Patients with Adrenal Insufficiency Report a Need for Improved Management of Their Condition

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• Publié par: viropharma-incorporated
• Nombre de lectures: 27
• Langue: English

Extrait

Patients with Adrenal Insufficiency Report a

Need for Improved Management of Their

Condition

PR Newswire

BRUSSELS, Sept. 14, 2012

- 87% of secondary AI patients and 60% of primary AI patients

reported that their condition affected quality of life

- Largest ever, worldwide AI patient survey data presented at the

15th Congress of the European NeuroEndocrine Association (ENEA),

Vienna, Austria

BRUSSELS

,

Sept. 14, 2012

/PRNewswire/ -- Patients with adrenal insufficiency

(AI) on conventional immediate release oral hydrocortisone replacement

therapy report a compromised quality of life, leading to significant changes in

work, social life and physical activity, according to new data presented at the

15th ENEA Congress in

Vienna, Austria

today.[1] The study authors suggest that

patients with AI feel that there is a need for improved management of the

condition and alternative options to standard glucocorticoid replacement

strategies, especially in patients with secondary AI.

The worldwide survey of 1,245 patients, recruited through patient

organisations,[1] represents the largest known AI patient survey of its kind.[2]

Results revealed that 87% of secondary AI and 60% of primary AI patients

reported that their condition affects their quality of life.[1] Secondary AI

patients reported a greater impact of fatigue on daily activities than primary AI

patients, including on work life (58% of secondary AI v 44% of primary AI

patients); social life (71% v 51%); physical activity (80% v 70%) and family life

(64% v 39%).[1]

Adrenal insufficiency (AI) is a rare, chronic and potentially fatal endocrine

disorder characterised by a reduction or failure in the production of the

hormone cortisol.[3],[4],[5] It is an orphan disease that affects less than 4.5

people in 10,000 in Europe.[6]

"Conventional immediate release oral hydrocortisone replacement therapy has

been the mainstay of adrenal insufficiency management for more than 50

years but this survey adds to a growing body of evidence that standard therapy

is not addressing the needs of patients, in particular those with secondary AI.

Hydrocortisone replacement therapy should replace the body's natural, daily

production of cortisol and mimic its diurnal variation, but immediate release

conventional therapy cannot fully mimic the body in this respect, despite

multiple dosing throughout the day," said survey co-author Dr Gudmundur

Johannsson, Senior Consultant, Department of Endocrinology at Sahlgrenska

University Hospital, Professor of Endocrinology, Sahlgrenska Academy,

University of

Gothenburg, Sweden

.

"As a result of unsatisfactory AI management patients have an increased

morbidity and a two to three-fold increase in mortality compared to the

background population. 4 out of 10 AI patients reported issues with multiple

daily dosing regimens which can result in compliance problems. It is therefore

not surprising that this survey reveals a significant number of patients who are

suggesting a need for improvement in their replacement therapy." Dr

Gudmundur Johannsson continued.

The survey was made possible through funding from DuoCort Pharma, a

wholly-owned subsidiary of ViroPharma Incorporated. "At ViroPharma

Incorporated we are committed to addressing the medical needs of people

living with rare (orphan) diseases. We worked closely with physicians and

patient organisations in adrenal insufficiency to gain these new insights into the

unmet needs of patients, and will be looking at how to address them," said Arun

Mistry, Senior Director, Medical Affairs, Europe. "With this new evidence, we

hope to improve disease management and hydrocortisone replacement

therapy to enable patients to better partake in their work, family and social

commitments."

About the Worldwide Patient Survey[1]

The aim of the survey was to document current practice in glucocorticoid

replacement therapy and to assess self-perceived health status and outcomes.

The results showed that:

87% of secondary AI patients reported their condition to affect their quality of life, along

with with 60% of primary AI patients

81% and 87% of secondary AI patients experienced morning and daytime fatigue

respectively, compared to 53% and 61% of primary AI patients

Secondary AI patients reported a greater impact of fatigue on daily activities than

primary AI patients and also greater impact on worklife (58% of secondary AI v 44% of

primary AI patients); social life (71% v 51%); physical activity (80% v 70%) and family

life (64% v 39%)

20% of secondary AI patients needed to adjust their dose to counteract morning or

daytime fatigue, compared to 16% of primary AI patients

In terms of their ability to work, only 39% of secondary AI patients reported they were fit

enough to work, compared to 65% of primary AI patients; and of these 59% and 74%

respectively reported full time employment

Participating patient organisations were:

Addison's Disease Self Help Group (ADSHG) in the UK; Association Surrenales in

France

; Swedish Addison Association and Hypofysis in

Sweden

;

Addisonforeningen and Danish Morbus Addison Site in

Denmark

; Dutch Addison

& Cushing Society (NVACP) in

the Netherlands

; Associazione Italiana Pazienti

Addison (AIPAd) in

Italy

; National Adrenal Diseases Foundation (NADF), CARES

foundation and Cushing's Support and Research Foundation (CSRF) in the

USA

and the Australian Addison's Disease Foundation.

About Adrenal Insufficiency

Adrenal insufficiency (AI) is a rare, chronic and potentially fatal endocrine

disorder characterised by a reduction or failure in the production of the

hormone cortisol.[3],[4],[5] It affects less than 4.5 in 10,000 people in

Europe.[6]

AI can lead to serious, life-threatening conditions such as cardiovascular,

malignant or infectious diseases, as well as disorders which impact on health

and quality of life.[7],[8] The many symptoms of AI include fatigue, anorexia,

weight-loss, fever, muscle weakness, abdominal pains, dizziness and

headaches.[3],[4],[5] Because these symptoms can be attributed to other

disorders, diagnosis can be difficult and delayed, leading to unnecessary

morbidity and mortality.[3],[4] To survive, AI patients need replacement

therapy with glucocorticoids (usually hydrocortisone) and because it is a chronic

condition, they require this life-saving therapy throughout their lives.[4]

There are two main types of AI:[4],[5]

1. Primary (Addison's disease) AI occurs when the cortex of the adrenal gland is not

functioning properly

2. Secondary AI occurs when the pituitary gland fails to produce enough adrenocorticotropin

(ACTH), a hormone that stimulates the adrenal glands to produce cortisol. Often, the

cause is damage to the pituitary gland following a pituitary tumour or surgery. Secondary

adrenal insufficiency is more common than primary.[9]

About ViroPharma Incorporated

ViroPharma Incorporated (Nasdaq: VPHM) is an international biopharmaceutical

company committed to developing and commercialising novel solutions for

physician specialists to address unmet medical needs of patients living with

diseases that have few, if any, clinical therapeutic options, including C1

esterase inhibitor deficiency, treatment of seizures in children and adolescents,

adrenal insufficiency, and

C. difficile

infection (CDI). Our goal is to provide

rewarding careers to employees, to create new standards of care in the way

serious diseases are treated, and to build international partnerships with the

patients, advocates and healthcare professionals we serve.

ViroPharma routinely posts information, including press releases, which may be

important to investors in the investor relations and media sections of our

company's website, http://www.viropharma.com/. The company encourages

investors to consult these sections for more information on ViroPharma and our

business.

Disclosure Notice

Certain statements in this press release contain forward-looking statements

that involve a number of risks and uncertainties. Forward-looking statements

provide our current expectations or forecasts of future events, including

statements that we may be able to improve disease management and

hydrocortisone replacement therapy to enable patients to better partake in

their work, family and social commitments. We cannot assure that we will be

successful in achieving this goal as factors, including, but not limited to those

described in our annual report on Form 10-K for the year ended

December 31,

2011

and 10-Q for the quarters ended

March 31, 2012

and

June 30, 2012

filed

with the Securities and Exchange Commission, could cause future results to

differ materially from the expectations expressed in this press release. The

forward-looking statements contained in this press release are made as of the

date hereof and may become outdated over time. ViroPharma does not

assume any responsibility for updating any forward-looking statements. These

forward looking statements should not be relied upon as representing our

assessments as of any date subsequent to the date of this press release.

References

[1] Forss M, et al. Secondary adrenal insufficiency patients report greater

impact of adrenal insufficiency than primary patients – a worldwide patient

survey. Poster Number 153. Presented

14th September 2012

, 12:00 local time

at the 15th Congress of the European NeuroEndocrine Association (ENEA),

12th-15th September 2012

,

Vienna, Austria

[2] Forss M et al. Current practice of glucocorticoid replacement therapy and

patient-perceived health outcomes in adrenal insufficiency – a worldwide

patient survey.

BMC Endocrine Disorders.

2012;12:8.

[3] Allolio B, et al. Adrenal Insufficiency.

The Lancet

. 2003 May

31;361(9372):1881-93

[4] Addison's Disease Self-Help Group (UK). What is Addison's disease? Available

at: http://www.addisons.org.uk/info/addisons/page1.html. Accessed

August

2012

.

[5] Patient.co.uk. Adrenal insufficiency and Addison's disease. Available at:

http://www.patient.co.uk/doctor/Adrenal-Insufficiency-and-Addison%27s-

Disease.htm. Accessed

August 2012

.

[6] European Medicines Agency (EMA). Rare disease designation. EU/3/06/372.

What is the estimated number of patients affected by the condition? Available

at: http://www.ema.europa.eu/ema/index.jsp?

curl=pages/medicines/human/orphans/2009/11/human_orphan_000675.jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac058001d12b.

Accessed

September 2012

.

[7] Johannsson G, et al. Improved cortisol exposure-time profile and outcome in

patients with adrenal insufficiency: a prospective randomized trial of a novel

hydrocortisone dual-release formulation.

J Clin Endrocinol Metab

.

2012;97(2):473-481.

[8] Neary N, et al. Adrenal insufficiency – etiology, diagnosis and treatment.

Curr Opin Endocrinol Diabetes Obes.

2010;17(3):217-223.

[9] National Endocrine and Metabolic Diseases Information Service. Adrenal

Insufficiency and Addison's disease. Available at:

http://endocrine.niddk.nih.gov/pubs/addison/addison.aspx#1. Last accessed

August 2012

.