In the Multicenter Anti-Atheroma Study, the effect of Simvastatin on atherosclerosis was assessed by quantitative coronary angiography in hypercholesterolemic patients with CHD. 1 The resultant reduction in hepatocyte cholesterol concentration triggers increased expression of hepatic LDL receptors, which clear LDL and LDL precursors from the circulation. (Mean % Change at Week 6) It is recommended that liver function tests be performed before the initiation of Simvastatin, and thereafter when clinically indicated. There was decreased fertility in male rats treated with Simvastatin for 34 weeks at 25 mg/kg body weight (4 times the maximum human exposure level, based on AUC, in patients receiving 80 mg/day); however, this effect was not observed during a subsequent fertility study in which Simvastatin was administered at this same dose level to male rats for 11 weeks (the entire cycle of spermatogenesis including epididymal maturation). L55351090619 therefore LDL level in plasma reduces. Simvastatin 80 mg q.p.m.¶. No evidence of mutagenicity was observed in a microbial mutagenicity (Ames) test with or without rat or mouse liver metabolic activation. * For patients with HoFH who have been taking 80 mg Simvastatin chronically (e.g., for 12 months or more) without evidence of muscle toxicity, do not exceed 40 mg Simvastatin when taking lomitapide. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3… CHD mortality, Secondary Patients who have a lipid disorder and are breastfeeding should be advised to discuss the options with their healthcare professional. Optic nerve degeneration was seen in clinically normal dogs treated with Simvastatin for 14 weeks at 180 mg/kg/day, a dose that produced mean plasma drug levels about 12 times higher than the mean plasma drug level in humans taking 80 mg/day. First pass in liver In this multicenter, randomized, double-blind, placebo-controlled study, patients were treated with standard care, including diet, and either Simvastatin 20 to 40 mg/day (n=2,221) or placebo (n=2,223) for a median duration of 5.4 years. This site needs JavaScript to work properly. Inclusion in the study required a baseline LDL-C level between 160 and 400 mg/dL and at least one parent with an LDL-‑C level >189 mg/dL. It is also used to decrease the risk of heart problems in those at high risk. The results of a subgroup analysis in 74 patients with type IV hyperlipidemia from a 130-patient, double-blind, placebo-controlled, 3-period crossover study are presented in Table 6. Simvastatin significantly reduced the risk of mortality by 30% (p=0.0003, 182 deaths in the Simvastatin group vs 256 deaths in the placebo group). Statins typically cause mild side effects, if any, but these drugs can, rarely, cause significant, and even life threatening, adverse effects. Effects of statins on vascular wall: vasomotor function, inflammation, and plaque stability. Patients using the 80 mg dose should be informed that the risk of myopathy, including rhabdomyolysis, is increased with use of the 80 mg dose. An overview on the mechanism of action of statins: HMG CoA reductase inhibitors,or statins are widely prescribed drugs. N = number of patients in each subgroup. In addition, Simvastatin significantly decreased the proportion of patients with new lesions and with new total occlusions. Drug treatment also significantly increased the incidence of lung adenomas in mid- and high-dose males and females. Clinically relevant pleiotropic effects of statins: drug properties or effects of profound cholesterol reduction? 2001 Oct;11(5):328-43. Reduce cholesterol synthesis results in a compensatory increase in uptake of plasma cholesterol mediated by an increase in the number of LDL receptors. Thyroid follicular cell adenomas were increased in males and females at both doses; thyroid follicular cell carcinomas were increased in females at 100 mg/kg/day. Mahabubnagar (Dt)-509302 Maximum effect: 4-6 weeks. Vytorin reduces total cholesterol and low density lipoprotein (LDL or "bad") cholesterol while it increases high density lipoprotein (HDL or "good") cholesterol. Simvastatin significantly decreased plasma levels of total-C, LDL-C, and Apo B (see Table 8). The risk of myopathy, including rhabdomyolysis, is greater in patients on Simvastatin 80 mg compared with other statin therapies with similar or greater LDL-C-lowering efficacy and compared with lower doses of Simvastatin. The beneficial effects of statins are the result of their capacity to reduce cholesterol biosyntesis, mainly in the liver, where they are selectively distributed, as well as to the modulation of lipid metabolism, derived from their effect of inhibition upon HMG-CoA reductase. We comply with the HONcode standard for trustworthy health information -, Dosage and Administration, Restricted Dosing for 80 mg (2.2), Patients with Homozygous Familial Hypercholesterolemia (2.4).  |  Comparato C, Altana C, Bellosta S, Baetta R, Paoletti R, Corsini A. Nutr Metab Cardiovasc Dis. The randomization was stratified by angina alone (21% of each treatment group) or a previous MI. Ding QY, Tian JX, Li M, Lian FM, Zhao LH, Wei XX, Han L, Zheng YJ, Gao ZZ, Yang HY, Fang XY, Tong XL. CNS vascular lesions, characterized by perivascular hemorrhage and edema, mononuclear cell infiltration of perivascular spaces, perivascular fibrin deposits and necrosis of small vessels were seen in dogs treated with Simvastatin at a dose of 360 mg/kg/day, a dose that produced mean plasma drug levels that were about 14 times higher than the mean plasma drug levels in humans taking 80 mg/day. In another 24-week study, Simvastatin 20 to 40 mg had no detectable effect on spermatogenesis. Nutrients.  |  In a study of 12 healthy volunteers, Simvastatin at the 80 mg dose had no effect on the metabolism of the probe cytochrome P450 isoform 3A4 (CYP3A4) substrates midazolam and erythromycin. Please enable it to take advantage of the complete set of features!