Observational study of compliance and continuance rates of raloxifene in the prevention and treatment of osteoporosis.

UNLABELLED

Abstract.

BACKGROUND

Medical practitioners face the challenge of noncompliance with prescriptions, particularly in chronic, asymptomatic, diseases such as osteoporosis.

OBJECTIVE

The aim of this study was to assess the raloxifene compliance and continuance rates and adverse effects over 24 months in clinical practice.

METHODS

Using a retrospective study of clinical histories obtained from a database at the Metabolic Research Institute, University of El Salvador School of Medicine, Buenos Aires, Argentina, as well as telephone interviews, we assessed compliance and continuance with raloxifene therapy in post-menopausal patients who had received prescriptions for raloxifene to prevent or treat osteoporosis. Patients were contacted by telephone 24 months after they had received a prescription for raloxifene. Compliance and continuance rates were calculated based on the data provided by the patients.

RESULTS

Data from 419 patients (mean [SD] age, 61.4 [7.4] years [range, 42-90 years]) were included in the study. At the time of the telephone interview, 225 (53.7%) were still receiving raloxifene, 105 (25.1%) had stopped treatment at their own discretion, 59 (14.1%) had not started treatment, and 30 (7.2%) had discontinued treatment as a result of advice from a physician. The reasons for not starting treatment were fear of thrombolytic events (21 patients [35.6%]); lack of interest in starting treatment (12 [20.3%]); other physician's advice (11 [18.6%]); family problems (3 [5.1%]); dissatisfaction with the prescribing physician, treatment cost, health problems unrelated to osteoporosis, and mistrust in the prescription (each, 2 [3.4%]); and advice from family/friends, fear of breast cancer, belief that raloxifene is hormonal, and that the patient was already polymedicated (each, 1 [1.7%]). Eleven of the 59 patients (18.6%) who had not started therapy were advised by a physician other than the prescribing physician not to start treatment and were excluded from the compliance analysis. Thus, the compliance analysis included 408 patients. The 2 most common reasons for discontinuing treatment at the patient's own discretion were health problems unrelated to osteoporosis (25 [23.8%]) and digestive problems not considered treatment related (16 [15.2%]). The compliance rates were 75.0%, 71.1%, 65.0%, 57.1%, and 52.0% at 3, 6, 12, 18, and 24 months, respectively. In patients who started raloxifene treatment, the continuance rates were 85.0%, 80.6%, 73.6%, 64.7%, and 58.9% at 3, 6, 12, 18, and 24 months, respectively. Sixty-two of the 135 patients who discontinued treatment did so within 3 months of receiving the prescription, accounting for 45.9% of all discontinuations.

CONCLUSIONS

In the present study of raloxifene compliance and continuance in clinical practice, the compliance rate appeared to be relatively high compared with those of hormone-replacement therapy (HRT) and other non-HRT treatments. Almost half of patients who discontinued treatment did so in the first 3 months.