Real-world evaluation of compliance and preference in Alzheimer's disease treatment.

PURPOSE: Rivastigmine transdermal patch has shown higher caregiver satisfaction and greater preference than oral formulation in patients with Alzheimer's disease. However, there is limited literature available related to caregiver preference or treatment compliance in real-world clinical settings. To date, no such data are available from Asia and the Middle East, which account for a sizeable proportion of patients with Alzheimer's disease. The objective of this study was to evaluate treatment preference and compliance with oral and transdermal medications in daily clinical practice in an ethnically diverse patient population from Asia and the Middle East with mild-to-moderate Alzheimer's disease. PATIENTS AND METHODS: RECAP (Real-world Evaluation of Compliance And Preference in the treatment of Alzheimer's disease) was a 24-week, multicenter, prospective, noninterventional study. Two treatment cohorts were observed during the study: oral (cholinesterase inhibitors or memantine) and transdermal (rivastigmine patch). Caregiver preference, physician preference, and patient compliance were evaluated at week 24. RESULTS: A total of 978 of 1,931 enrolled patients (mean age: 72.8 years; 50.5% female) were in the transdermal cohort. For patients with exposure to both oral and transdermal monotherapy (n=330), a significant caregivers' preference for the transdermal monotherapy was observed (82.7%; P<0.0001). Of the 89 participating physicians, 71 indicated preference for transdermal monotherapy. Patient compliance was also significantly higher for transdermal than oral monotherapy (P<0.0001). CONCLUSION: Our study showed higher caregiver and physician preference and greater patient compliance with transdermal monotherapy in daily practice.

Real-world effectiveness of amlodipine/valsartan and amlodipine/valsartan/hydrochlorothiazide in high-risk patients and other subgroups.

BACKGROUND: The clinical EXCITE (EXperienCe of amlodIpine and valsarTan in hypErtension) study reported clinically relevant blood pressure (BP) reductions across all doses of amlodipine/valsartan (Aml/Val) and Aml/Val/hydrochlorothiazide (HCT) single-pill combinations. The study prospectively observed a multiethnic population of hypertensive patients for 26 weeks who were treated according to routine clinical practice. Here, we present the results in high-risk subgroups including the elderly, obese patients, and patients with diabetes or isolated systolic hypertension. In addition, we present a post hoc analysis as per prior antihypertensive monotherapy and dual therapy. METHODS: Patients prescribed Aml/Val or Aml/Val/HCT were assessed in this 26±8 week, noninterventional, multicenter study across 13 countries in the Middle East and Asia. Changes in mean sitting systolic BP, mean sitting diastolic BP, and overall safety were assessed. RESULTS: Of a total of 9,794 patients analyzed, 8,603 and 1,191 patients were prescribed Aml/Val and Aml/Val/HCT, respectively. Among these, 15.5% were elderly, 32.5% were obese, 31.3% had diabetes, and 9.8% had isolated systolic hypertension. Both Aml/Val and Aml/Val/HCT single-pill combinations, respectively, were associated with clinically relevant and significant mean sitting systolic/diastolic BP reductions across all subgroups: elderly patients (-32.2/-14.3 mmHg and -38.5/-16.5 mmHg), obese patients (-32.2/-17.9 mmHg and -38.5/-18.4 mmHg), diabetic patients (-30.3/-16.1 mmHg and -34.4/-16.6 mmHg), and patients with isolated systolic hypertension (-25.5/-4.1 mmHg and -30.2/-5.9 mmHg). Incremental BP reductions with Aml/Val or Aml/Val/HCT single-pill combinations were also observed in patients receiving prior monotherapy or dual therapy for hypertension. Overall, both Aml/Val and Aml/Val/HCT were generally well tolerated. CONCLUSION: This large, multiethnic study supports the evidence that Aml/Val and Aml/Val/ HCT single-pill combinations are effective in diverse and clinically important subgroups of patients with hypertension.

A randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of tegaserod in patients from China with chronic constipation.

AIM: To evaluate the efficacy and safety of tegaserod, 6 mg twice daily (b.i.d.), in men and women with chronic constipation (CC) from China. METHODS: This was a multicenter, double-blind, placebo-controlled study. Following a 2-wk treatment-free baseline period, patients were randomized to receive either tegaserod (6 mg b.i.d.) or placebo (b.i.d.) for 4 wk. An analysis of covariance with repeated measures was used to determine the overall effect of treatment for the primary efficacy variable; the change from baseline in the number of complete spontaneous bowel movements (CSBMs) during the 4-wk treatment period. Secondary efficacy endpoints included other measures of response in terms of CSBMs, and patients' daily and weekly assessment of bowel habits. Safety was also assessed, based on the incidence and severity of adverse events (AEs). RESULTS: A total of 607 patients were randomized to receive either tegaserod (n = 304) or placebo (n = 303). Tegaserod treatment resulted in a rapid and significant increase from baseline in the adjusted mean number of CSBMs per week over wk 1-4 compared with placebo (1.39 vs 0.91, P = 0.0002). A statistically significant difference in favor of tegaserod was also observed for a mean increase > or = 1 CSBM/wk over wk 1-4 (47.7% vs 35.0%, tegaserod vs placebo, respectively, P = 0.0018) and for the absolute number of > or = 3 CSBMs/wk over wk 1-4 (25.0% vs 14.5%, tegaserod vs placebo, respectively, P = 0.0021). Improvements in other symptoms of CC were also seen in the tegaserod group, including improved stool form and reduced straining. In addition, more patients in the tegaserod group reported satisfactory relief from their constipation symptoms. The frequency and severity of AEs was comparable between tegaserod and placebo groups, with the exception of a greater incidence of diarrhea in patients receiving tegaserod (3.6%) compared with placebo (1.7%). CONCLUSION: Tegaserod treatment improved multiple symptoms of CC and was associated with a favorable safety profile.