Mirabegron versus vibegron in previously untreated female patients with overactive bladder: A randomized,single-clinic,open-label trial

Objectives

This study aimed to assess the efficacy and safety of mirabegron compared with vibegron (both 50 mg once daily) in Japanese female patients with symptoms of overactive bladder (OAB).

Methods

This prospective, 12-week, two-arm, parallel-group, open-label randomized trial (UMIN000038288) was conducted at a single clinic from December 2019 to September 2022. The primary efficacy outcome measure was the change in mean total overactive bladder symptom scores (OABSSs) from baseline to end of treatment (EOT) (Week 12). The secondary efficacy outcome measures were changes in mean International Prostate Symptom Score from baseline to EOT, the ratio of patients who achieved a minimal clinically important change (MCIC) of total OABSS, and individual domains of the King's Health Questionnaire. Safety assessments, such as adverse events (AEs), postvoid residual volume, and patient-reported incidences, were recorded at every visit.

Results

There was no statistically significant adjusted mean difference between mirabegron and vibegron in terms of the primary outcome of the mean change from baseline to EOT in the total OABSS. The difference in the percentage of patients in the mirabegron and vibegron groups achieving an MCIC on the total OABSS was not statistically significant but appeared to be clinically important. The incidence of treatment-related AEs was significantly higher for the vibegron group (38.5%) than the mirabegron group (19.1%) (p = .047).

Conclusions

These results showed that both drugs were effective in female OAB patients, with no significant differences in terms of efficacy. However, the safety of vibegron requires further investigation.     

Increased relative wall thickness is a marker of subclinical cardiac target-organ damage in African diabetic patients

Objective

To assess the prevalence and covariates of abnormal left ventricular (LV) geometry in diabetic outpatients attending Muhimbili National Hospital in Dar es Salaam, Tanzania.

Methods

Echocardiography was performed in 61 type 1 and 123 type 2 diabetes patients. LV hypertrophy was taken as LV mass/height^2.7 > 49.2 g/m^2.7 in men and > 46.7 g/m^2.7 in women. Relative wall thickness (RWT) was calculated as the ratio of LV posterior wall thickness to end-diastolic radius and considered increased if ≥ 0.43. LV geometry was defined from LV mass index and RWT in combination.

Results

The most common abnormal LV geometries were concentric remodelling in type 1 (30%) and concentric hypertrophy in type 2 (36.7%) diabetes patients. Overall, increased RWT was present in 58% of the patients. In multivariate analyses, higher RWT was independently associated with hypertension, longer isovolumic relaxation time, lower stress-corrected midwall shortening and circumferential end-systolic stress, both in type 1 (multiple R² = 0.73) and type 2 diabetes patients (multiple R² = 0.66), both p < 0.001. These associations were independent of gender, LV hypertrophy or renal dysfunction.

Conclusion

Increased RWT is common among diabetic sub-Saharan Africans and is associated with hypertension and LV dysfunction.     

酒石酸托特罗定联合经皮神经电刺激治疗老年女性膀胱过度活动症临床疗效分析

目的 探讨酒石酸托特罗定(舍尼亭)联合经皮神经电刺激(TENS)治疗老年女性膀胱过度活动症的临床疗效. 方法 选取2010年1～6月于我院泌尿外科门诊就诊并确诊为膀胱过度活动症的老年女性患者30例,随机分为两组.单独治疗组应用酒石酸托特罗定治疗,联合治疗组应用酒石酸托特罗定联合TENS治疗,疗程均为10 d.治疗前后应用膀胱过度活动症状评分(OABSS)、患者感知膀胱症状情况分级量表(PPBC)、生活质量评分(QOL)、视觉模拟量表(VAS)及5级疼痛评分法对疗效进行评价. 结果 治疗后单独治疗组24 h平均尿急次数、每周尿失禁次数、OABSS评分、PPBC评分、QOL评分、VAS评分及5级疼痛评分分别为(1.67±1.45)次/d、(1.53±1.25)次/周、(6.67±2.55)分、(2.07±0.96)分、(2.07±1.03)分、(3.67±0.90)分、(4.07±0.80)分,较治疗前的(6.40±1.45)次/d、(3.93±1.03)次/周、(13.00±1.00)分、(4.20±0.68)分、(3.80±0.68)分、(7.13±1.19)分、(9.40±1.55)分有明显改善(t=8.94、5.74、8.94、7.03、5.44、9.01、11.85,均P＜0.01);联合治疗组治疗后分别为(1.27±0.80)次/d、(1.20±0.77)次/周、(5.33±1.72)分、(1.67±0.62)分、(1.47±0.52)分、(2.93±0.80)分、(3.40±0.99)分,较治疗前的(6.20±1.26)次/ d、(4.00±1.25)次/周、(12.73±1.03)分、(4.07±0.80)分、(4.00±0.65)分、(7.47±0.74)分、(9.67±1.35)分亦有明显改善(t=12.77、7.36、14.29、9.21、11.77、16.09、14.55,均P＜0.01).治疗前后联合治疗组VAS评分及5级疼痛评分的评分差值均高于单独治疗组,差异具有统计学意义(t=4.88、2.75,P＜0.01). 结论 酒石酸托特罗定联合TENS治疗老年女性膀胱过度活动症状患者下尿路症状群安全、有效,可减轻疼痛程度并改善生活质量.     

Intima-media thickness is a useful marker of the extent of coronary artery disease in patients with impaired renal function

ObjectiveThe aim of the study was the assessment of intima-media thickness (IMT) in peripheral arteries (the carotid and the femoral artery) and its correlation with the extent of coronary artery disease (CAD). The second task was the analysis of the renal function's influence within IMT complex.Methods231 patients (men, mean age 52.8), who had undergone coronary angiography due to symptoms of CAD were enrolled. The ultrasound measurement of IMT in the common carotid artery (CCA), carotid bulb and common femoral artery (CFA) was performed. The relationship between IMT, renal function and the extent of CAD was evaluated.ResultsSignificantly higher values of IMT in the peripheral arteries were observed in patients with CAD than in those without (CCA—0.91 vs 0.61 mm, carotid bulb—1.31 vs 0.67, CFA—1.38 vs 0.63 respectively, p < 0.0001). The GFR values in the CAD patients significantly negatively correlated with IMT complex in CCA (p < 0.001) and carotid bulb (p < 0.05). Lower values of GFR in patients with three-vessel disease were observed than in those patients with one- or two-vessel disease (p < 0.05). In multifactoral analysis (post-hoc NIR test) we found that glomerular filtration rate (GFR) is strongly determined by age (p < 0.0001), BMI (p < 0.0001), value of carotid intima-media thickness (p < 0.001), value of IMT in the carotid bulb (p < 0.02) and the treatment with ACE-I (p < 0.05). In multifactoral analysis we did not find any statistical influence of lipid profile and glucose disturbances on GFR.ConclusionsHigher peripheral artery IMTs in patients with CAD than in those without and patients with three-vessel disease indicate that IMT may be used as an early marker of atherosclerosis and reflect the severity of CAD. A significant negative correlation between the value of a GFR and the IMT confirmed the usefulness of this noninvasive method for the estimation of preclinical stages of atherosclerotic changes’ development in patients with impaired renal function.     

QT dispersion in patients with mitral valve prolapse is related to the echocardiographic degree of the prolapse and mitral leaflet thickness.

BACKGROUND: Ventricular arrhythmias are common in patients with mitral valve prolapse (MVP). Previous studies have provided evidence that a higher degree of systolic mitral valve displacement and the presence of a thickened anterior mitral leaflet are related to an increased incidence of complex ventricular arrhythmias and risk of sudden death in these patients. The aim of our study was to investigate whether QT dispersion in patients with MVP is associated with the echocardiographic degree of the prolapse and mitral leaflet thickness. METHODS: QT and JT intervals and dispersions were measured in 89 patients with primary mitral valve prolapse (26 men and 63 women with mean age 39 +/- 14 years). All patients underwent a full echocardiographic examination and a scoring system was used to determine the degree of MVP. Anterior mitral leaflet thickness was also measured. Twenty-four hour Holter monitoring was used to assess ventricular arrhythmogenesis. RESULTS: According to their echocardiographic score. patients were divided into three groups (Group A. B and C) reflecting the different degrees of the prolapse. QT dispersion in patients with the highest degree of MVP, i.e. Group C was significantly greater (65 +/- 13 ms) than that of the other two groups (Group A: 38 +/- 14 ms, P<0.005 and Group B: 45 +/- 12 ms, P<0.005). Similar differences between groups were also found for JT dispersion. Multiple regression analysis revealed that among the demographic and clinical variables that were tested, only the echocardiographic degree of the prolapse and anterior mitral leaflet thickness were independently associated with QT dispersion. Holter monitoring showed that the incidence of complex ventricular arrhythmias was also higher in patients with more severe MVP. CONCLUSIONS: Our results indicate that QT and JT dispersions are related to the echocardiographic degree of MVP and mitral leaflet thickness. The echocardiographic assessment of the severity of the prolapse may help to identify a subgroup of patients at increased risk of life-threatening arrhythmias.     

Plasma NT-proBNP is a potential marker of disease severity and correlates with symptoms in patients with chronic rheumatic valve disease

BACKGROUND: A noninvasive marker of disease severity and presence of symptoms is required in patients with chronic rheumatic valve disease (RVD). AIMS: We sought to test the utility of measuring of N-terminal pro-B type natriuretic peptide (NT-proBNP) in chronic phase RVD. We also evaluated whether echocardiographic measures are interrelated with NT-proBNP levels. METHODS: The study comprised 92 patients with RVD (mean age of 40+/-14 years) and 50 age/gender-matched control subjects. Functional status was assessed. Detailed echocardiographic examination was performed and mitral valve score was estimated. Venous blood samples were taken for measuring the level of NT-proBNP. RESULTS: The plasma levels of NT-proBNP rose with increasing severity of mitral valve stenosis (p<0.001), increasing severity of mitral valve score (p<0.001), increasing severity of clinical symptom (p<0.001), increasing severity of mitral regurgitation (p<0.013), presence of mitral valve calcification (p<0.001), presence of tricuspid valve stenosis (p<0.001), increasing severity of tricuspid regurgitation (p<0.011), presence of aortic stenosis (p=0.043), decreasing left ventricular ejection fraction (p<0.001), presence of left atrial thrombus (p=0.0019), and with increasing left atrium dimensions (p=0.002). CONCLUSION: NT-proBNP levels in patients with chronic RVD are a potential marker of disease severity and correlates with symptoms.