|By PR Newswire||
|November 14, 2012 03:02 AM EST||
WOKINGHAM, England, November 14, 2012 /PRNewswire/ --
On World Diabetes Day, outputs from a consultation with physicians, including cardiologists and diabetologists, held during the World Congress on Prevention of Diabetes and its Complications (WCPD) in Madrid, has highlighted a requirement for improved guidance on how to treat cardiovascular disease risk in patients at risk of developing diabetes.
This call for guidance has come in response to further evidence presented at the WCPD that demonstrates how statins differ in their effect on developing diabetes., In addition, consulted physicians noted that recent warnings about the potential for statins to cause diabetes in certain patients were causing other treating physicians to be more cautious about prescribing these lipid-lowering drugs.
"Although no-one doubts the huge benefit of statins in reducing cardiovascular disease," said Prof Kausik Ray, Professor of Cardiovascular Disease Prevention, St George's, University of London, "these insights demonstrate how the medical community is taking the diabetogenic risk of statins seriously and highlight the need for further research and guidance in how to treat patients with high cholesterol who are at risk of developing diabetes."
Although statins are considered safe and well-tolerated, conflicting data exist regarding the effects of some statins on the risk of developing diabetes. The largest meta-analysis of these data included 13 trials with a total of 91,140 participants and concluded that statin therapy is associated with a 9% increased risk of new-onset diabetes. These studies resulted in a change made to the labels of some statins to include a warning of this risk.
Mechanisms explaining the potentially higher incidence of diabetes with statin therapy have not yet been identified and studies looking at statins' effect on glucose metabolism suggest that the effect may differ between statins. There are a number of markers that can be used to measure impacts on glucose metabolism such as increased fasting plasma glucose and HbA1c in the blood. Some statins (e.g. atorvastatin) have been associated with increased HbA1c levels in patients receiving intensive, but not moderate, therapy., Other statins (e.g. pitavastatin) have demonstrated neutral or favourable effects on glucose control in patients with and without diabetes or metabolic syndrome.-
New data presented during the WCPD demonstrated that both pitavastatin and pravastatin have no effect on fasting plasma glucose over 12 weeks in elderly patients and over 6 months in a group of patients with carefully defined metabolic syndrome who have multiple risk factors for diabetes. These data add to the building body of evidence suggesting pitavastatin has a positive effect on glucose metabolism and hence may not carry the same risk of developing diabetes as other statins.,- The J-PREDICT trial, currently being undertaken in Japan, will aim to clarify these data by evaluating the effect of pitavastatin on the risk for diabetes in more than 1,200 people with impaired glucose tolerance. This study is due to finish in 2015.
About the consultation
The consultation was conducted at the KOWA sponsored satellite symposium held during the World Congress on Prevention of Diabetes and its Complications (WCPD) from 11-14 November 2012 in Madrid, Spain.
LIVAZO® (pitavastatin) is a HMG-CoA reductase inhibitor indicated for patients with primary hyperlipidemia and mixed dyslipidemia as an adjunctive therapy to diet to reduce elevated TC, LDL-C, Apo B, TG, and to increase HDL-C. LIVAZO® is predominantly metabolized via glucuronidation and is only minimally metabolised by CYP system, which may help reduce its potential for CYP-mediated drug-drug interactions.
LIVAZO®, also known as LIVALO® and ALIPZA® in some markets, has been available in Spain, Portugal and Lebanon since 2011 and is available in the US (2010), Mexico (2012), Japan (2003), South Korea (2005), Thailand (2008), China (2009), Indonesia (2012) and Taiwan (2012).
In much of Europe, pitavastatin will be marketed by Recordati as LIVAZO®. Pitavastatin is available in three dosage strengths (1mg, 2mg and 4mg). For more information about the geographical availability of pitavastatin and marketing companies please visit the Kowa Pharmaceutical Europe website www.kowapharmaceuticals.eu
Kowa Company, Ltd. (KCL) is a privately held multinational company headquartered in Nagoya, Japan. Established in 1894, KCL is actively engaged in various business fields with major focuses on the manufacturing and sales of pharmaceutical products, LED lighting equipment and green products, and the trading of textile goods, machinery, building materials and chemical products. KCL's pharmaceutical division was founded in 1947, and is focused on cardiovascular therapeutics, with sales of the company's flagship product, pitavastatin (known as LIVALO®, LIVAZO® and ALIPZA® in different markets) totalling €500 million (approximately 16% market share) in Japan during 2011 fiscal year.
Kowa Research Europe Ltd. (KRE), established in 1999 in the United Kingdom, is responsible for European clinical trials for Kowa's strategic global pharmaceutical development.
Kowa Pharmaceutical Europe (KPE) Co. Ltd, established in 2000, is a specialty pharmaceutical company located in Wokingham, UK, focused primarily on cardiometabolic therapeutics. Working in harmony with KRE, these European pharmaceutical divisions of Japanese Kowa Company, Ltd. are committed to ground-breaking research, development and marketing to ensure quality products are made available to people around the world, enabling them to enjoy a better standard of health and a more comfortable life.
Visit our New Website: www.Kowapharmaceuticals.eu/
- Kowa data on file. Report from consultation at the KOWA sponsored satellite symposium held during the World Congress on Prevention of Diabetes and its Complications (WCPD) from 11-14 November 2012 in Madrid, Spain.
- Sponseller CA, Stender S, Zhu B, et al. Neutral effects of pitavastatin and pravastatin on fasting plasma glucose over 12 weeks in elderly patients with primary hyperlipidemia or mixed lipidemia. Abstract 2421526. Presented at the 7th World Congress on Prevention of Diabetes and its Complications 2012. Madrid, Spain.
- Hounslow N, Robillard P, Suzuki M, et al. Pitavastatin is without effect on glycaemic parameters in metabolic syndrome. Abstract 7161542. Presented at the 7th World Congress on Prevention of Diabetes and its Complications 2012. Madrid, Spain.
- Armitage J. The safety of statins in clinical practice. Lancet. 2007;370:1781-90.
- Sattar N, Preiss D, Murray HM, et al. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet. 2010;375(9716):735-742.
- Koh KK, Quon MJ, Han SH, et al. Atorvastatin causes insulin resistance and increases ambient glycemia in hypercholesterolemic patients. J Am Coll Cardiol 2010;55:1209-1216.
- Sabatine MS, Wiviott SD, Morrow DA, et al. High-dose atorvastatin associated with worse glycemic control: a PROVE-IT TIMI 22 substudy. Circ. 2004;110(Suppl 3):834.
- Yamakawa T, Takano T, Tanaka S, et al. Influence of pitavastatin on glucose tolerance in patients with type 2 diabetes mellitus. J Atheroscler Thromb. 2008;15:269-275.
- Yokote K, Saito Y. Influence of statins on glucose tolerance in patients with type 2 diabetes mellitus: subanalysis of the collaborative study on hypercholesterolemia drug intervention and their benefits for atherosclerosis prevention (CHIBA study). J Atheroscler Thromb. 2009;16:297-298.
- Teramoto T, Urashima M, Shimano H, et al. A large-scale study on cardio-cerebrovascular events during pitavastatin (LIVALO tablet) therapy in Japanese patients with hypercholesterolemia LIVES 5-year extension study. Jpn Pharmacol Ther. 2011;39:789-803.
- Teramoto T, Shimano H, Yokote K, Urashima M. New evidence on pitavastatin: efficacy and safety in clinical studies. Expert Opin Pharmacother. 2010;11:817-828.
- Saku K, Zhang B, Noda K, et al. Randomized head-to-head comparison of pitavastatin, atorvastatin and rosuvastatin for safety and efficacy - The PATROL study. Circ J. 2011;75(6):1493-505.
- Kryzhanovski V, Morgan R, Sponseller C et al. Pitavastatin 4mg provides significantly greater reduction in LDL-C compared to pravastatin 40mg with neutral effects on glucose metabolism: prespecified safety analysis from the short-term phase 4 prevail UK trial in patients with primary hyperlipidemia or mixed dyslipidemia. JACC. 2012;59:E1692
- Baker WL, Talati R, White CM, Coleman CI. Differing effect of statins on insulin sensitivity in non-diabetics: a systematic review and meta-analysis. Diabetes Res Clin Pract. 2010;87(1):98-107.
- Gumprecht J, Gosho M, Budinski D, Hounslow N. Comparative long-term efficacy and tolerability of pitavastatin 4 mg and atorvastatin 20-40 mg in patients with type 2 diabetes mellitus and combined (mixed) dyslipidaemia. Diabetes Obes Metab. 2011;13(11):1047-55.
- Kryzhanovski V, Eriksson M, Hounslow N and Sponseller C. Short-term and long-term effects of pitavastatin and simvastatin on fasting plasma glucose in patients with primary hyperlipidemia or mixed dyslipidemia and >2 risk factors for coronary heart disease. J Am Coll Cardiol. 2012;59(13s1):E1659.
- Yamazaki T, Kishimoto J, Ito C et al. Japan Prevention Trial of Diabetes by Pitavastatin in Patients With Impaired Glucose Tolerance (the J-PREDICT study): rationale, study design, and clinical characteristics of 1269 patients. Diabetol Int. 2011;2:134-40.
- Pitavastatin Summary of Product Characteristics. Available at http://www.kowapharmaceuticals.eu/_client/pdfs/livazo_smpc.pdf Accessed Sep 2012
SYS-CON Events announced today that Secure Infrastructure & Services will exhibit at SYS-CON's 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Secure Infrastructure & Services (SIAS) is a managed services provider of cloud computing solutions for the IBM Power Systems market. The company helps mid-market firms built on IBM hardware platforms to deploy new levels of reliable and cost-effective computing and hig...
Jul. 3, 2015 12:15 PM EDT
In the midst of the widespread popularity and adoption of cloud computing, it seems like everything is being offered “as a Service” these days: Infrastructure? Check. Platform? You bet. Software? Absolutely. Toaster? It’s only a matter of time. With service providers positioning vastly differing offerings under a generic “cloud” umbrella, it’s all too easy to get confused about what’s actually being offered. In his session at 16th Cloud Expo, Kevin Hazard, Director of Digital Content for SoftL...
Jul. 3, 2015 12:00 PM EDT Reads: 2,283
It is one thing to build single industrial IoT applications, but what will it take to build the Smart Cities and truly society-changing applications of the future? The technology won’t be the problem, it will be the number of parties that need to work together and be aligned in their motivation to succeed. In his session at @ThingsExpo, Jason Mondanaro, Director, Product Management at Metanga, discussed how you can plan to cooperate, partner, and form lasting all-star teams to change the world...
Jul. 3, 2015 12:00 PM EDT Reads: 2,338
"What Dyn is able to do with our Internet performance and our Internet intelligence is give companies visibility into what is actually going on in that cloud," noted Corey Hamilton, Product Marketing Manager at Dyn, in this SYS-CON.tv interview at 16th Cloud Expo, held June 9-11, 2015, at the Javits Center in New York City.
Jul. 3, 2015 11:45 AM EDT Reads: 762
Today air travel is a minefield of delays, hassles and customer disappointment. Airlines struggle to revitalize the experience. GE and M2Mi will demonstrate practical examples of how IoT solutions are helping airlines bring back personalization, reduce trip time and improve reliability. In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect with GE, and Dr. Sarah Cooper, M2Mi’s VP Business Development and Engineering, will explore the IoT cloud-based platform technologies drivi...
Jul. 3, 2015 11:45 AM EDT Reads: 1,149
Containers have changed the mind of IT in DevOps. They enable developers to work with dev, test, stage and production environments identically. Containers provide the right abstraction for microservices and many cloud platforms have integrated them into deployment pipelines. DevOps and Containers together help companies to achieve their business goals faster and more effectively. In his session at DevOps Summit, Ruslan Synytsky, CEO and Co-founder of Jelastic, reviewed the current landscape of...
Jul. 3, 2015 11:15 AM EDT Reads: 2,356
Explosive growth in connected devices. Enormous amounts of data for collection and analysis. Critical use of data for split-second decision making and actionable information. All three are factors in making the Internet of Things a reality. Yet, any one factor would have an IT organization pondering its infrastructure strategy. How should your organization enhance its IT framework to enable an Internet of Things implementation? In his session at @ThingsExpo, James Kirkland, Red Hat's Chief Arch...
Jul. 3, 2015 11:15 AM EDT Reads: 916
IT data is typically silo'd by the various tools in place. Unifying all the log, metric and event data in one analytics platform stops finger pointing and provides the end-to-end correlation. Logs, metrics and custom event data can be joined to tell the holistic story of your software and operations. For example, users can correlate code deploys to system performance to application error codes. In his session at DevOps Summit, Michael Demmer, VP of Engineering at Jut, will discuss how this can...
Jul. 3, 2015 11:00 AM EDT Reads: 624
The last decade was about virtual machines, but the next one is about containers. Containers enable a service to run on any host at any time. Traditional tools are starting to show cracks because they were not designed for this level of application portability. Now is the time to look at new ways to deploy and manage applications at scale. In his session at @DevOpsSummit, Brian “Redbeard” Harrington, a principal architect at CoreOS, will examine how CoreOS helps teams run in production. Attende...
Jul. 3, 2015 11:00 AM EDT Reads: 699
Containers are revolutionizing the way we deploy and maintain our infrastructures, but monitoring and troubleshooting in a containerized environment can still be painful and impractical. Understanding even basic resource usage is difficult – let alone tracking network connections or malicious activity. In his session at DevOps Summit, Gianluca Borello, Sr. Software Engineer at Sysdig, will cover the current state of the art for container monitoring and visibility, including pros / cons and liv...
Jul. 3, 2015 11:00 AM EDT Reads: 709
Live Webinar with 451 Research Analyst Peter Christy. Join us on Wednesday July 22, 2015, at 10 am PT / 1 pm ET In a world where users are on the Internet and the applications are in the cloud, how do you maintain your historic SLA with your users? Peter Christy, Research Director, Networks at 451 Research, will discuss this new network paradigm, one in which there is no LAN and no WAN, and discuss what users and network administrators gain and give up when migrating to the agile world of clo...
Jul. 3, 2015 11:00 AM EDT Reads: 784
Agile, which started in the development organization, has gradually expanded into other areas downstream - namely IT and Operations. Teams – then teams of teams – have streamlined processes, improved feedback loops and driven a much faster pace into IT departments which have had profound effects on the entire organization. In his session at DevOps Summit, Anders Wallgren, Chief Technology Officer of Electric Cloud, will discuss how DevOps and Continuous Delivery have emerged to help connect dev...
Jul. 3, 2015 11:00 AM EDT Reads: 1,075
WebRTC converts the entire network into a ubiquitous communications cloud thereby connecting anytime, anywhere through any point. In his session at WebRTC Summit,, Mark Castleman, EIR at Bell Labs and Head of Future X Labs, will discuss how the transformational nature of communications is achieved through the democratizing force of WebRTC. WebRTC is doing for voice what HTML did for web content.
Jul. 3, 2015 10:00 AM EDT Reads: 764
"A lot of the enterprises that have been using our systems for many years are reaching out to the cloud - the public cloud, the private cloud and hybrid," stated Reuven Harrison, CTO and Co-Founder of Tufin, in this SYS-CON.tv interview at 16th Cloud Expo, held June 9-11, 2015, at the Javits Center in New York City.
Jul. 3, 2015 09:00 AM EDT Reads: 790
The Internet of Things is not only adding billions of sensors and billions of terabytes to the Internet. It is also forcing a fundamental change in the way we envision Information Technology. For the first time, more data is being created by devices at the edge of the Internet rather than from centralized systems. What does this mean for today's IT professional? In this Power Panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, panelists addressed this very serious issue of pro...
Jul. 3, 2015 09:00 AM EDT Reads: 1,285