Clinically relevant differences between the statins: implications for therapeutic selection

Chong, Pang H; Seeger, John D.; Franklin, Cory

doi:10.1016/s0002-9343(01)00870-1

Cited by 179 publications

(158 citation statements)

References 77 publications

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“…Simvastatin is mainly metabolized by CYP3A4, while more than 90% of fluvastatin undergoes CYP2C9 biotransformation and pravastatin is eliminated mainly unchanged. [15][16][17] Therefore, differences in genetic variations in drug-metabolizing enzymes and even in other genes associated with lipid metabolism may be important to explain these differences. Second, possible gender differences in response to these medications may occur; in both previous investigations, samples consisted mainly of males, while in our study only 25.3% were men.…”

Section: Srebf-scap Pathway Snps and Variable Response To Simvastatinmentioning

confidence: 99%

Determinants of variable response to simvastatin treatment: the role of common variants of SCAP, SREBF-1a and SREBF-2 genes

et al. 2005

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We investigated the effect of single-nucleotide polymorphisms in sterol regulatory element-binding factors-1a and -2 (SREBF-1a and SREBF-2) and SREBF cleavage-activating protein (SCAP) genes on lipid-lowering response to simvastatin. In all, 146 hypercholesterolemic patients of European descent were prospectively treated with simvastatin 20 mg/day for over 6 months. Of these 99 subjects completed the 6-month follow-up. Plasma lipids and lipoproteins were measured before and throughout the study. The mean percentage decrease in plasma total cholesterol (TC) was greater in subject carriers of SCAP 2386G allele compared with those homozygous for 2386A allele (À29.6713.4 vs À22.1713.8%, P ¼ 0.007). About 61% of the 2386G carriers were above-average responders for TC levels (DTC À27.8%), whereas only 29% of 2386A homozygous reached this reduction (P ¼ 0.009). Our data suggest that the SCAP 2386A4G gene polymorphism was a significant predictor of TC and triglyceride responses to simvastatin treatment.

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Section: Srebf-scap Pathway Snps and Variable Response To Simvastatinmentioning

confidence: 99%

Determinants of variable response to simvastatin treatment: the role of common variants of SCAP, SREBF-1a and SREBF-2 genes

et al. 2005

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“…However, as the development of generic drugs is mainly based on pharmacological properties of the original brand, one would expect the same quality and almost similar effects like that of the original brand. 13 There is insufficient pharmacokinetics and bioequivalence study on widely used drugs in Bangladesh and atorvastatin is one of them. Similarly, no pharmacokinetics and bioequivalence evaluation of atorvastatin 40mg tablet have been established yet in Bangladesh despite enormous prescribing of atorvastatin from primary to tertiary care facilities.…”

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confidence: 99%

Bioequivalence Studies and Pharmacokinetic Properties of Atorvastatin 40Mg Tablet in Healthy Bengali Subjects

Saha

Khan

Poddar

et al. 2017

MOJBB

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Abbreviations: t max , time to reach the maximum concentration; C max , maximum plasma concentration; t 1/2 , half-life; AUC 0-24 , area under the plasma time curve up to last quantifiable time; AUC 0-∞ , area under the plasma time curve up to time infinity; k el , elimination rate constant; NCDs, non-communicable diseases; DGDA, directorate general of drug administration; TPR, total peripheral resistance IntroductionThere is an emerging importance of bioequivalence and pharmacokinetics analysis of highly prescribed brand drugs to judge their therapeutic effectiveness, toxicity, and quality to ensure therapeutic validity and patient's safety. Statin classes of lipidlowering agents are most commonly used treatment intervention for Non-Communicable Diseases (NCDs) like diabetes, obesity, hypertension, and dyslipidemia.1 Atorvastatin is an FDA approved synthetic lipid reducing agent under statin class. This drug, also known as 2-(4-fluorophenyl) -βR, δR-dihydroxy-5-(1-methyl ethyl)-3-phenyl-4(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid (Figure 1), is a second generation 3-hydroxy-3-methylglutaryl-CoA reductase inhibitor.2 This synthetic HMG-CoA reductase inhibitor significantly lowers total cholesterol, low-density lipoprotein cholesterol, and plasma triglycerides in clinical studies.3 According to IMS Health, Lipitor, the pioneer brand of atorvastatin is the world's one of the biggest selling prescription medicines with cumulative sales in excess of $130 billion, but most of the principal brands are now prescribed worldwide as far cheaper generic medicines. In Bangladesh, about 50 atorvastatin brands with different strengths and dosage forms are available and their average sales volume is nearly 1.17 crore taka monthly in the national local market according to Bangladesh Directorate General of Drug Administration (DGDA). This indicates widespread prescribing of this cholesterol-lowering drug in Bangladesh. However, there is no bioequivalence data for any of existing 50 brands of atorvastatin. Dose-dependent lowering of total cholesterol, LDL cholesterol and triglyceride levels have been noticed after oral administration of atorvastatin to patients with hypercholesterolemia and to patients who have hypertriglyceridemia. 4,5 The usual starting dose is 10mg atorvastatin daily. The dose should be adjusted in accordance with plasma lipid levels and can be increased to up to 80mg daily. AbstractThe present study is aimed to investigate the single-dosing pharmacokinetics of two pharmaceutical formulations of atorvastatin 40mg tablet, test (T) sample (Stacor®) and reference (R) sample (Lipitor®) in Bengali subjects. An open-label, randomizedsequence, two-way, two-period crossover study was designed with 24 healthy Bengali male volunteers. Plasma samples collected before and over 0.5-72.0h after a single oral dose per subject. Samples were analyzed by solid phase extraction method and a validated LCMS/MS method. The non-compartmental pharmacokinetic model was used to measure pharmacokinetic parameters of peak plas...

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“…All these beneficial effects have led physicians to consider statins as a useful intervention for atherosclerotic diseases (25). Therefore, when the lipid-lowering effect of the initial lipid-lowering therapy is inadequate, a stronger medicine should be used (26)(27). We found in our study that fibrates were often used for the treatment of hyperlipidemia.…”

Section: Drug Treatment Of Hyperlipidemiamentioning

confidence: 67%

Current Status of Lipid Management of Hypertensive Patients

et al. 2003

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Clinically relevant differences between the statins: implications for therapeutic selection

Cited by 179 publications

References 77 publications

Determinants of variable response to simvastatin treatment: the role of common variants of SCAP, SREBF-1a and SREBF-2 genes

Determinants of variable response to simvastatin treatment: the role of common variants of SCAP, SREBF-1a and SREBF-2 genes

Bioequivalence Studies and Pharmacokinetic Properties of Atorvastatin 40Mg Tablet in Healthy Bengali Subjects

Current Status of Lipid Management of Hypertensive Patients

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