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Astellas introduces Myrbetriq™, a new class of treatment for Canadian patients with overactive bladder

Par CNW on 22 avril 2013

Myrbetriq is now available in pharmacies across Canada

MARKHAM, ON, April 10, 2013 /CNW/ - Overactive bladder (OAB) is a chronic, debilitating condition that can have a profound, negative impact on a patient's quality of life. ¹ Many patients with OAB are plagued by depression,²experience a disruption in sleep,³ limit their social activity,⁴ and experience a loss of control and decreased self-esteem.⁵

An estimated 2.9 million Canadian men and women⁶ suffer from OAB symptoms⁷, which include:

• A strong, sudden urge to urinate
• The need to urinate more often than usual, usually more than eight times in a 24 hour period
• Waking up two or more times in the night to urinate (a condition called nocturia)
• Urge incontinence, the involuntary loss of urine immediately following an urgent need to urinate.

Astellas Pharma Canada, Inc., the Canadian subsidiary of Tokyo-based Astellas Pharma Inc., today announced the availability of Myrbetriq™ (mirabegron, extended-release tablets) for the treatment of OAB with symptoms of urge urinary incontinence, urgency and urinary frequency.⁸  Myrbetriq is now available in pharmacies across Canada.

"Simply focusing on the treatment of OAB symptoms is not enough for patients," says Dr. Blair Egerdie, BSc, MD, FRCSC, Investigator, Mirabegron Phase III trial and Vice President, Medical, St. Mary's General Hospital, Adjunct Professor of Urology at the University of Western Ontario. "We know OAB symptoms can be distressing; therefore, a focus on helping improve quality of life is critical. Everything from our patient's emotional well-being, to their productivity at work, mood, and social functioning can be affected. Treatment options that can help minimize this very real, very personal impact represent an important achievement in the treatment of OAB."

Myrbetriq's distinct mechanism of action helps to increase bladder capacity by relaxing the detrusor smooth muscle during the storage phase of the urinary bladder fill-void cycle.⁹  This β3-adrenoceptor agonist both reduces the activity of an overactive bladder as well as treats the related symptoms.¹

"Until now, when we've turned to medication to help with OAB symptoms, we've tried to block the chemical that causes bladder contractions," explains Dr. Egerdie. "β3-agonists, however, essentially quiet an overactive bladder by relaxing the bladder, thereby increasing its capacity. Because OAB affects individuals so differently, these kinds of treatment options are extremely important to both physicians and patients."

Myrbetriq was evaluated in three, 12-week, double-blind, randomized, placebo-controlled, parallel group, multicenter clinical trials in patients with OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency.

"Now that Myrbetriq is available through pharmacies, Canadian patients have access to the first new class of medication for the treatment of OAB in over 30 years," said Michael Tremblay, President, Astellas Pharma Canada, Inc. "Astellas is committed to improving quality of life for patients living with overactive bladder, and we are pleased to add Myrbetriq to our portfolio of treatment options."

About Myrbetriq¹¹

Myrbetriq has been studied extensively in more than 10,000 individuals over 10 years.

The efficacy of Myrbetriq has been evaluated in three phase 3 randomized, double blind, placebo controlled, 12-week studies for the treatment of OAB with symptoms of urgency and frequency with or without incontinence. Entry criteria required that patients had symptoms of overactive bladder for at least three months duration, at least 8 micturitions per day, and at least three episodes of urgency with or without incontinence over a three day period. The majority of patients were Caucasian (94%) and female (72%) with a mean age of 59 years (range 18 - 95 years). The population included both naïve patients who had not received prior antimuscarinic pharmacotherapy for OAB (48%) and those who had received prior antimuscarinic pharmacotherapy for OAB (52%).

The co-primary efficacy endpoints in all three trials were (1) change from baseline to end of treatment (Week 12) in mean number of incontinence episodes per 24 hours and (2) change from baseline to end of treatment (Week 12) in mean number of micturitions per 24 hours, based on a three-day micturition diary.

The recommended starting dose for Myrbetriq is 25 mg once daily with or without food. Based on individual efficacy and tolerability, the dose may be increased to 50 mg once daily.

About Overactive Bladder

Overactive bladder (OAB) is a symptomatic condition marked by the sudden, compelling desire to pass urine that is difficult to defer.¹² This sudden urge to urinate, which is difficult to suppress, can lead to the involuntary loss of urine (incontinence).¹³ OAB occurs when the bladder's smooth muscle, known as the detrusor muscle, involuntarily contracts, which creates the urgent need to urinate.¹⁴ Rushing to make it to the bathroom in time is common for people with OAB.

OAB symptoms occur in approximately equal numbers of men and women, and are more widespread in older patients of both genders.¹⁵ Urge incontinence is the most common form of urinary incontinence in older adults, but it is not an inevitable consequence of aging and therefore can, and should, be medically treated.¹⁶

OAB can greatly impact patients' lives. Patients who have incontinence as a result of their OAB symptoms experience an even greater impact on their quality of life than those who do not experience incontinence.¹⁷

About Astellas Pharma Canada, Inc.

Astellas Pharma Canada, Inc., headquartered in Markham, ON, is a Canadian affiliate of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. The organization is committed to becoming a global category leader in focused areas by combining outstanding R&D and marketing capabilities. In Canada, Astellas has an intense commercial focus on five therapeutic areas - Urology, Immunology, Infectious Disease, Dermatology and Oncology. For more information about Astellas Pharma Canada, Inc., please visit the corporate website:  www.astellas.ca.

 

1 Thom DH. Overactive bladder. Epidemiology and impact on quality of life. Contemp Ob/Gyn 2000; (Summer Suppl) 6-14.

2 Stewart WF, et al. Prevalence and Burden of Overactive Bladder in the United States. World J Urol 2003; 20:327-336.

3 Ouslander, J. Management of Overactive Bladder. The New England Journal of Medicine (Review Article) 2004; 350:786-99.

4 Ouslander, J. Management of Overactive Bladder. The New England Journal of Medicine (Review Article) 2004; 350:786-99.

5 Brown J, et al. Urge Incontinence: The Patient's Perspective. Journal of Women's Health 1998; 7:1263-1269.

6 Irwin DE, Milsom I, et al. Population-Based Survey of Urinary Incontinence, Overactive Bladder, and Other Lower Urinary Track Symptoms in Five Countries: Results of the EPIC Study. Euro Urol. 2006; Supplements 6:4-9.

7 Mayo Clinic. Overactive Bladder Symptoms. http://www.mayoclinic.com/health/overactive-bladder/DS00827/DSECTION=symptoms. Accessed on February 21, 2013.

8 Myrbetriq™ Canadian approved Product Monograph, dated March 4, 2013.

9 Myrbetriq™ Canadian approved Product Monograph, dated March 4, 2013.

10 Myrbetriq™ Canadian approved Product Monograph, dated March 4, 2013.

11 Myrbetriq™ Canadian approved Product Monograph, dated March 4, 2013.

12 Abrams P, et al. The Standardisation of Terminology of Lower Urinary Tract Function. Neurourology and  Urodynamics 2002; 21:167-178.

13 Mayo Clinic. Overactive Bladder Definition. http://www.mayoclinic.com/health/overactive-bladder/DS00827. Accessed February 23, 2013.

14 Ouslander, J. Management of Overactive Bladder. The New England Journal of Medicine (Review Article) 2004; 350:786-99.

15 Milsom I, et al. How Widespread are the Symptoms of an Overactive Bladder and how are they Managed? BJU Int. 2001 87:760-766.

16 Farage MA, et al. Psychosocial and Societal Burden of Incontinence in the Aged Population. Arch Gynecol Obstet. April 2008; 277(4):285-90.

17 Stewart K, et al. Overactive Bladder Patients and the Role of the Pharmacist. J Am Pharm Assoc 2002;42:469-78.

 

SOURCE: Astellas Pharma Canada, Inc.

For further information:

or to speak with a medical expert, please contact:

Stephanie Fitch 
energi PR 
416-425-9143 ext. 17 
Stephanie.fitch@energipr.com

Astellas présente le Myrbetriq(MC), un nouveau type de traitement pour les patients canadiens atteints d'hyperactivité vésicale

Par CNW on 10 avril 2013

Le Myrbetriq^MC est maintenant offert dans les pharmacies partout au Canada.

MARKHAM, ON, le 10 avril 2013 /CNW/ - L'hyperactivité vésicale (HV) est un trouble chronique et débilitant qui peut avoir des répercussions négatives considérables sur la qualité de vie d'une personne¹. De nombreux patients aux prises avec l'HV souffrent également de dépression², ont des troubles du sommeil³, limitent leurs activités sociales⁴, et vivent un sentiment de perte de contrôle et une diminution de l'estime d'eux-mêmes⁵.

On estime qu'au Canada, 2,9 millions d'hommes et de femmes ⁶ sont aux prises avec les symptômes de l'HV ⁷, dont :

• un besoin soudain et impérieux d'uriner;
• le besoin d'uriner plus souvent que la normale, généralement plus de huit fois par période de 24 heures;
• la nécessité de se lever deux fois ou plus la nuit pour uriner (un problème appelé nycturie);
• l'incontinence par impériosité, soit l'écoulement involontaire d'urine provenant d'un besoin urgent d'uriner.

Astellas Pharma Canada, Inc., une filiale d'Astellas Pharma Inc. dont le siège social est situé à Tokyo, a annoncé aujourd'hui la mise en marché du Myrbetriq^MC (mirabegron, comprimés à libération longue durée) pour le traitement de l'HV avec symptômes d'incontinence par impériosité, d'urgence mictionnelle et d'augmentation de la fréquence de miction⁸. Le Myrbetriq^MC est maintenant offert dans les pharmacies partout au Canada.

« L'HV constitue tout un enjeu, explique le Dr Luc Valiquette, M.D., FRCS (C), directeur du Département de chirurgie et spécialiste en chirurgie urologique à l'Université de Montréal. Elle peut miner le bien-être émotionnel, social et même économique d'une personne. Il est alors important d'avoir accès à de nouveaux médicaments qui peuvent non seulement aider à gérer les symptômes, mais aussi à minimiser les répercussions négatives que peut avoir l'HV sur la qualité de vie d'un patient. »

Le mécanisme d'action distinct du Myrbetriq^MC aide à accroître la capacité de la vessie en relaxant les fibres musculaires lisses du détrusor pendant la phase de remplissage du cycle mictionnel⁹. Cet agoniste bêta-3 réduit l'activité de la vessie hyperactive tout en traitant les symptômes qui lui sont associés¹.

« Chaque personne vit son hyperactivité vésicale différemment; conséquemment, le fait qu'il existe diverses options de traitement permet de trouver celui qui convient le mieux à chacun des patients, explique le Dr Valiquette. Plutôt que de prévenir les contractions anormales de la vessie, les agonistes bêta-3 la détendent et aident à accroître sa capacité. Les traitements comme le Myrbetriq^MC constituent une option thérapeutique importante lorsque les patients sont aux prises avec certains des effets secondaires les plus traditionnels comme la bouche sèche. »

Le Myrbetriq^MC a été évalué dans le cadre de trois essais cliniques d'une durée de 12 semaines, randomisées à double insu et contrôlées par placebo, chez les patients souffrant d'HV se caractérisant par des symptômes d'incontinence urinaire par impériosité, d'urgence mictionnelle et de pollakiurie.

« Maintenant que le Myrbetriq^MC est offert en pharmacie, les patients ont accès au premier nouveau type de médicament pour le traitement de l'HV depuis 30 ans, affirme Michel Tremblay, président d'Astellas Pharma Canada, Inc. Astellas s'est engagée à améliorer la qualité de vie des patients atteints d'hyperactivité vésicale, et nous sommes fiers d'ajouter le Myrbetriq^MC à notre portfolio d'options de traitement. »

À propos du Myrbetriq¹¹

Le Myrbetriq^MC a fait l'objet d'études approfondies auprès de plus de 10 000 individus sur une période de 10 ans.

L'efficacité du Myrbetriq^MC a été évaluée dans le cadre de trois essais cliniques de phase 3 d'une durée de 12 semaines, randomisés à double insu et contrôlés par placebo, chez des patients souffrant d'HV se caractérisant par des symptômes d'urgence mictionnelle et d'augmentation de la fréquence urinaire, avec ou sans incontinence. Selon les critères d'admissibilité, les patients devaient présenter des symptômes d'hyperactivité vésicale pendant au moins trois mois, au moins huit mictions par jour et au moins trois épisodes d'urgence mictionnelle, avec ou sans incontinence, sur une période de trois jours. La majorité des patients étaient de race blanche (94 %) et de sexe féminin (72 %), et la moyenne d'âge était de 59 ans (éventail d'âges de 18 à 95 ans). La population était composée de patients n'ayant jamais reçu de pharmacothérapie antimuscarinique contre l'HV (48 %), ainsi que de patients qui avaient reçu de la pharmacothérapie antimuscarinique contre l'HV (52 %).

Les deux principaux critères d'efficacité des trois essais étaient (1) variation par rapport à la valeur de référence jusqu'à la fin du traitement (semaine 12) en matière du nombre moyen d'épisodes d'incontinence par 24 heures et (2) variation par rapport à la valeur de référence jusqu'à la fin du traitement (semaine 12) en matière du nombre moyen de mictions par 24 heures, se fondant sur le nombre de mictions enregistré dans un journal pendant trois jours.

La dose initiale recommandée de 25 mg devrait être administrée une fois par jour, avec ou sans nourriture. Selon la tolérance du patient et l'efficacité du médicament chez ce dernier, la dose peut être augmentée jusqu'à un maximum de 50 mg, une fois par jour.

À propos de l'hyperactivité vésicale

L'hyperactivité vésicale (HV) est un trouble symptomatique caractérisé par une envie soudaine et impérieuse d'uriner qu'il est difficile d'ignorer¹². L'envie soudaine, urgente et irrépressible d'uriner peut mener à des écoulements urinaires involontaires (incontinence)¹³. L'HV se produit lorsque le muscle lisse de la vessie, appelé détrusor, se contracte involontairement, ce qui engendre un besoin impérieux d'uriner¹⁴. Les gens qui souffrent d'HV sont souvent appelés à se ruer à la toilette par crainte de ne pas arriver à temps.

Les symptômes de l'HV se manifestent autant chez les hommes que chez les femmes; ils sont cependant plus répandus chez les patients plus âgés des deux sexes¹⁵. L'incontinence impérieuse est la forme la plus courante d'incontinence chez les personnes âgées, mais puisqu'elle n'est pas une conséquence inévitable du vieillissement, elle peut et devrait être traitée de façon médicale¹⁶.

L'hyperactivité vésicale peut avoir des répercussions considérables sur la vie des patients. Ceux qui souffrent de l'incontinence qui peut en découler sont davantage touchés par les répercussions de leur trouble sur leur qualité de vie que les patients sans symptômes d'incontinence¹⁷.

À propos d'Astellas Pharma Canada, Inc.

Astellas Pharma Canada, Inc., basée à Markham en Ontario, est une filiale d'Astellas Pharma Inc., dont le siège social est situé à Tokyo. Cette société pharmaceutique a pour objectif d'améliorer la santé de la population mondiale grâce à la mise au point de produits pharmaceutiques innovateurs et fiables. La société se consacre à devenir un chef de file d'envergure mondiale dans des domaines ciblés en combinant ses activités de recherche et de développement hors pair avec son expertise de la commercialisation. Au Canada, Astellas axe son travail dans cinq domaines thérapeutiques : l'urologie, l'immunologie, les maladies infectieuses, la dermatologie et l'oncologie. Pour obtenir de plus amples renseignements sur Astellas Pharma Canada, Inc., veuillez consulter son site Web à l'adressewww.astellas.ca.

 

 

 

1 Thom, DH. Overactive bladder. Epidemiology and impact on quality of life. Contemp Ob/Gyn 2000; (Summer Suppl) 6-14.

2 Stewart, WF, et al. Prevalence and Burden of Overactive Bladder in the United States. World J Urol 2003; 20:327-336.

3 Ouslander, J. Management of Overactive Bladder. The New England Journal of Medicine (Review Article) 2004; 350:786-99.

4 Ouslander, J. Management of Overactive Bladder. The New England Journal of Medicine (Review Article) 2004; 350:786-99.

5 Brown, J, et al. Urge Incontinence: The Patient's Perspective. Journal of Women's Health 1998; 7:1263-1269.

6 Irwin, DE, Milsom, I, et al. Population-Based Survey of Urinary Incontinence, Overactive Bladder, and Other Lower Urinary Track Symptoms in Five Countries: Results of the EPIC Study. Euro Urol. 2006; Supplements 6:4-9.

7 Mayo Clinic. Overactive Bladder Symptoms.http://www.mayoclinic.com/health/overactive-bladder/DS00827/DSECTION=symptoms. Consulté le 21 février 2013.

8 Monographie canadienne du MyrbetriqMC, en date du 4 mars 2013.

9 Monographie canadienne du MyrbetriqMC, en date du 4 mars 2013.

10 Monographie canadienne du MyrbetriqMC, en date du 4 mars 2013.

11 Monographie canadienne du MyrbetriqMC, en date du 4 mars 2013.

12 Abrams, P, et al. The Standardisation of Terminology of Lower Urinary Tract Function. Neurourology and Urodynamics 2002; 21:167-178.

13 Mayo Clinic. Overactive Bladder Definition. http://www.mayoclinic.com/health/overactive-bladder/DS00827. Consulté le 23 février 2013.

14 Ouslander, J. Management of Overactive Bladder. The New England Journal of Medicine (Review Article) 2004; 350:786-99.

15 Milsom, I, et al. How Widespread are the Symptoms of an Overactive Bladder and how are they Managed? BJU Int. 2001 87:760-766.

16 Farage, MA, et al. Psychosocial and Societal Burden of Incontinence in the Aged Population. Arch Gynecol Obstet. Avril 2008; 277(4):285-90.

17 Stewart, K, et al. Overactive Bladder Patients and the Role of the Pharmacist. J Am Pharm Assoc 2002;42:469-78.

 

 

 

SOURCE : Astellas Pharma Canada, Inc.

Renseignements :

ou pour parler à un expert médical, veuillez communiquer avec :

Catherine Gratton-Gagné 
energi RP 
514 288-8500, poste 235 
catherine.gratton-gagne@energipr.com

Loyola Researchers to Determine if Certain Bacteria Cause Overactive Bladder Symptoms

Par Nora Dudley on 4 avril 2013

Thousands of women suffer from overactive bladder (OAB) or the sudden need to urinate, yet many don’t get relief from medication. Researchers at Loyola University Health System believe certain bacteria may be to blame. Loyola has launched a clinical trial to determine if the bacteria present in the urine of women who respond to treatment for overactive bladder are different than those who do not respond. “Overactive bladder can be caused by a number of issues, which may explain why medication works for some and not others,” said Linda Brubaker, MD, a urogynecologist at Loyola University Health System and dean of Loyola University Chicago Stritch School of Medicine. “If we can identify differences in the bacteria in women who respond to treatment and those who do not, we can better manage these patients and improve their quality of life." OAB is a socially debilitating disease that may result from various issues, including cancer or neurological diseases. Urinary tract infections also lead to symptoms of OAB with the difference being bacteria. “Certain bacteria in the urine may contribute to urinary symptoms,” Dr. Brubaker said. “While further research is needed, women with these bacteria may benefit from antibiotics rather than traditional treatments for OAB." Loyola researchers are looking to recruit women for this study. Study participants will complete a questionnaire and will undergo a series of screening procedures. Women involved in the study also will provide urine samples, which researchers will evaluate with traditional cultures and DNA-based detection measures to identify the bacteria present. Women can call (708) 216-2067 to determine if they are eligible to participate in the study.

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New Nationwide Survey Finds Many Women with Symptoms of Overactive Bladder Are Not Diagnosed

Par National Association for Continence (NAFC) on 14 mars 2013

Many Sufferers Think Bladder Leakage Will Worsen Over Time Newswise — Today, the National Association for Continence (NAFC) announced findings from a new, nationwide survey of women about overactive bladder (OAB). The survey compared responses from 1,017 women aged 40-65 with no symptoms of OAB and another 652 women aged 40-65 with symptoms of mild to moderate OAB. Strikingly, the survey found that of the women with OAB symptoms, only 13 percent have ever been diagnosed with the condition, pointing to the fact that many women experience OAB symptoms, but are not diagnosed. Moreover, more than half of the women with OAB symptoms (53%) said they think their bladder leakage will get worse over time. MSD Consumer Care, Inc., a subsidiary of Merck & Co., Inc., paid for the survey to be developed and fielded. Affecting more than 20 million women in the U.S., OAB is characterized by the presence of bothersome urinary symptoms, including urgency, frequency and/or urgency incontinence (leakage). OAB and urinary urgency incontinence occur about twice as frequently in women as in men and can have a far reaching impact on sufferers’ emotional and physical well-being. In fact, the survey found that nearly a third (30%) of women with mild to moderate OAB symptoms are concerned about the health of their bladder and 28 percent worry about not being able to control their bladder in public. In contrast, just three percent of women without OAB symptoms are concerned about their bladder health and only one percent worries about having an accident in public. Additionally, only slightly more than half (57%) of women with OAB symptoms said they feel in control of their lives most of the time compared to the majority of women (78%) without symptoms. “At this stage in life, women should be free to travel, spend time with friends and family and do what they love most without the burdensome and interrupting symptoms of OAB,” said Nancy Muller, PhD, executive director of NAFC. “There are several options that women can explore to help manage their OAB symptoms, including lifestyle and behavioral changes, prescription treatments and a new, over-the-counter treatment coming soon.” Survey Methodology Utilizing the Health Belief Model, a social learning and psychological model that attempts to explain and predict health behaviors, NAFC developed a Health Beliefs Survey completed by 1,017 women (aged 40-65) with no symptoms of OAB and compared the results with responses from 652 women (aged 40-65) with symptoms of mild to moderate OAB. The purpose of the survey was to learn about perceptions and concerns that arise as women age and where bladder health ranks in their list of worries. In order to identify and segregate women with mild to moderate symptoms from those with more severe symptoms, the research firm applied a published, validated screening tool in recruiting potential respondents. This valuable tool was used to identify OAB sufferers for this nationwide consumer survey. The margin of error in comparing the two groups of respondents is +/- 3.8 percent. This research was conducted by Kelton Global Research, a market research company. MSD Consumer Care, Inc., a subsidiary of Merck & Co., Inc., paid for the survey to be developed and fielded and provided editorial input on this announcement. About NAFC The National Association For Continence is a 501(c) 3 corporation whose mission is threefold: 1) to educate the public about the causes, diagnosis categories, treatment options and management alternatives for incontinence, voiding dysfunction, nocturnal enuresis and related pelvic floor disorders; 2) to network with other organizations and agencies to elevate the visibility and priority given to these areas; and 3) to advocate on behalf of consumers who suffer from such symptoms as a result of disease or other illness, obstetrical, surgical or other trauma, or deterioration due to the aging process itself. NAFC is broadly funded by consumers, health care professionals and industry. It is the world’s largest and most prolific consumer advocacy organization devoted exclusively to this field. NAFC celebrated its 30th anniversary year in 2012.

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Astellas Pharma Canada, Inc. reçoit l'avis de conformité de Santé Canada pour Myrbetriq(MC) (mirabegron)

Par CNW on 8 mars 2013

MARKHAM, ON, le 8 mars 2013 /CNW/ - Astellas Pharma Canada, Inc., la filiale canadienne d'Astellas Pharma Inc. de Tokyo, a annoncé aujourd'hui que Myrbetriq^MC (mirabegron, comprimés à libération longue durée) a reçu l'approbation de Santé Canada.

Le mirabegron convient au traitement de l'hyperactivité vésicale (HV) dont les symptômes sont l'urgence d'uriner, l'incontinence par impériosité et une augmentation de la fréquence de miction¹. Mirabegron, un agoniste sélectif des récepteurs bêta-3 adrénergiques, est un nouvel agent thérapeutique d'une classe à part dont le mécanisme d'action diffère de celui des agents antimuscariniques², le traitement standard actuel contre l'HV. Les agonistes bêta-3 détendent les fibres musculaires lisses du détrusor pendant la phase de remplissage du cycle mictionnel, ce qui accroît la capacité de la vessie³.

Le Dr Sender Herschorn est professeur d'urologie à l'Université de Toronto, urologue traitant et directeur du laboratoire de dynamique urinaire du Sunnybrook Health Sciences Centre, ainsi que secrétaire général de l'International Continence Society (ICS). Selon lui, de nombreuses personnes atteintes d'hyperactivité vésicale souffrent en silence, car elles sont trop embarrassées pour en parler à leur médecin.

« Ces patients ne réalisent peut-être pas qu'ils ne sont pas forcés de vivre avec l'hyperactivité vésicale, explique le Dr Herschorn. Il existe d'excellentes options de traitement sur le marché qui pourraient améliorer considérablement leur qualité de vie globale. »

Le mirabegron, qui a été approuvé au Japon (juillet 2011), aux États-Unis (juin 2012) et en Europe (décembre 2012), s'ajoute au Vesicare (succinate de solifénacine) dans le portfolio des traitements de l'hyperactivité vésicale d'Astellas Pharma Canada.

« Le Myrbetriq^MC est le premier d'une nouvelle classe de médicaments contre l'hyperactivité vésicale à être mis au point en plus de 30 ans, affirme Michael Tremblay, président d'Astellas Pharma Canada. La santé urologique se situe toujours au cœur des priorités d'Astellas et nous sommes très heureux d'être les premiers à offrir aux patients canadiens une nouvelle option de traitement. »

ESSAIS CLINIQUES
Myrbetriq a été évalué dans le cadre de trois essais cliniques d'une durée de 12 semaines, randomisées à double insu et contrôlées par placebo, en groupes parallèles et multicentriques, chez les patients souffrant d'hyperactivité vésicale se caractérisant par des symptômes d'incontinence urinaire par impériosités vésicales, d'urgence mictionnelle et de pollakiurie. Selon les critères d'admissibilité, les patients devaient présenter des symptômes d'hyperactivité vésicale pendant au moins 3 mois, au moins 8 mictions par jour et au moins 3 épisodes d'urgence mictionnelle, avec ou sans incontinence, au cours d'une période de 3 jours. La majorité des patients étaient de race blanche (94 %) et de sexe féminin (72 %) et la moyenne d'âge était de 59 ans (éventail d'âges de 18 à 95 ans). La population était composée de patients n'ayant jamais reçu de pharmacothérapie antimuscarinique contre l'hyperactivité vésicale (48 %), ainsi que de patients qui avaient reçu de la pharmacothérapie antimuscarinique pour l'HV (52 %).

Les deux principaux critères d'efficacité des trois essais étaient (1) variation par rapport à la valeur de référence jusqu'à la fin du traitement (semaine 12) en matière du nombre moyen d'épisodes d'incontinence par 24 heures et (2) variation par rapport à la valeur de référence jusqu'à la fin du traitement (semaine 12) en matière du nombre moyen de mictions par 24 heures, se fondant sur le nombre de mictions enregistré dans un journal pendant 3 jours.

AU SUJET DE L'HYPERACTIVITÉ VÉSICALE 
L'hyperactivité vésicale (HV) est un trouble courant qui se définit par l'urgence mictionnelle, avec (HV de type humide) ou sans (HV de type sec) incontinence impérieuse, habituellement associée à une augmentation de la fréquence de miction le jour et à la nocturie⁵. Dans une étude récente basée sur la population canadienne, les symptômes de l'HV ont été décelés chez 13,9 % des répondants (13,1 % chez les hommes et 14,7 % chez les femmes⁶).

À PROPOS D'ASTELLAS PHARMA CANADA, INC.
Astellas Pharma Canada, Inc., basée à Markham, en Ontario, est une filiale canadienne d'Astellas Pharma Inc. dont le siège social est situé à Tokyo. Astellas est une société pharmaceutique qui a pour objectif d'améliorer la santé de la population mondiale grâce à la mise au point de produits pharmaceutiques innovateurs et fiables. La société se consacre à devenir un chef de file d'envergure mondiale dans des domaines ciblés en combinant ses activités de recherche et de développement hors pair avec son expertise de la commercialisation. Au Canada, Astellas axe son travail sur cinq domaines thérapeutiques : l'urologie, l'immunologie, les maladies infectieuses, la dermatologie et l'oncologie. Pour obtenir de plus amples renseignements sur Astellas Pharma Canada, Inc., veuillez consulter son site Web à l'adresse www.astellas.ca.

 

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1} Monographie canadienne de Myrbetriq^MC, en date du 4 mars 2013.

² Nitti, V., Auerbach, S., Martin, N., Calhoun, A., Lee, M., Herschorn, S., Results of a Randomized Phase III Trial of Mirabegron in Patients with Overactive Bladder, The Journal of Urology® (2012), doi: 10.1016/j.juro.2012.10.017.

³ Aizawa, N., Igawa, Y., Nishizawa, O. et al.: Effects of CL316,243, a beta 3-adrenoceptor agonist, and intravesical prostaglandin E2 on the primary bladder afferent activity of the rat. Neurourol Urodyn, 29: 771, 2010.

⁴ Monographie canadienne de Myrbetriq^MC, en date du 4 mars 2013.

^5,6 Bettez M, Tu le M, Carlson K et al. Can Urol Assoc J 2012;6(5):354-63.

SOURCE : Astellas Pharma Canada, Inc.

Renseignements :

Astellas Pharma Canada, Inc.
Naomi Côté
Bureau des communications
905 946-5621
naomi.cote@astellas.com

Astellas Pharma Canada, Inc. receives a Notice of Compliance from Health Canada for Myrbetriq™ (mirabegron)

Par CNW on 8 mars 2013

MARKHAM, ON, March 8, 2013 /CNW/ - Astellas Pharma Canada, Inc., the Canadian subsidiary of Tokyo-based Astellas Pharma Inc., announced today Health Canada's approval of Myrbetriq™ (mirabegron, extended-release tablets).

Mirabegron is indicated for the treatment of overactive bladder (OAB) with symptoms of urgency, urgency incontinence and urinary frequency.¹ Mirabegron, a selective β3-adrenoceptor agonist, is a "first in class" therapeutic agent with a mechanism of action distinct from antimuscarinic agents², the current treatment standard for OAB. β3-agonists relax the detrusor smooth muscle during the storage phase of the urinary bladder fill-void cycle, which increases bladder capacity.³

Dr. Sender Herschorn is Professor of Urology at the University of Toronto, attending Urologist and Head of Urodynamics Laboratory at Sunnybrook Health Sciences Centre and the general secretary of the International Continence Society (ICS). He says many people who are experiencing overactive bladder simply suffer in silence because they are too embarrassed to discuss it with their physician.

"What these patients may not realize is that they don't just have to live with overactive bladder," said Dr. Herschorn. "There are good treatment options available that could significantly improve their overall quality of life."

Mirabegron, approved in Japan (July 2011), the US (June 2012) and Europe (December 2012), joins Vesicare (solifenacin succinate) in Astellas Pharma Canada's OAB portfolio.

"Myrbetriq is the first in a new class of medications for the treatment of OAB in over 30 years," said Michael Tremblay, President, Astellas Pharma Canada. "Urological health continues to be a key priority for Astellas and we are very pleased to be the first to offer Canadian patients a new treatment option."

CLINICAL TRIALS⁴
Myrbetriq was evaluated in three, 12-week, double-blind, randomized, placebo-controlled, parallel group, multicenter clinical trials in patients with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Entry criteria required that patients had symptoms of overactive bladder for at least 3 months duration, at least 8 micturitions per day, and at least 3 episodes of urgency with or without incontinence over a 3 day period. The majority of patients were Caucasian (94%) and female (72%) with a mean age of 59 years (range 18 - 95 years). The population included both naïve patients who had not received prior antimuscarinic pharmacotherapy for overactive bladder (48%) and those who had received prior antimuscarinic pharmacotherapy for OAB (52%).

The co-primary efficacy endpoints in all 3 trials were (1) change from baseline to end of treatment (Week 12) in mean number of incontinence episodes per 24 hours and (2) change from baseline to end of treatment (Week 12) in mean number of micturitions per 24 hours, based on a 3-day micturition diary.

ABOUT OVERACTIVE BLADDER

Overactive bladder (OAB) is a common condition defined as urgency, with (OAB wet) or without urgency incontinence (OAB dry), usually associated with increased daytime frequency and nocturia.⁵ In a recent Canadian population-based study, OAB symptoms were reported in 13.9% of respondents (13.1% of men and 14.7% of women).⁶

ABOUT ASTELLAS PHARMA CANADA, INC.
Astellas Pharma Canada, Inc., headquartered in Markham, ON, is a Canadian affiliate of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. The organization is committed to becoming a global category leader in focused areas by combining outstanding R&D and marketing capabilities. In Canada, Astellas has an intense commercial focus on five therapeutic areas - Urology, Immunology, Infectious Disease, Dermatology and Oncology. For more information about Astellas Pharma Canada, Inc., please visit the corporate website:  www.astellas.ca

¹ Myrbetriq™ Canadian approved Product Monograph, dated March 4, 2013.

² Nitti, V., Auerbach, S., Martin, N., Calhoun, A., Lee, M., Herschorn, S., Results of a Randomized Phase III Trial of Mirabegron in Patients with Overactive Bladder, The Journal of Urology® (2012), doi: 10.1016/j.juro.2012.10.017.

³ Aizawa, N., Igawa, Y., Nishizawa, O. et al.: Effects of CL316,243, a beta 3-adrenoceptor agonist, and intravesical prostaglandin E2 on the primary bladder afferent activity of the rat. Neurourol Urodyn, 29: 771, 2010

⁴ Myrbetriq™ Canadian approved Product Monograph, dated March 4, 2013.

^5,6 Bettez M, Tu le M, Carlson K et al. Can Urol Assoc J 2012;6(5):354-63.

SOURCE: Astellas Pharma Canada, Inc.

For further information:

Astellas Pharma Canada, Inc.
Naomi Côté, Corporate Communications
905-946-5621
naomi.cote@astellas.com

Bedwetting Prevention is Possible

Par The You Docs on 6 mars 2013

Q: I have a 75-year-old mother and a 5-year-old son—and both of them are wetting the bed. Double help! — Jean F., Boise, Idaho A: Bedwetting and incontinence are challenging problems for both those experiencing the trouble and the caretaker—you. Fortunately, with a little work, both conditions can be managed pretty well. Your son is only 5, and occasional bedwetting is common up to age 7; about 20 per cent of 5-year-olds can’t always stay dry at night. They may not have fully developed bladder control mechanisms, or they’re not producing enough of the hormone vasopressin, which reduces urine production at night. Rarely is bedwetting a sign of illness. Your best bet is to use absorbent pads and underwear at night, eliminate all caffeine-containing drinks (colas, for example), and make sure he urinates regularly during the day and right before bed. You also can use a moisture alarm that will wake him at the first sign of dampness. In six to 12 weeks he may begin to recognize the feeling that he has to go and wake himself up. For many older folks, incontinence is a problem. (In Japan, diaper sales for older folks exceed diaper sales for infants.) When it happens at night, it’s usually from an overactive bladder—and leakage can happen with or without the sensation that you gotta go. Some medications trigger OAB, as can neurological disease, injury or infection, but much of the time the cause is unknown. Fortunately, there are potential solutions. Your mom can try pelvic floor muscle exercises (Kegels) and bladder retraining to increase her ability to hold in urine. Medications are also effective. Check with her doc and ask about oxybutynin, which inhibits nerve impulses that cause leakage, and darifenacin, which reduces muscle spasms of the bladder and urinary tract. For severe cases, Dr. Mike’s Cleveland Clinic suggests Interstim—a therapy that uses an implanted electrical stimulator to control the nerve that triggers urination. Q: When I had my hip replacement, I found out everything I could about the doctor, the hospital, the implant and the procedure before I had it done. A friend of mine who also got a new hip never even found out what kind of implant she was getting. Now she’s having trouble, while I’m back to running around with no problems. Could just knowing what’s going on have made the difference for me? — Terry H., New York A: Knowledge is power, and when it comes to knowledge about your body and your medical treatments, it’s the power to stay healthy! We know that if you’re more knowledgeable about procedures before and after surgery, get a second opinion and search for the most competent doctor for any significant treatment or surgery, you’ll have better health outcomes. As for your friend, we’re sorry she is having trouble, but it’s never too late to get proactive about wellness. Let her know that she can do a lot to make herself feel better and encourage her to become better informed. Help her write out a list of questions for her surgeon, primary care doctor and physical therapist (she does have one, doesn’t she?). Suggest that she go to a reputable website (we like ours: ClevelandClinic.org and NewYorkPresbyterian.org) to find out about hip replacements. She can catch up on all the latest info, and that should make her feel more confident and more engaged the next time she goes in for a checkup or if she needs repair of her previous surgery.

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The CCF Overactive Bladder Survey

Par The Canadian Continence Foundation (TCCF) on 1 mars 2013

The Canadian Continence Foundation (TCCF) would like to invite you to take a few minutes to complete this brief survey. The purpose of the survey is to allow TCCF to collect insights and perspectives about overactive bladder (OAB) from patients and caregivers in order to complete two patient evidence submissions; one for MIRABEGRON, and another for BOTOX. Both of these medications for OAB will soon be going through a review process that invites patient groups like TCCF to prepare and send in submissions so that patients and caregivers like you can be heard. So please join us and have your say about OAB. We ask that you complete the survey by March 15, 2013. Thank you for your participation.

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5 Diet Tips to Help Control an Overactive Bladder

Par Michele Borboa on 22 janvier 2013

Click here!

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10 Myths About Overactive Bladder

Par Better Medicine on 7 janvier 2013

Popular Myths, Busted

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