Objectives:
Sodium-glucose co-transporter 2 (SGLT-2) inhibitors reduce the incidence of heart failure and death in patients with type-2 diabetes mellitus. Arterial stiffness is a prominent risk factor for heart failure and overall mortality. The aim of this study was to evaluate the effects of dapagliflozin on ambulatory brachial and central blood pressure (BP) levels and arterial stiffness parameters in patients with type-2 diabetes mellitus.
Methods:
This is a double-blind, randomized, placebo-controlled clinical trial including 85 adult patients with type-2 diabetes mellitus on monotherapy or combination therapy with two of: metformin, sulphonylurea, DPP-4 inhibitor, or insulin. Patients were randomized in a 1 : 1 ratio to oral dapagliflozin 10 mg per day or placebo for 12 weeks. Study participants underwent 24-h ambulatory BP monitoring with the Mobil-O-Graph NG monitor at baseline and study-end.
Results:
Baseline demographic, clinical and laboratory parameters were similar in the two groups. During follow-up, 24-h brachial SBP/DBP (129.0 ± 12.6/77.3 ± 7.3 vs. 123.2 ± 12.4/75.1 ± 6.4 mmHg; P < 0.001/P = 0.008) and central SBP/DBP (117.4 ± 10.5/78.9 ± 7.3 vs. 113.3 ± 8.8/77.3 ± 6.5 mmHg; P = 0.002/P = 0.047) significantly decreased in dapagliflozin but not in the placebo group. Corresponding reductions of 24-h brachial SBP (−5.8 ± 9.5 vs. −0.1 ± 8.7, P = 0.005) and central SBP (−4.1 ± 8.0 vs. −0.7 ± 7.8; P = 0.046) were greater with dapagliflozin than placebo. Twenty-four-hour heart-rate adjusted augmentation index significantly decreased with dapagliflozin and insignificantly with placebo. Importantly, there was a significant difference in change of estimated 24-h PWV (−0.16 ± 0.32 vs. 0.02 ± 0.27; P = 0.007) favoring dapagliflozin. In generalized linear mixed models including 24-h brachial SBP as a random covariate, the adjusted marginal means of delta 24-h central SBP and delta 24-h PWV were not significantly different between-groups.
Conclusion:
Treatment with dapagliflozin significantly reduces ambulatory brachial and central BP levels and PWV in patients with type-2 diabetes mellitus. Improvement in these parameters may substantially contribute to the cardiovascular benefits of SGLT-2 inhibitors.
Systemic sclerosis (SSc)-related pulmonary arterial hypertension (SSc-PAH) is a leading cause of mortality in SSc. The extent of peripheral microvasculopathy assessed through nailfold capillaroscopy might correlate with the presence of PAH in SSc patients. We searched the PubMed, Cochrane Library, Scopus, and Web of Science databases and performed a random effects meta-analysis of observational studies comparing nailfold capillaroscopic alterations in SSc-PAH versus SSc-noPAH patients. Weighted mean differences (WMD) with the corresponding confidence intervals (CIs) were estimated. The quality of the included studies was evaluated using a modified Newcastle–Ottawa scale. Seven studies with 101 SSc-PAH and 277 SSc-noPAH participants were included. Capillary density was marginally reduced in the SSc-PAH group (WMD: −1.0, 95% CI: −2.0 to 0.0, I2 = 86%). This effect was strengthened once PAH diagnosis was confirmed by right heart catheterization (WMD: −1.2, 95% CI: −2.3 to −0.1, I2 = 85%). An increase in capillary loop width was observed in SSc-PAH compared to SSc-noPAH patients (WMD: 10.9, 95% CI: 2.5 to 19.4, I2 = 78%). Furthermore, SSc-PAH patients had a 7.3 times higher likelihood of active or late scleroderma pattern (95% CI: 3.0 to 18.0, I2 = 4%). SSc-PAH patients presented with worse nailfold capillaroscopic findings compared to SSc-noPAH patients.
Erectile dysfunction has a lower prevalence in renal transplant recipients compared to dialysis patients. Despite this observation, the effect of renal transplantation on erectile function remains unknown. We aimed to assess the role of renal transplantation on erectile function and to determine potential factors improving or deteriorating erectile dysfunction. Materials and Methods: We conducted a systematic review and random effects meta-analysis of observational studies comparing erectile function preoperatively and postoperatively in renal transplant recipients (PROSPERO ID: CRD42020189580). Records reporting relevant outcomes were identified through search of PubMedÒ, EmbaseÒ, Cochrane Library and ScopusÒ databases from inception to September 2020. Judgment of the strength of evidence was performed with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Results: We included 20 studies with 1,695 renal transplant recipients. At postoperative evaluation the number of patients with erectile dysfunction was reduced (RR 1.21, 95% CI 1.02e1.45, I 2 [88%). Renal transplant recipients reported an improvement in erectile function (RR 2.53, 95% CI 1.44e4.44, I 2 [90%) and the mean International Index of Erectile Function score increased by 3.04 points (95% CI 0.63e5.45, I 2 [96%) after renal transplantation. These effects were not demonstrated in the sensitivity analysis. In individuals reporting severe erectile dysfunction, no favorable effect of renal transplantation was observed (RR 1.51, 95% CI 0.85e2.68, I 2 [33%). For all outcomes the strength of evidence was considered low or very low due to methodological concerns and high heterogeneity among the included studies. Conclusions: Renal transplantation improves erectile function and the risk of erectile dysfunction reduces postoperatively compared to preoperatively. However, evidence on the matter is mostly based on low quality data. More studies with standardized outcomes are needed to validate and strengthen our findings.
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