A dose-specific meta-analysis of lipid changes in randomized controlled trials of atorvastatin and simvastatin

Rogers, Sophie; Magliano, Dianna J.; Levison, Dane B.; Webb, Kate; Clarke, Philippa; Grobler, Mendel P; Liew, Danny

doi:10.1016/j.clinthera.2007.02.001

Cited by 33 publications

(21 citation statements)

References 28 publications

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“…Several clinical trials reported HDL increasing beneficial effect of atorvastatin. 25 These results were in agreement with those of Meena who reported that treatment with commercial formulation of atorvastatin calcium (Lipicure) and Poly lactideco-glycolic acid (PLGA) nanoparticles formulations had shown almost equal effects in reducing levels of CHO, TG, LDL-C and elevated HDL-C levels. 5 Nanoparticles have been reported to increase the absorption of the encapsulated drugs when compared to the suspension form or any simple formulation type of the drug.…”

Section: Discussionsupporting

confidence: 82%

Biochemical and histopathological assessment of atorvastatin-loaded nanoemulsion effectiveness in Rats

Balamash

Al-ddyni

2018

Int J Basic Clin Pharmacol

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Background: Atorvastatin (ATV), a lipid lowering agent, has low solubility and poor dissolution affects its oral bioavailability. Nanoemulsion (NE) has been developed to improve the delivery of therapeutic agents. This study was aimed to assess the ability of the NE in enhancing ATV bioavailability and minimizing its side effects in hyperlipidemic rats.Methods: Thirty-five rats divided into seven groups were utilized in this study. Hyperlipidemia was induced by feeding rats high fat diet (HFD) for 3 months. The antihyperlipidemic activity of 10 and 20 mg/kg of ATV loaded in two different delivery systems; nanoemulsion (10% and 20% ATV-LNE) or in water (10% and 20% ATV-sol), were investigated. At the end of the experiment, body weight, serum and plasma biochemical parameters (lipid profile, glucose, insulin, liver and kidney functions, oxidative stress markers were assessed. Liver and kidney were histopathologically examined. The physical characteristics of NE were determined by the Zetasizer (the z-average diameter and zeta potential).Results: 20% ATV-LNE had the smallest nanoparticles (38.12±6.71nm) whereas it had the largest zeta negative potential of -26.8±4.16mV. The serum biochemical results and the histopathological examination revealed that treatment with 20% ATV-LNE improved the lipid profile by significantly increasing HDL and decreasing cholesterol and low-density lipoprotein. Both 10 and 20% ATV-LNE reduced serum glucose level compared to other used formulas.Conclusions: NE formulas have the potential to improve the bioavailability and efficacy of ATV and reduce its side effects.

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Section: Discussionsupporting

confidence: 82%

Biochemical and histopathological assessment of atorvastatin-loaded nanoemulsion effectiveness in Rats

Balamash

Al-ddyni

2018

Int J Basic Clin Pharmacol

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“…Secondly, reduction in hepatic cholesterol levels would lead to an increase in LDL-receptor expression and hence increased binding of VLDL and LDL particles reduction in both cholesterol and triglyceride levels [24]. There have been a number of clinical trials reporting the HDL-C increasing beneficial effect of atorvastatin [25], however, there is no established mechanism explaining this phenomenon. Another pleiotropic effect of atorvastatin includes insulin sensitization through which it reduces the glucose levels to some extent.…”

Section: In Vivo Efficacy Parametersmentioning

confidence: 99%

Oral Nanoparticulate Atorvastatin Calcium is More Efficient and Safe in Comparison to Lipicure^® in Treating Hyperlipidemia

Meena

Ratnam

Godugu

et al. 2008

Lipids

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Atorvastatin calcium (AC) is a second-generation 3-hydroxy-3-methylglutaryl-CoA reductase inhibitor approved for clinical use as a lipid lowering agent. AC, the world's best selling drug is associated with poor oral bioavailability and serious adverse effects like rhabdomyolysis on chronic administration. A biodegradable nanoparticulate approach was introduced here with a view to improving the efficacy and safety of AC. Poly lactide-co-glycolic acid (PLGA) nanoparticles containing atorvastatin calcium were prepared using two stabilizers i.e. didodecyl dimethyl ammonium bromide (DMAB) and Vitamin E tocopheryl polyethylene glycol 1000 succinate (Vit E-TPGS) using a co-solvent approach by emulsion-diffusion-evaporation method. AC loaded PLGA nanoparticles prepared using DMAB and Vit E-TPGS were found to be 120.0 +/- 4.2 nm and 140.0 +/- 1.5 nm (z-average) in size respectively. In vitro release studies at pH 7.4 revealed a zero order release profile for nanoparticles. Efficacy and safety parameters of the prepared nanoparticles against marketed formulation were evaluated in high fat diet fed (hyperlipidemic) rats. It was found that atorvastatin calcium nanoparticles were equally effective in comparison to Lipicure, at a 66%-reduced dose in treating the hyperlipidemia characterized by alterations in PTC, LDL-C, VLDL-C, HDL-C, PTG and PGL in the high fat diet fed rats. On the other hand, when evaluated for safety, nanoparticulate formulation showed no/negligible myotoxicity characterized by lower PC, BUN, CK, LDH and AST levels in comparison to the marketed formulation.

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“…Assuming a 2:1 ratio of LDL-C lowering potency for atorvastatin versus simvastatin [7,10], SFK data from the first 3 months of 2009 indicate that 33.7%, 47.2% and 19.1% of switches from atorvastatin were to less potent, equipotent and more potent doses, respectively, of generic simvastatin. The weighted average daily dose of initial atorvastatin was 19.6 mg, and 32.9 mg for switched generic simvastatin.…”

Section: Patterns Of Switching From Atorvastatin and Generic Simvastatinmentioning

confidence: 99%

Potential cardiovascular consequences of switching from atorvastatin to generic simvastatin in the Netherlands

Liew

Webb²,

Meerding³

et al. 2012

Neth Heart J

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Background The statin authorisation form implemented in the Netherlands in January 2009 has led to significant switching of patients from atorvastatin to generic simvastatin, but often to less than equipotent doses. We sought to assess the potential consequences of this. Methods A modelling analysis was undertaken using data from a pharmacy database covering the majority of drug prescriptions in the Netherlands. Recent meta-analyses provided data on the dose-specific, lipid-modifying potencies of atorvastatin and simvastatin, and the relationship between reduction in low-density lipoprotein cholesterol (LDL-C) achieved by statin therapy and relative reduction in risk of cardiovascular disease (CVD). Results In the first quarter of 2009, 33.7%, 47.2% and 19.1% of Dutch patients initially on atorvastatin were switched to less potent, equipotent and more potent doses of simvastatin, respectively. The net effect was estimated to be a 6.8% increase in LDL-C. Assuming a pre-switch LDL-C of 2 mmol/L, the predicted relative increases (95%CI) in the risks of all-cause mortality and major cardiovascular events were 1.7% (0.9%-2.6%) and 2.8% (1.6%-4.1%), respectively. Conclusions In the Netherlands, policy-driven switching from atorvastatin to generic simvastatin led overall to less potent doses being used, with possible significant clinical implications.

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A dose-specific meta-analysis of lipid changes in randomized controlled trials of atorvastatin and simvastatin

Cited by 33 publications

References 28 publications

Biochemical and histopathological assessment of atorvastatin-loaded nanoemulsion effectiveness in Rats

Biochemical and histopathological assessment of atorvastatin-loaded nanoemulsion effectiveness in Rats

Oral Nanoparticulate Atorvastatin Calcium is More Efficient and Safe in Comparison to Lipicure^® in Treating Hyperlipidemia

Potential cardiovascular consequences of switching from atorvastatin to generic simvastatin in the Netherlands

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A dose-specific meta-analysis of lipid changes in randomized controlled trials of atorvastatin and simvastatin

Cited by 33 publications

References 28 publications

Biochemical and histopathological assessment of atorvastatin-loaded nanoemulsion effectiveness in Rats

Biochemical and histopathological assessment of atorvastatin-loaded nanoemulsion effectiveness in Rats

Oral Nanoparticulate Atorvastatin Calcium is More Efficient and Safe in Comparison to Lipicure® in Treating Hyperlipidemia

Potential cardiovascular consequences of switching from atorvastatin to generic simvastatin in the Netherlands

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Oral Nanoparticulate Atorvastatin Calcium is More Efficient and Safe in Comparison to Lipicure^® in Treating Hyperlipidemia