Objective: To compare compliance rates for twice-daily dosing of galantamine and daily dosing of vitamin E, and to determine caregiver and physician satisfaction with galantamine in AD patients with caregivers in a community setting.
Design: This was an open-label, multicenter, postapproval study in patients with caregivers. Patients were randomized in a blinded fashion in a 3:1 ratio of galantamine to vitamin E for a period of 12 weeks. The starting dose of galantamine was 4 mg bid, with escalation every 4 weeks to 24 mg/day for 12 weeks, with the option to stay at 16 mg/day at Week 8. Vitamin E was administered as 800 IU daily qhs for the entire treatment period.
Materials and methods: Primary analysis consisted of testing noninferiority of average compliance rates between groups using a 2-sided 95% confidence interval (CI) approach. To declare noninferiority, the difference between the lower confidence limits had to be ³ –4% for the per-protocol population. Both unadjusted and adjusted rates were calculated. The Reminyl Satisfaction Questionnaire (RSQ) was administered to physicians and caregivers of galantamine patients at 4-week intervals in a 12-week, open-label study. The RSQ inquired about satisfaction with medical care and ease of use, compliance, and willingness to continue treatment with galantamine.
Results: Of the 2,114 patients enrolled (1,636 galantamine, 478 vitamin E), 1,398 completed the study (1,058 galantamine, 340 vitamin E). Average compliance rates for both regimens were 91.2% (SD: galantamine 10.77, vitamin E 11.8). Mean average patient compliance rates were similar for both groups, regardless of caregiver visit frequency, and comparable between treatment groups during each 4-week interval, across intervals, and regardless of dose. In the galantamine group, the treating physicians were primary care physicians for 61.9% of patients, neurologists for 27.9%, and psychiatrists for 10.2%. The majority of caregivers were spouses (46.3%) or children (34.6%). 81% of caregivers reported satisfaction with their patients' medical care at baseline; >90% reported satisfaction with medical care at each follow-up visit (Weeks 4, 8, 12). Satisfaction with medical care significantly increased from baseline to Week 12 (p < 0.001). At each follow-up visit, >85% of caregiver and physician responses indicated satisfaction with their patients' galantamine treatment. >90% of caregivers found galantamine easy and convenient to use. Physicians responded that, in 96.9% of patients, it was easy or very easy to start galantamine treatment. When caregivers were asked at Week 12, “Would you like the patient to have the opportunity to continue taking galantamine?”, 86.8% of caregivers answered either “Yes, definitely” or “Yes, probably.”
Conclusion: Similar compliance rates for galantamine and vitamin E suggest that twice-daily dosing does not adversely affect compliance in patients with caregivers during a 12-week period. Physicians and caregivers report high levels of satisfaction with galantamine treatment in patients with mild-to-moderate AD.
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