Krankenversicherungsdaten zur Versorgungssituation von Osteoporose-Patientinnen

Zusammenfassung

Die REAL-Studie ist eine retrospektive Beobachtungsstudie auf der Basis von Krankenversicherungsunterlagen aus den Vereinigten Staaten mit zwei Kohorten: 12215 Patientinnen, die einmal wöchentlich 35 mg Risedronat erhielten und 21615 Patientinnen, die einmal wöchentlich 35 mg (8%) oder 70 mg (92%) Alendronat erhielten. Nach sechs Behandlungsmonaten wies die Risedronat-Kohorte eine um 19% niedrigere Inzidenz von nichtvertebralen Frakturen auf als die Alendronat-Kohorte. Nach zwölf Behandlungsmonaten hatte die Risedronat-Kohorte eine um 18% niedrigere Inzidenz von nichtvertebralen Frakturen verglichen mit der Alendronat-Kohorte. Gegenüber der Alendronat-Kohorte wies die Risedronat-Kohorte nach sechs Behandlungsmonaten eine um 46% niedrigere Inzidenz von Hüftfrakturen auf. Nach zwölf Behandlungsmonaten hatte die Risedronat-Kohorte eine um 43 % niedrigere Inzidenz von Hüftfrakturen als die Alendronat-Kohorte. Diese Ergebnisse lassen sich nichtdurch das Auftreten von Baseline-Unterschieden im Frakturrisikozwischen den Kohorten erklären. Weiterhin stimmten die beobachteten Frakturraten mit denjenigen aus klinischen Studien überein. Es zeigte sich damitzumindestfürden amerikanischen Raum, dass Patienten, die Risedronat erhalten, im ersten Behandlungsjahr besservor Hüft-und nichtvertebralen Frakturen geschützt sind als Patienten, die Alendronat erhalten.

Summary

The REAL study is a retrospective observational study based on US health services utilization data with two cohorts: 12215 patients receiving risedronate 35 mg onceweekly and 21615 patients receiving alendronate once weekly either 35 mg (8%) or 70 mg (92%). After 6 months of treatment the risedronate cohort had a 19% lower incidence of nonvertebrale fractures than the alendronate cohort. After 12 months of therapy the risedronate cohort had an 18 % lower incidence of nonvertebrale fracture than the alendronate cohort. After 6 months of therapy the risedronate cohort had a 46 % lower incidence of hip fractures than the alendronate cohort. After 12 months of therapy the risedronate cohort had a 43 % lower incidence of hip fractures than the alendronate cohort. These results do not appear to be explained by baseline differences in fracture risks between the cohorts. In addition, the observed rates of fractures were consistent with fracture rates in clinical trials. Thus it appears, at least for the US data, patients receiving risedronate are better protected from hip and nonvertebral fractures during their first year of therapy than patients receiving alendronate.

Schlüsselwörter

Osteoporose - Bisphosphonate - nichtvertebrale Frakturen

Keywords

Osteoporosis - bisphosphonates - nonvertebral fractures

• Literatur

• 1 Black DM, Cummings SR, Karpf DB. et al. Randomised Trial of Effect of Alendronate on Risk of Fracture in Women with Existing Vertebral Fractures. Fracture Intervention Trial Research Group. Lancet 1996; 348: 1535-1541.
• 2 Black DM, Thompson DE, Bauer DC. et al. Fracture Risk Reduction with Alendronate in Women with Osteoporosis: The Fracture Intervention Trial. J Clin Metab 2000; 85: 4118-4124.
• 3 Chesnut CH, Skag A, Chriatiansen C. et al. Effects of Oral Ibandronate Administered Daily or Intermittently on Fracture Risk in Postmenopausal Osteoporosis. J Bone Miner Res 2004; 19: 1241-1249.
• 4 Cummings SR, Black DM, Thompson DE. et al. Effect of Alendronate on Risk of Fractures in Women with Low Bone Density but Without Vertebral Fractures: Results from the Fracture Intervention Trial. JAMA 1998; 280: 2077-2082.
• 5 Harrington JT, Ste-Marie LG, Brandi ML. et al. Risedronate Repidly Reduces the Risk for Nonvertebral Fractures in Women with Postmenopausal Osteoporosis. Calcif Tissue Int 2004; 74: 129-135.
• 6 Harris ST, Watts NB, Genant HK. et al. Effects of Risedronate Treatment on Vertebral and Nonvertebral Fractures in Women with Postmenopausal Osteoporosis: A Randomized Controlled Trial. Vertebral Efficacy with Risedronate Therapy (VERT) Study Group. JAMA 1999; 282: 1344-1352.
• 7 Liberman UA, Weiss SR, Broll J. et al. Effect of Oral Alendronate on Bone Mineral Density and the Incidence of Fractures in Postmenopausal Osteoporosis. The Alendronate Phase III Osteoporosis Treatment Study Group. N Engl J Med 1995; 333: 1437-1443.
• 8 McClung MR, Geusens P, Miller PD. et al. Effect of Risedronate on the Risk of Hip Fracture in Elderly Women. Hip Intervention Program Study Group. N Engl J Med 2001; 344: 333-340.
• 9 Melton LJ, 3rd, Crowson CS, O’Fallon WM. Fracture Incidence in Olmsted County, Minnesota: Comparison of Urban with Rural Rates and Changes in Urban Rates over Time. Osteoporos Int 1999; 9: 29-37.
• 10 Reginster J, Minne HW, Sorensen OH. et al. Randomized Trial of the Efficacy of Risedronate on Vertebral Fractures in Women with Established Postmenopausal Osteoporosis. Vertebral Efficacy with Risedronate Therapy (VERT) Study Group. Osteopros Int 2000; 11: 83-91.
• 11 Silverman SL, Watts NB, Delmas PD. et al. Effectiveness of Bisphosphonates on Nonvertebral and Hip Fractures in the First Year od Therapy: The Risedronate and Alendronate (REAL). Cohort Study Osteopros Int 2007; 18: 25-34.
• 12 U.S. Department of Health and Human Services.. Bone Health and Osteoporosis: A Report of the Surgeon General. Rockville, MD: U.S. Department of Health and Human Services, Office of the Surgeon General 2004 .