Rosa J, Vanuga P, Payer J, Svobodník A
DC MEDISCAN - Euromedic/Osteocentrum Praha.
Vnitr Lek. 2008 Mar;54(3):217-9, 221-4.
Osteoporosis is a disease causing higher bone fragility and bone ruptures occurring even in minimal traumas. Good patient compliance is the prerequisite for long-term efficacy of osteoporosis treatment. Compliance data from randomised clinical studies may not provide reliable information about compliance in clinical practice which is usually lower. CORAL (COmpliance with RALoxifene therapy) is a local, Slovak, non-interventional, open, prospective, uncontrolled and multicentre study of woman patients on raloxifen therapy in current clinical practice. Raloxifen is a selective estrogen receptor modulator (SERM) indicated for the treatment and prevention of postmenopausal osteoporosis.
The primary objective of the study was to assess compliance with raloxifen therapy in the conditions of current clinical practice. The secondary objectives were the assessment of the impact of therapy on the quality of life, of treatment satisfaction and treatment safety.
A total of 1497 patients with proven postmenopausal osteoporosis were enrolled in the 18-month study performed in 40 centres. Compliance was evaluated on the basis of the number of omissions in the use of the evaluated drug. Treatment satisfaction was evaluated by the patients who used a 0-100 visual analogue scale (VAS). Quality of life was evaluated by means of an EQ-5D quality of life questionnaire. In order to measure treatment safety, all adverse events were recorded by the supervising physician in a dedicated questionnaire at every visit. Statistical methods used: The non-parametrical Mann-Whitney test was used to assess the relation between raloxifen treatment compliance and the selected parametres (quality of life, treatment satisfaction, changes in health condition, premature discontinuation of therapy). The maximum likelihood ratio chi2 test and Fisher's exact test (for 2 x 2 tables) were used to analyse the ratio between compliance and reasons for enrolment in the study. Changes in treatment satisfaction in the course of the study were analysed using the Wilcoxon test. All the used tests were bilateral and data was assessed at a 5 % level of significance.
The mean age of the patients enrolled in the study was 63.4 +/- 8.0 years. 58 % of patients were enrolled on the basis ofdensitometric evidence of osteoporosis, 74% of patients were enrolled for proven osteoporosis which had been manifested by a fracture, and osteoporotic fracture as such was the reason to start therapy in 10 % of patients. The majority of patients enrolled in the study (77%) had natural menopause. The mean period from menopause to the study was 15 years. Acceptable cooperation (> or =80% of medication used) was recorded for more than 90% of patients during the study, and total dosing adherence was recorded more than 58 % of patients. A significantly higher satisfaction with pharmacotherapy was observed in the patients who adhered to the prescribed dosing schedule. Adherence to the prescribed dosing schedule was also associated with a considerable better health condition and a higher quality of life. In a total of 1,497 evaluated patients, treatment was prematurely discontinued in 87 (5.8 %) women. The attending physician's decision, adverse events or the patient's request were relatively evenly distributed among the reasons for the discontinuation of therapy. Premature discontinuation of therapy was mostly recorded in patients who were not satisfied with the pharmacotherapy of osteoporosis as such, in women who were less satisfied with their overall health condition and who had a lower quality of life.
The study showed very good patient compliance with raloxifen. The above findings associate with a significant correlation between the degree of adherence to therapy, treatment satisfaction and the overall health condition and quality of life. Premature discontinuation of therapy was observed in a very low number of women. It can be concluded that raloxifen therapy provides effective treatment of osteoporosis based on long-term cooperation of patients.
Effective treatment of postmenopausal osteoporosis with raloxifen is related to excellent cooperation of patients on a long-term basis.
骨质疏松症是一种导致骨脆性增加的疾病，即使在轻微创伤时也会发生骨折。良好的患者依从性是骨质疏松症治疗长期有效的前提。随机临床研究中的依从性数据可能无法提供有关临床实践中依从性的可靠信息，而临床实践中的依从性通常较低。CORAL（雷洛昔芬治疗依从性）是一项在斯洛伐克当地开展的非干预性、开放性、前瞻性、非对照多中心研究，研究对象为当前临床实践中接受雷洛昔芬治疗的女性患者。雷洛昔芬是一种选择性雌激素受体调节剂（SERM），用于治疗和预防绝经后骨质疏松症。
本研究的主要目的是评估当前临床实践中雷洛昔芬治疗的依从性。次要目的是评估治疗对生活质量、治疗满意度和治疗安全性的影响。
共有1497例确诊为绝经后骨质疏松症的患者参加了在40个中心进行的为期18个月的研究。依从性根据所评估药物使用中的遗漏次数进行评估。治疗满意度由使用0 - 100视觉模拟量表（VAS）的患者进行评估。生活质量通过EQ - 5D生活质量问卷进行评估。为了衡量治疗安全性，监督医生在每次就诊时使用专用问卷记录所有不良事件。使用的统计方法：采用非参数曼 - 惠特尼检验评估雷洛昔芬治疗依从性与所选参数（生活质量、治疗满意度、健康状况变化、治疗过早停药）之间的关系。使用最大似然比卡方检验和费舍尔精确检验（用于2×2表格）分析依从性与研究入选原因之间的比例。使用威尔科克森检验分析研究过程中治疗满意度的变化。所有使用的检验均为双侧检验，数据在5%的显著性水平上进行评估。
纳入研究的患者平均年龄为63.4±8.0岁。58%的患者基于骨质疏松症的骨密度证据入选，74%的患者因已证实的骨质疏松症伴骨折入选，10%的患者因骨质疏松性骨折本身作为开始治疗的原因入选。纳入研究的大多数患者（77%）为自然绝经。从绝经到研究的平均时间为15年。在研究期间，超过90%的患者记录到可接受的合作（使用药物≥80%），超过58%的患者记录到完全剂量依从性。在遵守规定给药方案的患者中观察到对药物治疗的满意度显著更高。遵守规定给药方案还与相当好的健康状况和更高的生活质量相关。在总共1497例评估患者中，87例（5.8%）女性过早停药。主治医生的决定、不良事件或患者的要求在停药原因中分布相对均匀。过早停药主要记录在对骨质疏松症药物治疗不满意、对整体健康状况不太满意且生活质量较低的患者中。
该研究显示患者对雷洛昔芬的依从性非常好。上述发现表明治疗依从程度、治疗满意度与整体健康状况和生活质量之间存在显著相关性。观察到极少数女性过早停药。可以得出结论，基于患者的长期合作，雷洛昔芬治疗为骨质疏松症提供了有效的治疗。
雷洛昔芬有效治疗绝经后骨质疏松症与患者长期的良好合作有关。
