Showing posts with label cases. Show all posts
Showing posts with label cases. Show all posts

Saturday, 27 July 2013

Fullest clinical report of Saudi MERS cases to date points to important differences with SARS

Main Category: Infectious Diseases / Bacteria / Viruses
Also Included In: Flu / Cold / SARS
Article Date: 26 Jul 2013 - 2:00 PDT Current ratings for:
Fullest clinical report of Saudi MERS cases to date points to important differences with SARS
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Saudi and UK scientists provide the most detailed picture yet of the clinical and laboratory characteristics of Middle East Respiratory Syndrome (MERS) coronavirus, revealing a wide range of clinical symptoms and an extremely high death rate among patients with co-existing medical conditions.

The new research, published in The Lancet Infectious Diseases, also reveals some important differences with severe acute respiratory syndrome (SARS).

MERS emerged a year ago in Saudi Arabia and almost all those infected have been reported there, or have been linked to people who contracted the virus there.

The new analysis, the largest case series to date, includes 47 cases (46 adults, 1 child) of confirmed MERS infections from Saudi Arabia between Sept 1, 2012, and June 15, 2013.

By combining clinical records, laboratory results, and imaging findings with demographic data, the authors noted a trend of older patients, more men, and patients with underlying medical conditions who succumb to the disease.

As with SARS, MERS infections presented with a wide spectrum of symptoms. Most patients admitted to hospital exhibited fever (98%), chills/rigors (87%), cough (83%), shortness of breath (72%), and muscle pain (32%). A quarter of patients also experienced gastrointestinal symptoms, including diarrhoea and vomiting.

However, in contrast to SARS, the majority of cases (96%) occurred in people with underlying chronic medical conditions including diabetes (68%), high blood pressure (34%), chronic heart disease (28%), and chronic renal disease (49%).

"Despite sharing some clinical similarities with SARS (eg, fever, cough, incubation period), there are also some important differences such as the rapid progression to respiratory failure, up to 5 days earlier than SARS"*, explains Professor Ziad Memish, the Deputy Minister for Public Health from the Kingdom of Saudi Arabia, who led the research.

"In contrast to SARS, which was much more infectious especially in healthcare settings and affected the healthier and the younger age group, MERS appears to be more deadly with 60% of patients with co-existing chronic illnesses dying, compared with the 1-2% toll of SARS. Although this high mortality rate with MERS is probably spurious due to the fact that we are only picking up severe cases and missing a significant number of milder or asymptomatic cases, so far there is little to indicate that MERS will follow a similar path to SARS."*

According to co-author Professor Ali Zumla from University College London, "The recent identification of milder or asymptomatic cases of MERS in health care workers, children, and family members of contacts of MERS cases indicates that we are only reporting the tip of the iceberg of severe cases and there is a spectrum of milder clinical disease which requires urgent definition. Ultimately the key will be to identify the source of MERS infection, predisposing factors for susceptibility to infection, and the predictive factors for poor outcome. Meanwhile infection control measures within hospitals seem to work."*

Writing in a linked Comment, Professor Christian Drosten from the University of Bonn Medical Centre in Germany points to the urgent need for accurate diagnostic tests to help focus control efforts and minimise the risk of spread to others, "To ascertain relevant data for MERS epidemiology, we need to develop serological assays using samples from well defined groups of patients, such as described here. Population-based antibody testing could establish the extent of MERS-CoV infection, instead of only seeing the tip of the iceberg represented by cases admitted, such as those summarised in this important paper."

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.

*Quotes direct from authors and cannot be found in text of Article.

The Lancet

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

MLA

Lancet, The. "Fullest clinical report of Saudi MERS cases to date points to important differences with SARS." Medical News Today. MediLexicon, Intl., 26 Jul. 2013. Web.
27 Jul. 2013. APA

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


'Fullest clinical report of Saudi MERS cases to date points to important differences with SARS'

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View the original article here

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
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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

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

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
not yet ratednot yet rated

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

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