isosorbide mononitrate (Mono Mack 50D / Mono Mack)

Isosorbide Mononitrate/Cilostazol for Lacunar Cerebral Small Vessel Disease-Outcomes at 6 Months in the LACI-2 Randomized Controlled Trial.

Bath Philip M PM, Woodhouse Lisa J LJ, Mhlanga Iris I, Bamford John J et al.

Lacunar stroke can cause cognitive decline and dependency. The LACI-2 (Lacunar Intervention Trial-2) trial showed that 12 months of treatment with isosorbide-mononitrate (ISMN) or cilostazol improved these outcomes. We tested whether this effect was present at 6 months. LACI-2 was a prospective randomized open-label blinded-end point 2×2-factorial phase-2b trial assessing feasibility, safety, and proof-of-concept of 1 year of ISMN (40-60 mg) or cilostazol (200 mg). Participants aged >30 years had clinical lacunar stroke, compatible neuroimaging, and capacity to consent. The primary clinical outcome was the composite of stroke, myocardial infarction, dependency (modified Rankin Scale score >2), cognitive impairment (Diagnostic and Statistical Manual version 5, 7-level >0) and death; key secondary outcomes included the composite components, mood and stroke impact scale. Global analysis of the stroke impact scale was analyzed using the Wei-Lachin test with result given as Mann-Whitney difference. Baseline characteristics were balanced across 363 participants: median age 64 (56-72) years, 31% female, and median onset to randomization 79 (27-244) days. At 6 months, participants allocated to ISMN versus control had fewer composite events (adjusted odds ratio [OR], 0.74 [95% CI, 0.55-0.99]) and improved stroke impact (Mann-Whitney difference, -0.15 [95% CI -0.25 to -0.05]). Cilostazol versus control improved cognition (Diagnostic and Statistical Manual version 5, 7-level scale, adjusted common OR, 0.64 [95% CI, 0.41-0.99]). ISMN/cilostazol versus control improved cognition (Diagnostic and Statistical Manual version 5, 7-level adjusted common OR, 0.40 [95% CI, 0.21-0.78]), mood (Zung adjusted mean difference, -6.94 [95% CI, -12.25 to -1.64]) and global stroke impact (Mann-Whitney difference, -0.23 [95% CI, -0.37 to -0.09]). A reduction in the composite outcome, cognitive impairment, dependency, and stroke impact was seen within 6 months of starting ISMN or cilostazol. URL: www.isrctn.com; Unique Identifier: ISRCTN14911850.

Retraction of: Isosorbide Mononitrate Increases Bone Formation and Decreases Bone Resorption in Postmenopausal Women: A Randomized Trial.

Isosorbide dinitrate as an effective adjunct therapy for acute urinary retention: A randomized controlled trial.

Soltani Salman S, Ghorbani Hamid Reza HR, Tavakkoli Mahmoud M, Sadabadi Fatemeh F et al.

To evaluate the synergistic effect and safety of sublingual isosorbide dinitrate (ISDN) to facilitate successful voiding trial after catheterization for acute urinary retention (AUR) secondary to benign prostatic hyperplasia (BPH). In this randomized clinical trial, male patients aged ≥ 50 years presenting with first-episode AUR secondary to BPH at our urology emergency department were enrolled during 2019-2020. Participants were randomly assigned to receive either standard therapy (α1-blocker and 5α-reductase inhibitor) alone (n = 40) or in combination with daily sublingual ISDN 10 mg for 21 days (n = 40). Primary outcomes included successful voiding post-catheter removal as trial without catheter (TWOC) and post-void residual (PVR) volume. Secondary outcomes included post-treatment prostate-specific antigen (PSA) levels and adverse events. Data were analysed using independent t-tests and chi-square tests. A total of 80 men with similar baseline characteristics were enrolled (mean ages: 70.3 ± 7.97 in the ISDN group vs. 68.2 ± 8.73 years in the controls). The rate of successful TWOC was significantly higher in the ISDN plus standard therapy group compared with standard therapy alone (50.0% vs. 22.5%, p = 0.011). PVR volume decreased significantly after treatment in both groups (within-group p < 0.001), with a greater overall reduction observed in the ISDN group (p = 0.002). PSA levels remained stable, with no significant within- or between-group differences. On multivariable logistic regression analysis, adjunctive ISDN therapy independently predicted successful TWOC (adjusted OR 3.27, 95% CI 1.23-8.70; p = 0.017). No serious adverse events were observed. Adjunctive sublingual ISDN significantly improves urinary outcomes following AUR and reduces residual urine volume without increasing adverse events. This combination therapy offers a safe and effective strategy to improve the success of TWOC in patients with BPH-related AUR.

Comparative Resection Efficiency of a Hysteroscopic Tissue Removal System: A Prospective Multicenter Bench Study Using a Standardized Fibroid Model.

Berman Jay M JM, Haimovich Sergio S, Levine David J DJ, Skalnyi Eugene E

To evaluate the resection efficiency of the Aveta hysteroscopic tissue removal system and compare its performance with three established hysteroscopic morcellation devices using a standardized synthetic fibroid model designed to simulate the mechanical resistance of dense leiomyoma tissue. Prospective, multicenter comparative bench study with repeated measures in an incomplete blocks design. Simulated hysteroscopic fibroid resections under standardized conditions. Ninety-one Ob/Gyn practicing physicians routinely performing hysteroscopic myomectomy procedures participated in the study. Simulated hysteroscopic resections using four commercially available hysteroscopic tissue removal systems (Aveta Flex, MyoSure Reach, MyoSure XL, and TruClear Dense Tissue Shaver Plus (DTSP)) were performed in a synthetic fibroid analog tissue model with rheologic properties calibrated to simulate the mechanical resistance of highly fibrotic or partially calcified leiomyomas. Resection efficiency was quantified by measuring the mass of fibroid analog removed in g/min. Ninety-one physicians participated and a total of 220 device observations were included: Aveta Flex (n = 91), MyoSure Reach (n = 56), MyoSure XL (n = 37), and TruClear DTSP (n = 36). Least squares mean resection rates were 0.506 g/min for Aveta Flex, 0.184 g/min for MyoSure Reach, 0.274 g/min for MyoSure XL, and 0.389 g/min for TruClear DTSP. Parametric and nonparametric analyses demonstrated significantly higher resection rates for Aveta Flex compared with MyoSure Reach, MyoSure XL, and TruClear DTSP (mixed-effects model p < .005; Skillings-Mack p < .0001). In this prospective, multicenter study using a standardized synthetic fibroid analog model, the Aveta Flex hysteroscopic tissue removal system demonstrated significantly higher resection efficiency compared with established hysteroscopic morcellation devices. Given the importance of procedural efficiency in operative hysteroscopy, particularly within the limitations imposed by fluid deficit thresholds, these findings may have implications for operative duration, likelihood of complete resection, and overall procedural workflow in hysteroscopic myomectomy.