So sánh Ibandronate hàng tháng với Risedronate hàng tuần về sở thích, sự tiện lợi và các chỉ số chuyển hóa xương ở phụ nữ Hàn Quốc sau mãn kinh mắc bệnh loãng xương

Yoon-Sok Chung1, Sung-Kil Lim2, Ho-Yeon Chung3, In-Kyu Lee4, Il-Hyung Park5, Ghi-Su Kim6, Yong-Ki Min7, Moo-Il Kang8, Dong-Jin Chung9, Yong-Ki Kim10, Woong Hwan Choi11, Min Ho Shong12, Ji-Hyun Park13, Dong-Won Byun14, Hyun-Koo Yoon15, Chan Soo Shin16, Yil-Seob Lee17, Nam-Hee Kwon18
1Department of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon, Korea
2Division of Endocrinology and Metabolism, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea
3Division of Endocrinology and Metabolism, Department of Internal Medicine, KyungHee University, Seoul, Korea
4Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Korea
5Department of Orthopedic Surgery, Kyungpook National University, School of Medicine, Daegu, Korea
6Division of Endocrinology and Metabolism, Department of Internal Medicine, Asan Medical Center, Seoul, Korea
7Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
8Division of Endocrinology and Metabolism, Department of Internal Medicine, The Catholic University of Korea, Seoul St. Mary’s Hospital, Seoul, Korea
9Division of Endocrinology and Metabolism, Department of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea
10Division of Endocrinology and Metabolism, Department of Internal Medicine, Pusan National University College of Medicine, Pusan, Korea
11Division of Endocrinology and Metabolism, Department of Internal Medicine, Hanyang University, Seoul, Korea
12Division of Endocrinology and Metabolism, Department of Internal Medicine, ChungNam National University, Daejeon, Korea
13Division of Endocrinology and Metabolism, Department of Internal Medicine, Chonbuk National University Hospital, Jeonju, Korea
14Division of Endocrinology and Metabolism, Department of Internal Medicine, SoonChunHyang University Hospital, Seoul, Korea
15Division of Endocrinology and Metabolism, Department of Internal Medicine, Kwandong University College of Medicine, Cheil General Hospital & Women’s Healthcare Center, Seoul, Korea
16Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea
17GlaxoSmithKline Korea, Seoul, Korea
18GlaxoSmithKline Asia-Pacific, Singapore, Singapore

Tóm tắt

Sở thích của bệnh nhân, sự tiện lợi và các chỉ số chuyển hóa xương đã được đánh giá giữa phác đồ ibandronate hàng tháng và risedronate hàng tuần ở phụ nữ Hàn Quốc sau mãn kinh mắc bệnh loãng xương. Đây là một nghiên cứu đa trung tâm, mở, ngẫu nhiên, tiến cứu kéo dài 6 tháng với thiết kế điều trị chéo hai giai đoạn và hai chuỗi. Sau một giai đoạn sàng lọc 30 ngày, những người tham gia đủ điều kiện mắc bệnh loãng xương sau mãn kinh được ngẫu nhiên nhận ibandronate dùng đường uống hàng tháng 150 mg trong 3 tháng, tiếp theo là risedronate dùng đường uống hàng tuần 35 mg trong 12 tuần (chuỗi A) hoặc phác đồ tương tự theo thứ tự đảo ngược (chuỗi B). Sở thích và sự tiện lợi của bệnh nhân được đánh giá bằng bảng hỏi. Thay đổi trong mức C-telopeptide huyết thanh sau 3 tháng điều trị được phân tích. Tổng cộng có 365 bệnh nhân tham gia vào nghiên cứu này (chuỗi A: 182, chuỗi B: 183). Trong số các bệnh nhân thể hiện sở thích (83,4%), 74,8% chọn phác đồ ibandronate hàng tháng thay vì phác đồ hàng tuần (25,2%). Nhiều phụ nữ cho biết phác đồ ibandronate hàng tháng thuận tiện hơn (84,2%) so với phác đồ hàng tuần (15,8%). Không có sự khác biệt đáng kể về thay đổi trong đánh giá các chỉ số chuyển hóa xương giữa hai liệu pháp. Cả hai phác đồ đều có độ dung nạp tương tự nhau. Có ít sự kiện bất lợi hơn trong nhóm ibandronate hàng tháng so với nhóm risedronate hàng tuần liên quan đến các tác dụng phụ đường tiêu hóa (buồn nôn và đầy bụng). Nghiên cứu này cho thấy sở thích và sự tiện lợi mạnh mẽ cho ibandronate hàng tháng hơn là risedronate hàng tuần ở phụ nữ Hàn Quốc sau mãn kinh mắc chứng loãng xương. Không có sự khác biệt đáng kể nào trong thay đổi chỉ số chuyển hóa xương và hồ sơ an toàn giữa hai phác đồ.

Từ khóa

#Ibandronate #Risedronate #phụ nữ sau mãn kinh #loãng xương #chỉ số chuyển hóa xương #sở thích bệnh nhân #sự tiện lợi

Tài liệu tham khảo

Cooper C, Compion G, Melton LJ (1992) Hip fractures in the elderly: a worldwide projection. Osteoporos Int 2:285–289

Chesnut IC, Skag A, Christiansen C, Recker R, Stakkestad JA, Hoiseth A, Felsenberg D, Huss H, Gilbride J, Schimmer RC, Delmas PD (2004) Effects of oral ibandronate administered daily or intermittently on fracture risk in postmenopausal osteoporosis. J Bone Miner Res 19:1241–1249

Epstein S (2005) The roles of bone mineral density, bone turnover, and other properties in reducing fracture risk during antiresorptive therapy. Mayo Clin Proc 80:379–388

Harris ST, Watts NB, Genant HK, McKeever CD, Hangartner T, Keller M, Chesnut CH III, Brown J, Eriksen EF, Hoseyni MS, Axelrod DW, Miller PD (1999) 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 282:1344–1352

Liberman UA, Weiss SR, Broll J, Minne HW, Quan H, Bell NH, Rodriguez-Portales J, Downs RW Jr, Dequeker J, Favus M (1995) 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 333:1437–1443

Miller PD, McClung MR, Macovei L, Stakkestad JA, Luckey M, Bonvoisin B, Reginster JY, Recker RR, Hughes C, Lewiecki EM, Felsenberg D, Delmas PD, Kendler DL, Bolognese MA, Mairon N, Cooper C (2005) Monthly oral ibandronate therapy in postmenopausal osteoporosis: 1-year results from the MOBILE study. J Bone Miner Res 20:1315–1322

World Health Organization (2003) Prevention and management of osteoporosis. World Health Organ Tech Rep Ser 921:1–164

Reginster JY, Rabenda V, Neuprez A (2006) Adherence, patient preference and dosing frequency: understanding the relationship. Bone 38:S2–S6

Lombas C, Hakim C, Znachetta JR (2001) Compliance with alendronate treatment in an osteoporosis clinic. J Bone Miner Res 15 Suppl 1:S529

Jahng KH, Martin LR, Golin CE, DiMatteo MR (2005) Preferences for medical collaboration: patient–physician congruence and patient outcomes. Patient Educ Couns 57:308–314

Kendler D, Kung AW, Fuleihan Gel H, Gonzalez Gonzalez JG, Gaines KA, Verbruggen N, Melton ME (2004) Patients with osteoporosis prefer once weekly to once daily dosing with alendronate. Maturitas 48:243–251

Simon JA, Lewiecki EM, Smith ME, Petruschke RA, Wang L, Palmisano JJ (2002) Patient preference for once-weekly alendronate 70 mg versus once-daily alendronate 10 mg: a multicenter, randomized, open-label, crossover study. Clin Ther 24:1871–1886

Bartl R, Goette S, Hadji P, Hammerschmidt T (2005) Persistence and compliance with daily and weekly administered bisphophonates for osteoporosis treatment in Germany. Osteoporos Int 16 Suppl 3:S45

Cramer JA, Amonkar MM, Hebborn A, Suppapanya N (2004) Does dosing regimen impact persistence with bisphosphonate theapy among postmenopausal osteoporotic women. J Bone Miner Res 19 Suppl 1:S448

Ettinger MP, Gallagher R, Amonkar M, Mahoney PM, Gilbride J (2004) Medication persistence is improved with less frequent dosing of bisphosphonates, but remains inadequate. Arthritis Rheum 50:S513

Emkey R, Koltun W, Beusterien K, Seidman L, Kivitz A, Devas V, Masanauskaite D (2005) Patient preference for once-monthly ibandronate versus once-weekly alendronate in a randomized, open-label, cross-over trial: the Boniva Alendronate Trial in Osteoporosis (BALTO). Curr Med Res Opin 21:1895–1903

Hadji P, Minne H, Pfeifer M, Bourgeois P, Fardellone P, Licata A, Devas V, Masanauskaite D, Barrett-Connor E (2008) Treatment preference for monthly oral ibandronate and weekly oral alendronate in women with postmenopausal osteoporosis: a randomized, crossover study (BALTO II). Joint Bone Spine 75:303–310

Gart JJ (1969) An exact test for comparing matched proportions in cross-over designs. Biometrika 56:75–80

Prescott RJ (1981) The comparison of success rates in cross-over trials in the presence of an order effect. Appl Stat 30:9–15

Claxton AJ, Cramer J, Pierce C (2001) A systematic review of the associations between dose regimens and medication compliance. Clin Ther 23:1296–1310

Richter A, Anton SE, Koch P, Dennett SL (2003) The impact of reducing dose frequency on health outcomes. Clin Ther 25:2306–2335

Curtis JR, Westfall AO, Cheng H, Saag KG, Delzell E (2009) Risedronate and Alendronate Intervention over Three Years (REALITY): minimal differences in fracture risk reduction. Osteoporos Int 20:973–978

Takada J, Iba K, Imoto K, Yamashita T (2007) Changes in bone resorption markers among Japanese patients with postmenopausal osteoporosis treated with alendronate and risedronate. J Bone Miner Metab 25:142–146

Umland EM, Boyce EG (2001) Risedronate: a new oral bisphosphonate. Clin Ther 23:1409–1421

Kamatari M, Koto S, Ozawa N, Urao C, Suzuki Y, Akasaka E, Yanagimoto K, Sakota K (2007) Factors affecting long-term compliance of osteoporotic patients with bisphosphonate treatment and QOL assessment in actual practice: alendronate and risedronate. J Bone Miner Metab 25:302–309

Eisman JA, Rizzoli R, Roman-Ivorra J, Lipschitz S, Verbruggen N, Gaines KA, Melton ME (2004) Upper gastrointestinal and overall tolerability of alendronate once weekly in patients with osteoporosis: results of a randomized, double-blind, placebo-controlled study. Curr Med Res Opin 20:699–705

Hamilton B, McCoy K, Taggart H (2003) Tolerability and compliance with risedronate in clinical practice. Osteoporos Int 14:259–262

Lanza FL, Hunt RH, Thomson AB, Provenza JM, Blank MA (2000) Endoscopic comparison of esophageal and gastroduodenal effects of risedronate and alendronate in postmenopausal women. Gastroenterology 119:631–638

Rossini M, Bianchi G, Di Munno O, Giannini S, Minisola S, Sinigaglia L, Adami S (2006) Determinants of adherence to osteoporosis treatment in clinical practice. Osteoporos Int 17:914–921

Tosteson AN, Grove MR, Hammond CS, Moncur MM, Ray GT, Hebert GM, Pressman AR, Ettinger B (2003) Early discontinuation of treatment for osteoporosis. Am J Med 115:209–216

Delmas PD, Recker RR, Chesnut CH III, Skag A, Stakkestad JA, Emkey R, Gilbride J, Schimmer RC, Christiansen C (2004) Daily and intermittent oral ibandronate normalize bone turnover and provide significant reduction in vertebral fracture risk: results from the BONE study. Osteoporos Int 15:792–798

Miller PD, Epstein S, Sedarati F, Reginster JY (2008) Once-monthly oral ibandronate compared with weekly oral alendronate in postmenopausal osteoporosis: results from the head-to-head MOTION study. Curr Med Res Opin 24:207–213

Harris ST, Reginster JY, Harley C, Blumentals WA, Poston SA, Barr CE, Silverman SL (2009) Risk of fracture in women treated with monthly oral ibandronate or weekly bisphosphonates: The Evaluation of Ibandronate Efficacy (VIBE) database fracture study. Bone 44:758–765

Cooper A, Drake J, Brankin E (2006) Treatment persistence with once-monthly ibandronate and patient support vs. once-weekly alendronate: results from the PERSIST study. Int J Clin Pract 60:896–905