Prospective Open-label Study Research Articles

Clinical experience with the use of citicoline in mild cognitive impairment of vascular origin

Cardiovascular factors significantly increase the risk of vascular cognitive impairment (VCI). Currently, there are no specific treatments for VCI. A promising therapeutic strategy is the administration of citicoline, which has a neuroprotective effect.Objective: to evaluate the effect of treatment with citicoline (Noocil®) on cognitive function and quality of life (QoL)in patients with mild cognitive impairment (MCI) developed in a background of arterial hypertension and cerebral arteriosclerosis.Material and methods. An open-label prospective observational study enrolled 32 patients with neuroimaging-confirmed vascular cognitive impairment who received baseline therapy (antihypertensive, lipid-lowering, and antiplatelet therapy) and achieved target blood pressure and low-density lipoprotein cholesterol levels. All patients were assessed with a neuropsychological status assessment (MoCA-test). The efficacy of therapy was assessed by the Short Form-36 Quality of Life Questionnaire (SF-36).Results. The most common complaints of the patients were poor concentration, fatigue, forgetfulness, mood lability, sleep disturbances, more often in the form of early waking, and headaches. After 3 months of taking the drug Noocil®, all patients noted an increase in the ability to work, an improvement in concentration, memory and reproduction of the information received, both physical and mental indicators of QoL improved. The positive dynamics in terms of cognitive status (especially the functions of attention, short-term memory, several aspects of executive functions), QoL of patients, which was associated with the effect of Noocil® therapy, was accompanied by the absence of adverse events. A distinctive feature of domestic citicoline (Noocil®) is the presence of an original dosage form – a 240 ml bottle for oral administration, which improves adherence to long-term therapy.Conclusion. The efficacy, safety and good tolerability of Noocil® therapy in patients with predemental VCI was demonstrated.

Reduced urine pregnenolone concentration after clinical response in patients with depression: An open-label short-term prospective study

BackgroundIdentifying biological alterations in patients with depression, particularly those that differ between responders and non-responders, is of interest to clinical practice. Biomarker candidates involve neuroactive steroids, including pregnenolone (PREG) and allopregnanolone (ALLO). However, alterations in PREG and ALLO associated with treatment response are understudied. This study's main aim was to evaluate the effects of antidepressant treatment, clinical response, and treatment duration on PREG and ALLO in depression. Materials and MethodsIn a 4-week, open-label trial, participants were allocated randomly to the venlafaxine (n = 27) or mirtazapine (n = 30) group. Urine concentrations of PREG and ALLO were assessed through gas chromatography-mass spectrometry. Participants collected night urine between 10:30 p.m. and 8:00 a.m. Two primary outcomes were analyzed. Firstly, the effect of treatment (mirtazapine or venlafaxine), clinical response (operationalized through the Hamilton Depression Rating Scale), and time (baseline compared to 28 days) on the urine concentrations of PREG or ALLO in depression. Finally, the effect of clinical response and time on the urine concentration of PREG or ALLO, independently of the antidepressant given (mirtazapine or venlafaxine). Linear mixed models were carried out. ResultsThere was no significant difference in PREG and ALLO concentrations between baseline and 28 days in responders and non-responders when investigating the venlafaxine or the mirtazapine group. However, we found a significant reduction of urine PREG concentration after 28 days of treatment in responders who received either venlafaxine or mirtazapine (estimate = −0.56; p = 0.016; 95CI [−1.003; −0.115]; Cohen’s d = −0.61). ConclusionsOur main results indicate that responders in depression show reduced urinary PREG concentrations after 4-weeks of therapy, independently of the antidepressant used. More studies are needed to confirm these findings.

Particularities of coronary physiology in patients with atrial fibrillation: insights from combined pressure and flow indices measurements.

Symptoms suggestive of myocardial ischemia are frequently encountered in patients with atrial fibrillation (AF) even in the absence of obstructive coronary artery disease. Nevertheless, an in-depth characterisation of coronary physiology in patients with AF is currently lacking. We aim to provide an insight into the characteristics of coronary physiology in AF, by performing simultaneous invasive measurements of coronary flow- and pressure- indices in a real-life population of patients with AF and indication of coronary angiography. This is a prospective open label study including patients with permanent or persistent AF and indication of coronary angiography showing intermediate coronary stenosis requiring routine physiological assessment (n = 18 vessels from 14 patients). We measured FFR (fractional flow reserve), and Doppler-derived coronary flow indices, including CFR (coronary flow reserve) and HMR (hyperaemic microvascular resistance). From the analysed vessels, 18/18 vessels (100%) presented a pathological CFR (<2.5), indicative of coronary microvascular dysfunction (CMD), and 3/18 (17%) demonstrated obstructive epicardial coronary disease (FFR ≤ 0.8). A large proportion of vessels (15/18; 83%) showed discordant FFR/CFR with preserved FFR and low CFR. 47% of the coronary arteries in patients with AF and non-obstructive epicardial coronary disease presented structural CMD (HMR ≥ 2.5 mmHg/cm/s), and were associated with high BMR and an impaired response to adenosine. Conversely, vessels from patients with AF and non-obstructive epicardial coronary disease with functional CMD (HMR < 2.5 mmHg/cm/s) showed higher bAPV. The permanent AF subpopulation presented increased values of HMR and BMR compared to persistent AF, while structural CMD was more often associated with persistent symptoms at 3 months, taking into account the limited sample size of our study. Our findings highlight a systematically impaired CFR in patients with AF even in the absence of obstructive epicardial coronary disease, indicative of CMD. In addition, patients with AF presented more prevalent structural CMD (HMR ≥ 2.5 mmHg/cm/s), characterized by reduced hyperaemic responses to adenosine, possibly interfering with the FFR assessment.

Assessment of the change of antiemetic prophylaxis from double to triple combination in patients with high dose carboplatin chemotherapy.

Chemotherapy-induced nausea and vomiting (CINV) is one of the adverse events that most affects oncologic patients' quality of life. Carboplatin AUC ≥ 4 belongs to agents with high emetic risk (moderate risk in ASCO guidelines). We aimed to compare the effectiveness of netupitant/palonosetron and dexamethasone triple combination (TC) therapy versus ondansetron and dexamethasone double combination (DC) therapy as antiemetic prophylaxis in patients with carboplatin AUC ≥ 4. As a secondary endpoint, in TC group we evaluated the effectiveness of changing NEPA administration timing from 1 h to 15 min before chemotherapy. Open-label prospective study conducted in a tertiary-care hospital in patients receiving carboplatin AUC ≥ 4. CINV was evaluated using MASCC antiemetic tool, in acute (<24 h) and delayed phase (24-120 h). Results were analyzed using χ2 test. Two-hundred four completed questionnaires (CQ) were analyzed (76 in DC and 128 in TC). The proportion of patients who remained emesis-free was superior for TC-treated group compared to DC, either in acute (99.2% vs 92.1%, p = 0.0115) and delayed phase (97.6% vs 90.7%, p = 0.043). Likewise, a higher proportion of TC-treated patients compared to DC remained nausea-free for the first 24 h after treatment (90.6% vs 71%, p = 0.0004) and between 24 and 120 h (82.3% vs 62.7%, p = 0.0025). The change of NEPA administration time showed similar effectiveness in terms of CINV control (81.6% vs 74.5%, p = 0.70). TC showed superiority in early and delayed CINV control in carboplatin AUC ≥ 4 regimens, with no significant differences among cancer types. Change in NEPA administration timing has beneficial implications; it allows NEPA to be administered at hospitals before chemotherapy session.

Routine use of a 3D mapping system in the ablation of supraventricular arrhythmias with as low as reasonably achievable X-ray exposure (AALARA): protocol for a prospective, observational, multicentre, multinational, open-label registry study

IntroductionThe reduction of fluoroscopic exposure during catheter ablation of supraventricular arrhythmias is widely adopted by experienced electrophysiology physicians with a relatively short learning curve and is becoming standard of care...

Preoperative respiratory strength training is feasible and safe and improves pulmonary physiologic capacity in individuals undergoing cardiovascular surgery

ObjectiveTo determine the safety, feasibility, and physiologic impact of a preoperative respiratory strength training (RST) program in individuals undergoing elective cardiac surgery (CS). MethodsTwenty-five adults undergoing an elective CS at an academic hospital setting enrolled and completed RST 5 days/week (50 repetitions, 50% training load, ≥3 weeks) at home via telehealth in this open-label prospective cohort study. RST adherence, telehealth attendance, and adverse events were tracked. Pre- and post-RST outcomes of maximum expiratory pressure (MEP), maximum inspiratory pressure (MIP), voluntary cough spirometry, and patient-reported dyspnea were collected. Descriptive analyses and Wilcoxon signed rank-tests were performed. ResultsTwo participants (9%) did not complete the prescribed RST program. No significant RST-related adverse events occurred. Treatment adherence for all enrolled participants was 90%, and telehealth attendance was 99%. Of the CS patients who completed the prescribed program (n = 23; 91%), treatment adherence and telehealth attendance were excellent (98% and 100%, respectively). Significant increases in primary outcomes were observed: MEP mean change, +15.4 (95% confidence interval [CI], +3.4 to +27.3, P < .007); MIP mean change, +14.9 (95% CI, +9.4 to +20.4, P < .0001). No statistically significant differences in voluntary cough or perceived dyspnea outcomes were observed (P > .05). ConclusionsThese preliminary data demonstrate that a preoperative RST program is safe and feasible and can improve short-term respiratory physiologic capacity (MEP and MIP) in CS patients. Future research is warranted to validate the current findings in a larger cohort of CS patients and to determine whether RST improves postoperative extubation outcomes, airway clearance capacity, and aspiration following cardiac surgery.

Qualitative feasibility study of the mobile app Destroke for clinical stroke monitoring based on the NIH stroke scale

BackgroundStroke is a leading cause of severe disability in the United States, but there is no effective method for patients to accurately detect the signs of stroke at home. We developed a mobile app, Destroke, that allows remote performance of a modified NIH stroke scale (NIHSS) by patients. AimsTo assess the feasibility of a mobile app for stroke monitoring and education by patients with a history of stroke. Materials and methodsWe enrolled 25 patients with a history of stroke in a prospective open-label study to evaluate the feasibility of the Destroke app in patients with stroke. Nineteen patients completed all study assessments, with a median time from stroke onset to enrollment of 5.6 years (range 0.1–12 years). We designed a modified NIHSS that assessed 12 out of 16 tasks on the NIHSS. Patients completed this test eight times over a 28-day period. We conducted pre-study surveys that assessed demographic information, stroke and cardiovascular history, baseline NIHSS, and experience using mobile technologies, and mid- and post-study surveys that assessed patient satisfaction on app usage and confidence in stroke detection. ResultsTen men and nine women participated in this study (median age of 64 (33–76)), representing ten US states and Washington D.C. Median baseline NIHSS was 0 (0–4). 15 patients reported using health apps. On a 5-point Likert scale, patients rated the app as 4.2 on being able to understand and use the app and 4.3 on using the app when instructed by their doctor. For eight patients with poor confidence in detecting the signs of a stroke before the study, six showed higher confidence after the study. ConclusionsThe use of an at-home stroke monitoring app is feasible by patients with a history of stroke and improves confidence in detecting the signs of stroke.

Endothelial dysfunction in the mother–placenta–fetus system after a new coronavirus infection SARS-CoV-2: An open prospective cross-sectional study

Background. Generalized endotheliopathy in SARS-CoV-2 is associated with the release of the vasoactive peptide endothelin-1, which stimulates the activation of both the plasma and platelet clotting pathways. It is believed that endothelin-1 is one of the most potent vasopressors of the human cardiovascular system and has a strong pressor and thrombogenic effect on many vessels, including in the motherplacentafetus system.&#x0D; Aim. To study endothelial dysfunction in pregnant women with new coronavirus infection SARS-CoV-2.&#x0D; Materials and methods. An open-label prospective continuous cross-sectional study enrolled 96 patients who survived COVID-19 at various gestational ages. Depending on the severity of the underlying disease, patients were divided into groups: Group 1 (n=18) included patients with mild SARS-CoV-2 coronavirus infection, Group 2 (n=56) included women with moderate severity, Group 3 (n=22) included patients with severe COVID-19. The control group consisted of 100 pregnant women who had no COVID-19 or signs of acute respiratory viral infection. In all groups, endothelin-1 levels were determined by enzyme-linked immunosorbent assay.&#x0D; Results. In pregnant women with no COVID-19 and patients after mild COVID-19, the level of endothelin-1 corresponds to the reference values; in pregnant women with moderate and severe underlying disease, the level of endothelin-1 was 2.04.0 pmol/L. It reflects the increased activity of the endothelium in the uterine bloodstream and blood vessels in the motherplacentafetus system. Placental insufficiency in women after COVID-19 is caused by endothelial dysfunction that triggers vasospasm and increased vascular resistance in the uterine arteries (r=0.8; p0.01).&#x0D; Conclusion. The diagnosis of endothelial dysfunction in the motherplacentafetus system after COVID-19 can be helpful in the prediction and prevention of vascular complications, both placental, associated with great obstetrical syndromes (premature birth, intrauterine growth retardation, preeclampsia, antenatal fetal death), and extraplacental ones (arterial and venous thrombosis).

Correction of the prooxidant-antioxidant balance disorders in patients with diabetic kidney disease

The present study aimed to evaluate the effect of sodium-glucose co-transporter 2 (SGLT2) inhibitor dapagliflozin therapy on the prooxidant-antioxidant balance (PAB) in patients with diabetic kidney disease.&#x0D; Methods. A total of 88 patients with type 2 diabetes mellitus (DM) and diabetic nephropathy (DN) were included in this single-center randomized open-label prospective study. All patients were randomly divided into 2 groups: 45 patients received a standard course of treatment, which included antidiabetic drugs, renin-angiotensin-aldosterone system blockers, and HMG-CoA reductase inhibitors (statins). In addition to the standard therapy, the remaining 43 patients were prescribed the SGLT2 inhibitor dapagliflozin 10 mg per day. Patients were re-examined after 6 months of treatment. The blood PAB was calculated as the ratio of total hydroperoxides (THP) to total antioxidant activity (TAA). The level of THP and TAA was determined by the colorimetric method.&#x0D; Results. PAB was significantly elevated in type 2 DM patients with nephropathy due to TAA decrease and THP level increase when compared to the control group. The highest values of PAB were found in the late stages of DN in patients with glomerular filtration rates &lt;60 ml/min/1.73m2. In patients who received dapagliflozin, significant PAB elevation by 30,55% (р &lt; 0.05) was observed as well as THP decrease and TAA increase in blood. In the standard therapy group, no significant changes in PAB parameters were detected.&#x0D; Conclusions. Add-on treatment with dapagliflozin resulted in a more significant improvement of the PAB in patients with DN in comparison with standard treatment.

#4590 A PROSPECTIVE STUDY OF EPLERENONE IN THE TREATMENT OF PATIENTS WITH GLOMERULONEPHRITIS

Abstract Background and Aims Clinical evidence suggests that high aldosterone plasma levels contributes to progressive kidney disease. Although administration of angiotensin-converting enzyme inhibitors (ACEi) or angiotensin type 1 receptor blockers (ARB) can delay kidney disease progression, plasma aldosterone levels may increase to a significant extent even after the initiation of such treatment. Thus, administration of mineralocorticoid receptor antagonists such as spironolactone, on top of treatment with ACEi or ARBs has been shown to reduce albuminuria and slow down kidney function deterioration. Nevertheless, there is scanty evidence on the effect of eplerenone in patients with kidney disease due to glomerulonephritis. Method In this prospective open-label study, we evaluated the effects of eplerenone in patients with biopsy proven glomerulonephritis already treated with ACEi or ARBs. Patients were divided in the active treatment arm, who received 25 mg of eplerenone daily besides ACEi or ARBs, and a control group that received only standard treatment. Protein excretion in 24 h urine, eGFR, blood pressure and serum K+ levels were measured at 3, 6 and 12 months after study initiation. Results Out of 83 patients who were screened, 62 patients were included in the final analysis. Twenty-six received eplerenone and 36 were treated with ACEi (25) or ARBs (9) alone (controls). After 1 year of treatment with eplerenone, proteinuria decreased from 1597 to 1145 mg/24 h while it did not alter in controls. Eplerenone reduced proteinuria especially in those with baseline proteinuria of &amp;gt;1000 mg/24 h. Kidney function remained stable in patients treated with eplerenone (from eGFR: 82.51±22.6 to 84.68±31.7 ml/min/1.73 m2, p = 0.8) and showed a non significant deterioration in controls (from eGFR: 68.39±26.2 to 66.63±29.8 ml/min/1.73 m2, p = 0.08). Systolic blood pressure was significantly reduced in the active treatment arm (from 128.1±17.5 to 126.3±10.93 mmHg, p = 0.03), whereas eplerenone did not increase serum K+ levels or had any other significant adverse effect. Conclusion Administration of eplerenone at a dose of 25 mg/day, on top of treatment with ACEi or ARBs, can further reduce proteinuria and systolic blood pressure in patients with chronic glomerulonephritis.

#5848 ROLE OF STATINS IN THE CONTRAST-INDUCED ACUTE KIDNEY INJURY PREVENTION AFTER COMPUTED TOMOGRAPHY WITH CONTRAST MEDIA

Abstract Background and Aims Contrast-induced acute kidney injury (CI-AKI) is a serious complication of the use of iodinated contrast media (CM). A number of researches have shown that statins have a protective role in the prevention of CI-AKI due to their pleiotropic effects. The aim of the study was to assess the influence of statins on the incidence of CI-AKI after intravenous CM administration. Method A randomized controlled open-label prospective study was conducted. Statin naive patients with cardiovascular diseases referred for contrast-enhanced computed tomography (CT) were included. Exclusion criteria were the use of statins and chronic kidney disease (CKD) stages 4-5. Acute kidney injury was defined as an increase in serum creatinine level by more than 44 μmol/L (0.5 mg/dL) or 25% from baseline within 48 hours after CM administration according to KDIGO guidelines. Glomerular filtration rate was calculated using the CKD-EPI formula. Overall, 181 patients were included in the study and divided into two groups. The first group (120 people) received high doses of atorvastatin (80mg or 40mg) 24 hours after and before the CM administration, while the second group (61 people), the control group, did not receive any statin therapy. Low-osmolar solutions in an amount of 100 ml were used. All patients were given intravenous hydration with saline before the study and 24 hours later. The statistical analysis was done using IBM SPSS Statistics v26.0. Results The patients in both groups did not significantly differ in age, BMI, coexisting conditions, and medications taken (Table 1). Both groups showed an increase in average creatinine levels after CT with intravenous CM administration, however, in the group of patients receiving high doses of statins, the average level increased less, p = 0.092 (Table 2). AKI developed in 12 individuals (6.7%), 9 of them were in the control group, and 3 were in the group receiving high doses of statins, p = 0.003. The chances of AKI development in the group receiving high doses of statins were 6.95 times lower compared to the control group (OR = 6.05, 95% CI: 1.7-21.5). Most of the patients had preserved kidney function and did not suffer from diabetes mellitus. There were statistically significantly more patients with preserved kidney function in the statin group, p = 0,007, OR: 2,374 (CI 95% 1,258 - 4,479), and fewer patients with CKD 3a stage, p = 0,05, OR: 0,406 (CI 95% 0,195 – 0,844). Conclusion Despite the presence of patients at risk, the incidence of CI-AKI was 6.7%, possibly due to additional prevention of this complication with intravenous saline before and after administration of the CM. In this trial, we observed that periprocedural administration of atorvastatin in high doses for a short duration, reduced the incidence of CI-AKI.

Effect of glycated hemoglobin on the recurrence rate of paroxysmal atrial fibrillation in patients with type 2 diabetes mellitus who used different glucose-lowering agents

Objective. To evaluate the effects of glycated hemoglobin (HbA1c) levels during different glycemic control regimens on the occurrence of paroxysmal atrial fibrillation (AF) episodes in patients with concurrent type 2 diabetes mellitus (DM) (T2DM). Subjects and methods. The randomized prospective open-label study involved 73 patients (41 males and 32 females; their mean age was 61.4±10.5 years) with paroxysmal AF and T2DM. According to the prescribed therapy, the patients were divided into groups: Group 1 included 39 patients who received combination therapy with dapagliflozin (at a dose of 10 mg/day) and metformin; Group 2 consisted of 34 patients who took sulfonyl urea agents and metformin. The groups were matched for the main clinical and laboratory parameters. Results. At a HbA1c level of 6.5–7.0%, the patients had significantly less frequently episodes of AF in both groups compared to those having an HbA1c 7.0– 7.5% (30.4% versus 77.8%). After treatment, episodes of AF were significantly less frequently seen in Group 1 than in Group 2 (33.3% versus 58.8%; р&lt;0.05). Conclusion. It is desirable to achieve target HbA1C values of 6.5–7.0% (in the absence of contraindications) in patients with paroxysmal AF concurrent with T2DM during sugar-lowering therapy. It is recommended that sugar-lowering agents, such as dapagliflozin, with an organ-protective potential, should be used.

Short-term efficacy of empagliflozin in children with glycogen storage disease type Ⅰb

Objective: To analyze the short-time efficacy of empagliflozin in the treatment of glycogen storage disease type Ⅰb (GSD Ⅰb). Methods: In this prospective open-label single-arm study, the data of 4 patients were collected from the pediatric department in Peking Union Medical College Hospital from December 2020 to December 2022. All of them were diagnosed by gene sequencing and had neutropenia. These patients received empagliflozin treatment. Their clinical symptoms such as height and weight increase, abdominal pain, diarrhea, oral ulcer, infection times, and drug applications were recorded at 2 weeks, 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, and 15 months after treatment to assess the therapeutic effect. The liquid chromatography-tandem mass spectrometry method was used to monitor the changes in 1, 5-anhydroglucitol (1, 5AG) concentration in plasma. At the same time, adverse reactions such as hypoglycemia and urinary tract infection were closely followed up and monitored. Results: The 4 patients with GSD Ⅰb were 15, 14, 4 and 14 years old, respectively at the beginning of empagliflozin treatment, and were followed up for 15, 15, 12 and 6 months, respectively. Maintenance dose range of empagliflozin was 0.24-0.39 mg/(kg·d). The frequency of diarrhea and abdominal pain decreased in cases 2, 3, and 4 at 1, 2 and 3 months of treatment, respectively. Their height and weight increased at different degrees.The absolute count of neutrophils increased from 0.84×109, 0.50×109, 0.48×109, 0.48×109/L to 1.48×109, 3.04×109, 1.10×109, 0.73×109/L, respectively. Granulocyte colony-stimulating factor was gradually reduced in 1 patients and stopped in 3 patient. Plasma 1, 5 AG levels in 2 children were significantly decreased after administration of empagliflozin (from 46.3 mg/L to 9.6 mg/L in case 2, and from 56.1 mg/L to 15.0 mg/L in case 3). All 4 patients had no adverse reactions such as hypoglycemia, abnormal liver or kidney function, or urinary system infection. Conclusion: In short-term observation, empagliflozin can improve the symptoms of GSD Ⅰb oral ulcers, abdominal pain, diarrhea, and recurrent infection, also can alleviate neutropenia and decrease 1, 5AG concentration in plasma, with favorable safety.

Vestibular tissue changes following administration of intravaginal prasterone: a vulvoscopic open-label pilot study in menopausal women with dyspareunia.

Prasterone, an intravaginal dyspareunia treatment in menopausal women, improves vaginal health through intracellular conversion of dehydroepiandrosterone into androgens and estrogens. Phase 3 trials for prasterone showed significant improvement in vaginal tissue health and reduction of pain. To assess vestibular changes with daily use of intravaginal prasterone in menopausal women with moderate to severe dyspareunia. This open-label prospective pilot study was conducted over 20 weeks. It included 11 menopausal women (median age,56 years) who were treated daily with intravaginal inserts of 6.5-mg prasterone and assessed monthly. During vulvoscopy, vestibular pain was assessed by cotton-tipped swab testing, and vestibular and vaginal health was independently assessed with the Visual Scale (VS). In addition, vulvoscopic photographs were obtained and assessed via the Vulvoscopic Genital Tissue Appearance (VGTA) scale to evaluate overall genital tissue health. Mean changes from baseline for genital tissue health and pain assessments were analyzed by repeated measures 1-way analysis of variance, followed by a Dunnett post hoc test. Sexual event diaries were completed and adverse events recorded. Outcomes included indices of genital tissue health: pain assessment by cotton-tipped swab testing, VS of the vestibule and vagina, VGTA, and sexual event diary. Aggregate scores from the cotton-tipped swab test progressively improved, reaching statistical significance at week 16, which was maintained through week 20 (-7.27, P= .019). VS scores significantly improved from baseline by week 4 and were maintained through week 20 for the vestibule (-3.00, P= .004) and vagina (-4.00, P= .002). An overall 1607 vulvoscopic photographs were examined; all showed reduction in vestibular erythema and pallor at the end of the study. The mean change from baseline at week 20 for the VGTA score was -7.9 (P= .0016). Intercourse associated with pain was reduced from 81.3% of initiated events during the first month of the study to 8.3% during the last month. Sexual activities that were discontinued due to discomfort were reduced from 45.8% to 6.3%. No prasterone-related serious adverse events were reported. Prasterone, a safe and effective intravaginal hormone treatment, significantly improves vestibular health parameters. Strengths are the prospective study design and the use of multiple outcome measures to assess vestibular tissue health and pain associated with sexual activity. Limitations are the small study cohort and use of nonvalidated outcome measures. Our findings suggest that intravaginal prasterone exerts biologic activity on the androgenic endodermal vestibule, as the medication passes from vagina to vestibule, resulting in amelioration of pain associated with sexual activity.

Comparing the Efficacy of Myo-Inositol Plus α-Lactalbumin vs. Myo-Inositol Alone on Reproductive and Metabolic Disturbances of Polycystic Ovary Syndrome.

Despite the beneficial effect of myo-inositol on metabolic, hormonal, and reproductive parameters of polycystic ovary syndrome (PCOS) patients, 28% to 38% could be resistant to this treatment. The combination with the milk protein α-lactalbumin can be a useful therapeutic approach to overcome inositol resistance and achieve ovulation in these women. This open-label prospective study aimed to compare the effects of supplementing myo-inositol plus α-lactalbumin vs myo-inositol alone on reproductive and metabolic abnormalities in PCOS. A total of 50 anovulatory women with a PCOS diagnosis were randomly assigned to receive myo-inositol alone or a combination of myo-inositol and α-lactalbumin for three months. Anthropometric measures, hormonal levels, and menstrual cycle duration were collected at baseline and after treatment. The therapy with myo-inositol plus α-lactalbumin improved both ovulation rate and menstrual cycle duration more than myo-inositol alone. The body weight was significantly reduced in women receiving myo-inositol plus α-lactalbumin, while patients in the myo-inositol group experienced no change. In addition, the improvement of hyperandrogenism was more prominent in patients treated with myo-inositol plus α-lactalbumin. The benefits of associating myo-inositol and α-lactalbumin clearly make this combination a true edge in the management of PCOS.

A prospective open-label study of the antifungal activity of external forms of activated zinc pyrithione in the treatment of Malassezia-associated skin diseases

Background. There is insufficient data on the antifungal activity of activated zinc pyrithione, which is widely used in practice. Taking into account the reports about a significant role of Malassezia in the pathogenesis of a number of dermatoses, the study of this issue is of scientific, practical interest.&#x0D; Aims. To evaluate the antifungal activity of external forms of activated zinc pyrithione in the treatment of psoriasis, seborrheic dermatitis, pityriasis versicolor.&#x0D; Materials and methods. An open prospective study was conducted between March and July 2022. Patients with psoriasis, seborrheic dermatitis, pityriasis were treated with external forms of activated zinc pyrithione for 21 days. Skin scales and circular prints from lesion foci, as well as from skin areas without clinical manifestations before and after therapy were studied. A quantitative assessment of skin colonization by micromycetes of Malassezia was performed using microscopic, cultural methods of examination. Clinical efficacy and drug safety of the therapy was assessed using the Dermatological Symptom Scale Index, by recording adverse events at weeks 0, 1, 2, 3.&#x0D; Results. 64 patients aged 18 to 65 years with diagnoses of psoriasis, seborrheic dermatitis, and pityriasis versicolor were included. 60 patients completed the study, 4 were excluded due to failure to adhere to the schedule.&#x0D; In patients with seborrheic dermatitis and pityriasis versicolor in the lesion foci after therapy, a significant decrease colonization level according to the results of microscopic, cultural studies was observed. In psoriasis patients, a significant decrease in the colonization level was obtained only based on the results of microscopic examination.&#x0D; In all groups, significant differences in comparison to the initial level were registered already at the 1st week of treatment. No adverse events were registered.&#x0D; Conclusion. Activated zinc pyrithione in the form of cream and aerosol showed moderate antifungal activity against micromycetes of the genus Malassezia.

Results on SARS-CoV-2 mRNA Vaccine Booster from an Open-Label Multicenter Study in Ofatumumab-Treated Participants with Relapsing Multiple Sclerosis.

Few data exist on how ofatumumab treatment impacts SARS-CoV-2 booster vaccination response. KYRIOS is an ongoing prospective open-label multicenter study on the response to initial and booster SARS-CoV-2 mRNA vaccination before or during ofatumumab treatment in relapsing MS patients. The results on the initial vaccination cohort have been published previously. Here, we describe 23 patients who received their initial vaccination outside of the study but booster vaccination during the study. Additionally, we report the booster results of two patients in the initial vaccination cohort. The primary endpoint was SARS-CoV-2-specific T-cell response at month 1. Furthermore, serum total and neutralizing antibodies were measured. The primary endpoint was reached by 87.5% of patients with booster before (booster cohort 1, N = 8) and 46.7% of patients with booster during ofatumumab treatment (booster cohort 2, N = 15). Seroconversion rates for neutralizing antibodies increased from 87.5% at baseline to 100.0% at month 1 in booster cohort 1 and from 71.4% to 93.3% in booster cohort 2. Of note, 3 of 4 initially seronegative patients in booster cohort 2 and one seronegative patient in the initial vaccination cohort seroconverted after the booster during ofatumumab treatment. Booster vaccinations increase neutralizing antibody titers in ofatumumab-treated patients. A booster is recommended in ofatumumab-treated patients.

Beneficial effects of luseogliflozin on lipid profile and liver function in patients with type 2 diabetes mellitus (BLUE trial): a single-center, single-arm, open-label prospective study

BackgroundArteriosclerosis and non-alcoholic fatty liver disease are major complications of diabetes mellitus. Hyperglycemia, insulin resistance, obesity, and metabolic syndrome are associated with the progression of these complications. Sodium-glucose transporter 2 inhibitors such as luseogliflozin are oral hypoglycemic agents that reduce glucose levels, induce loss of weight or body fat, and improve liver function. However, the effects of these agents on lipid profiles are unclear. Therefore, this study aimed to investigate these effects and their relationship with arteriosclerosis and non-alcoholic fatty liver disease.MethodsThis single-center, single-arm, open-labeled prospective study enrolled 25 outpatients with type 2 diabetes mellitus who visited Minami Osaka Hospital. Laboratory tests and body measurements were performed at weeks 0 and 24. Luseogliflozin was started at 2.5 mg/day after breakfast, and data from weeks 0 and 24 were evaluated. There were no changes in the doses of other antidiabetic and dyslipidemia drugs a month prior to or during the study.ResultsThe patients showed significant reductions in the levels of triglycerides, remnant-like particle cholesterol, and triglyceride/high-density lipoprotein cholesterol ratio, along with significant increases in the levels of high-density lipoprotein cholesterol and apolipoprotein A-1. Alanine aminotransferase, γ-glutamyl transpeptidase, and the fatty liver index were significantly reduced.ConclusionsLuseogliflozin-induced changes in the lipid profile were related to the suppression or improvement of arteriosclerosis and liver function, respectively. Patients who received this drug also showed improvements in the levels of liver enzymes and reductions in the fatty liver index. Earlier use of luseogliflozin might prevent diabetic complications.Trial registration This study was registered in the University Hospital Medical Information Network Clinical Trial Registry (UMIN 000043595) on April 6th, 2021

End Treatment Response and Sustained Viral Response in Patients With Hepatitis C Virus Receiving Sofosbuvir and Daclatasvir.

Objective The main purpose of this study was to determine the end treatment response (ETR) and sustained viral response (SVR) in hepatitis C virus (HCV) patients receiving sofosbuvir and daclatasvir daily for 12 weeks. Methods This is a prospective open-label interventional study conducted from March 2018 to December 2020 in theoutpatient departments of Abbasi Shaheed Hospital and Lyari General Hospital, Karachi. Patients with chronic infection of HCV, confirmed with ribonucleic acid (RNA) polymerase chain reaction (PCR) (qualitative analysis) were invited to participate in the study. All patients with positive HCV antibodies were evaluated clinically, with laboratory, and imaging assessment earlier to treatment. Statistical analysis was performed using SPSSversion 20.0 (Armonk, NY: IBM Corp.). Results A total of 1043 patients participated in the study with a female predominance, 699 (67%) females. A majority (67.9%) of the study participants were aged between 15 and 45 years. After treatment of 12 weeks with sofosbuvir and daclatasvir 1039 (99.9%) patients achieved SVR while 1038 (99.6%) achieved an end treatment response. There was no significant association found between changes in alanine aminotransferase (ALT) levels, gender, and age among study participants. Conclusion Sofosbuvir and daclatasvir are found to be extremely effective for patients with hepatitis C in Pakistan. However, additional investigation including a larger sample size and involving a multicenter setting is recommended.

Nd:YAG 1064-nm laser for residual infantile hemangioma after propranolol treatment

Infantile hemangiomas (IH) are common benign tumors of infancy. Most IH involute, either spontaneously, or secondary to pharmacological treatment with systemic propranolol. Propranolol treatment mostly leads to regression of hemangiomas with satisfactory aesthetic results, but unfortunately not in all cases. To assess the safety and efficacy of long pulsed Nd:YAG 1064 nm laser in treating patients with residual infantile hemangioma after systemic propranolol treatment. This is an open-label prospective cohort study. 30 patients with focal residual IH that had sub-optimal responses to systemic propranolol treatment were enrolled in the study. The patients were treated with 1 to 3 sessions with long pulsed Nd:YAG 1064 nm laser. The maximal response of the IH was assessed using a 4-point scale evaluation scale system. Of the 30 patients enrolled, 18 patients exhibited a great response (> 76% improvement), 10 patients had a good response (> 51–75% improvement), while only 2 patients showed a moderate response (< 50% improvement) to the treatment. No patients had an unsatisfactory response. No serious side effects were observed, and only minor side effects were reported. The treatment with long pulsed Nd:YAG 1064 nm laser for residual IH, which were resistant to systemic propranolol treatment, is safe and effective. Thus, we suggest its use as a second-line treatment for patients with sub-optimal aesthetic results following systemic propranolol.