Sorry, Readability was unable to parse this page for content.
Source: http://twitter.com/ras_bo/statuses/222229121495867392
ihop statins chardon sean young juan pablo montoya free pancakes at ihop martina navratilova
Tuesday, July 10, 2012
Abiraterone: Indication of considerable added benefit in certain patients
![[ Back to EurekAlert! ]](http://www.eurekalert.org/images/back2e.gif){kind=small}
Public release date: 10-Jul-2012[ | E-mail |
Share ] Contact: Dr. Anna-Sabine Ernst
presse@iqwig.de
49-221-356-85153
Institute for Quality and Efficiency in Health Care
Advantages for men with metastatic hormone-refractory prostate cancer who are no longer eligible for docetaxel therapy
Abiraterone (trade name: Zytiga) has been approved since September 2011 for men with metastatic prostate cancer that is no longer responsive to hormone therapy and progresses further during or after therapy with the cytostatic drug docetaxel. In an early benefit assessment pursuant to the "Act on the Reform of the Market for Medicinal Products" (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether abiraterone offers an added benefit compared with the present standard therapy.
IQWiG finds an indication of a considerable added benefit of abiraterone in patients who are not eligible for further treatment with docetaxel. In contrast, an added benefit is not proven in patients who can still be treated with docetaxel, as the dossier submitted by the drug manufacturer provides inadequate information for this group of patients.
Separate assessment for two groups of patients
In accordance with the specifications of the Federal Joint Committee (G-BA), IQWiG separately assessed abiraterone in two groups of patients. The G-BA has specified different appropriate comparator therapies for the two groups.
The "best supportive care population" contains patients who are not eligible for further treatment with docetaxel. The appropriate comparator therapy for this group is palliative treatment with dexamethasone, prednisone, prednisolone or methylprednisolone, as well as "best supportive care".
"Best supportive care" means the therapy that provides the patient with the best possible individually optimized supportive treatment to alleviate symptoms (e.g. adequate pain therapy) and improve quality of life.
The "docetaxel-retherapy population" comprises patients who are still eligible for further treatment with docetaxel. The appropriate comparator therapy for this patient population is docetaxel in combination with prednisone or prednisolone.
Indication of increase in survival and delay in consequences of disease
One study (COU-AA-301), which considers patient-relevant outcomes and provides relevant data, was included in the assessment of added benefit in the "best supportive care population". This study compared treatment with abiraterone versus placebo, in each case combined with prednisone and "best supportive care".
IQWiG finds an indication of an added benefit in patients treated with abiraterone: the above study provides indications that abiraterone can prolong survival and delay consequences of prostate cancer, such as fractures or operations due to bone metastases. In addition, the "time to pain progression" was prolonged in study participants receiving abiraterone.
IQWiG classifies the extent of this added benefit as "considerable". The corresponding legal ordinance has specified three grades to determine the extent of added benefit: "minor", "considerable" and "major".
The study data presented on health-related quality of life assessments cannot be used; an added benefit of abiraterone is therefore not proven for this outcome.
The indications of advantages for abiraterone are not accompanied by proof of greater harm.
Added benefit in the docetaxel-retherapy population not proven
The manufacturer presented inadequate data for the "docetaxel-retherapy population". The required search in trial registries was missing in the dossier. Moreover, studies presented by the manufacturer, such as indirect comparisons and one-arm studies, cannot be used due to deficits in methods and content. An added benefit in this patient group is therefore not proven.
G-BA decides on the extent of added benefit
The procedure for inferring the overall conclusion on the extent of added benefit is a proposal from IQWiG. The G-BA, which has opened a formal commenting procedure, decides on the extent of added benefit.
###
The website gesundheitsinformation.de, which is issued by IQWiG, provides easily understandable brief information.
The G-BA website contains both general information on benefit assessments pursuant to 35a Social Code Book V and specific information on the assessment of abiraterone.
[ | E-mail | Share ] ?
AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert! system.
Public release date: 10-Jul-2012[ | E-mail |
Share ] Contact: Dr. Anna-Sabine Ernst
presse@iqwig.de
49-221-356-85153
Institute for Quality and Efficiency in Health Care
Advantages for men with metastatic hormone-refractory prostate cancer who are no longer eligible for docetaxel therapy
Abiraterone (trade name: Zytiga) has been approved since September 2011 for men with metastatic prostate cancer that is no longer responsive to hormone therapy and progresses further during or after therapy with the cytostatic drug docetaxel. In an early benefit assessment pursuant to the "Act on the Reform of the Market for Medicinal Products" (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether abiraterone offers an added benefit compared with the present standard therapy.
IQWiG finds an indication of a considerable added benefit of abiraterone in patients who are not eligible for further treatment with docetaxel. In contrast, an added benefit is not proven in patients who can still be treated with docetaxel, as the dossier submitted by the drug manufacturer provides inadequate information for this group of patients.
Separate assessment for two groups of patients
In accordance with the specifications of the Federal Joint Committee (G-BA), IQWiG separately assessed abiraterone in two groups of patients. The G-BA has specified different appropriate comparator therapies for the two groups.
The "best supportive care population" contains patients who are not eligible for further treatment with docetaxel. The appropriate comparator therapy for this group is palliative treatment with dexamethasone, prednisone, prednisolone or methylprednisolone, as well as "best supportive care".
"Best supportive care" means the therapy that provides the patient with the best possible individually optimized supportive treatment to alleviate symptoms (e.g. adequate pain therapy) and improve quality of life.
The "docetaxel-retherapy population" comprises patients who are still eligible for further treatment with docetaxel. The appropriate comparator therapy for this patient population is docetaxel in combination with prednisone or prednisolone.
Indication of increase in survival and delay in consequences of disease
One study (COU-AA-301), which considers patient-relevant outcomes and provides relevant data, was included in the assessment of added benefit in the "best supportive care population". This study compared treatment with abiraterone versus placebo, in each case combined with prednisone and "best supportive care".
IQWiG finds an indication of an added benefit in patients treated with abiraterone: the above study provides indications that abiraterone can prolong survival and delay consequences of prostate cancer, such as fractures or operations due to bone metastases. In addition, the "time to pain progression" was prolonged in study participants receiving abiraterone.
IQWiG classifies the extent of this added benefit as "considerable". The corresponding legal ordinance has specified three grades to determine the extent of added benefit: "minor", "considerable" and "major".
The study data presented on health-related quality of life assessments cannot be used; an added benefit of abiraterone is therefore not proven for this outcome.
The indications of advantages for abiraterone are not accompanied by proof of greater harm.
Added benefit in the docetaxel-retherapy population not proven
The manufacturer presented inadequate data for the "docetaxel-retherapy population". The required search in trial registries was missing in the dossier. Moreover, studies presented by the manufacturer, such as indirect comparisons and one-arm studies, cannot be used due to deficits in methods and content. An added benefit in this patient group is therefore not proven.
G-BA decides on the extent of added benefit
The procedure for inferring the overall conclusion on the extent of added benefit is a proposal from IQWiG. The G-BA, which has opened a formal commenting procedure, decides on the extent of added benefit.
###
The website gesundheitsinformation.de, which is issued by IQWiG, provides easily understandable brief information.
The G-BA website contains both general information on benefit assessments pursuant to 35a Social Code Book V and specific information on the assessment of abiraterone.
[ | E-mail | Share ] ?
AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert! system.
Source: http://www.eurekalert.org/pub_releases/2012-07/ifqa-aio071012.php
storage auctions storage auctions les miles les miles beyonce dance for you video beyonce dance for you video asu football
Caffeine (for Mac)
Mac users who like to preserve every ounce of their notebooks' charges, or like to keep prying eyes away from their desktops, benefit from setting their computers to fall asleep, dim the screen, or launch the screensaver after a set amount of time. There comes a time, however, when you may want to temporarily disable those features without digging through OS X's system preferences.
That's where Caffeine (free) comes in to play. Caffeine is a Mac utility that sticks an icon in the right side of your menu bar, and prevents your Mac from automatically going into a rest state. Caffeine is available for download from both the manufacturer's website (http://lightheadsw.com/caffeine/) and the Apple Mac App Store. The tiny program, featherweight at 0.3MB, is a lightning-fast download for anyone with a decent internet connection, and a useful tool to boot.
Taking a Shot of Caffeine
I performed three experiments to test caffeine's ability to keep a Mac awake. I set the computer to fall asleep, dim the screen, and launch the screensaver after a minute's time. Caffeine, after I clicked its icon, kept the computer awake each time. I like that you can tell whether Caffeine is running by checking to see if the coffee cup icon is full (activated) or empty (deactivated).
Caffeine's one drawback is that it doesn't prevent a closed laptop from going to sleep, dimming the screen, or launching the screensaver. When I lowered the laptop lid and raised it a few minutes later, I heard the hard drive spindle swirling awake.
Make It a Double
Caffeine is a small, but useful OS X utility that lets you stave a computer's nap time with a simple icon click?no need to dive into Preferences to alter the system ?settings. Admittedly, Caffeine is a niche app, but if the idea of it appeals to you in any manner, it's worth a download.
More Utilities Reviews:
??? Caffeine (for Mac)
??? Focus Booster (for Mac)
??? Afloat (for Mac)
??? CoconutBattery 2.7.3 (for Mac)
??? AppCleaner (for Mac)
?? more
Source: http://feedproxy.google.com/~r/ziffdavis/pcmag/~3/cpmfZu0K8-0/0,2817,2406803,00.asp
rudolph the red nosed reindeer adam carolla rick neuheisel rick neuheisel andrea bocelli john hughes panasonic lumix dmc lx5
Subscribe to:
Posts (Atom)