Combined therapy with alendronate and calcitriol may have additive effects on bone density. An observational study was performed to evaluate the efficacy and safety of Maxmarvil, a combinative agent of alendronate (5 mg) and calcitriol (0.5 µg), and to identify factors associated with efficacy.
A total of 568 postmenopausal women with osteoporosis were enrolled by family physicians in 12 hospitals. The study subjects took Maxmarvil daily for 12 months. Questionnaires about baseline characteristics, socioeconomic status, and daily calcium intake were completed at the first visit. Adverse events were recorded every 3 months and bone mineral density (BMD) in the lumbar spine was measured using dual-energy X-ray absorptiometry at baseline and after 12 months. We evaluated the efficacy and safety of Maxmarvil, and the factors related to BMD improvement.
A total of 370 patients were included in final analysis. The median BMD was 0.81 ± 0.12 g/cm2 at pre-treatment and 0.84 ± 0.13 g/cm2 after one year. The average BMD improvement was 3.4% ± 6.4% (P < 0.05), and 167 (45.1%) patients showed improvement. Factors associated with improved BMD were continuation of treatment (odds ratio [OR], 2.41; 95% confidence interval [CI], 1.15 to 5.07) and good compliance (OR, 2.54; 95% CI, 1.29 to 5.00). Adverse events were reported by 35 of the 568 patients, with the most common being abdominal pain and dyspepsia.
Maxmarvil was found to be safe, well tolerated and effective in osteoporosis treatment. Continuation of treatment and good compliance were the factors associated with efficacy.
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In order to evaluate the factors of compliance with a lipid lowering therapy, a prospective observational study of patients with hypercholesterolemia using rosuvastatin was carried out.
A total of 2,607 patients who were newly prescribed rosuvastatin were enrolled from 32 family physicians in Korea from March 2009 to December 2009. Of them, 301 patients were excluded due to incomplete data or follow-up compliance data. The patients were regularly observed to ascertain the compliance associated with rosuvastatin at intervals of 12 and 24 weeks. We collected risk factors for the compliance using a structured questionnaire. The criteria for evaluating compliance are to measure clinic attendance, to assess the continuity of therapy, and to calculate the percentage of doses taken.
Among a total of 2,306 patients, the degree of compliance was 54.1%. According to logistic regression analysis, the factors for compliance with the lipid lowering drug included old age (odds ratio [OR], 2.68; 95% confidence interval [CI], 2.09 to 3.45), frequent exercise (OR, 1.76; 95% CI, 1.43 to 2.18), previous statin therapy (OR, 4.02; 95% CI, 3.22 to 5.01), hypertension (OR, 1.80; 95% CI, 1.48 to 2.19), diabetes mellitus (OR, 2.20; 95% CI, 1.69 to 2.87), concomitant medication (OR, 2.28; 95% CI, 1.88 to 2.77), and high coronary heart disease (CHD) risk category (OR, 1.82; 95% CI, 1.39 to 2.38). The compliance decreased with high low density lipoprotein cholesterol levels (OR, 0.20; 95% CI, 0.16 to 0.26).
The compliance of patients using rosuvastatin was 54.1% in primary care. The factors related to higher compliance were old age, regular exercise, previous statin therapy, concomitant medication, presence of hypertension or diabetes, and higher CHD risk level.
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