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Dosing Option (dosing + option)
Selected AbstractsSolifenacin treatment for overactive bladder in Hispanic patients: patient-reported symptom bother and quality of life outcomes from the VESIcare® Open-Label TrialINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 1 2008J. P. Capo' Jr Summary Objective:, The primary goal of overactive bladder (OAB) treatment is to reduce symptoms and improve health-related quality of life (HRQoL). Although trials open enrolment to everyone, most OAB studies feature Caucasians. Here we present Hispanic data. Methods:, VESIcare® Open-Label Trial was a 12-week, open-label, flexible-dosing study in patients with OAB symptoms for , 3 months. All patients started on solifenacin 5 mg/day, with a dosing option of 5 or 10 mg/day at weeks 4 and 8. Three patient-reported outcome (PRO) measures assessed symptom improvement and treatment satisfaction: the Patient Perception of Bladder Condition (PPBC) scale, a Visual Analogue Scale (VAS), the Overactive Bladder Questionnaire (OAB-q). Results:, 94/2205 patients in the full population were Hispanic. Urgency was most frequently reported at baseline (93.6%), followed by frequency (91.5%), nocturia (84.0%) and urge incontinence (UI) (67.0%). Frequency was reported as the most bothersome symptom (MBS) by a higher proportion of Hispanics than the full population (40.4% vs. 28.1%). UI was reported as the MBS by a smaller proportion of Hispanics (18.1% vs. 27.3%). Patients reporting moderate-to-severe problems related to bladder condition at baseline reported improvement to ,some minor problems' at week 12. Over 72.0% of patients experienced PPBC score improvement. Both groups reported significant improvements in urgency, UI, frequency and nocturia on the VAS (all p < 0.001) and all OAB-q domains (all p < 0.001) at week 12. Conclusion:, Although numbers were small, Hispanics receiving solifenacin for OAB reported improvement from baseline in symptom bother and HRQoL, as assessed by three independent PRO measures. [source] Two-Year Results of Once-Weekly Administration of Alendronate 70 mg for the Treatment of Postmenopausal OsteoporosisJOURNAL OF BONE AND MINERAL RESEARCH, Issue 11 2002R Rizzoli Abstract The aim of this study was to provide confirmation that once-weekly dosing with 70 mg of alendronate (seven times the daily oral dose) and twice-weekly dosing with 35 mg is equivalent to the 10-mg once-daily regimen and to gain more extensive safety experience with this new dosing regimen. Twelve hundred fifty-eight postmenopausal women (aged 42,95 years) with osteoporosis (bone mineral density [BMD] of either lumbar spine or femoral neck at least 2.5 SDs below peak young adult mean or prior vertebral or hip fracture) were assigned to receive oral once-weekly alendronate, 70 mg (n = 519); twice-weekly alendronate, 35 mg (n = 369); or daily alendronate 10 mg (n = 370) for a total of 2 years of double-blind experience. Mean BMD increases from baseline (95% CI) at 24 months in the once-weekly, twice-weekly, and daily treatment groups, respectively, were 6.8% (6.4, 7.3), 7.0% (6.6, 7.5), and 7.4% (6.9, 7.8) at the lumbar spine and 4.1% (3.8, 4.5), 4.3% (3.9, 4.7), and 4.3% (3.9, 4.7) at the total hip. These increases in BMD as well as the BMD increases at the femoral neck, trochanter, and total body and the reductions of biochemical markers of bone resorption (urinary cross-linked N-telopeptides of type I collagen [NTx]) and bone formation (serum bone-specific alkaline phosphatase [BSAP]) were similar for the three dosing regimens. All treatment regimens were well tolerated with a similar incidence of upper gastrointestinal (GI) adverse experiences. The incidence rates of clinical fractures, captured as adverse experiences, were similar among the groups. The 2-year results confirm the conclusion reached after 1 year that once-weekly alendronate is therapeutically equivalent to daily dosing, providing patients with a more convenient dosing option that may potentially enhance adherence to therapy. [source] A novel option for dosing of proton pump inhibitors: dispersion of lansoprazole orally disintegrating tablet in water via oral syringeALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 11 2004D. A. Gremse Summary Background :,A new formulation of lansoprazole, the lansoprazole orally disintegrating tablet, rapidly disintegrates in water eliminating the need for swallowing whole pills. Aim :,To assess the effect that dispersing the lansoprazole orally disintegrating tablet in water would have on lansoprazole pharmacokinetics. Methods :,Forty healthy adult men and women (18,43 years) received two single 15 mg lansoprazole orally disintegrating tablet doses separated by 3 days (one administered directly onto the tongue without water and one dispersed in water and administered orally via syringe) in a randomized, crossover fashion. Serial plasma samples were determined from 0 to 12 h for each dose. Ratios of central values for peak plasma exposure (Cmax) and mean overall extent of exposure (area under the plasma concentration) were used to compare the bioavailability. Results :,The two dosing regimens were bioequivalent, with the point estimate for area under the plasma concentration equalling 1.080 (confidence interval 1.012,1.152) and the point estimate for Cmax equalling 1.082 (confidence interval 0.961,1.218). Conclusions :,Dispersing the 15 mg lansoprazole orally disintegrating tablet in water and administering the dose orally via syringe is bioequivalent to the 15 mg intact lansoprazole orally disintegrating tablet with respect to lansoprazole area under the plasma concentration and Cmax. This dosing route provides an additional, convenient dosing option for lansoprazole. [source] Safety, Efficacy, and Pharmacokinetic Overview of Low-Dose Daily Administration of TadalafilTHE JOURNAL OF SEXUAL MEDICINE, Issue 7 2009Rebecca Wrishko PhD ABSTRACT Introduction., Several phosphodiesterase type 5 (PDE5) inhibitors are commercially available for the treatment of erectile dysfunction (ED). Development of the first once-daily alternative dosing regimen with a PDE5 inhibitor was motivated by the behavioral complexities associated with sexual intimacy. Aim., To provide an alternative dosing option for certain men who may benefit from the removal of the temporal linkage between administration of an ED therapy and sexual intimacy or for men and their partners who anticipate at least twice-weekly sexual activity. Methods., Pharmacokinetic predictions of tadalafil plasma concentrations were generated based upon empirical data following 20-mg, single-dose administration coupled with tadalafil usage patterns from as-needed clinical trials. To support the pharmacokinetic simulations and pharmacodynamic assumptions, clinical trials were conducted to demonstrate the efficacy and safety of once-daily, low-dose tadalafil 2.5 and 5 mg. Main Outcome Measures., Simulated tadalafil plasma concentrations and comparison with safety and efficacy measures from clinical trials. Results., Based upon pharmacodynamic and pharmacokinetic data, once-daily doses of tadalafil 5 mg were predicted to provide therapeutic concentrations that would be maintained throughout the 24-hour dosing interval. Additionally, for a subgroup of men who anticipate at least twice-weekly sexual activity and are currently taking tadalafil 20 mg, a reduction in daily tadalafil exposure was predicted. To support the hypothesis that low-dose, once-daily tadalafil may be a safe and effective treatment alternative, clinical trials were conducted to demonstrate the safety and efficacy of once-daily tadalafil 2.5 and 5 mg. These results were similar to those of historical as-needed studies evaluating tadalafil 10 and 20 mg. Conclusions., Consistent with pharmacokinetic predictions, data from clinical trials indicate that once-daily use of low-dose tadalafil is a safe and effective treatment for men with ED. Wrishko R, Sorsaburu S, Wong D, Strawbridge A, and McGill J. Safety, efficacy, and pharmacokinetic overview of low-dose daily administration of tadalafil. J Sex Med 2009;6:2039,2048. [source] | ||||||||||