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31 August 2021

Real-world evidence demonstrates significant difference in fracture risk reduction for osteoporosis patients using gastro-resistant risedronate (Actonel® GR*) when compared with those using alendronate IR oral bisphosphonate

FOR MEDICAL BUSINESS/INDUSTRY TRADE MEDIA ONLY

Patients on gastro-resistant risedronate (Actonel® GR), compared with patients on alendronate immediate release (IR), experienced:

  • 19% lower incidence of fracture, regardless of the fracture site (p<0.05)1
  • 31% reduction in the incidence of spine fractures1
  • Fewer hospitalisations over the mean observation period of 4.45 years (p<0.05)1

London, 28 August 2021: New data from a real-world evidence study presented at the 21st World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases 2021 demonstrates significant difference for risedronate GR (Actonel® GR) in reducing fracture risk in patients with osteoporosis when directly compared with another oral bisphosphonate (alendronate IR.)2

The study directly compared risedronate GR with alendronate IR and patients were matched at the start of the study by age, previous fractures, and current comorbidities (or illnesses).1 Risedronate GR-treated patients showed a 19% lower incidence rate of fractures of any site versus the alendronate cohort (p<0.05) and a 31% reduction in the risk of spine fractures (p<0.05).1

Patients in the risedronate GR cohort incurred fewer hospitalisations over the mean observation period of 4.45 years than patients in the alendronate IR cohort (p<0.05).2 This translates into numerically lower hospitalisation costs (average per-patient-per-year; GR: $3,605; alendronate: $4,572, p=0.0681).2

The data is from a real-world study that analysed healthcare claims data from over 5,000 women with osteoporosis to demonstrate a 17% reduction in incidence of any site fractures for patients taking risedronate GR compared with those taking any oral IR bisphosphonates (p<0.05) 1

Lead study investigator, Dr Friederike Thomasius, commented:

“Osteoporosis causes one in three women over the age of 50 to suffer a life-changing, but preventable, fragility fracture. However, many patients are not diagnosed or treated until a fracture occurs. The healthcare community should carefully consider all of the options available to our patients to reduce fracture risk.”

Bisphosphonates have a number of restrictions associated with how they are taken, for example, the need to fast overnight before taking and for 30 minutes afterwards.3,4,5 Up to a third of patients treated with bisphosphonates incorrectly take them with food, which may increase fracture risk through reduced treatment efficacy.6 Risedronate GR is the only oral bisphosphonate which can be taken with food and keep its efficacy due to its enteric coating.7

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

“We are delighted with this robust head-to-head data set, that further supports Actonel® GR as a reliable treatment, with a convenient treatment regimen and, most importantly, significant difference when it comes to risk of fracture and hospitalisation versus more traditional oral IR bisphosphonates. Osteoporosis is a condition affecting 200 million women globally, and as our mission at Theramex is solely dedicated to improving women’s health, we hope this real-world evidence will help improve the management of osteoporosis and patients’ quality of life.”

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 worldwide8
  • Osteoporosis affects more women than men and risk increases with age9
  • After the menopause women start to lose bone at a faster rate, raising the risk especially for women who have had an early menopause or hysterectomy9
  • One in three women aged over 50 will suffer a fragility fracture10
  • Up to a third of patients treated with bisphosphonates (one in three) take their bisphosphonate with food, which may increase fracture risk6
  • Hip, spine and wrist fractures are the most common fractures, which have a debilitating impact on daily activities and quality of life (QoL)10
  • After a spine fracture mortality is increased immediately after the fracture event11
  • Vertebral fractures can lead to back pain, loss of height, deformity, immobility, decrease of QoL, and activities of daily living12,13,14

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.15,16

All 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:3,4,5

  • 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.6

Poor compliance can result in suboptimal efficacy and 45% increased risk of fractures.17

About Risedronate Gastric Resistant (GR) (Actonel®)

Risedronate GR is an oral bisphosphonate. Due to its gastro-resistant enteric coating risedronate GR bypasses the stomach and is absorbed in the small intestine, where the absorption of a bisphosphonate is most important.18 Risedronate GR, therefore,provides 2-4 times higher bioavailability than oral IR bisphosphonates when taken with food.18 Risedronate GR tablets should be taken orally in the morning immediately after breakfast.7 Risedronate GR was approved by the European Medicines Agency (EMA), as a treatment for patients with Osteoporosis, in October 2016.

About the study

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

All patients were observed for ≥2 years and classified into the risedronate GR or alendronate IR cohort based on the treatment initiated. Women from the two cohorts were then matched 1:1 based on patient characteristics and history (n=1,807 in each cohort).2 Fracture incidence rates and healthcare resource use were compared between the two cohorts.2 Patients with a history of Paget’s disease or specific malignancies were excluded from the study.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@theramex.com / +44 (0)7864 167962

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 presented at 13th International Conference on, Osteoporosis, Arthritis and Musculoskeletal Disorders, April 23-24, Dubai 2021
  2. Thomasius, F. et al. a COMPARISON OF FRACTURE RATES AND ECONOMIC OUTCOMES BETWEEN WOMEN WITH OSTEOPOROSIS RECEIVING RISEDRONATE GASTRO-RESISTANT (GR) AND ALENDRONATE. Abstract presented at 21st World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases, August 26-29, 2021, London.
  3. Warner Chilcott UK Ltd. Actonel 5 mg SmPC. 2018
  4. Accord Healthcare Ltd. Alendronic acid 10 mg SmPC. 2017
  5. Consilient Health Ltd. Ibandronic acid 50 mg SmPC. 2019
  6. Vytrisalova et al CLIMACTERIC 2015;18:608–616
  7. Theramex Ltd. Risedronate sodium gastro-resistant SmPC  
  8. 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
  9. IOF. Risk Factors. https://www.osteoporosis.foundation/patients/about-osteoporosis/risk-factors Last accessed: July 2021
  10. IOF Compendium of Osteoporosis. 25th September 2019. www.osteoporosis.foundation/sites/iofbonehealth/files/2020-01/IOF-Compendium-of-Osteoporosis-web-V02.pdf Last accessed: July 2021
  11. Johnell O et al. Mortality After Osteoporosis Fractures. Osteoporos Int 15, 38-42 (2004)
  12. Nevitt MC et al. (1998), Ann Intern Med 128:793.
  13. Lips P et al  (1999), Osteoporos Int 10:150.
  14. Tosteson AN et al , (2001), Osteoporos Int 12:1042
  15. Lin J. Bisphosphonates: a review of their pharmacokinetic properties. Bone. 1996;18:75–85
  16. Kanis JA et al. European guidance for the diagnosis and management of osteoporosis in postmenopausal women. Osteoporosis International (2019) 30:3–44
  17. 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
  18. Pazianas M, et al. Ther Clin Risk Manag 2013;9:395–402

12 July 2021

Theramex appoints Sigurd Kirk to the Board of Directors

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