RESUMEN
OBJECTIVE: The objective of this sub-analysis of the PERSAT study was to evaluate the efficacy of hexanic extract of S. Repens (HESr) and alpha-blockers (AB), at 6 months in patients with moderate to severe LUTS/BPH. METHODS: The PERSAT observational study was conducted in France by general practitioners on patients with BPH with an IPSS≥12 score. The primary endpoint was the percentage of responders (decrease in total IPSS score ≥ 3) at 6 months. Improvement in quality of life (IPSS-QoL) as well as patient satisfaction were also measured. RESULTS: Of the 759 patients in the study, 324 treated with HESr and 309 with AB were reviewed at 6 months, with no change in treatment during follow-up. Characteristics at inclusion were globally similar with a mean IPSS of 18.2±4.9. The response rates at 6 months (IPSS-total decrease ≥ 3) were 93.7% and 94.8% for patients treated with HESr and AB, with a mean decrease in IPSS score of 10.1±5.6 points, which reached 13.6 and 14.8 points respectively, in severe patients (IPSS>19), without major difference between groups. More than 95% of HESr or AB patients reported a significant overall improvement in their LUTS/BPH. The most frequently reported adverse events with AB were ejaculation disorders (4.9%) and hypotension (4.2%) and with HESr digestive disorders (1.5%). CONCLUSION: This sub-analysis of the PERSAT cohort reported the clinical efficacy of HESr and AB as a first-line treatment in the management of moderate or severe LUTS/BPH patients.
Asunto(s)
Síntomas del Sistema Urinario Inferior , Hiperplasia Prostática , Masculino , Humanos , Hiperplasia Prostática/tratamiento farmacológico , Calidad de Vida , Fitoterapia , Síntomas del Sistema Urinario Inferior/tratamiento farmacológico , Extractos Vegetales/uso terapéutico , Antagonistas Adrenérgicos alfa/uso terapéutico , Resultado del TratamientoRESUMEN
PURPOSE: The objective of the PERSAT study was to evaluate first-line treatment of BPH-associated LUTS in real-life conditions. METHODS: This prospective observational study was conducted in France by general practitioners (GP) on patients with moderate to severe LUTS (IPSS ≥12). GPs freely decided to prescribe either an alpha-blocker (AB) or phytotherapeutic treatment (PT). The main criterion was the percentage of responding patients (decrease in total IPSS score ≥3) at 6 months. RESULTS: Of the 849 patients included, 759 were analysed (381 treated with AB and 378 with PT); 718 were followed up at 6 months, 90% of which had no treatment modification. Their inclusion characteristics were similar between the AB and PT groups (mean IPSS: 18.6±4.5 and 17.8±4.1, respectively). Treatment response rates at 6 months were 94.2% [91.2%; 96.4%] in AB and 92.5% [89.2%; 95.1%] in PT. The IPSS decreased by 10.0±5.6 points, with no difference between groups. The proportion of patients bothered by their LUTS (IPSS-QoL ≥4) evolved from 88.5% to 6.5% at 6 months. The improvement of LUTS was perceived by more than 94% of patients (PGI-I) and doctors (CGI-I), 93% of patients were satisfied with the treatment at 6 months, regardless of the treatment initiated. The most reported adverse reactions were ejaculation disorder (3.9% for AB and 0.9% for PT). CONCLUSION: PERSAT confirms in current practice the effectiveness of AB and PT treatments, recommended as first-line treatment in LUTS/BPH. LEVEL OF PROOF: 3.
Asunto(s)
Antagonistas Adrenérgicos alfa/uso terapéutico , Síntomas del Sistema Urinario Inferior/tratamiento farmacológico , Fitoterapia , Hiperplasia Prostática/tratamiento farmacológico , Anciano , Medicina General , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Estudios ProspectivosRESUMEN
PURPOSE: To evaluate the efficacy of intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections (IVT) in diabetic macular edema (DME) in real-life practice using the Save Sight Registries (SSR). MATERIAL AND METHODS: We conducted an observational, single-centre, retrospective study in the department of ophthalmology of the Dijon University Hospital. We included treatment-naive patients who presented with DME between January 2016 and December 2017. Demographic and clinical data, follow-up visits, and treatments administered were entered into the SSR, an international online ophthalmic registry. Primary endpoints were the change in best-corrected visual acuity (BCVA) and central subfield thickness (CST) from baseline to 12 and 24 months. RESULTS: Fifty-eight eyes of 43 patients with a mean [standard deviation (SD)] age of 67.1 [9.5] years were included. Forty-one eyes completed 12 months of follow-up, and 17 eyes completed 24 months of follow up. Median [SD] baseline BCVA was 56.1 [22.9] ETDRS letters and the median [95% confidence interval (95% CI)] baseline CST was 447.9 [161.0] micrometers (µm). Median [95% CI] improvement in BCVA from baseline to months 12 and 24 were respectively, +5.6 [+0.5; +10.7] ETDRS letters and +7.7 [-2.8; +18.2] ETDRS letters. The median [95% CI] decrease in CST from baseline to months 12 and 24 were respectively, -110.9 [-154.5; -67.3] µm and -125.5 [-198.0; -53.0] µm. CONCLUSION: Our clinical practice can be evaluated easily with the SSR system. In real life, anti-VEGF IVT are an effective treatment for DME, which result in improved BCVA and decreased CST.
Asunto(s)
Bevacizumab/administración & dosificación , Retinopatía Diabética/tratamiento farmacológico , Edema Macular/tratamiento farmacológico , Centros Médicos Académicos , Anciano , Inhibidores de la Angiogénesis/administración & dosificación , Inhibidores de la Angiogénesis/efectos adversos , Bevacizumab/efectos adversos , Retinopatía Diabética/epidemiología , Femenino , Estudios de Seguimiento , Francia/epidemiología , Humanos , Inyecciones Intravítreas , Edema Macular/epidemiología , Masculino , Persona de Mediana Edad , Pautas de la Práctica en Medicina/estadística & datos numéricos , Sistema de Registros , Estudios Retrospectivos , Resultado del Tratamiento , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidores , Factor A de Crecimiento Endotelial Vascular/inmunologíaRESUMEN
PURPOSE: To assess early efficacy of dexamethasone intravitreal implant 0.7mg (OZURDEX®) at the time of peak efficacy (2 months after injection) in patients with decreased visual acuity secondary to diabetic macular edema (DME). MATERIALS AND METHODS: Retrospective monocentric study. Inclusion criteria were best-corrected visual acuity (BCVA)≤70 letters (20/40) due to DME and central retinal thickness (CRT)≥300 microns (Cirrus 2, Carl Zeiss Meditec, Inc, Dublin). Enrolled patients could be treatment naive or not (after failure of laser photocoagulation and/or anti-VEGF therapy). Follow-up was at least 6 months. Our primary endpoint was BCVA gain at M2 after injection. Secondary endpoints were best-corrected visual acuity at 2 and 4 months, central retinal thickness at 2 and 4 months, mean interval between 2 injections, and adverse events. RESULT: Nineteen eyes of 19 patients were included in this study. The mean age was 67.45 years, sex ratio was 2.17 men/women, and the patients were all type 2 diabetics. Three of 19 patients were treatment naive for anti-VEGF intravitreal injection, and 52.3% were pseudophakic (10/19 patients). The mean gain of BCVA at M2 was +7.7 letters. The mean BCVA was 51.1 ETDRS letters at baseline and 58.8 at M2. Mean CRT was 568.9µm at baseline and 291.2µm at M2. Treatment with dexamethasone implant was mainly a second-line treatment after failure of other treatments (macular laser photocoagulation and/or intravitreal injection of anti-VEGF). Three patients were naive of anti-VEGF treatment. Intraocular pressure≥25mmHg was found in 2 patients, and controlled medically. No glaucoma surgery was performed. CONCLUSION: The dexamethasone implant (OZURDEX®) allows an anatomical and functional improvement in patients suffering from vision loss due to DME. In this series, the implant was well tolerated.