Diğer

VIBE: Evaluation of Ibandronate Efficacy - Original Investigation

  • J-Y Reginster
  • S Poston

Turk J Osteoporos 2008;14(3):-

A Retrospective Cohort Study Comparing Fracture Rates For Women Receiving Monthly Ibandronate vs Weekly BisphosphonatesPresentation of a Sub-Group Analysis Excluding Patients with Osteopenia, Alendronate 35mg and Corticosteroid UseSummaryNo prospective head-to-head trials comparing the fracture efficacy of the currently marketed weekly and monthly bisphosphonates have been conducted. Due to the large sample size such studies would require to reliably detect differences in fracture risk and the associated high costs, they are considered to be impractical. Whilst providing the highest level of evidence, clinical trials also have inherent limitations. Patients are selected by a number of criteria and therefore usually do not represent the normal patient population. Also due to a protocol, normal clinical practice is usually not reflected. In contrast, database studies allow the assessment of treatments in normal clinical practice. Whilst observational studies have limitations owing to more confounding variables, they do have an important place in evidence-based medicine (especially in the absence of prospective clinical trials), and if well-designed can give some indications regarding the comparative efficacy of osteoporosis therapies in real-world clinical practice. (From the World of Osteoporosis 2008;14: 62-5)Key words: Efficacy, IbandronateÖzetHaftalik ve aylik uygulanan bifosfonatlarin kiriklar üzerindeki etkinligini bire-bir [head-to-head] karsilastiran prospektif çalismalar yapilmamistir. Kirik riskindeki farkliliklari güvenilir biçimde saptamak için gerek duyulacak büyük örneklem boyutu ve bununla iliskili yüksek maliyetlerden ötürü, bu gibi çalismalarin pratik olmadiklari kabul edilmektedir. En yüksek düzeydeki kanitlari saglamakla birlikte, klinik çalismalarin da çalismanin özelliginden kaynaklanan kisitlari vardir. Hastalar bir dizi kritere göre seçildiginden, çogunlukla normal hasta popülasyonunu temsil etmemektedirler. Ayrica, uygulanan protokol, normal klinik uygulamayi genellikle yansitmamaktadir. Buna karsilik, veri tabani çalismalari normal klinik uygulamadaki tedavilerin degerlendirilmesine imkan vermektedir. Gözlemsel çalismalarin, daha fazla çeldirici degisken içermelerinden ötürü kisitlari olmasina karsin, bunlar kanita-dayali tipta önemli bir yere sahiptir (özellikle prospektif klinik çalismalar bulunmadiginda) ve eger iyi tasarlanmislarsa, gerçek dünyada klinik uygulamadaki osteoporoz tedavisinde karsilastirmali etkinlige dair bazi göstergeler saglayabilirler. (Osteoporoz Dünyasindan 2008;14: 62-5)Anahtar kelimeler: Ibandronat, etkinlik

VIBE Study

The VIBE (EValuation of IBandronate Efficacy) study was a retrospective study of women ≥45 years taking once monthly BONVIVA 150mg (345) or weekly alendronate 35mg/70mg (865) or risedronate 35mg (972). The study used eligibility, pharmacy claims and medical claims from research databases in the US. There are important differences in the treatment and management of osteoporosis in the US and Europe, so to create a population that was more reflective of bisphosphonate labels in Europe, the following were excluded:• patients with osteopenia • glucocorticoid use • alendronate 35mgHere we present the results of the analysis of this osteoporotic sub-group which included 41,858 patients (876).