Current medical research and opinion
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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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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.
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Multicenter Study Observational Study
Pain assessment for chronic lower back pain: performance of the PAL-S and PAL-I patient-reported measures for symptoms and impacts.
Objective: The Patient Assessment for Low Back Pain-Symptoms (PAL-S) and the Patient Assessment for Low Back Pain-Impacts (PAL-I) were developed to incorporate patient perspective of treatment benefit in chronic low back pain (cLBP) trials. This study documents psychometric measurement properties of the PAL-S and PAL-I. Methods: In this multicenter, observational study, eligible participants clinically diagnosed with cLBP provided sociodemographic information and completed PAL measures and other patient-reported outcome measures of pain and/or disability. ⋯ Both measures significantly differentiated between pain intensity levels (based on numeric response scale) and painDETECT groups. Conclusion: The PAL-S and PAL-I generated highly reliable scores with substantial evidence of construct validity. Routine use of these measures in treatment trials will enhance comparability of LBP-related symptom and impact results, including patient perspective of treatment benefit.