Now proof of minor added benefit from Fidaxomicin in severe cases or recurrences of C. difficile infections

Main Category: Infectious Diseases / Bacteria / Viruses
Article Date: 27 Jul 2013 - 0:00 PDT Current ratings for:
Now proof of minor added benefit from Fidaxomicin in severe cases or recurrences of C. difficile infections

In the commenting procedure on early benefit assessment pursuant to the German Act on the Reform of the Market for Medicinal Products (AMNOG), under certain circumstances drug manufacturers may submit to the Federal Joint Committee (G-BA) additional documents for dossiers. The Institute for Quality and Efficiency in Health Care (IQWiG) has now assessed such additional information for two studies comparing the antibiotic fidaxomicin, which is used for diarrhoea caused by Clostridium difficile infections, with vancomycin.

In contrast to the first dossier assessment, the Institute now sees proof of a minor added benefit of fidaxomicin versus the appropriate comparator therapy in patients with severe or recurrent disease. An added benefit is still not proven in patients with mild disease; the manufacturer provided no new data for this indication.

Manufacturer dossier did not allow an overall conclusion

The antibiotic fidaxomicin (trade name: Dificlir) has been approved in Germany since December 2011 for the treatment of adults with diarrhoea caused by Clostridium difficile. IQWiG already presented an assessment pursuant to AMNOG in April 2013.

On the basis of the dossier submitted by the manufacturer, an advantage of fidaxomicin for the outcome "global cure" could be inferred for severe cases and recurrences. However, the magnitude of this advantage could not be inferred from the data presented. In addition, it could not be excluded that more severe side effects occurred precisely in these cases, thus outweighing advantages with regard to global cure. An overall conclusion on added benefit was therefore not possible.

Greater harm not proven in patients with severe disease

In the commenting procedure the manufacturer subsequently provided study results in a form that allows the weighing of positive and negative effects. Whereas no statistically significant difference between fidaxomicin and vancomycin was shown for all-cause mortality, the data provide proof of an added benefit for the outcome "global cure" in patients with severe or recurrent disease. In addition, in these subpopulations there is no suggestion of greater harm from fidaxomicin than from vancomycin.

An overall conclusion is thus possible: an added benefit of fidaxomicin versus the appropriate comparator therapy (vancomycin) is now proven for the treatment of patients with severe or recurrent Clostridium difficile infections. IQWiG classifies the extent of added benefit as minor.

An added benefit in patients with mild disease was not claimed by the manufacturer.

G-BA decides on the extent of added benefit

The dossier assessment is part of the overall procedure for early benefit assessments supervised by the G-BA. After publication of the manufacturer's dossier and the IQWiG dossier assessment, the G-BA conducted a commenting procedure in which the manufacturer submitted additional information. The G-BA subsequently commissioned IQWiG on 28 May 2013 to undertake a new assessment including the additional data.

If, in the course of the discussions on a commission of the G-BA, a need for further revision arises, IQWiG presents its report in the form of an addendum. The Institute sent this addendum to the contracting agency (the G-BA) on 12 June 2013. The G-BA then decides on the extent of the added benefit in each case, thus completing the early benefit assessment.

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our infectious diseases / bacteria / viruses section for the latest news on this subject.

The website gesundheitsinformation.de, published by IQWiG, provides easily understandable and brief German-language information on fidaxomicin (English-language information [addendum and health information] will also be available in the near future; if you would like to be informed when this is published, please send an email to info@iqwig.de).

The G-BA website contains both general English-language information on benefit assessments pursuant to §35a Social Code Book V and specific German-language information on the assessment of fidaxomicin.

Addendum

Benefit assessment (dossier assessment)

Institute for Quality and Efficiency in Health Care

Please use one of the following formats to cite this article in your essay, paper or report:

MLA

Institute for Quality and Efficiency in Health Car. "Now proof of minor added benefit from Fidaxomicin in severe cases or recurrences of C. difficile infections." Medical News Today. MediLexicon, Intl., 27 Jul. 2013. Web.
27 Jul. 2013. APA
Institute for Quality and Efficiency in Health Car. (2013, July 27). "Now proof of minor added benefit from Fidaxomicin in severe cases or recurrences of C. difficile infections." Medical News Today. Retrieved from
http://www.medicalnewstoday.com/releases/263932.php.

Please note: If no author information is provided, the source is cited instead.

'Now proof of minor added benefit from Fidaxomicin in severe cases or recurrences of C. difficile infections'

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Now proof of minor added benefit from Fidaxomicin in severe cases or recurrences of C. difficile infections

Main Category: Infectious Diseases / Bacteria / Viruses
Article Date: 27 Jul 2013 - 0:00 PDT Current ratings for:
Now proof of minor added benefit from Fidaxomicin in severe cases or recurrences of C. difficile infections

In the commenting procedure on early benefit assessment pursuant to the German Act on the Reform of the Market for Medicinal Products (AMNOG), under certain circumstances drug manufacturers may submit to the Federal Joint Committee (G-BA) additional documents for dossiers. The Institute for Quality and Efficiency in Health Care (IQWiG) has now assessed such additional information for two studies comparing the antibiotic fidaxomicin, which is used for diarrhoea caused by Clostridium difficile infections, with vancomycin.

In contrast to the first dossier assessment, the Institute now sees proof of a minor added benefit of fidaxomicin versus the appropriate comparator therapy in patients with severe or recurrent disease. An added benefit is still not proven in patients with mild disease; the manufacturer provided no new data for this indication.

Manufacturer dossier did not allow an overall conclusion

The antibiotic fidaxomicin (trade name: Dificlir) has been approved in Germany since December 2011 for the treatment of adults with diarrhoea caused by Clostridium difficile. IQWiG already presented an assessment pursuant to AMNOG in April 2013.

On the basis of the dossier submitted by the manufacturer, an advantage of fidaxomicin for the outcome "global cure" could be inferred for severe cases and recurrences. However, the magnitude of this advantage could not be inferred from the data presented. In addition, it could not be excluded that more severe side effects occurred precisely in these cases, thus outweighing advantages with regard to global cure. An overall conclusion on added benefit was therefore not possible.

Greater harm not proven in patients with severe disease

In the commenting procedure the manufacturer subsequently provided study results in a form that allows the weighing of positive and negative effects. Whereas no statistically significant difference between fidaxomicin and vancomycin was shown for all-cause mortality, the data provide proof of an added benefit for the outcome "global cure" in patients with severe or recurrent disease. In addition, in these subpopulations there is no suggestion of greater harm from fidaxomicin than from vancomycin.

An overall conclusion is thus possible: an added benefit of fidaxomicin versus the appropriate comparator therapy (vancomycin) is now proven for the treatment of patients with severe or recurrent Clostridium difficile infections. IQWiG classifies the extent of added benefit as minor.

An added benefit in patients with mild disease was not claimed by the manufacturer.

G-BA decides on the extent of added benefit

The dossier assessment is part of the overall procedure for early benefit assessments supervised by the G-BA. After publication of the manufacturer's dossier and the IQWiG dossier assessment, the G-BA conducted a commenting procedure in which the manufacturer submitted additional information. The G-BA subsequently commissioned IQWiG on 28 May 2013 to undertake a new assessment including the additional data.

If, in the course of the discussions on a commission of the G-BA, a need for further revision arises, IQWiG presents its report in the form of an addendum. The Institute sent this addendum to the contracting agency (the G-BA) on 12 June 2013. The G-BA then decides on the extent of the added benefit in each case, thus completing the early benefit assessment.

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our infectious diseases / bacteria / viruses section for the latest news on this subject.

The website gesundheitsinformation.de, published by IQWiG, provides easily understandable and brief German-language information on fidaxomicin (English-language information [addendum and health information] will also be available in the near future; if you would like to be informed when this is published, please send an email to info@iqwig.de).

The G-BA website contains both general English-language information on benefit assessments pursuant to §35a Social Code Book V and specific German-language information on the assessment of fidaxomicin.

Addendum

Benefit assessment (dossier assessment)

Institute for Quality and Efficiency in Health Care

Please use one of the following formats to cite this article in your essay, paper or report:

MLA

Institute for Quality and Efficiency in Health Car. "Now proof of minor added benefit from Fidaxomicin in severe cases or recurrences of C. difficile infections." Medical News Today. MediLexicon, Intl., 27 Jul. 2013. Web.
27 Jul. 2013. APA
Institute for Quality and Efficiency in Health Car. (2013, July 27). "Now proof of minor added benefit from Fidaxomicin in severe cases or recurrences of C. difficile infections." Medical News Today. Retrieved from
http://www.medicalnewstoday.com/releases/263932.php.

Please note: If no author information is provided, the source is cited instead.

'Now proof of minor added benefit from Fidaxomicin in severe cases or recurrences of C. difficile infections'

Please note that we publish your name, but we do not publish your email address. It is only used to let you know when your message is published. We do not use it for any other purpose. Please see our privacy policy for more information.

If you write about specific medications or operations, please do not name health care professionals by name.

All opinions are moderated before being included (to stop spam). We reserve the right to amend opinions where we deem necessary.

Contact Our News Editors

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Please send any medical news or health news press releases to:

Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional. For more information, please read our terms and conditions.

View the original article here

Predicting STEMI, the most severe heart attack: JACC study

Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices / Diagnostics
Article Date: 19 Jul 2013 - 2:00 PDT Current ratings for:
Predicting STEMI, the most severe heart attack: JACC study

Infraredx, Inc., a medical device company committed to advancing the diagnosis and management of coronary artery disease, has announced the publication of key data supporting the ability of its TVC Imaging System to detect lipid core plaque in patients with ST-Segment Elevation Myocardial Infarction (STEMI). The study, published in JACC: Cardiovascular Interventions, details the identification of a specific cholesterol signature by Near Infrared Spectroscopy (NIRS) at the site of the culprit lesions causing STEMI, a dangerous type of heart attack. While the TVC Imaging System has been used in more than 3,000 patients worldwide, the present study is the first report of its use in a consecutive series of STEMI patients.

The research was led by Ryan D. Madder, M.D., a practicing interventional cardiologist at Spectrum Health, in Grand Rapids, Mich. The study utilized the TVC Imaging System, which is a first-in-class intravascular imaging system that integrates near-infrared spectroscopy (NIRS) lipid core plaque detection and enhanced intravascular ultrasound (IVUS) imaging technology to assess vessel composition and structure.

"We have discovered a near-infrared spectroscopic signature of the plaques which cause myocardial infarction, a leading cause of morbidity and mortality worldwide," said Dr. Madder. "This signature is detectable at the time of cardiac catheterization using a novel intracoronary imaging device. It is our hope that this signature may be capable of predicting a myocardial infarction before it happens. Through an international collaboration with several other centers, further studies are currently underway and others are being planned to validate this signature and to determine if near-infrared spectroscopy can accurately predict future myocardial infarction."

In this study, researchers utilized the TVC imaging system to image the culprit vessel, as identified by angiography, in 20 STEMI patients referred acutely for primary percutaneous coronary intervention. In 19 of the 20 patients, a distinct signature of lipid core plaque (LCP) was identified with NIRS specifically at the location of the culprit lesion. To confirm plaque composition, the researchers compared the NIRS imaging results from the sites causing the blockage and subsequent heart attack to results from non-culprit segments of the patients' vessels as well as to 46 autopsy specimens serving as the gold-standard of histology. The study's novel in vivo findings of lipid core plaque at STEMI culprit sites correspond with multiple autopsy studies that have demonstrated that rupture of a large lipid core plaque is the most frequent cause of a fatal myocardial infarction. Most importantly for predictive and preventive purposes, it is likely that the large lipid core plaques observed at STEMI culprit sites were present and detectable before plaque rupture and thrombus formation and the acute coronary event.

"There are many possible treatments already available for coronary plaques at increased risk for rupture and thrombosis," said James E. Muller, M.D., founder and chief medical officer of Infraredx. "The primary challenge cardiologists have faced has been the identification of plaques likely to cause major adverse events, including heart attacks. The identification of a clear signal so closely associated with culprit plaques in patients suffering STEMI is a major step forward in the effort to identify and treat vulnerable coronary plaques before they cause a catastrophic event."

Myocardial infarctions (heart attack) occur when a plaque ruptures and its contents are exposed to blood, creating a thrombus (blood clot) that, in turn, leads to a rapid, complete blockage of an artery. ST-Segment Elevation Myocardial Infarction (STEMI) is the more severe type of heart attack. In the United States alone, more than 1 million individuals experience a myocardial infarction or sudden cardiac death each year.[1]

The TVC Imaging System™ is a first-in-class intravascular imaging system that holds the potential to revolutionize the management of coronary artery disease by providing information that is critical for evaluating vessel structure and composition, also known as true vessel characterization. The TVC Imaging System helps interventional cardiologists identify which patients are prone to complications during stenting. The device enables cardiologists to predict peri-procedural heart attacks by assessing not only the degree of stenosis, but also the presence and extent of lipid-rich plaques (LRP).

The device is the only multimodality imaging system to combine both intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS). Through IVUS technology, the TVC Imaging System provides clear and relevant information about vessel structure, in real time. The TVC Imaging System is the only device available in both the U.S. and Europe for the detection of LCPs. NIRS measurements have been made in over 5,000 patients in over 90 hospitals worldwide.

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our cardiovascular / cardiology section for the latest news on this subject.

[1] Heart disease and stroke statistics – 2012 update: a report from the American Heart Association. Circulation 2012; 125;e2-e220.

The paper: "Detection of Near-infrared Spectroscopy of Large Lipid Core Plaques at Culprit Sites in Patients with Acute ST-Segment Elevation Myocardial Infarction," is available online.

Infraredx

Please use one of the following formats to cite this article in your essay, paper or report:

MLA

Infraredx. "Predicting STEMI, the most severe heart attack: JACC study." Medical News Today. MediLexicon, Intl., 19 Jul. 2013. Web.
20 Jul. 2013. APA

Please note: If no author information is provided, the source is cited instead.

'Predicting STEMI, the most severe heart attack: JACC study'

Please note that we publish your name, but we do not publish your email address. It is only used to let you know when your message is published. We do not use it for any other purpose. Please see our privacy policy for more information.

If you write about specific medications or operations, please do not name health care professionals by name.

All opinions are moderated before being included (to stop spam)

Contact Our News Editors

For any corrections of factual information, or to contact the editors please use our feedback form.

Please send any medical news or health news press releases to:

Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional. For more information, please read our terms and conditions.

View the original article here