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This site is intended for US healthcare professionals
Patients ≥65 years
Patients taking multiple medications
Patients with type 2 diabetes
Patients with 2 or more risk factors for CHD
Patients taking CCBs
Patients taking warfarin
Patients of Asian descent
2018 ACC/AHA Guidelines have identified a number of risk enhancers associated with ASCVD, including metabolic syndrome (most patients with T2D will have metabolic syndrome by current criteria)3
The Guidelines state that statins modestly increase the risk of new-onset diabetes mellitus in individuals with3:
LIVALO 4 mg demonstrated a nonsignificant change in fasting blood glucose levels vs Lipitor® (atorvastatin) 20 mg2
Increases in HbA1c and fasting serum glucose levels have been reported with statins, including LIVALO. Optimize lifestyle measures, including regular exercise, maintaining a healthy body weight, and making healthy food choices.1
LIVALO 4 mg and Lipitor® (atorvastatin) 20 mg were not statistically different on LDL-C*1,2
Study 305: 12-week, randomized, multicenter, double-blind, double-dummy, parallel-group, active-controlled, non-inferiority, Phase 3 study of pitavastatin vs atorvastatin in 410 adult patients with combined dyslipidemia and type 2 diabetes mellitus. Mean percent change from baseline in LDL-C at Week 12 was -41% (pitavastatin 4 mg) vs -43% (atorvastatin 20 mg). Treatment difference (95% CI) in adjusted mean percent change in LDL-C was -2% (-6.2%, 1.5%), P=0.235. However, the -6.2% lower limit of CI slightly exceeded the -6% non-inferiority limit. The study failed to demonstrate that LIVALO was not significantly different than atorvastatin in lowering LDL-C in patients with type 2 diabetes mellitus and mixed dyslipidemia.1,2
Lipitor is a registered trademark of Pfizer, Inc.
ASCVD=atherosclerotic cardiovascular disease.
*The primary non-inferiority objective was not met.
See how LIVALO is metabolized.
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Kowa Pharmaceuticals America, Inc. hereby authorizes you to copy documents published on the World Wide Web by Kowa Pharmaceuticals America, Inc. solely for non-commercial use within your organization, provided that each copy of these documents which you make shall retain all copyright and other proprietary notices contained herein.
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The Site may contain, from time to time, links to other third-party websites. These links are provided for your convenience only. Kowa has no control over the content of these sites or their policies. You should review the terms and conditions, and privacy policies of each site you visit after you leave the Site. You further acknowledge and agree that Kowa shall not be responsible or liable, directly or indirectly, for any damage or loss caused or alleged to be caused by or in connection with use of or reliance on any such content or sites available on or through any such site or resource.
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Kowa Pharmaceuticals America, Inc.
530 Industrial Park Boulevard
Montgomery, AL 36117
Last updated February 6, 2019
Personally Identifiable Information
Kowa may collect personally identifiable information (such as name, address, telephone/fax number, and e-mail address) only when voluntarily provided by a visitor to our websites. This information will not be used for any direct marketing or unsolicited follow-up unless we have previously informed you of this possible use and you have given us your express permission when submitting it. Kowa may use this information for such purposes as:
Collection of Browser, Log, and Statistical Information
We may collect and/or track information provided to us by your browser, including the website you came from, the type of browser you use, the time and date of access, and other information that does not personally identify you. In addition, we may gather information about you that is automatically collected by our web server, such as your IP address and domain name.
Kowa may make use of non-personally identifiable statistical information collected from users (browser type, geographical location, age, gender) for optimization of its websites as part of its continual internal review process and in a general way to learn more about its clients. We may use IP addresses to analyze trends, administer the site, track users’ movements, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information. This information will not be disclosed to third parties by Kowa. This data will only be used for the stated purpose and will not be used for any unsolicited communication unless you give us permission.
Kowa may utilize "cookies," web beacons, and other similar technologies on our website. We may use first- and/or third-party "browser" or "HTTP" cookies, which are unique text files that may be used for data analysis and enable our website to tailor information for the visitor. We may use browser cookies for purposes such as to personalize the user's experience on our site, to remember a user when the user registers for products or services, for fraud prevention, or to track visits to our websites. We also may use "web beacons" (also referred to as pixel tags, clear gifs, or other terms) or similar technologies to collect information such as how long a visitor remains on a particular page. If you do not want us to deploy browser cookies to your device when you visit our websites, you may set the browser to reject cookies or to notify the user when a website tries to place cookies in the browser program (see below). Rejecting cookies may affect your ability to use some of the features offered by the website. If you use our website without setting your browser to block cookies, you consent to the placement of cookies on your device.
Third parties, including our service providers or marketing partners, may collect information about a visitor to our site over time and/or across different websites when the visitor uses our website. This information often is aggregate data or individual information that is tied to a browser or device rather than specific identifiers such as the visitor's name and address, but some of this information might be considered to be personally identifiable under some federal or state laws.
Some Internet browsers offer what often is referred to as "do-not-track" mechanisms for browser users to automatically signal privacy preferences to websites that they visit. Our site(s) do not currently respond to do-not-track signals; however, you can exercise other choices available to you, including limiting the placement of browser cookies on your device using your browser's cookie control features and other choices described in this Policy.
Use of Information
Kowa may use the information we collect through our website(s) for the following purposes:
Disclosure of Information
We may disclose information with your consent or as otherwise necessary or appropriate to process a transaction that you may request.
We may disclose information to comply with FDA or other regulatory requirements.
We may disclose information that we collect through our website(s) with agents, affiliated businesses, and service providers providing services on our behalf.
In the event that our company or some of our assets are sold or transferred or used as security or to the extent we engage in business negotiations with our business partners, the information collected on our websites or mobile applications, including this site, may be transferred or shared with third parties as part of that transaction or negotiation.
If we receive a request from law enforcement officials or judicial authorities to provide information on individuals, we may provide such information. In matters involving claims of personal or public safety or in litigation where the data is pertinent, we may use or disclose your personal information without a court order. We may use information you submit to investigate security breaches, misconduct, or otherwise cooperate with authorities pursuant to a legal matter.
We do not share, sell, or lease personal information about you except as set forth in this Policy.
Kowa has implemented reasonable security features to help protect the personally identifiable information that you have submitted from unauthorized access, use, alteration, or release. Please note, however, that although Kowa has endeavored to create a secure and reliable Site for users, we cannot guarantee the confidentiality of any communication or material transmitted to and/or from Kowa via the Site or e-mail. Accordingly, we are not responsible for the security of information transmitted via the Internet.
Access and Correction
It is our policy, with certain exceptions, to provide individuals with access to personal information that Kowa collects through our website(s). In some cases, the site you used may allow you to log in to directly access and/or correct information you have provided. In other cases, such as web forms that you may submit through the site, if you would like to obtain a copy of the information you provided or request a correction, you can contact us at firstname.lastname@example.org. When you update information, we may keep a copy of the prior version for our records.
Children and young people under 18 are requested to get permission from their parent or guardian before they submit personal data to Kowa websites.
This policy may be modified from time to time, and changes will be communicated promptly on this page.
Kowa Pharmaceuticals America, Inc.
530 Industrial Park Boulevard
Montgomery, AL 36117