Fracture rates and economic outcomes in patients with osteoporosis prescribed risedronate gastro-resistant versus other oral bisphosphonates: a claims data analysis

Thomasius, Friederike; Palacios, Santiago; Alam, Asif; Boolell, Mitra; Vekeman, Francis; Gauthier, Geneviève

doi:10.1007/s00198-021-06108-w

Cited by 9 publications

(22 citation statements)

References 35 publications

(61 reference statements)

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“…Indeed, this is supported by findings from a recent retrospective observational study of 5,452 post‐menopausal women from a US claims database: prescription of GR risedronate was associated with a lower incidence of fractures versus other oral bisphosphonates 21 …”

Section: Discussionmentioning

confidence: 56%

“…Indeed, this is supported by findings from a recent retrospective observational study of 5,452 post-menopausal women from a US claims database: prescription of GR risedronate was associated with a lower incidence of fractures versus other oral bisphosphonates. 21 Limitations of this study included that the majority of participants were male (75%) and Caucasian (96%). Furthermore, the proportion of men and women differed between groups.…”

Section: Discussionmentioning

confidence: 96%

“…The bioavailability of oral BPs is low 9 and is further inhibited by food 10‐12 . For this reason, patients may benefit from the availability of a GR formulation of oral BP that would allow them to take their medication with food 21 . The aim of this study was to assess the relative absorption of four GR formulations of risedronate 35 mg under fasted conditions with IR risedronate 35 mg.…”

Section: Discussionmentioning

confidence: 99%

“…21,27 A GR formulation of risedronate 35 mg that could be taken with food would not only provide a more flexible dosing option to patients, but may also improve adherence and thus has the potential to be more effective in reducing fragility fractures. 4,17,21,28…”

Section: Discussionmentioning

confidence: 99%

“…[10][11][12] For this reason, patients may benefit from the availability of a GR formulation of oral BP that would allow them to take their medication with food. 21 The aim of this study was to assess the relative absorption of four GR formulations of risedronate 35 mg under fasted conditions with IR risedronate 35 mg. In addition, this study investigated the effect of food on the relative absorption of these four GR risedronate formulations and their site of disintegration.…”

Section: Discussionmentioning

confidence: 99%

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An open‐label randomized study of the relative absorption of gastro‐resistant risedronate taken fasted or with food versus immediate‐release risedronate

Kleinermans

Joyson²,

Wray³

2022

Pharmacology Res & Perspec

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Patients with osteoporosis often take oral bisphosphonates with food, rendering these medications ineffective. This study compared the relative absorption of four formulations of gastro‐resistant (GR; formulations 1–4) risedronate 35 mg versus immediate‐release (IR) risedronate 35 mg taken fasted. Secondarily, it compared the relative absorption of GR formulations administered fed and fasted, and determined the site of disintegration. Healthy participants (N = 160) were randomized to one of nine treatment groups: IR risedronate taken fasted (group A) or formulations 1–4 taken fasted or fed (groups B–I). Fasted groups fasted for 8 h pre‐dose and 4 h post‐dose. Fed groups fasted for 7.5 h, then took risedronate with breakfast. Urine was collected until 72 h post‐dose and analyzed using liquid chromatography. From each group, up to seven participants underwent scintigraphic monitoring to assess tablet disintegration. The percentage of total dose recovered in urine (A’e) was ~0.5% for group A. The A’e of formulations 1–4 taken fasted was 0.220% (90% confidence interval 0.124–0.389), 0.298% (0.122–0.730), 0.154% (0.090–0.264), and 0.108% (0.051–0.231), respectively. With food, the A’e of formulation 1 decreased least versus fasted (−27%) compared with the A’e of formulations 2, 3, and 4 (−73%, −80%, and −65%, respectively). Formulations 1–3 disintegrated in the small intestine, formulation 4 closer to the large intestine. All GR formulations were well tolerated and in line with the known safety profile for IR risedronate. Formulation 2 had the highest absorption when taken fasted, whereas the absorption of formulation 1 was least affected by food.

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Section: Discussionmentioning

confidence: 56%

Section: Discussionmentioning

confidence: 96%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 3 more Smart Citations

An open‐label randomized study of the relative absorption of gastro‐resistant risedronate taken fasted or with food versus immediate‐release risedronate

Kleinermans

Joyson²,

Wray³

2022

Pharmacology Res & Perspec

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Fracture risk in women with osteoporosis initiated on gastro-resistant risedronate versus immediate release risedronate or alendronate: a claims data analysis in the USA

Eisman

Cortet²,

Boolell³

et al. 2023

Osteoporos Int

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The study results indicate that women with osteoporosis initiated on gastro-resistant risedronate have a lower risk of fracture than those initiated on immediate release risedronate or alendronate. A large proportion of women discontinued all oral bisphosphonate therapies within 1 year of treatment start. Purpose Using a US claims database (2009)(2010)(2011)(2012)(2013)(2014)(2015)(2016)(2017)(2018)(2019), we compared risk of fractures between women with osteoporosis initiated on gastro-resistant (GR) risedronate and those initiated on (a) immediate release (IR) risedronate or (b) immediate release alendronate. Methods Women aged ≥ 60 years with osteoporosis who had ≥ 2 oral bisphosphonate prescription fills were followed for ≥ 1 year after the first observed bisphosphonates dispensing (index date). Fracture risk was compared between the GR risedronate and IR risedronate/alendronate cohorts using adjusted incidence rate ratios (aIRRs), both overall and in subgroups with high fracture risk due to older age or comorbidity/medications. Site-specific fractures were identified based on diagnosis codes recorded on medical claims using a claims-based algorithm. Persistence on bisphosphonate therapy was evaluated for all groups. Results aIRRs generally indicated lower fracture risk for GR risedronate than IR risedronate and alendronate. When comparing GR risedronate to IR risedronate, statistically significant aIRRs (p < 0.05) were observed for pelvic fractures in the full cohorts (aIRRs = 0.37), for any fracture and pelvic fractures among women aged ≥ 65 years (aIRRs = 0.63 and 0.41), for any fracture and pelvic fractures among women aged ≥ 70 years (aIRRs = 0.69 and 0.24), and for pelvic fracture among high-risk women due to comorbidity/medications (aIRR = 0.34). When comparing GR risedronate to alendronate, statistically significant aIRRs were observed for pelvic fractures in the full cohorts (aIRR = 0.54), for any fracture and wrist/arm fractures among women aged ≥ 65 years (aIRRs = 0.73 and 0.63), and for any fracture, pelvic, and wrist/arm fractures among women aged ≥ 70 years (aIRRs = 0.72, 0.36, and 0.58). In all cohorts, ~ 40% completely discontinued oral bisphosphonates within 1 year. Conclusions Discontinuation rates of oral bisphosphonate therapy were high. However, women initiated on GR risedronate had a significantly lower risk of fracture for several skeletal sites than women initiated on IR risedronate/alendronate, particularly those aged ≥ 70 years.

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Novel formulations of oral bisphosphonates in the treatment of osteoporosis

et al. 2022

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Oral bisphosphonates are a key intervention in the treatment of osteoporosis and in reducing the risk of fragility fractures. Their use is supported by over 3 decades of evidence; however, patient adherence to oral bisphosphonates remains poor in part due to complex dosing instructions and adverse events, including upper gastrointestinal symptoms. This problem has led to the development of novel oral bisphosphonate formulations. Buffered, effervescent alendronate is dissolved in water and so seeks to reduce upper gastro-intestinal adverse events, and gastro-resistant risedronate aims to reduce the complexity of dosing procedure (e.g. fasting prior to consumption) whilst still maintaining the efficacy of fracture risk reduction. Clinical trials and real-world data have been employed to demonstrate some benefits in terms of reduced upper gastro-intestinal adverse events, adherence, persistence and health economic outcomes. This report describes the result of an ESCEO (European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis) expert working group, which explores where oral bisphosphonates sit in current clinical practice guidelines, review their risk–benefit profile and the consequences of poor adherence before exploring novel oral bisphosphonate formulations and their potential clinical and health economic impact. Further research is required but there are signs that these novel, oral bisphosphonate formulations may lead to improved tolerance of oral bisphosphonates and thus, improved adherence and fracture outcomes.

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Fracture rates and economic outcomes in patients with osteoporosis prescribed risedronate gastro-resistant versus other oral bisphosphonates: a claims data analysis

Cited by 9 publications

References 35 publications

An open‐label randomized study of the relative absorption of gastro‐resistant risedronate taken fasted or with food versus immediate‐release risedronate

An open‐label randomized study of the relative absorption of gastro‐resistant risedronate taken fasted or with food versus immediate‐release risedronate

Fracture risk in women with osteoporosis initiated on gastro-resistant risedronate versus immediate release risedronate or alendronate: a claims data analysis in the USA

Novel formulations of oral bisphosphonates in the treatment of osteoporosis

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