Current medical research and opinion
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Randomized Controlled Trial
Efficacy and safety of ertugliflozin across racial groups in patients with type 2 diabetes mellitus.
Objective: To assess the efficacy and safety of the sodium-glucose cotransporter 2 inhibitor ertugliflozin across racial groups in patients with type 2 diabetes mellitus (T2DM). Methods: Pooled analysis of data from randomized, double-blind studies in the ertugliflozin phase III development program. Seven placebo- and comparator-controlled studies were used to assess safety (N = 4859) and three placebo-controlled studies were used to assess efficacy (N = 1544). ⋯ Conclusions: In patients with T2DM, treatment with ertugliflozin improved HbA1c, body weight and SBP across all racial subgroups. Ertugliflozin had a generally similar safety profile across racial subgroups and was generally well tolerated. Clinicaltrials.gov identifiers: NCT01986855, NCT01999218, NCT01958671, NCT02099110, NCT02036515, NCT02033889, and NCT02226003.
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Objective: Prior evaluations of ulcerative colitis (UC)-related costs are dated or encompassed limited follow-up. This study assessed the incremental direct and indirect work loss-related costs of privately-insured patients with UC in the United States, overall and in specific subgroups. Methods: In this retrospective matched cohort study, the OptumHealth Care Solutions, Inc (formerly Optum Health Reporting and Insights employer) database (01 January 1999-31 March 2017) was used to identify adult patients with ≥2 claims for UC, who were matched 1:5 to patients with no claims for inflammatory bowel disease (IBD). ⋯ Patients in the UC cohort also incurred more work loss days, resulting in $2142 higher work loss-related costs PPPY ($3165 vs. $5307; p < .001). Direct and work loss-related costs were particularly high in the UC subgroups, with patients undergoing UC-related surgery incurring the highest costs. Conclusions: Over ∼5 years follow-up, patients with UC had significantly higher all-cause direct healthcare and indirect work loss-related costs compared to matched patients without IBD.
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Objective: To evaluate the effect of individual lower urinary tract symptoms (LUTS) and LUTS-specific bother on daily/leisure activities, work productivity and treatment behaviors and satisfaction in a Brazilian population reporting symptoms of the overactive bladder (OAB) syndrome. Methods: Secondary analysis of Brazil LUTS study data, including individuals ≥40 years old with a possible diagnosis of OAB, based on a score of ≥8 on the OAB-V8 questionnaire. Participants used a 5-point Likert scale to rate occurrence of LUTS during the previous month. ⋯ Treatment seeking for OAB was low among men and women overall (35.1 and 43.6%, respectively), with highest rates among individuals in the 60-69 age group. Conclusions: LUTS of all categories impacted all domains studied. These results highlight the importance of comprehensive LUTS assessment in OAB patients, including voiding, storage and post-micturition symptoms.