Raloxifene in clinical practice. Results of non-interventional study CORAL (COmpliance with RALoxifene)

Czech version

Authors: J. Rosa ¹; P. Vaňuga ²; J. Payer ³; A. Svobodník ⁴
Authors‘ workplace: DC MEDISCAN - Euromedic/Osteocentrum Praha, vedoucí MUDr. Petr Kasalický, CSc. ¹; Národný endokrinologický a diabetologický ústav Ľubochňa, Slovenská republika, riaditeľ doc. MUDr. Jozef Michálek, CSc. ²; V. interná klinika Lekárskej fakulty UK a FNsP Bratislava, Slovenská republika, prednosta prof. MUDr. Juraj Payer, CSc. ³; Institut biostatistiky a analýz MU Brno, ředitel doc. RNDr. Ladislav Dušek, Dr. ⁴
Published in: Vnitř Lék 2008; 54(3): 217-224
Category: Original Contributions

Overview

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.

Objectives:
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.

Patients and methods:
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 χ2 test and Fisher’s exact test (for 2 × 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.

Results:
The mean age of the patients enrolled in the study was 63.4 ± 8.0 years. 58 % of patients were enrolled on the basis of densitometric 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 (≥ 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.

Discussion:
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.

Conclusion:
Effective treatment of postmenopausal osteoporosis with raloxifen is related to excellent cooperation of patients on a long-term basis.

Keywords:
raloxifene – osteoporosis – compliance – non-interventional study

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