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26 April 2021

Real world evidence demonstrates that risedronate GR (Actonel®GR) has superior outcomes for fracture risk reduction in patients with osteoporosis compared to immediate release oral bisphosphonates

FOR MEDICAL BUSINESS/INDUSTRY TRADE MEDIA ONLY

Patients on risedronate GR, compared with patients on oral immediate release (IR) bisphosphonates, experienced:

• 17% lower incidence of fracture, regardless of the fracture site (p<0.05)1

• 29% reduction in the incidence of spine fractures (p=0.05)1

• Time to first fracture was delayed for the risedronate GR cohort, reaching statistical significance at 36 months (p=0.037)1

London, [26 April 2021]: A real world evidence study, presented at the 13th International Conference on Osteoporosis, Arthritis and Musculoskeletal Disorders has shown for the first time via direct comparison, that risedronate GR (Actonel® GR) demonstrated superior outcomes for fracture risk reduction in patients with osteoporosis, compared to those who received an immediate release (IR) bisphosphonate.1

The study used healthcare claims data from over 5,000 osteoporosis patients to demonstrate a 17% reduction in incidence of any site fractures for patients taking risedronate GR compared with those taking oral IR bisphosphonates (p<0.05).1 This difference was even more pronounced in spine fractures where a 29% reduction in fracture incidence was seen (p<0.05).1 Time to first fracture was delayed for those receiving risedronate GR, reaching statistical significance at 36 months.1 The incidence of gastric adverse events was broadly similar between the two patient groups.1

Lead study investigator, Dr Friederike Thomasius, comments:

“These data are crucial for all healthcare professionals managing osteoporosis and provide an important insight into real-world evidence. I see patients every day who are struggling with medication compliance due to the inflexible regimes of some bisphosphonates. We know that one in three women over the age of 50 will suffer a fragility fracture that can be life changing. As clinicians we need to carefully consider the options for our patients and what this means for lowering fracture risk.”

Bisphosphonates are recommended by guidelines as a first line treatment but there are a number of restrictions associated with how they are taken, for example, the need to fast overnight before taking and for 30 minutes afterwards.2,3,4 Up to a third of patients treated with bisphosphonates take them with food, which may increase fracture risk.5 risedronate GR is the only oral bisphosphonate which can be taken with food due to its enteric coating.6

Robert Stewart, Chief Executive Officer of Theramex, also shared his thoughts:

“We knew that Actonel GR offered a treatment choice that could remove the variability of compliance experienced with oral immediate release bisphosphonates. We set out to explore the impact of this in a real-world setting. What we found was significantly improved clinical outcomes in fracture risk reduction for patients taking Actonel GR versus oral immediate release bisphosphonates. When we consider bisphosphonates are the first line treatment in a condition affecting 200 million women globally, this is an important finding and completely aligned to our mission at Theramex as a company solely dedicated to improving women’s health.” Ends

Notes to Editor: About Osteoporosis

Osteoporosis remains largely underdiagnosed and undertreated, resulting in a large number of fractures.

  • It is a significant health issue – affecting ~200 million people worldwide7
  • Osteoporosis affects more women than men and risk increases with age8
  • After the menopause women start to lose bone at a faster rate, raising the risk for women who have had an early menopause or hysterectomy8
  • One in three women aged over 50 will suffer a fragility fracture9
  • Up to a third of patients treated with bisphosphonates (one in three) take their bisphosphonate with food, which may increase fracture risk5
  • Hip, spine and wrist fractures are the most common fractures, which have a debilitating impact on daily activities and quality of life9 
  • After a spine fracture mortality decreased over a 5-year period by up to 16% per year10
  • Vertebral fracturescan lead to back pain, loss of height, deformity, immobility, QoL, and activities of daily living11,12,13

About treatment

Bisphosphonates are recommended as first-line treatment for osteoporosis by guidelines. Even when taken correctly, only 1% of the dose is absorbed and this can be impaired by food, calcium, iron, coffee, tea and orange juice.14,15  Most patients take their bisphosphonates before breakfast as there are a number of restrictions when taking oral bisphosphonates, which can be a major inconvenience. Patients must:2,3,4

  • Fast overnight before taking the medication
  • Fast for 30 minutes after taking the medication (before having breakfast)
  • Stay upright for 30 minutes after taking the medication
  • Take with a glass of water (not juice or coffee)
  • Take separately from other medications

Real-world evidence indicates that many patients do not comply with the complex dosing instructions.5 Poor compliance can result in suboptimal efficacy and 45% increased risk of fractures.16

About Risedronate Gastric Resistant (GR) (Actonel®)

Risedronate GR is an oral bisphosphonate which has flexible administration requirements for patients.6 Due to its gastro-resistant enteric coating risedronate GR can bypass the stomach and is absorbed in the small intestine, where the absorption of a bisphosphonate is most important.17 Risedronate GR, therefore,provides 2-4 times higher bioavailability than oral IR bisphosphonates when taken with food.17 Risedronate GR is the only oral bisphosphonate which can be taken with food and, therefore, can be taken immediately after breakfast.6 The flexibility offered by risedronate GR dosing offers a convenient option for patients who may struggle with more restrictive treatment dosing requirements. Risedronate GR was approved by the European Medicines Agency (EMA), as a treatment for patients with Osteoporosis, in October 2016.

About the study1

This retrospective, observational analysis of US healthcare database claims compared the fracture rate and economic burden in female osteoporosis patients who received risedronate GR (n=2,726) with those treated with immediate release bisphosphonates (n=2,726).1 The two cohorts were matched based on patient characteristics and history.1

All patients had ≥1 prescription fill for an oral bisphosphonate, had ≥1 medical claim associated with ≥6 months of continuous eligibility for both pharmacy and medical benefits 6 months prior to the observational period of this study. Patients with a history of Paget’s disease or specific malignancies were excluded from the study.1

Patients without a treatment switch were observed for ≥2 years from the first study-related prescription.1 New fracture events were identified from relevant diagnosis codes from medical claims. In the case of recurrent fracture, the claim was required to occur ≥30 days after the previous fracture claim at distinct skeletal sites and ≥90 days apart if occurring at the same site. Healthcare resource use was also compared.1

About Theramex

Theramex is a leading, global speciality pharmaceutical company dedicated to women and their health. With a broad portfolio of innovative and established brands covering contraception, fertility, Menopause and Osteoporosis, we support women at every stage of their lives. Our commitment is to listen and understand our patients, serve their needs, and offer healthcare solutions to help improve their lives. Our vision is to be a lifetime partner for women and the healthcare professionals who treat them, by providing innovative and effective solutions that care for and support women as they advance through each stage of their lives.

Contacts:

Andrew Bradley, Head of Communications Theramex

andrew.bradley@theramex.com / +44 (0)7864 167962

Helen Rae, Makara Health

helenrae@makarahealth.com / +44(0)7503 652311

References:

  1. Thomasius, F. et al. Fracture rates and economic outcomes in patients with osteoporosis receiving gastro-resistant risedronate versus other oral bisphosphonates: A claims data analysis. Abstract presented at 13th International Conference on, Osteoporosis, Arthritis and Musculoskeletal Disorders, April 23-24, Dubai 2021
  2. Warner Chilcott UK Ltd. Actonel 5 mg SmPC. 2018
  3. Accord Healthcare Ltd. Alendronic acid 10 mg SmPC. 2017
  4. Consilient Health Ltd. Ibandronic acid 50 mg SmPC. 2019
  5. Vytrisalova et al CLIMACTERIC 2015;18:608–616
  6. Theramex Ltd. Risedronate sodium gastro-resistant SmPC
  7. Noh JY, Yang Y and Jung H. Molecular mechanisms and emerging therapeutics for osteoporosis. Int J Mol Sci. 2020; 21, 7623 DOI: 10.3390/ijms21207623
  8. IOF. Risk Factors. https://www.osteoporosis.foundation/patients/about-osteoporosis/risk-factors Last accessed: April 2021
  9. IOF Compendium of Osteoporosis. 25th September 2019. www.osteoporosis.foundation/sites/iofbonehealth/files/2020-01/IOF-Compendium-of-Osteoporosis-web-V02.pdf Last accessed: April 2021
  10. Johnell O et al. Mortality After Osteoporosis Fractures. Osteoporos Int 15, 38-42 (2004)
  11. Nevitt MC et al. (1998), Ann Intern Med 128:793.
  12. Lips P et al  (1999), Osteoporos Int 10:150.
  13. Tosteson AN et al , (2001), Osteoporos Int 12:1042
  14. Lin J. Bisphosphonates: a review of their pharmacokinetic properties. Bone. 1996;18:75–85
  15. Kanis JA et al. European guidance for the diagnosis and management of osteoporosis in postmenopausal women. Osteoporosis International (2019) 30:3–44
  16. Penning-van Beest F.J.A, Erkens J.A, Olson M., Herings R.M.C, Loss of treatment benefit due to low compliance with bisphosphonate therapy, Osteoporos Int. 2008, 19(4): 511-517
  17. Pazianas M, et al. Ther Clin Risk Manag 2013;9:395–402

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