Current medical research and opinion
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Objective: To evaluate the risk of chronic kidney disease (CKD), cardiovascular disease (CVD), and osteoporotic fractures in human immunodeficiency virus (HIV) patients utilizing data within the Veteran's Affairs (VA) Administration system. Methods: A retrospective cohort study utilizing VA system claims (January 2000-December 2016) were extracted from the VA Informatics and Computing Infrastructure (VINCI). Cases included Veterans with an ICD-9/10 for HIV who had at least one prescription for a complete antiretroviral therapy (ART) regimen. ⋯ The average age was 49.3 years, 38% were black, 32% were white, and 97% were male for both the HIV and control cohorts. The adjusted models demonstrated that HIV was associated with a 78% increased rate of CKD (OR = 1.78, 95% CI = 1.68-1.89), a 32% increased risk of CVD (RR = 1.32, 95% CI = 1.28-1.37), and a 38% increased risk of fractures (RR = 1.38, 95% CI = 1.23-1.56) compared to non-HIV controls. Conclusions: The risk/rate of the three outcomes were significantly higher in HIV patients compared to controls.
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Multicenter Study
Long-term treatment with plecanatide was safe and tolerable in patients with irritable bowel syndrome with constipation.
Objective: This open-label, multi-center, fixed-dose study (NCT02706483) evaluated the long-term safety and tolerability of plecanatide for the treatment of adults with irritable bowel syndrome with constipation (IBS-C). Methods: Safety and tolerability of once-daily plecanatide 6 mg for up to 53 weeks was assessed in patients with IBS-C who either had been enrolled in one of the phase 3 studies or were study-naïve but met eligibility criteria of the double-blind studies. Safety was assessed by treatment-emergent adverse events (AEs). ⋯ Conclusions: Plecanatide 6 mg was safe and well tolerated in patients with IBS-C treated for up to 53 weeks, with an overall safety profile similar to the 12-week IBS-C studies. Patients reported high rates of relief and satisfaction with treatment, and interest in continuing therapy. Trial registration: ClinicalTrials.gov identifier: NCT02706483.
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Objective: To identify systemic treatment in the real-world following treatment with a cyclin-dependent kinase 4/6 inhibitor (CDKi) among post-menopausal women with hormone receptor positive, human epidermal growth factor receptor 2 Negative (HR+/HER2-) metastatic breast cancer (mBC). Methods: Post-menopausal women with HR+/HER2- mBC were identified from MarketScan claims databases between January 1, 2012 and October 31, 2017. Eligible mBC patients who received a CDKi-based line of therapy following metastasis diagnosis were selected. ⋯ Of post-CDKi second line regimens (n = 208), 38.0% were endocrine only, 35.6% were chemotherapy-based, 14.4% were everolimus-based, 9.6% were also CDKi-based line, and 2.4% were others. After adjusting for demographic and clinical characteristics, patients transitioning from a CDKi-based line to chemotherapy (vs others) had a trend of being more likely to have recurrent rapidly progressing disease, and were significantly less likely to have the prior CDKi-based line in combination with an AI (both p < .05). Conclusions: This population-based study suggests that rapidly progressing disease, metastatic site location, age, and endocrine therapy partner may be predictive of subsequent systemic therapy regimen selection after progression on a CDKi-based line therapy in patients with HR+/HER2- mBC.
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Aim: The aim of study was to investigate the opportunities of local phlebectomy in the elimination of isolated pelvic-perineal reflux (PPR), as well as to determine the feasibility of endovascular embolization of the tributaries of internal iliac veins in PPR. Clinical trial no. NCT01598051. ⋯ Endovascular embolization of the tributaries of the internal iliac veins is not an essential component in the treatment of PPR. The present study has a limitation due to the absence of patients with PCS. The effectiveness of phlebectomy in the treatment of isolated PPR was studied.
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Randomized Controlled Trial Multicenter Study
Efficacy of different photoprotection strategies in preventing actinic keratosis new lesions after photodynamic therapy. The ATHENA study: a two-center, randomized, prospective, assessor-blinded pragmatic trial.
Background: Treatment of actinic keratosis (AK) and field cancerization with photodynamic therapy (PDT) is an effective therapeutic approach with a significant reduction in the number of AK lesions (-75% or more) associated with a significant cosmetic improvement of the photodamaged skin. Recently, also, the daylight PDT (DL-PDT) has proven to be as effective as the conventional PDT (C-PDT), but with a better tolerability. After C-PDT and DL-PDT it is advised to use photoprotection strategies to improve the clinical evolution and prevent the appearance of new AK lesions that usually appear 3-6 months after the last phototherapy session. ⋯ The percentage of subjects with an IGA score of 4/3 (very good or good) was 81% in the ACTX and 55% in the SS group (p = 0.06). Conclusion: In subjects with AK treated with C-PDT or DL-PDT, a "medicalized" photoprotection treatment is associated with a favorable clinical outcome with progressive reduction of lesions. In contrast to a very high photoprotection (SPF50+ or SPF100+/photolyase), the use of piroxicam 0.8%/SPF 50+ is associated with a significantly greater improvement in clinical evolution of AK lesions.