Jean Yves Reginster1, J M Kaufman2, V Gangjii3. 1. Bone and Cartilage Metabolism Research Unit, University of Liege, Liege, Belgium. 2. Department of Endocrinology, University Hospital, Ghent, Belgium. 3. Rheumatology Service, Ersame Hospital, Brussels, Belgium.
Abstract
BACKGROUND: Preference for and acceptability of a drug are crucial for complianceand hence optimal treatment of diseases that require long-term management (eg, osteoporosis). The preference for and acceptability of a chewable tablet containing calcium and vitamin D3 and a dose-comparable effervescent powder were assessed in a Phase 4, randomized, open-label, crossover trial in 5 European countries (Sweden, Finland, Belgium, the Netherlands, and Greece). OBJECTIVE: The aim of the present analysis was to compare the preference for and acceptability, including tolerability, of these 2 formulations based on the Belgian results of the previously mentioned study. METHODS:Patients were recruited from 3 osteoporosis units and universityhospitals in Brussels, Liege, and Ghent, Belgium. Adult patients at risk for calcium and vitamin D deficiencies were enrolled. The study drugs included 2 formulations of a dietary supplement containing a combination of calcium plus vitamin D3: chewable tablets (calcium carbonate, 1250 mg; vitamin D3, 400 IU) (A) and effervescent powder (calcium carbonate, 1250 mg; vitamin D3, 440 IU) (B). Patients were randomly assigned to receive 1 of 2 treatment sequences: AB or BA. Both formulations were given PO BID for 14 days, with a switch to the alternate formulation occurring on day 15 of the study. Preference and acceptability were assessed using 2 questionnaires: one assessed 5 variables of acceptability using 11-point scales, and the other assessed preference using yes/no questions. Compliance and tolerability were recorded throughout the study, with unused dose counts and recording of adverse events (AEs), respectively. RESULTS: The study comprised 200 patients, 199 of whom received at least 1 dose of study medication and were included in the intent-to-treat analysis (174 women, 25 men; mean age, 66 years [range, 30-87 years]). Preference data were available in 178 patients, 129 of whom (72.5%) preferred the chewable tablet compared with 34 (19.1%) who preferred the effervescent powder and 15 (8.4%) who had no preference (both, P < 0.001 vs tablet). The preference for the tablet was based on consistently and significantly higher mean scores on all 5 variables of acceptability (all, P < 0.001). The most common AEs were gastrointestinal (tablet, 27/192 patients [14.1%]; powder, 31/190 patients [16.3%]). Eighteen patients (9.0%) discontinued the trial due to ≥1 AE (12 receiving the tablet and 6 receiving the powder). CONCLUSIONS: In this study of preference for and acceptability of 2 formulations (chewable tablet and effervescent powder) of a dietary supplement containing a combination of calcium plus vitamin D3 in Belgian adults at risk for calcium and vitamin D deficiencies, the chewable tablet was preferred by a significant majority. Based on 5 variables, the tablet was found to be significantly more acceptable than the powder. Tolerability was similar between the 2 formulations.
RCT Entities:
BACKGROUND: Preference for and acceptability of a drug are crucial for complianceand hence optimal treatment of diseases that require long-term management (eg, osteoporosis). The preference for and acceptability of a chewable tablet containing calcium and vitamin D3 and a dose-comparable effervescent powder were assessed in a Phase 4, randomized, open-label, crossover trial in 5 European countries (Sweden, Finland, Belgium, the Netherlands, and Greece). OBJECTIVE: The aim of the present analysis was to compare the preference for and acceptability, including tolerability, of these 2 formulations based on the Belgian results of the previously mentioned study. METHODS:Patients were recruited from 3 osteoporosis units and universityhospitals in Brussels, Liege, and Ghent, Belgium. Adult patients at risk for calcium and vitamin D deficiencies were enrolled. The study drugs included 2 formulations of a dietary supplement containing a combination of calcium plus vitamin D3: chewable tablets (calcium carbonate, 1250 mg; vitamin D3, 400 IU) (A) and effervescent powder (calcium carbonate, 1250 mg; vitamin D3, 440 IU) (B). Patients were randomly assigned to receive 1 of 2 treatment sequences: AB or BA. Both formulations were given PO BID for 14 days, with a switch to the alternate formulation occurring on day 15 of the study. Preference and acceptability were assessed using 2 questionnaires: one assessed 5 variables of acceptability using 11-point scales, and the other assessed preference using yes/no questions. Compliance and tolerability were recorded throughout the study, with unused dose counts and recording of adverse events (AEs), respectively. RESULTS: The study comprised 200 patients, 199 of whom received at least 1 dose of study medication and were included in the intent-to-treat analysis (174 women, 25 men; mean age, 66 years [range, 30-87 years]). Preference data were available in 178 patients, 129 of whom (72.5%) preferred the chewable tablet compared with 34 (19.1%) who preferred the effervescent powder and 15 (8.4%) who had no preference (both, P < 0.001 vs tablet). The preference for the tablet was based on consistently and significantly higher mean scores on all 5 variables of acceptability (all, P < 0.001). The most common AEs were gastrointestinal (tablet, 27/192 patients [14.1%]; powder, 31/190 patients [16.3%]). Eighteen patients (9.0%) discontinued the trial due to ≥1 AE (12 receiving the tablet and 6 receiving the powder). CONCLUSIONS: In this study of preference for and acceptability of 2 formulations (chewable tablet and effervescent powder) of a dietary supplement containing a combination of calcium plus vitamin D3 in Belgian adults at risk for calcium and vitamin D deficiencies, the chewable tablet was preferred by a significant majority. Based on 5 variables, the tablet was found to be significantly more acceptable than the powder. Tolerability was similar between the 2 formulations.
Authors: M C Chapuy; R Pamphile; E Paris; C Kempf; M Schlichting; S Arnaud; P Garnero; P J Meunier Journal: Osteoporos Int Date: 2002-03 Impact factor: 4.507
Authors: M C Chapuy; M E Arlot; F Duboeuf; J Brun; B Crouzet; S Arnaud; P D Delmas; P J Meunier Journal: N Engl J Med Date: 1992-12-03 Impact factor: 91.245
Authors: Debby den Uyl; Piet P M M Geusens; Frank N R van Berkum; Harry H M L Houben; Max C Jebbink; Willem F Lems Journal: Clin Rheumatol Date: 2009-12-22 Impact factor: 2.980