Current medical research and opinion
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Objective: Endometriosis affects up to 10% of women of reproductive age, and the main goal of treatment is to relieve symptoms. Progestins have been the mainstay of endometriosis suppression, of which dienogest has become an important option in many parts of the world. This is an expert literature review, with recommendations on the use of dienogest in the context of various clinical considerations when treating endometriosis. ⋯ Counseling women on potential bleeding risks before starting treatment may be helpful, and evidence suggests that few women discontinue treatment for this reason, with the benefits of treatment outweighing any impact of bleeding irregularities. Conclusions: Overall, the evidence demonstrates that dienogest offers an effective and tolerable alternative or adjunct to surgery and provides many advantages over combined hormonal contraceptives for the treatment of endometriosis. It is important that treatment guidelines are followed and care is tailored to the woman's individual needs and desires.
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Randomized Controlled Trial Multicenter Study Comparative Study
Comparative study of dulaglutide single-use pen Ateos versus insulin degludec FlexTouch on learning and mock administration time in Japanese patients with type 2 diabetes mellitus - a post-hoc analysis.
Aims: Clinical data have shown that patients with diabetes require shorter training time to use Ateos versus FlexTouch. Using data acquired from a previous study, self-administration procedures that necessitated more time and repetition during mock injection were evaluated. Methods: In this open-label task- and interview-based crossover study, 48 self-injection naïve participants with type 2 diabetes mellitus (T2DM) were randomized to 1 of 2 sequences to perform a mock injection of Ateos and FlexTouch into a rubber pad after receiving training. ⋯ There was 1 repeat per person for Ateos injections versus multiple repeats for FlexTouch injections. Conclusions:Post-hoc analysis demonstrates the time needed for overall administration was shorter for Ateos than FlexTouch, and time for each procedure was shorter or similar for Ateos versus FlexTouch. Ateos was easy for participants with T2DM to learn with fewer repeated steps due to procedural errors, and easy for healthcare professionals to introduce to their patients.
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Objective: To perform evaluations of the CONTOUR PLUS LINK 2.4 blood glucose monitoring system (BGMS) assessed according to ISO 15197:2013 criteria. Methods: Clinical trial registered at ClinicalTrials.gov (NCT01824355). In a laboratory study (Study 1), capillary fingertip blood samples from 100 subjects were evaluated in duplicate, using three test strip lots. ⋯ Most subjects found the BGMS easy to use. There were three non-serious, non-device related adverse events. Conclusion: The BGMS exceeded minimum ISO 15197:2013-specified accuracy criteria in the laboratory and in the hands of lay users with diabetes.
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Background: Mantle cell lymphoma (MCL), a rare and aggressive disease, accounts for approximately 5% of all B-cell non-Hodgkin's lymphomas. Evidence on the burden of this disease, for patients and healthcare providers, is scarce. Methods: Four systematic literature reviews were developed to identify epidemiological, real-world clinical, economic and humanistic burden data on patients with MCL. ⋯ Conclusions: We identified significant data gaps for many G20 countries for epidemiology, real-world clinical, economic and humanistic burden. These literature reviews demonstrate the ongoing unmet need for MCL patients globally. Future research to further understand the real-world impact of MCL is needed along with new therapeutic options to improve patient outcomes.
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Randomized Controlled Trial Multicenter Study
IncobotulinumtoxinA for upper- and lower-limb spasticity in Japanese patients.
Introduction: The safety and tolerability of incobotulinumtoxinA 400 U for upper- and lower-limb post-stroke spasticity was assessed in a small cohort of Japanese patients during the open-label lead-in tolerability periods (LITP) of two phase 3 studies (CTI-153029 and CTI-153030; Japan Pharmaceutical Information Centre). Methods: Adult patients received a single incobotulinumtoxinA injection session (total dose of 400 U) in the upper (J-PURE) or lower limb (J-PLUS). Adverse events (AEs) were assessed at 1, 4, 8 and 12 weeks post-injection during the 12 week follow-up. ⋯ Non-serious, transient AEs of special interest reported by two patients in J-PURE comprised muscular weakness and eyelid ptosis. No patient discontinued due to AEs. Conclusion: Preliminary results in this small population suggest that incobotulinumtoxinA 400 U is well tolerated for treating upper- or lower-limb post-stroke spasticity in Japanese patients.