objective:The study was conducted to provide information on how consumers would use orlistat 60 mg, especially in terms of product dosing, in a setting without physician supervision. Methods and Procedures: A 3-month, open-label, naturalistic study was conducted in an over-the-counter (OTC) setting in 18 pharmacies. Consumers ≥18 years were allowed to purchase orlistat packages containing a bottle of orlistat 60 mg plus educational materials, which provided lifestyle information and tools to encourage successful weight loss. Data were collected at pharmacy visits and during telephone interviews at 14, 30, 60, and 90 days after enrollment. Results: A total of 237 subjects purchased and used the product, and completed at least one interview. Most subjects followed the dosing directions and took two to three capsules per day with meals throughout the study. The majority of subjects took a daily multivitamin, as directed. Approximately, 80% of subjects used the educational materials and found them useful or very useful. Over the study duration, most subjects reported following a diet and 51% of subjects reported more frequent or longer exercise than at enrollment. Approximately, 80% of subjects indicated they were satisfied or very satisfied with the weight loss achieved; measured and self-reported relative median weight loss was ~5% after ≥60 days of using orlistat. Most common adverse events were gastrointestinal (GI), and majority of subjects did not interrupt or discontinue orlistat due to these GI events.Discussion: These results demonstrate that orlistat 60 mg can be used appropriately and safely and with high consumer satisfaction without physician supervision or dietary counseling. Collectively, results indicate that orlistat 60 mg is an appropriate weight loss therapy in the OTC environment.
The use of orlistat 60 mg by mildly to moderately overweight individuals produced significant weight loss in conjunction with a reduced calorie diet and self-instructional materials. This amount of weight loss was associated with improvements in several weight-related risk factors. Orlistat 60 mg may be a useful adjunct to lifestyle measures and has the potential to contribute significantly to weight and risk factor improvement for overweight individuals.
Aim: Examine safety and pharmacodynamics of patisiran alone or with concomitant transthyretin stabilizers from the Phase II open-label extension study and safety and efficacy of patisiran in patients with prior transthyretin stabilizer use from the Phase III APOLLO study. Patients & methods: Post hoc analyses in patients with hereditary transthyretin-mediated amyloidosis with polyneuropathy. Results: Patisiran safety was consistent regardless of concomitant or prior transthyretin stabilizers. In the Phase II open-label extension (n = 27), transthyretin reduction was similar over 24 months, regardless of concomitant transthyretin stabilizers. In APOLLO (n = 225), patisiran-treated groups showed stabilization or improvements in neurological function (modified Neuropathy Impairment Score +7) and quality of life (Norfolk Quality of Life-Diabetic Neuropathy questionnaire) at 18 months, regardless of prior transthyretin stabilizers. Conclusion: Patients benefit from patisiran regardless of transthyretin stabilizer use.
IntroductionDoxylamine tablets are approved as an over-the-counter sleep aid. We developed a doxylamine succinate intranasal metered-dose delivery system with the expectation of a more rapid onset of action with reduced side-effect potential compared with the oral tablet.MethodsThis phase I study randomized 24 adults with chronic intermittent sleep impairment to receive either single doses of intranasal doxylamine succinate 3.2, 6.3, or 12.7 mg or doxylamine succinate 25-mg oral tablet. Doxylamine pharmacokinetics were assessed using noncompartmental methods; pharmacodynamics were evaluated using the Karolinska Sleepiness Scale (KSS) and numerous psychomotor tests. Adverse events (AEs) were monitored.ResultsNone of the intranasal dose levels produced a mean maximum plasma concentration (Cmax) above the 50 ng/mL target level or a time to maximum concentration shorter than that of the oral tablet. At the highest intranasal dose, Cmax and area under the doxylamine concentration–time curve were approximately 25% of the values achieved with the oral dose. Variation in most pharmacokinetic parameters was higher with intranasal compared with oral dosing. A relationship between plasma doxylamine concentration and KSS change from baseline was evident for the 25-mg tablet and, to a lesser extent, for the 12.7-mg intranasal dose. Changes from baseline in psychomotor parameters did not show a relationship to intranasal dose, and did not distinguish between intranasal versus oral dosing. The most common AEs with intranasal dosing were nasal congestion, nasal dryness, and frontal headache.ConclusionThe nasal spray did not increase doxylamine absorption or systemic bioavailability compared with the oral tablet.
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