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

- 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.