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Purpose

This study aimed at reporting a head-to-head comparison between water vapor thermal therapy using the Rezūm? system and prostatic urethral lift using the Urolift? system in men with lower urinary tract symptoms due to benign prostatic hyperplasia (BPH).

Patients and methods

From December 2017 to November 2019, consecutive patients who underwent Rezūm? and Urolift? procedures in two urology centers have been retrospectively considered. Only patients with a prostate size less than 80 mL were included. We used the PSM method to adjust baseline differences between both groups. The co-primary endpoint included the change in International Prostate Symptom Score (IPSS) and IPSS- quality of life (QoL) from baseline to 12 months.

Results

A total of 61 (52.1%) and 56 (47.9%) patients underwent Rezum? and Urolift? procedures, respectively. After PSM adjustment, 24 patients were included in both groups. No serious adverse events occurred (>?Clavien II) in both groups. At 12 months, higher IPSS improvement was observed in the Rezum? group (median:4 [IQR 3–5]) than in the Urolift? group (median:8 [IQR 7–12]), without statistical difference (p?=?0.08). The improvement in term of QoL at 12 m was similar (p?=?0.43). The retreatment rates were 25% (Urolift?) and 8.3% (Rezum?), p?=?0.24. Erection and ejaculatory function scores did not change significantly in either treatment group. Results in the full cohort showed that Rezum? appeared to deliver greater improvements for IPSS and IPSS-QoL (p?<?0.001 and p?=?0.006, respectively) and lower reintervention rate (p?=?0.006) than Urolift?.

Conclusions

In this small retrospective study, our results indicate that both Rezum? and Urolift? provide a clinically significant improvement in symptoms and QoL, although some of these improvements were greater in the Rezum? arm. Future studies are needed to definitively assess which treatment would be best suited for each patient.

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Purpose

Novel therapies to treat chronic obstructive pulmonary disease are highly desirable. The safety, tolerability, and pharmacokinetic (PK) parameters of nemiralisib, a phosphoinositide 3-kinase δ inhibitor, administered via the Ellipta dry powder inhaler (GlaxoSmithKline, Research Triangle Park, North Carolina) was evaluated, including an assessment of oral bioavailability.

Methods

This single-center, 3-part, placebo-controlled trial in 22 healthy subjects evaluated single (100 and 200 μg) and repeat (200 μg for 10 days) doses of inhaled nemiralisib in parts A (n?=?12) and B (n?=?12) (double-blind) and single doses of inhaled nemiralisib (200 µg) with and without charcoal block in Part C (n?=?6) (open-label, 2-period, crossover). There was a minimum 14-day washout period between dosing days.

Findings

21 subjects completed the study, mean age was similar in the three parts (A: 49 years; B: 44 years; C: 55 years). After single doses of nemiralisib, observed plasma Cmax dropped rapidly, followed by a slower elimination phase. Near-dose proportionality was observed: mean (95% CI) plasma Cmax and AUC0–24 values were 174.3 pg/mL (96.9–313.3) and 694.6 pg·h/mL (503.5–958.2) for 100 μg and 398.9 pg/mL (318.3–500.1) and 1699.6 pg·h/mL (1273.3–2268.7) for 200 μg, respectively. Repeat dosing for 10 days showed exposures ~2- to 4-fold higher than on the single dose (peak, trough, and AUC0–24 levels), achieving steady-state by day 6. Mean AUC0–24 was 2193.6 pg·h/mL and 1645.3 pg·h/mL in the absence/presence of charcoal. Two non–drug-related adverse events were observed; neither was serious or resulted in withdrawal.

Implications

Inhalation of nemiralisib was well tolerated in these healthy subjects. Plasma pharmacokinetic variables were well defined, and charcoal block data indicate that ~23% of the total systemic exposure after inhalation from Ellipta was attributable to orally absorbed drug. ClinicalTrials.gov identifier: NCT02691325.  相似文献   
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Clinical Rheumatology - The positive effects of physical activity in both rheumatoid arthritis and ankylosing spondylitis have been proven, but no clear data is yet published regarding psoriatic...  相似文献   
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