Aydan Oral, Roman Lorenc for the FLINT-ACT Study Investigators

Günlük esnek veya sabit doz risedronat rejimiuygulanan postmenopozal osteoporozlu kadınlardatedaviye uyum, devam etme ve tercih sonuçları:Çok merkezli, prospektif, paralel grup çalışma

Amaç: Çalışmanın amacı günlük risedronat (5 mg) tedavisini üç farklı zaman rejiminde (A, ‘kahval¬tıdan önce’; B, ‘öğünler arası’; C, ‘yatmadan önce’) olmak üzere sabit doz şeklinde veya esnek doz bazlı alan hastalarda tedaviye uyum ve devam etme düzeylerini değerlendirmekti. Ayrıca hastaların doz re¬jimlerine yönelik tercihleri ve doz rejimlerinin idrar NTX-I düzeyi üzerine etkileri de değerlendirildi.Çalışma planı: Çalışma 448 hastanın her birinin tedavi sekanslarının diziliminin değiştirilmesi (per¬mutasyon) (ABC, BCA, gibi) ile oluşan altı farklı tedavi grubundan birine rasgele atandığı bir çapraz tedavi fazı (3x1 hafta) ve her bir hastanın günlük esnek (rejim A,B veya C’den her hangi biri) ve sabit zamanlı (yalnızca rejim A, ya da B veya C) rejimlerden birine 23 hafta süreyle randomize edildiği has¬tanın tercihi fazını içeriyordu.Bulgular: 433 hasta ikinci faza katıldı; %49.7’si esnek rejimi ve %50.3’ü sabit rejimi tercih etti. Esnek ve sabit tedavi rejimleri arasında bileşik olarak tedaviye hem uyum hem de devamlılık gösteren, olumlu hareket edenler olarak nitelenen hasta oranı açısından anlamlı bir fark saptanmazken (sırasıyla %54.4 ve %53.7, p=0.8803), iki tedavi rejimi arasında tedaviye devam etme açısından esnek rejim lehine anlamlı bir fark belirlendi (p=0.0306). Tedavi uyumu konusunda esnek ve sabit rejimler arasında anlamlı bir farklılık gözlenmedi (p=0.4611). İdrar NTX-I düzeylerindeki değişiklikler iki rejim arasında anlamlı bir farklılık göstermedi. Son vizitte esnek rejim grubundaki hastaların %51’i ve sabit rejimdeki hastala¬rın %55’i kullanılan risedronat rejimini mükemmel veya çok iyi olarak değerlendirdi (p=0.1440).Çıkarımlar: Bu küçük ölçekli, seçilmiş hasta grubundan elde edilen verilere dayanılarak esnek doz günlük risedronat tedavisinin tedavi uyumu ve devamlılığı açısından kayda değer bir alternatif sundu¬ğu düşünülebilir.

Anahtar Kelimeler:

Tedavi uyumu; günlük sabit doz; günlük esnek doz; osteoporoz; tedaviye devam etme; risedronat

Compliance, persistence, and preference outcomes of postmenopausal osteoporotic women receiving a flexible or fixed regimen of daily risedronate: A multicenter, prospective, parallel group study

Objective: The aim of this study was to examine the level of compliance and persistence in patients with postmenopausal osteoporosis (OP) receiving daily risedronate (5 mg) with either fixed dosing of three different timing regimens (A: before breakfast; B: in-between meals; C: before bedtime) or with flexible dosing and the effect on urinary N-terminal telopeptide of Type 1 collagen (NTX-1).Methods: The study included 448 patients with postmenopausal OP. Patients were randomly assigned into six treatment groups each with a permutation of the treatment sequence (ABC, BCA, etc.) in the crossover phase (3x1 week) and randomized to 23 weeks of either the daily flexible (either regimen A, B or C) or fixed timing (only regimen A, B, or C) in the patient’s preference phase. Urinary NTX-1 was tested.Results: A total of 433 patients participated in the patient’s preference phase (49.7% preferred flexible and 50.3% fixed timing). There was no significant difference between the proportion of responders who were both compliant and persistent in the flexible (54.4%) and fixed regimens (53.7%) (p=0.8803). A significant difference between the flexible and fixed regimens was seen in persistence in favor of the flexible regimen (p=0.0306). There was no significant difference between the flexible and fixed regimens in terms of compliance (p=0.4611). Change in urinary NTX-1 did not show any difference between the two regimens. At the final visit, 51% of patients in the flexible and 55% in the fixed regimen group considered the used risedronate regimen as excellent or very good (p=0.1440).Conclusion: A flexible dosing with daily risedronate appears be a valuable option in terms of compliance and persistence for patients with postmenopausal OP.

Keywords:

Compliance, daily fixed dosing, daily flexible dosing, osteoporosis, persistence risedronate,

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