The benefits of the PCSK9 inhibitors, alirocumab and evolocumab, in lowering LDL-cholesterol and preventing major adverse cardiac events (MACE) have been demonstrated in pivotal clinical trials. However, few studies of routine clinical practice have been conducted to analyse and compare the efficacy and safety of the two drugs. Retrospective observational study of patients treated with a PCSK9 inhibitor in five hospitals in Andalusia (southern Spain). Baseline demographic and clinical data, LDL-cholesterol levels and the occurrence of MACEs during the follow-up period were recorded. A total of 141 patients were included in the study: 90 were treated with alirocumab and 51 with evolocumab. The patients’ mean age (IQR) was 58 (11) years and 58 (41%) were women. The most frequent concomitant medications were statins, 94 (66.7%), followed by antiplatelet therapy (66%) and ezetimibe (65.2%). The median (IQR) follow-up period was 18 (18) months, with 18 (24) for alirocumab and 11 (18) for evolocumab. At the six-month follow-up visit, LDL-cholesterol values had decreased to pre-treatment levels and remained significantly decreased (p < 0.05) over time, for both drugs, and a greater reduction was achieved in patients with established cardiovascular disease and concomitant treatment with statins. With respect to adverse effects, there were nine MACEs (6.4%), of which seven were with alirocumab (7.8%) and two with evolocumab (3.9%) (p NS). Other adverse effects (9.2%) included local erythema (3.5%), muscle cramps (2.1%), respiratory symptoms (2.1%) and asthaenia (1.4%). The efficacy and safety of alirocumab and evolocumab in routine clinical practice are consistent with the findings of the pivotal clinical trials.
Aim: To determine periodontitis prevalence in patients with systemic lupus erythematosus (SLE) and to assess whether periodontitis in SLE patients is associated with a greater subclinical atherosclerosis.Methods: An observational case–control study was conducted in SLE (cases) and patients without any rheumatic diseases (controls), matched for sex. Sociodemographic and cardiometabolic variables were gathered, and SLE activity was assessed through several indexes. Periodontal examination registered probing pocket depth, clinical attachment level, bleeding on probing, plaque index, and tooth loss. Subclinical atherosclerosis was assessed by measuring the carotid–femoral pulse wave velocity (PWV) by Doppler velocimetry, homocysteine levels, C‐reactive protein (CRP), and erythrocyte sedimentation rate (ESR). Bivariate analyses and logistic regression were used to assess the association of any of the studied variables with SLE.Results: Seventy‐one cases and 72 controls were included in the study. Thirty‐nine SLE patients (54.9%) were diagnosed with periodontitis, compared with 16 controls (22.2%). High levels of PWV (≥7.7 m/s, 75th percentile) were shown by 44.3% of the cases vs. 22.4% of the controls (p = .011). Among SLE patients, those with periodontitis showed higher PWV values (8.1 ± 1.52 vs. 7.16 ± 1.11 m/s, p = .006) and higher homeostasis model assessment index (indicative of insulin resistance) (1.7 ± 0.73 vs. 2.92 ± 3.05, p = .028) compared to those with periodontal health. Logistic regression showed that waist circumference (OR 1.06, 95% CI 1.01–1.12, p = .015); ESR (OR 1.09, 95% CI 1.03–1.16, p = .003); and bleeding on probing (OR 1.1, 95% CI 1.01–1.19, p = .018) were associated with the risk of SLE.Conclusion: Systemic lupus erythematosus patients showed a higher periodontitis percentage than controls. Higher PWV values were found in SLE patients with periodontitis, indicating a higher prevalence of subclinical atherosclerosis. Patients with higher gingival bleeding showed a higher risk of SLE.
Objective: Renal denervation (RDN) is indicated in patients despite the use of three or more anti-hypertensive drugs including a diuretic, which, having ruled out secondary causes of hypertension (HT), are not controlled and are classified as resistant hypertension (RHT). The approximate prevalence is 10% -20% of the hypertensive population and represents a high incidence of adverse cardiovascular events in these patients. RND is a minimally invasive method, but the effectiveness of this technique has shown some contradictory data due to a heterogeneity in the design of these studies. Our objective is to evaluate the clinical experience in patients undergoing RDN in our unit. Design and method: Retrospective record of the 2009–2019 period. 16 patients with RHT treated by RDN with Symplicity-Flex or Spyral devices have been included. The statistical study was made with Spss program. Results: 56.3% were male. Mean age of 53 ± 8 years. The average preRDN clinical SBP 169 ± 19 mmHg; DBP clinical preRDN mean 101 ± 17 mmHg; Mean postRDN clinical SBP 149 ± 26 mmHg; DBP clinical postRDN mean 88 ± 11 mmHg; Average number of preRDN drugs 5.88 ± 0.8; Average number of postRDN drugs of 4.67 ± 1.4. 75% of the procedures were done with the spiral symplicity method. Average number of ablations 24 ± 9 per procedure. There was no deterioration of renal function or complications. Conclusions: Our data provide a decrease in clinical BP after RDN, with a decrease in the number of drugs used to control their BP, and there seems to be a better response to the spiral symplicity method with greater number of ablations. The RDN technique has been proven safe, with no relevant complications and preserved renal function. The data therefore guarantee the safety and efficacy of this technique, which coincide with the recent national registries published in real life and that support its use in selected patients and in experienced centers.