Background The management of severe persistent pulmonary hypertension (PPHN) can be very challenging in many resource-limited centers without access to inhaled nitric oxide or extracorporeal membrane oxygenation. Objectives The current study aimed to investigate the efficacy of oral sildenafil and intravenous milrinone infusion and compare the effects of these drugs in combination versus as monotherapy in neonates with PPHN. Methods A double-blind randomized controlled trial was conducted in which neonates with PPHN were divided into three groups of 20 patients each: group 1 received oral sildenafil starting at 0.5 mg/kg every 6 h to a target maintenance dose of 2 mg/kg every 6 h; group 2 received intravenous milrinone 0.5 μg/kg/min as a continuous infusion; and group 3 received both oral sildenafil and intravenous milrinone. Results Post-treatment pulmonary artery systolic pressure was significantly lower in group 3 than in groups 1 and 2, which both received monotherapy (p = 0.031). The oxygenation index also decreased significantly in the dual-therapy group (p = 0.002) compared with the monotherapy groups. Combined use of both drugs demonstrated a beneficial synergistic effect with better outcomes and reduced mortality. Conclusion Dual therapy using sildenafil and milrinone was superior to monotherapy with either drug in neonates with severe PPHN and is recommended for use in resource-constrained settings. Registration Pan African Clinical Trial Registry identifier number PACTR201902691230243.
Background: Adding glimepiride to metformin monotherapy was reported to improve the glycemic status of patients with type 2 diabetes mellitus (T2DM), with tolerable safety profile. Aim of Work:The present real-life study aimed to investigate the safety and effectiveness of glimepiride add-on therapy in poorly controlled T2DM patients with metformin monotherapy. Patients and Methods:In the present prospective study, we included 1050 poorly controlled T2DM patients from Egypt, and for whom the investigators decided to prescribe glimepiride in addition to metformin. Glimepiride was added to patients uncontrolled on metformin monotherapy for at least three months despite reaching the maximally tolerated dose. Regimen doses were decided by the investigators to reflect the in-practice approach. We followed the included patients for at three months and safety outcomes were measured throughout the study period.Results: After three months of treatment, the mean HbA1c level decreased by 1.54% (95% CI: -1.61 to -1.46%), with a mean percentage reduction of 16.3% (p<0.001). In addition, 31.7% of the included patients achieved the targeted HbA1c level < 7%. The total number of adverse events was 15 adverse events occurred in 11 patients. Ten episodes of non-serious hypoglycemia were recorded. Conclusion:The present real-life study confirms the efficacy of glimepiride add-on therapy to metformin monotherapy among poorly controlled T2DM patients from Egypt. Moreover, glimepiride/metformin regimen exhibits welltolerable safety profile.
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