3.Dietary calcium decreases plasma cholesterol level only in female but not in male hamster fed a high cholesterol diet.
Ka Ying MA ; Yin Tong LIANG ; Jing Nan CHEN ; Yue JIANG ; Kin Ming KWAN ; Cheng PENG ; Rui JIAO ; Yuan Yuan ZUO ; Yu HUANG ; Zhen Yu CHEN
Biomedical and Environmental Sciences 2012;25(4):392-398
OBJECTIVETo investigate the effect of dietary calcium on plasma lipoprotein profile in castrated and ovariectomized hamsters.
METHODSMale, castrated, female and ovariectomized hamsters (n=36 each group) were randomly divided into three sub-groups (n=12) and fed one of the three diets containing 0, 2, and 8 g calcium per kg diet for a period of six weeks. Changes in plasma lipoprotein profile were monitored at the end of week 0, 3 and 6.
RESULTSPlasma total cholesterol (TC), non-high density lipoprotein cholesterol (non-HDL-C), triacylglycerols (TG) and TC/HDL-C were decreased only in intact female and ovariectomized hamsters. In contrast, three levels of dietary calcium had no effect on lipoprotein profiles in both intact male and castrated hamsters.
CONCLUSIONBeneficial modification of lipoprotein profile by dietary calcium was gender-dependent at least in hamsters.
Animals ; Calcium, Dietary ; therapeutic use ; Cholesterol ; blood ; Cholesterol, Dietary ; adverse effects ; Cholesterol, HDL ; blood ; Cricetinae ; Female ; Male ; Triglycerides ; blood
4.Efficacy and safety of various doses of hybutimibe monotherapy or in combination with atorvastatin for primary hypercholesterolemia: a multicenter, randomized, double-blind, double-dummy, parallel-controlled phase Ⅲ clinical trial.
Si Yu CAI ; Xiang GU ; Pei Jing LIU ; Rong Shan LI ; Jian Jun JIANG ; Shui Ping ZHAO ; Wei YAO ; Yi Nong JIANG ; Yue Hui YIN ; Bo YU ; Zu Yi YUAN ; Jian An WANG
Chinese Journal of Cardiology 2023;51(2):180-187
Objective: To evaluate the efficacy and safety of hybutimibe monotherapy or in combination with atorvastatin in the treatment of primary hypercholesterolemia. Methods: This was a multicenter, randomized, double-blind, double-dummy, parallel-controlled phase Ⅲ clinical trial of patients with untreated primary hypercholesterolemia from 41 centers in China between August 2015 and April 2019. Patients were randomly assigned, at a ratio of 1∶1∶1∶1∶1∶1, to the atorvastatin 10 mg group (group A), hybutimibe 20 mg group (group B), hybutimibe 20 mg plus atorvastatin 10 mg group (group C), hybutimibe 10 mg group (group D), hybutimibe 10 mg plus atorvastatin 10 mg group (group E), and placebo group (group F). After a dietary run-in period for at least 4 weeks, all patients were administered orally once a day according to their groups. The treatment period was 12 weeks after the first dose of the study drug, and efficacy and safety were evaluated at weeks 2, 4, 8, and 12. After the treatment period, patients voluntarily entered the long-term safety evaluation period and continued the assigned treatment (those in group F were randomly assigned to group B or D), with 40 weeks' observation. The primary endpoint was the percent change in low density lipoprotein cholesterol (LDL-C) from baseline at week 12. Secondary endpoints included the percent changes in high density lipoprotein cholesterol (HDL-C), triglyceride (TG), apolipoprotein B (Apo B) at week 12 and changes of the four above-mentioned lipid indicators at weeks 18, 24, 38, and 52. Safety was evaluated during the whole treatment period. Results: Totally, 727 patients were included in the treatment period with a mean age of (55.0±9.3) years old, including 253 males. No statistical differences were observed among the groups in demographics, comorbidities, and baseline blood lipid levels. At week 12, the percent changes in LDL-C were significantly different among groups A to F (all P<0.01). Compared to atorvastatin alone, hybutimibe combined with atorvastatin could further improve LDL-C, TG, and Apo B (all P<0.05). Furthermore, there was no significant difference in percent changes in LDL-C at week 12 between group C and group E (P=0.991 7). During the long-term evaluation period, there were intergroup statistical differences in changes of LDL-C, TG and Apo B at 18, 24, 38, and 52 weeks from baseline among the statins group (group A), hybutimibe group (groups B, D, and F), and combination group (groups C and E) (all P<0.01), with the best effect observed in the combination group. The incidence of adverse events was 64.2% in the statins group, 61.7% in the hybutimibe group, and 71.0% in the combination group during the long-term evaluation period. No treatment-related serious adverse events or adverse events leading to death occurred during the 52-week study period. Conclusions: Hybutimibe combined with atorvastatin showed confirmatory efficacy in patients with untreated primary hypercholesterolemia, which could further enhance the efficacy on the basis of atorvastatin monotherapy, with a good overall safety profile.
Male
;
Humans
;
Middle Aged
;
Atorvastatin/therapeutic use*
;
Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use*
;
Hypercholesterolemia/drug therapy*
;
Cholesterol, LDL/therapeutic use*
;
Anticholesteremic Agents/therapeutic use*
;
Treatment Outcome
;
Triglycerides
;
Apolipoproteins B/therapeutic use*
;
Double-Blind Method
;
Pyrroles/therapeutic use*
5.Anti-hypercholesterolemic effect of Pistacia lentiscus fatty oil in egg yolk-fed rabbits: a comparative study with simvastatin.
Chinese Journal of Natural Medicines (English Ed.) 2014;12(8):561-566
AIM:
The current study was undertaken to assess anti-hyperlipidemic activity of Pistacia lentiscus fatty oil (PLFO) in rabbits following a hyperlipidemic diet.
METHOD:
Twenty healthy female (WNZ) rabbits were divided into four groups of five animals each: (a) normal control (NC group) receiving standard diet, (b) hyperlipidemic control (EY) group receiving standard diet and gavaged daily with egg yolk (10 mL), (c) hyperlipidemic + PLFO (EY + PLFO) group receiving as the EY group and treated daily with PLFO (2 mL/kg BW, (d) hyperlipidemic + simvastatin (EY + SVS) group receiving as the EY group and treated once daily with 2.5 mg/kg BW of simvastatin. At the end of the six-week experimental period, the lipidemic profiles of the different groups were investigated.
RESULTS:
In the EY group, the egg yolk resulted in a significant increase of total cholesterol (TC), triglycerides (TG), HDL-C, LDL-C, and the LDL-C/HDL-C ratio. Both the EY + PLFO and EY + SVS groups, when compared to the EY group, showed a significant decrease of TC, TG, LDL-C, and the LDL-C/HDL-C ratio. However, with respect to HDL-C the differences were not significant. The TGs were significantly lower (P < 0.001) in the simvastatin-treated group when compared to rabbits treated in the PLFO group.
CONCLUSION
The study concludes that P. lentiscus fatty oil (PLFO) possesses anti-hyperlipidemic properties at least in reducing total cholesterol, LDL-cholesterol and triglycerides.
Animals
;
Anticholesteremic Agents
;
pharmacology
;
therapeutic use
;
Cholesterol
;
blood
;
Cholesterol, HDL
;
blood
;
Cholesterol, LDL
;
blood
;
Diet
;
Egg Yolk
;
Female
;
Fruit
;
Hyperlipidemias
;
blood
;
drug therapy
;
etiology
;
Lipids
;
blood
;
Phytotherapy
;
Pistacia
;
Plant Oils
;
pharmacology
;
therapeutic use
;
Rabbits
;
Simvastatin
;
pharmacology
;
therapeutic use
;
Triglycerides
;
blood
6.Lipid-lowering efficacy and safety of varying doses of Simvastatin in patients with early stage acute coronary syndromes: one-year follow-up study.
Yangchun ZOU ; Dayi HU ; Xianchun YANG ; Zhimin XU ; Liang CUI ; Xiaohui LIU ; Yu WEI ; Mingming GAO
Chinese Medical Journal 2003;116(6):853-856
OBJECTIVETo investigate whether patients, who are at risk of major acute coronary events, are safe to undergo and benefit from early intervention after using simvastatin.
METHODSThe study was a randomized, open, two-dosage-controlled trial to evaluate the safety and benefits of simvastatin administered to 197 patients (10 mg group, n = 98 and 20 mg group, n = 99), within 48 hours of hospitalization for a diagnosis of unstable angina or acute myocardial infarction (MI), with total cholesterol (TC) >/= 180 mg/dL or low-density lipoprotein cholesterol (LDL-C) >/= 100 mg/dL. Lipid levels were measured immediately, followed by the 3rd, 6th and 12th month after admission and all adverse events were recorded during follow-up.
RESULTSTC levels fell by 10.15% and 14.52% in the 10 mg and 20 mg groups (P < 0.05), and LDL-C levels fell 13.87% and 19.38% in the 10 mg and 20 mg groups, respectively (P < 0.01), 12 months after using simvastatin. The rates of achieving target TC reached 26.3% and 36.5% in the 10 mg and 20 mg groups (P < 0.01), and that of LDL-C reached 28.2% and 40.3% in the 10 mg and 20 mg groups, respectively (P < 0.01). There were higher rates of MI and re-hospitalization resulting from angina pectoris and revascularization in the 10 mg group compared with the 20 mg group.
CONCLUSIONSThe results suggest that early intervention with the HMG-CoA reductase inhibitor, simvastatin, in acute coronary syndromes is possible and safe. It also indicates that the clinical dosage of simvastatin are relatively smaller than that for satisfactory lipid control in patients with acute coronary syndromes.
Acute Disease ; Aged ; Cholesterol ; blood ; Cholesterol, LDL ; blood ; Coronary Disease ; blood ; drug therapy ; Female ; Follow-Up Studies ; Humans ; Hypolipidemic Agents ; therapeutic use ; Male ; Middle Aged ; Simvastatin ; therapeutic use
7.Dietary treatment and success rate of control in hypercholesterolemia patients treated with lipid lowering drugs: a multi-center study of current status on clinical control of hypercholesterolemia in China.
Zhen-jie WANG ; Xiu-zhi TIAN ; Xian LI ; Zuo CHEN ; Lian-cheng ZHAO ; Bei-fan ZHOU ; Yang-feng WU ; null
Chinese Journal of Cardiology 2005;33(4):372-375
OBJECTIVETo assess the current status in dietary treatment of hypercholesterolemia and its effects on control of this disease in China.
METHODSTwenty five Tertiary-A hospitals from 12 provinces in China were selected, in which 2136 patients were recruited who had had hypercholesterolemia and had been receiving lipid lowering treatment for at least 2 months. Serum lipids level was determined for each patient at the time of enrollment, and using a simplified food frequency method carried out dietary intake survey. Patients who take meat of less than 75 g per day and eggs of less than 5 per week, and fried foods of less than 5 times per week, and butter cakes and pastry of less than 5 times per week were considered as having their diet controlled.
RESULTSAmong 1746 responded patients, 68.3% reported having controlled diet. Among those reported "controlled", 75% had a diet meeting the requirements suggested by the Chinese Recommendations on Prevention and Treatment of Hypercholesterolemia (CRPTH). The percentage of patients having their serum total cholesterol under control in diet controlled group, according to the CRPTH, was significantly higher than that in diet uncontrolled group (28.8% vs 13.6%, P < 0.01). After adjustment for drug treatment and other covariates, the diet controlled group showed a significantly higher rate in control of hypercholesterolemia than the diet uncontrolled group (OR = 2.7, 95% CI: 1.4 approximately 5.2).
CONCLUSIONDiet control significantly improves the status in control of hypercholesterolemia and thus should be reinforced in routine clinical practice.
Anticholesteremic Agents ; therapeutic use ; Cholesterol, HDL ; blood ; Cholesterol, LDL ; blood ; Humans ; Hypercholesterolemia ; blood ; diet therapy ; drug therapy ; Hypolipidemic Agents ; therapeutic use ; Treatment Outcome
8.A survey on the status of lipid-lowering therapy in 180 hypercholesterolemic patients.
Siyu CAI ; Shunying XIA ; Haibao XIE ; Xueyan YAO ; Lihong WANG
Chinese Journal of Epidemiology 2002;23(5):378-372
OBJECTIVETo determine the percentage of hypercholesterolemic patients who had met the criteria as total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C), defined by the Chinese National Recommendations for Prevention and Treatment of Dyslipidemia.
METHODSAdult patients with hypercholesterolemia, who had been receiving the same lipid-lowering therapy for at least 2 months, were enrolled. Lipid levels were determined at the time of enrollment, to assess whether the patients' lipid levels had reached the criteria for treatment. Patients' cardiovascular risk factors and lipid-lowering treatments were also collected.
RESULTSOne hundred and eighty patients with mean age of 65.8 were studied. Of these, 6.7% had no risk factors and no definite disease of atherosclerosis (low-risk group), 65.5% had risk factors but no documented atherosclerosis (high-risk group), and 27.8% had established atherosclerosis diseases or diabetes mellitus. Overall, only 44% of patients achieved both TC and LDL-C target levels. The success rates were higher among low and high-risk groups than that among patients with atherosclerosis or diabetes mellitus. The relationship between four different lipid-lowering drug therapies and successful patient outcome was also investigated. The success rates were 51.8% for simvastatin, 42.9% for pravastatin, 31.6% for fluvastatin, 12.5% for other drugs respectively.
CONCLUSIONMore than half of the hypercholesterolemic patients receiving lipid-lowering therapy had not achieved TC and LDL-C target levels. Data from this study indicated that a significant gap still existed between dyslipidemia prevention principles and clinical practices, suggesting that more aggressive treatment of dyslipidemia is needed.
Aged ; Anticholesteremic Agents ; therapeutic use ; Cholesterol ; blood ; Cholesterol, LDL ; blood ; Female ; Humans ; Hypercholesterolemia ; blood ; drug therapy ; Male ; Middle Aged
9.Low fat milk powder containing esterified plant sterols improves the blood lipid profile of adults with hypercholesterolemia.
Jianqin SUN ; Danfeng XU ; Hua XIE ; Yan WANG ; Min CHEN ; Xifeng CHANG ; Yiru PAN ; Yuan LIU ; Huijun XUE ; Hu ZHAO ; Yanqiu CHEN ; Fei XIAO
Chinese Journal of Cardiology 2014;42(7):588-592
OBJECTIVETo observe the impact of plant sterol esters (PSE) mixed in low fat milk powder (2.5 g of PSE/day) on plasma cholesterol levels in hypercholesterolemic subjects during a 6-week intervention period.
METHODSIn this double-blind, randomized, placebo-controlled study, 59 subjects (19 males, mean age (60.28 ± 6.98) years) with primary hypercholesterolemia (fasting LDL cholesterol between 3.4-6.0 mmol/L) were randomly divided into two groups (treatment group, 2.5 g of plant sterol esters a day, n = 30) and placebo group (n = 29). Blood samples were collected at week 0, 3 and 6. The primary outcome was change in plasma LDL-cholesterol (LDL-C). Secondary outcomes were changes in total cholesterol (TC), HDL cholesterol (HDL-C), triglycerides (TG), anthropometry and blood biochemistry.
RESULTSLDL-C significantly reduction from baseline (4.18 ± 0.54) mmol/L to (3.44 ± 0.61) mmol/L (-17.7%, P < 0.05) at week 3 and (3.35 ± 0.39) mmol/L (-19.9%, P < 0.05) at week 6 in the treatment group, whereas in placebo group from (4.11 ± 0.54) mmol/L at baseline to (3.47 ± 0.60) mmol/L (-15.57%, P < 0.05) and (3.61 ± 0.39) mmol/L (-12.17%, P < 0.05) at week 3 and week 6, respectively. TC was reduced from (6.30 ± 0.86) mmol/L at baseline to (5.92 ± 0.75) mmol/L (-6.03%, P > 0.05) at week 3 and (5.43 ± 0.77) mmol/L (-13.8%, P < 0.05) at week 6 in treatment group, from (6.20 ± 0.76) mmol/L at week 0 to (5.70 ± 0.76) mmol/L (-8.06%, P < 0.05) at week 3 and (5.84 ± 0.75) mmol/L (-5.81%, P < 0.05) at week 6 in placebo group. PSE-enriched milk did not affect plasma HDL-C level and TG level at both week 3 and week 6. After normalization to the placebo group, the treatment group showed significant reduction in LDL-C and total cholesteron after 6 weeks. The observed difference of reduction was 7.69% (-0.33 mmol/L, P < 0.05) for LDL-C and 8.00% (-0.51 mmol/L, P < 0.05) for TC between the two groups. There were no significant changes in safety parameters, including blood biochemistry tests during the study period.
CONCLUSIONPlant sterol ester enriched milk powder is effective in reducing LDL-C among Chinese hypercholesterolemic subjects at a dosage recommended by EFSA.
Animals ; Cholesterol ; Cholesterol, HDL ; Cholesterol, LDL ; Double-Blind Method ; Female ; History, 18th Century ; Humans ; Hypercholesterolemia ; diet therapy ; Lipids ; Male ; Middle Aged ; Milk ; Phytosterols ; pharmacology ; therapeutic use ; Triglycerides