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Feng-Chi Chen, Kuo-Liang Yeh
Pfizer's atorvastatin (Lipitor) is a blockbuster drug for the treatment of cardiovascular diseases. In China, a critical polymorph patent of this drug has been recently invalidated by the Supreme People's Court for insufficiency of disclosure. Here, we discuss the particularities in patent litigation in China worth attention from the community.
September 19, 2016: Trends in Pharmacological Sciences
Mei Sheng Duh, Pierre Cremieux, Marc Van Audenrode, Francis Vekeman, Paul Karner, Haimin Zhang, Paul Greenberg
PURPOSE: To compare the patient characteristics and the inter-temporal reporting patterns of adverse events (AEs) for atorvastatin (Lipitor(®) ) and sibutramine (Meridia(®) ) in social media ( versus the FDA Adverse Event Reporting System (FAERS). METHODS: We identified clinically important AEs associated with atorvastatin (muscle pain) and sibutramine (cardiovascular AEs), compared their patterns in social media postings versus FAERS and used Granger causality tests to assess whether social media postings were useful in forecasting FAERS reports...
December 2016: Pharmacoepidemiology and Drug Safety
Ziming Ye, Ying Liu, Xiao Deng, Xiangren Chen, Cuiting Lin, Yanyan Tang, Ying Su, Lanji Fang, Yuan Wu, Chao Qin
BACKGROUND This retrospective clinical investigation aimed to evaluate the short-term effectiveness and safety of SBCAS for symptomatic bilateral high-grade CS. MATERIAL AND METHODS From 2009 to 2014, 145 patients were recruited. Among them, 70 underwent SBCAS, and other 75 patients underwent SAMM and served as controls. The immediate postprocedural complications and postprocedural neurological evaluation, as well as restenosis at 6-month and 1-year follow-ups in the SBCAS group are reported. Additionally, baseline risk factors for ischemic stroke, adverse effects of drugs, and outcomes at 30-day, 6-month, and 1-year follow-ups were compared between the 2 groups...
August 19, 2016: Medical Science Monitor: International Medical Journal of Experimental and Clinical Research
Cynthia A Jackevicius, Jack V Tu, Harlan M Krumholz, Peter C Austin, Joseph S Ross, Therese A Stukel, Maria Koh, Alice Chong, Dennis T Ko
BACKGROUND: Although generic medications are approved based on bioequivalence with brand-name medications, there remains substantial concern regarding their clinical effectiveness and safety. Lipitor(®), available as generic atorvastatin, is one of the most commonly prescribed statins. Therefore, we compared the effectiveness of generic atorvastatin products and Lipitor(®). METHODS AND RESULTS: We conducted a population-based cohort study, using propensity score matching to minimize potential confounding of patients ≥65 years, discharged alive after acute coronary syndrome (ACS) hospitalization between 2008 and 2012 in Ontario, Canada, who were prescribed Lipitor(®) or generic atorvastatin within 7 days of discharge...
April 19, 2016: Journal of the American Heart Association
Iman S Ahmed, Rania El-Hosary, Samia Shalaby, Marwa M Abd-Rabo, Dalia G Elkhateeb, Samia Nour
In this work lyophilized poly-ε-caprolactone nanoparticles (NPs) loaded with atorvastatin calcium (AC) were developed in an attempt to improve the in-vivo performance of AC following oral administration. The individual and combined effects of several formulation variables were previously investigated using step-wise full factorial designs in order to produce optimized AC-NPs with predetermined characteristics including particle size, drug loading capacity, drug release profile and physical stability. Four optimized formulations were further subjected in this work to lyophilization to promote their long-term physical stability and were fully characterized...
May 17, 2016: International Journal of Pharmaceutics
J F Huang, T Zhan, X L Yu, Q A He, W J Huang, L Z Lin, Y T Du, Y T Pan
The aim of this study was to explore the therapeutic effect of Pleurotus eryngii cellulose on experimental fatty liver in rats. Rats were fed high-fat fodder to establish a rat fatty liver model, and were then fed different concentrations of Pleurotus eryngii cellulose for six weeks. Lipitor was used as a positive control. Measured levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), total cholesterol (TC), and total triglyceride (TG); the activity of malondialdehyde (MDA), superoxide dismutase (SOD), hepatic lipase (HL), and lipoprotein lipase; and liver histopathological changes...
February 26, 2016: Genetics and Molecular Research: GMR
Qiaofei Liu, Yuan Li, Zheyu Niu, Yi Zong, Mengyi Wang, Lutian Yao, Zhaohui Lu, Quan Liao, Yupei Zhao
BACKGROUND: Interactions of inflammatory cells with pancreatic cancer cells play crucial roles in pancreatic cancer, however the dynamic changes of inflammatory cell populations in pancreatic cancerogensis and after chemotherapy have not been well eclucidated. The combinational use of aspirin and atrovastatin (Lipitor) have been widely prescribled for cardio-cerebral vascular diseases mainly by regulation of inflammations, and they have been also reported to have plausible anti-tumor effects, however their potential roles in pancreatic cancerogenesis and chemotherapeutic effects have been seldom investigated...
February 16, 2016: Journal of Experimental & Clinical Cancer Research: CR
Priyanka Prabhu, Vandana Patravale
Atorvastatin calcium (AC) is a BCS class II drug which shows poor bioavailability due to inadequate dissolution. Solid dispersions present a promising option to enhance the solubility of poorly soluble drugs. Co-grinding with hydrophilic excipients is an easy and economical technique to improve the solubility of poorly soluble drugs and is free from usage of organic solvents. The aim of the present study was to explore novel carrier VBP-1 (organosulphur compound) for formulating a solid dispersion by using a simple, commercially viable co-grinding technique to enhance the dissolution of AC and to develop an oral formulation of the same...
August 2016: Drug Delivery and Translational Research
Qunfu Kang, Weihong Liu, Hongxu Liu, Mingxue Zhou
Compound Chuanxiong Capsule (CCC), a Chinese herbal compound, can exhibit antiatherosclerotic effect; however, its mechanism is still unclear. This study is designed to study the mechanism of CCC on atherosclerosis in the ApoE-knockout (ApoE(-/-)) mice fed with a high-fat diet. After 6 weeks of high-fat feeding, 40 ApoE(-/-) mice were randomized (n = 10) and treated with lipitor, high-dose or low-dose CCC, or distilled water (ApoE(-/-) group) for 7 weeks. The blood lipids in serum and the plaque areas of the mice were measured and the mRNA expressions of phosphatidylinositol-3-kinases (PI3K), Akt, nuclear factor-kappa B (NF-κB), tumor necrosis factor-α (TNF-α), and interleukin-6 (IL-6) of the aortae were determined...
2015: Evidence-based Complementary and Alternative Medicine: ECAM
Ju-Hee Oh, Ji Eun Lee, Yu Jeong Kim, Tack-Oon Oh, SungKyun Han, Eun Kyung Jeon, Kyungmin Shin, Dong-Hyun Kim, Chi Hye Park, Young-Joo Lee
Patients with type 2 diabetes mellitus have a high risk of cardiovascular disease mainly caused by dyslipidemia. Metformin and atorvastatin are preferentially used to treat type 2 diabetes mellitus and dyslipidemia, respectively. The aim of this study was to develop a once-a-day fixed-dose combination tablet containing metformin and atorvastatin. For this purpose, we designed gastroretentive bilayer tablets consisting of 500 mg metformin in a sustained release layer and 10 mg atorvastatin in an immediate release layer...
2016: Drug Development and Industrial Pharmacy
Lei Zhang, Qi Zhang, Yun You, Ming-xue Zhou, Li-hua Wang, He-bing Chen, Xian-zhong Yan, Xian-zhong Liu, Wei-hong Liu
OBJECTIVE: To explore evolution rules of phlegm and blood stasis syndrome ( PBSS) in hyperlipidemia and atherosclerosis (AS) using NMR-based metabolic profiling and metabonomic approaches based on formulas corresponding to syndrome. METHODS: Totally 150 SD rats were divided into the normal group, the model group, the Erchen Decoction (ED) group, the Xuefu Zhuyu Decoction (XZD) group, the Lipitor group, 30 in each group. The hyperlipidemia and AS rat model was duplicated by suturing carotid artery, injecting vitamin D3, and feeding with high fat diet...
July 2015: Chinese Journal of Integrated Traditional and Western Medicine
Thomas Faunce
In Australian Competition and Consumer Commission v Pfizer Australia Pty Ltd [2015] FCA 113, the ACCC alleged that Pfizer's "Project LEAP" involved a scheme to lock pharmacists into substituting its generic version of the high sales volume anti-cholesterol drug, patent-expired atorvastatin (Lipitor), which took advantage of a substantial degree of market power for a purpose proscribed by s 46(1)(c) of the Competition and Consumer Act 2010 (Cth). The ACCC also claimed that Pfizer's actions constituted a course of exclusive dealing pursuant to s 47(1)(d) and (e) for the proscribed purpose of lessening competition...
June 2015: Journal of Law and Medicine
Jong-Min Han, Jin-Seok Lee, Hyeong-Geug Kim, In-Chan Seol, Hwi-Jin Im, Jung-Hyo Cho, Chang-Gue Son
ETHNOPHARMACOLOGICAL RELEVANCE: The medicinal plants Artemisia iwayomogi and Curcuma longa radix are both used to treat hyperlipidemia in traditional Korean and Chinese medicine. AIM OF THE STUDY: To evaluate the anti-hyperlipidemic effects of the 30% ethanol extracts of A. iwayomogi (AI), C. longa (CL), and the mixture of A. iwayomogi and C. longa (ACE), using a high-fat diet-induced hyperlipidemia model. MATERIALS AND METHODS: Six of seven groups of C57BL/6N male mice (i...
September 15, 2015: Journal of Ethnopharmacology
Yuan-zheng Sun, Jing Song
OBJECTIVE: To observe the clinical effect of acupuncture therapy combined with Lipitor in the treatment of primary hyperlipidemia (spleen deficiency and food stagnation type). METHODS: Sixty primary hyperlipidemia patients (spleen deficiency and food stagnation type) were equally randomized into medication group and acupuncture plus medication group. Patients of both groups were treated by oral administration of Lipitor (20 mg/tablet, one tablet per day) for 6 weeks...
February 2015: Zhen Ci Yan Jiu, Acupuncture Research
Xiaoyan Dou, Jing Wei, Aiqin Sun, Genbao Shao, Chandra Childress, Wannian Yang, Qiong Lin
PDZ binding-kinase (PBK) (also named T-lymphokine-activated killer cell-originated protein kinase (TOPK)), a serine/threonine kinase, is tightly controlled in normal tissues but elevated in many tumors, and functions in tumorigenesis and metastasis. However, the signaling that regulates expression of PBK in cancer cells remains elusive. Here we show that atorvastatin (Lipitor), an inhibitor of hydroxymethylglutaryl co-enzyme A (HMG-CoA) reductase that is a rate-limiting enzyme of mevalonate pathway, down-regulates expression of PBK by impairing protein geranylgeranylation...
2015: Cancer Cell International
Yun-Zhou Zhao, Hai-Bin Yang, Xiang-Ying Tang, Min Shi
Rh(II)-catalyzed intermolecular [3+2] cycloaddition of 2 H-azirines with N-sulfonyl-1,2,3-triazoles is disclosed, in which a series of fully functionalized pyrroles is produced via rhodium azavinyl carbene intermediates. A distinct feature of this reaction is that the azavinyl carbene serves as a [2 C] equivalent, instead of as [1 C] or aza-[3 C] synthons, which have been reported previously in cyclopropanations and [3+n] cycloadditions. Moreover, this methodology has also been successfully applied in the total synthesis of URB447 as well as the formal synthesis of Atorvastatin (Lipitor)...
February 23, 2015: Chemistry: a European Journal
Mallesh Kurakula, A M El-Helw, Tariq R Sobahi, Magdy Y Abdelaal
Cationic charged chitosan as stabilizer was evaluated in preparation of nanocrystals using probe sonication method. The influence of cationic charge densities of chitosan (low CS(L), medium CS(M), high CS(H) molecular weights) and Labrasol(®) in solubility enhancement and modifying the release was investigated, using atorvastatin (ATR) as poorly soluble model drug. Compared to CS(M) and CS(H); low cationic charge of CS(L) acted as both electrostatic and steric stabilizer by significant size reduction to 394 nm with charge of 21...
2015: International Journal of Nanomedicine
Jeffrey M Vinokur, Tyler P Korman, Michael R Sawaya, Michael Collazo, Duillio Cascio, James U Bowie
In animals, cholesterol is made from 5-carbon building blocks produced by the mevalonate pathway. Drugs that inhibit the mevalonate pathway such as atorvastatin (lipitor) have led to successful treatments for high cholesterol in humans. Another potential target for the inhibition of cholesterol synthesis is mevalonate diphosphate decarboxylase (MDD), which catalyzes the phosphorylation of (R)-mevalonate diphosphate, followed by decarboxylation to yield isopentenyl pyrophosphate. We recently discovered an MDD homolog, mevalonate-3-kinase (M3K) from Thermoplasma acidophilum, which catalyzes the identical phosphorylation of (R)-mevalonate, but without concomitant decarboxylation...
February 2015: Protein Science: a Publication of the Protein Society
Steven R Erickson, Paul Workman
OBJECTIVE: To document the availability of selected pharmacy services and out-of-pocket cost of medication throughout a diverse county in Michigan and to assess possible associations between availability of services and price of medication and characteristics of residents of the ZIP codes in which the pharmacies were located. DESIGN: Cross-sectional telephone survey of pharmacies coupled with ZIP code-level census data. SETTING: 503 pharmacies throughout the 63 ZIP codes of Wayne County, MI...
November 2014: Journal of the American Pharmacists Association: JAPhA
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