Servier (Spain)

To estimate the clinical and economic benefits derived from increasing the use of fixed-dose combinations of high-intensity statins and ezetimibe in patients at high/very high cardiovascular risk, from the perspective of the Spanish National Health System (SNS). A baseline scenario (current market shares) was compared with scenarios that increased the use of fixed-dose combinations (alternative: 30% increase; optimized: 69% increase). The potential annual increase in the number of controlled patients, cardiovascular events avoided and the associated savings in direct medical costs were estimated, including the cost of pharmacological treatment, follow-up, and managing cardiovascular events over a three-year time horizon. Over the three years of the study, the baseline scenario estimated a total of 1,552,686 controlled patients and 39,449 cardiovascular events, with a total cost to the NHS of €1,841,057,122. In the alternative scenario, controlled patients would increase by 36.1%, and 139 cardiovascular events would be avoided, resulting in savings for the NHS of 36,116,631 €. In the optimized scenario, there would be a 64% increase in controlled patients and 250 CV events would be avoided, leading to savings of 56,415,300 € for the NHS. Increased use of high-intensity statin and ezetimibe fixed-dose combinations in patients with high/very high CV risk may increase the number of controlled patients, reduce CV events and produce economic savings from an NHS perspective. Estimar el beneficio clínico y económico derivado del incremento del uso de combinaciones a dosis fijas de estatinas de alta intensidad y ezetimiba en el tratamiento de pacientes de alto/muy alto riesgo cardiovascular, desde la perspectiva del sistema nacional de salud (SNS) español. Se comparó un escenario basal (cuotas actuales de mercado) frente a escenarios que incrementaban el uso de las combinaciones fijas (alternativo: incremento del 30%; optimizado: 69%). Se estimó el potencial aumento anual en el número de pacientes controlados, eventos cardiovasculares evitados y ahorro de costes directos médicos asociados incluyendo; coste del tratamiento farmacológico, de seguimiento, y manejo de los eventos cardiovasculares, a lo largo de un horizonte temporal de tres años. A lo largo de los tres años de estudio, en el escenario basal se estimaron un total de 1.552.686 pacientes controlados y 39.449 eventos cardiovasculares, con un coste total para el SNS de 1.841.057.122 €. En el escenario alternativo los pacientes controlados aumentarían un 36,1%, se evitarían 139 eventos cardiovasculares, con un ahorro para el SNS de 36.116.631 €. En el escenario optimizado existiría un aumento del 64% de pacientes controlados y llegarían a evitarse 250 eventos cardiovasculares, con un ahorro para el SNS de 56.415.300 €. El aumento del uso de las combinaciones de estatina de alta intensidad y ezetimiba en dosis fija en pacientes de alto y muy alto riesgo cardiovascular puede aumentar el número de pacientes controlados, reducir complicaciones cardiovasculares y producir ahorros económicos desde la perspectiva del SNS.

The aim of this systematic review was two-fold: (i) to evaluate the long-term (≥5 years) stability of the gingival margin position, keratinized tissue width (KTW) and gingival thickness (GT) in sites that underwent root coverage (RC) or gingival augmentation (GA); and (ii) to assess the influence of different local variables on the long-term stability of dental and gingival tissues. Randomized controlled trials (RCTs) and non-RCTs reporting short-term (i.e., 6-12 months after baseline surgical intervention) and long-term (≥5 years) follow-up data after surgical treatment of adult patients presenting single or multiple mucogingival deformities, defined as sites presenting gingival recession defects (GRDs) and/or (KTW) deficiency (i.e., <2 mm), were considered eligible for inclusion. MEDLINE-PubMed, EMBASE and Cochrane Central Register of Controlled Trials databases were searched for articles published up to 15 May 2023. Mixed-effects multiple linear regression was used to assess the association between KTW, type of surgical procedure and time (i.e., independent variables) on the stability of the gingival margin in sites that received RC or GA therapy. Of the 2569 potentially eligible records, 41 (reporting 40 studies) met the eligibility criteria. Graphical estimates including data from all RC procedures found an upward trend in recession depth (RD) increase over time. Conversely, it was observed that in 63.63% of RC studies and in 59.32% of RC treatment arms KTW increased over time, particularly in sites treated with subepithelial connective tissue grafts (SCTGs). Conversely, sites that underwent GA procedures generally exhibited an overall reduction of KTW over time. However, sites treated with free gingival grafts (FGGs) showed a decrease in RD after 10 years of follow-up. Three main findings derived from the pooled estimates were identified: (i) Gingival margin stability was associated with the amount of KTW present during short-term assessment (i.e. the greater the KTW at 6-12 months after treatment, the more stable the gingival margin). (ii) The use of autogenous soft-tissue grafts was associated with lower RD increase over time. (iii) Treatment approaches that contribute to the three-dimensional enhancement of the gingival phenotype, as clearly demonstrated by FGG, were associated with gingival margin stability. The extent of apical migration of the gingival margin appears to be directly related to the amount of KTW and GT upon tissue maturation. Interventions involving the use of autogenous grafts, either SCTG or FGG, are associated with greater short-term KTW gain and lower RD increase over time.

This study was primarily aimed at assessing the effect that specific periodontal phenotypical characteristics have on alveolar ridge remodelling after tooth extraction. Patients in need of extraction of a non-molar maxillary tooth were enrolled. Baseline phenotypical characteristics (i.e., mid-facial and mid-palatal soft tissue and bone thickness, and supracrestal soft tissue height [STH]) were recorded upon extraction. A set of clinical, digital imaging (linear and volumetric), and patient-reported outcomes were assessed over a 14-week healing period. A total of 78 subjects were screened. Forty-two subjects completed the study. Linear and volumetric bone changes, as well as vertical linear soft tissue and alveolar ridge volume (soft tissue contour) variations, were indicative of a marked dimensional reduction of the alveolar ridge over time. Horizontal facial and palatal soft tissue thickness gain was observed. Thin facial bone (≤1 mm) upon extraction, compared with thick facial bone (>1 mm), was associated with greater linear horizontal (-4.57 ± 2.31 mm vs. -2.17 ± 1.65 mm, p=.003) and vertical mid-facial (-0.95 ± 0.67 mm vs. -4.08 ± 3.52 mm, p < 0.001) and mid-palatal (-2.03 ± 2.08 mm vs. -1.12 ± 0.99 mm, p=0.027) bone loss, as well as greater total (-34% ± 10% vs. 15% ± 6%, p < 0.001), facial (-51% ± 19% vs. 28% ± 18%, p=0.040), and palatal bone volume reduction (-26% ± 14% vs. -8% ± 10%, p < 0.001). Aside from alveolar bone thickness, STH was also found to be a predictor of alveolar ridge resorption since this variable was directly correlated with bone volume reduction. Patient-reported discomfort scores progressively decreased over time, and the mean satisfaction upon study completion was 94.5 ± 0.83 out of 100. Alveolar ridge remodelling is a physiological phenomenon that occurs after tooth extraction. Post-extraction alveolar ridge atrophy is more marked on the facio-coronal aspect. These dimensional changes are more pronounced in sites exhibiting a thin facial bone phenotype (Clinicaltrials.gov NCT02668289).

Few treatment options exist for patients with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (NHL) who fail first- and second-line therapies. Pixantrone is a novel aza-anthracenedione agent with reduced potential for cardiotoxicity but maintained anti-tumour activity relative to anthracyclines. The current retrospective, observational, real-life study was undertaken in 79 patients who received pixantrone monotherapy for multiply R/R aggressive B-cell NHL in Spain and Italy. Before pixantrone, patients had received a median of 3 prior therapies and 84.6% of them were refractory to the last regimen. Median progression-free survival (mPFS) was 2.8months (95% confidence interval [CI] 2.1-3.6) and median overall survival (mOS) was 4.0months (95%CI 5.6-7.9), with an objective response rate (ORR) of 29% (complete remission [CR]: 13.2%, partial remission [PR]: 15.2%). Patients receiving ≥2 cycles of pixantrone showed mPFS and mOS of 3.1 and 6.0months, respectively, and an ORR of 36.8% (CR: 17.5%, PR: 19.3%). Overall, 63.3% of patients reported ≥1 adverse event (AE), most commonly haematological AEs. One patient developed grade 2 sinus tachycardia. Pixantrone was effective and well tolerated in a real-world population of multiply R/R patients with aggressive B-cell NHL, many of whom had very poor prognostic factors.

In order to determine the perception of general practitioners (GPs) and specialists regarding their clinical experience with the use of the low-dose fixed combination of perindopril 2 mg plus indapamide 0.625 mg in hypertensive patients with diabetes, a multicenter survey carried out across Spain was performed. A total of 894 physicians (597 GPs and 297 specialists) participated in the survey. A total of 5126 patients were included (3434 in the GPs’ group and 1692 in the specialists’ group). Associated risk factors and organ damage were more frequently documented in the specialists’ group. At baseline, 1.7% of the GPs’ patients and 1.3% of the specialists’ patients had their blood pressure controlled and with the combined therapy the blood pressure control rate attained 30.7 and 29.8%, respectively (p < 0.001 vs baseline and not significant intergroups). Less than 85% of physicians considered the efficacy and tolerability of combined therapy as ‘good’ or ‘very good’ but 93% of the patients were ‘satisfied’ or ‘very satisfied’ with combined therapy.