastatin10mg/d for12weeks. Before and after12-week treatment, bloodsamples were taken in diet and fasting state for biochemical tests including TC,TG, LDL, HDL, Lp(a),ALT, AST, CK, CK-MB, and so on. If myasthenia,myalgia, fatigue, fever, flushed face, abnormal liver function, ALT>3*ULN,CK>5*ULN were observed in any patient, the related treatment would beterminated. Data analysis were performed by SPSS13.0,Comparisons betweengroups were made using T test for continuous variables and Pearson's χ2testor Fisher's exact test for categorical variables, P<0.05was consideredstatistically significant.Results:1. After12-week treatment of rosuvastatin10mg/d, TC, LDL-C, TC/HDLwere decreased significantly(p＜0.05), but HDL-C, TG, Lp(a)had nosignificant changes compared with the baseline.2. After12-week treatment of niaspan plus rosuvastatin, there weresignificant differences of TC, TG, LDL-C, Lp(a), TC/HDL compared to thebaseline(p＜0.05), and HDL increased significantly(p＜0.05).3. Compared to rosuvastatin group, niaspan plus rosuvastatin had asignificant effect on decreasing TC, LDL-C and TC/HDL-C(p＜0.05).4. Compared to rosuvastatin, niaspan plus rosuvastatin had an excellentclinical effect(P＜0.05). 5. Safety5.1No severe adverse effect was observed among all the patients.Compared to the baseline, ALT, CK, CK-MB, LDH, blood glucose, uric acid,heart rate, blood pressure, routine test and uric test had no significantdifference.(p＞0.05)5.2Both groups had one patient felt nausea, upset stomach, and wasrelieved after administration of proton pump inhibitors. All the patients canfinish this investigation. In the Niaspan plus rosuvastatin group,10patientsmanifested flushed faces complicated by pruritus, and were relieved afteradministration of aspirin0.1/d for4weeksConclusions: Niaspan plus rosuvastatin has an excellent clinical effecton postmenopausal patients with coronary heart disease complicated byhyperlipoproteinemia (a), especially the effect on decreasing lipoproteinemia(a) levels. Niaspan plus rosuvastatin has favourable safety and tolerability. |
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