BACKGROUND: Prior research has indicated @entity1 dissatisfaction with the odor, size, and taste of @entity205 capsules, as well as the halitosis and body odor the capsules can cause. OBJECTIVES: The purposes of this investigation were to (1) compare the overall @entity205 capsule preference (Gengraf vs Neoral) in stable, solid-organ transplant recipients, (2) assess @entity1 preference based on specific capsule attributes, and (3) determine the reliability of the @entity205 Capsule SatiSfaCtion Survey (original to this study). METHODS: In this multicenter, randomized, open-label, parallel-group, preference study, @entity1 were recruited from 144 centers in North America with established transplant programs. Solid-organ transplant recipients who had taken stable doses of @entity205 (Neoral) for >/=2 consecutive months were randomized in a 9:1 ratio to receive another @entity205 formulation (Gengraf) or to remain on Neoral therapy. @entity1 completed the @entity205 Capsule Satisfaction Survey prior to randomization (baseline survey) and after taking the study drug for 4 weeks (final survey). The survey consisted of multiple attribute items with high face validity in assessing @entity1 ' perceptions and preferences with regard to their overall experience, as well as specific attributes of @entity205 capsules known to affect @entity1 acceptance. RESULTS: The intent-to-treat population included 1906 @entity1 (1211 @entity1 , 693 @entity1 [sex unknown in 2 @entity1 ]; mean [SD] age, 50.2 [12.4] years). A total of 1708 @entity1 were switched to Gengraf; 198 continued on Neoral. Based on their overall experience with both capsule formulations, the majority of @entity1 switched to Gengraf (61.9%) responded that they preferred the Gengraf capsule, compared with 13.7% who preferred the Neoral capsule and 24.4% who indicated no preference (P < 0.001). A similar preference for Gengraf was observed based on capsule odor (66.3%), ease of swallowing (51.5%), taste (57.1%), and impact on breath odor (52.5%) and body odor (48.4%) (P < 0.001 for each test). The results of internal consistency and reproducibility calculations were high for the @entity205 Capsule Satisfaction Survey. Internal consistency ranged from alpha = 0.84 to 0.95 for the subscales and was alpha = 0.95 for the overall score. Ranges for reproducibility in the subscales were r = 0.75 to 0.79, with an overall reproducibility of r = 0.85. Guyatt's responsiveness statistics for the subscale and overall scores were moderately high to very high, indicating that the survey is capable of measuring change in response to treatment. CONCLUSIONS: Of the transplant recipients receiving Gengraf in this study, most preferred Gengraf to Neoral based on overall experience, capsule odor, difficulty swallowing, taste, breath odor, and body odor. Among all study @entity1 , fewer @entity1 receiving Gengraf were bothered by capsule odor, difficulty in swallowing, taste, or the impact on breath or body odor compared with @entity1 who continued to receive Neoral. Internal consistency, reproducibility, and responsiveness results show that the @entity205 Capsule Satisfaction Survey is a psychometrically valid instrument that is appropriate for use in clinical trials.

Randomized, open-label preference study of two XXXX capsule formulations (usp modified) in stable solid-organ transplant recipients.

@entity1 :: ('9606', 'Species') :: ['women', 'Patients', 'patients', 'patient', 'men'] @entity205 :: ('MESH:D016572', 'Chemical') :: ['Cyclosporine', 'cyclosporine']
@entity205 :: (MESH:D016572,Chemical) :: ['cyclosporine']
