Current medical research and opinion
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Objective: Comorbidities and comedications are important factors influencing optimal therapy because people are living longer with HIV infection. This study describes the long-term comorbidity profile and treatment burden among people with HIV-1 infection. Methods: This retrospective study included Medicaid claims data from patients with ≥1 antiretroviral (ARV) claim between 2016 and 2017 (most recent claim defined the index date), ≥1 HIV diagnosis within 1 year before index, age ≥18 years at first HIV diagnosis and <65 years at index, ≥12 months of continuous eligibility before index, and no history of HIV-2 infection. ⋯ In the year before index, mean (SD) daily pill burden was 2.1 (1.4) for ARVs and 5.9 (5.9) for non-ARVs. Older age and prior treatment experience were associated with higher rates of comorbidities and greater pill burden. Conclusions: In people with HIV infection, comorbidities and concomitant medication use increased with age, supporting considerations for streamlined ARV regimens highlighted in treatment guidelines.
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Objective: To explore health-related quality of life (HRQoL) and assess preferences for medical treatment attributes to obtain information of the relative importance of the different attributes in a Danish population with ulcerative colitis (UC). Methods: We used data from an online survey collected in March 2018 among people with self-reported UC. A total of 302 eligible respondents answered the HRQoL questionnaires (EuroQol-5 Dimensions (EQ-5D-5L) and the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)), and 212 also completed the discrete choice experiment (DCE). ⋯ Additionally, respondents stated a preference for avoiding taking steroids, for fast onset of effect and for oral formulations. Conclusions: HRQoL correlates with disease severity, and patients with UC have lower HRQoL than the general population. The most important treatment attribute was efficacy, but patients also would like to avoid steroids, value fast onset of effect and prefer oral formulations.
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Multicenter Study
The mirogabalin ALDAY phase 3 program in pain associated with fibromyalgia: the lessons learned.
Aims: The main aim of this work was to identify and to share the lessons learned from the negative outcome of the mirogabalin ALDAY phase 3 clinical program in pain associated with fibromyalgia. These lessons are important to improve planning and design of future phase 3 programs in fibromyalgia. Methods: A systematic review from Cochrane Library, Medline, Embase, clinicaltrials.gov, pharmaceutical companies, and regulatory agencies' websites, was carried out starting from the development of gabapentin, the first α2δ ligand studied for the treatment of neuropathic pain and ending with the mirogabalin program. ⋯ Outcome: In terms of main lessons learned from ALDAY, the first was the need for a comprehensive patient-focused strategy to preliminarily identify the challenges of fibromyalgia based on patient perspective and study complexity. Second, there was a need for a harmonized, truly patient-centric, global regulatory guidance accepted by regulatory agencies. Third, ALDAY proved that a phase 2 proof of concept, dose ranging study is necessary before commencing any phase 3 program in fibromyalgia.
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Multicenter Study Observational Study
Patient-reported outcomes in elderly patients with type 2 diabetes mellitus treated with dual oral therapy: a multicenter, observational study from Italy.
Objective: To assess patient-reported outcomes after two years of use of dual oral anti-diabetes drug (OAD) therapy in elderly people (≥65 years) with type 2 diabetes mellitus (T2DM) from Italy under real-life settings. Methods: 3-AGE was a prospective, non-interventional study in elderly people with T2DM inadequately controlled on metformin monotherapy (defined as glycated hemoglobin [HbA1c] 7.0-9.0%), in whom a second OAD was prescribed. Primary endpoint was to assess the physical and psychological symptoms associated with T2DM from baseline to 24 months using the Diabetes Symptom Check List revised (DSC-R) questionnaire. ⋯ Physicians expressed good satisfaction with patients' treatment (across efficacy, tolerability and compliance domains) at Month 12. Overall, 32 adverse reactions (in 24 patients) and four hypoglycemic episodes were reported during the 24 months. Conclusion: Addition of a second OAD improved physical and psychological symptoms associated with T2DM and was well tolerated in elderly people under real-life settings.
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Randomized Controlled Trial Comparative Study
Real-world outcomes of treatment with insulin glargine 300 U/mL versus standard-of-care in people with uncontrolled type 2 diabetes mellitus.
Objective: To compare real-world outcomes with newer (insulin glargine 300 U/mL; Gla-300) versus standard of care (SoC) basal insulins (BIs) in the REACH (insulin-naïve; NCT02967224) and REGAIN (basal insulin-treated; NCT02967211) studies in participants with uncontrolled type 2 diabetes (T2DM) in Europe and Brazil. Methods: In these open-label, parallel-group, pragmatic studies, patients (HbA1c > 7.0%) were randomized to Gla-300 or SoC BI for a 6-month treatment period (to demonstrate non-inferiority of Gla-300 vs SoC BIs for HbA1c change [non-inferiority margin 0.3%]) and a 6-month extension period (continuing with their assigned treatment). Insulin titration/other medication changes were at investigator/patient discretion post-randomization. ⋯ Hypoglycemia incidence was low and similar between treatment arms in both studies. Conclusions: In both REACH and REGAIN, no differences in glycemic control or hypoglycemia outcomes with Gla-300 versus SoC BIs were seen over 12 months. However, the suboptimal insulin titration in REACH and REGAIN limits comparisons of outcomes between treatment arms and suggests that more titration instruction/support may be required for patients to fully derive the benefits from newer basal insulin formulations.