The effects of dutasteride or tamsulosin alone and in combination on storage and voiding symptoms in men with lower urinary tract symptoms (LUTS) and benign prostatic hyperplasia (BPH): 4-year data from the Combination of Avodart and Tamsulosin (CombAT) study
Montorsi F.,Vita-Salute San Raffaele University |
Roehrborn C.,University of Texas Southwestern Medical Center |
Garcia-Penit J.,Hospital Costa del Sol |
Borre M.,Aarhus University Hospital |
And 4 more authors.
BJU International | Year: 2011
Study Type - Therapy (RCT) Level of Evidence 1b What's known on the subject? and What does the study add? Long-term treatment with combination therapy (dutasteride plus tamsulosin) is significantly superior to tamsulosin but not dutasteride at reducing the relative risk of AUR or BPH-related surgery. Furthermore, combination therapy is significantly superior to both monotherapies at reducing the relative risk of BPH clinical progression, and provides significantly greater reductions in IPSS. In addition, combination therapy significantly improves patient-reported, disease specific QoL and treatment satisfaction compared with either monotherapy. Two-year results from the CombAT study showed that combination therapy was more effective than either monotherapy in controlling both storage and voiding symptoms, irrespective of baseline prostate volume (for men with prostate volume ≥30 cc). This post-hoc two-year analysis also showed that treatment with dutasteride not only improved voiding symptoms, as would be expected from its effects on prostate volume, but was also as effective as the α-blocker tamsulosin in the control of storage symptoms. Objective: To assess the effects of combined therapy with dutasteride and tamsulosin on voiding and storage symptoms compared with those of dutasteride or tamsulosin alone, using 4-year data from the Combination of Avodart and Tamsulosin (CombAT) study. Patients and methods: Men (n = 4844) aged ≥50 years with moderate-to-severe lower urinary tract symptoms (LUTS) due to benign prostate hyperplasia (BPH), a prostate volume of ≥30 mL, and a serum prostate-specific antigen level of 1.5-10 ng/mL. CombAT was a multicentre, double-blind, parallel-group study. Oral dutasteride (0.5 mg) or tamsulosin (0.4 mg) alone or in combination was taken daily for 4 years. Mean changes from baseline in storage and voiding symptoms at 4 years were assessed using subscales of the International Prostate Symptom Score. Results: At 4 years, the mean reduction in the storage subscore was significantly greater in the combined therapy group vs the dutasteride (adjusted mean difference -0.43) and tamsulosin (adjusted mean difference -0.96) monotherapy groups (P < 0.001). Also at 4 years, the mean reduction in the voiding subscore was significantly greater in the combined therapy group vs the dutasteride (adjusted mean difference -0.51) and tamsulosin (adjusted mean difference -1.60) monotherapy groups (P < 0.001). The improvement in the storage subscore with combined therapy was significantly better (P < 0.001) than dutasteride and tamsulosin from 3 months and 12 months, respectively. Similarly, the improvement in the voiding subscore with combined therapy was significantly better than dutasteride (P < 0.001) and tamsulosin (P ≤ 0.006) from 3 months and 6 months, respectively. Improvements in the storage and voiding symptom subscores with combined therapy were achieved irrespective of prostate volume, although in men with the highest baseline prostate volumes (≥58 mL), combined therapy was not better than dutasteride. Conclusions: In men with a prostate volume of ≥30 mL, combined therapy with dutasteride plus tamsulosin provided better long-term (up to 4 years) control of both storage and voiding LUTS compared with tamsulosin monotherapy. Combined therapy was better than dutasteride monotherapy in men with prostate volumes of ≥30 to <58 mL, but not in men with a prostate volume of ≥58 mL. © 2011 BJU International.
Alvarez Aldean J.,Hospital Costa del Sol |
Aristegui J.,Hospital Universitario Of Basurto |
Lopez-Belmonte J.L.,Sanofi S.A. |
Pedros M.,IMS Health |
Sicilia J.G.,Hospital Universitario La Paz
Vaccine | Year: 2014
Severe rotavirus gastroenteritis is common in children under 5 years of age. A literature review was performed to investigate the economic and psychosocial impact of rotavirus infection in children in this age group. We retrieved 56 articles on the economic burden of the disease in Europe, 18 of them reported data from Spain; 8 articles were retrieved analysing its psychosocial impact. In Spain, rotavirus is responsible for 14% to 30% of all cases of gastroenteritis, and a quarter of these require hospitalisation. It is also associated with high use of health care resources (emergency and primary care visits). Rotavirus gastroenteritis costs the Spanish national health system EUR 28 million a year and causes productivity loss in two-thirds of parents (mean of 4 days). Taking into account these costs, it was estimated that implementing universal vaccination could prevent 76% to 95% of hospital admissions due to rotavirus gastroenteritis, as well as reduce emergency and paediatric visits, nosocomial infections, and days missed from work (77% reduction). Rotavirus gastroenteritis also has a considerable psychosocial impact on the family, although it is difficult to compare results due to the diversity of study designs and the low specificity of the measurement tools used. It also causes high stress among parents, adding to their workload and adversely affecting their quality of life. © 2014 Elsevier Ltd.
Del Boz J.,Hospital Costa del Sol |
Crespo V.,Complejo Hospitalario Carlos Haya |
De Troya M.,CIBER ISCIII
Pediatric Dermatology | Year: 2012
Tinea faciei (TF) is a common clinical form of tinea in children that is frequently misdiagnosed and treated with corticosteroids. No large case series of TF focusing on children have been published. The aim of this study was to analyze the main epidemiologic, clinical, and microbiologic features of TF in children over a period of 30 years and compare these features with those of other tineas. We undertook a retrospective study of 818 cases of tinea in children at a referral hospital in southern Spain, diagnosed between 1977 and 2006, concentrating for this study on TF. Of the 73 cases of TF diagnosed, 50.7% were in girls. Most children (46.6%) were 4 to 9 years old. At the time of diagnosis, 29.2% of the cases had been treated with topical steroids. The most frequently isolated dermatophyte was Trichophyton mentagrophytes, which was isolated significantly more frequently in TF than in the other tineas. Cases of TF in children were not extremely unusual, emphasizing that TF must be considered in children with inflammatory facial eruptions. This consideration and the more-frequent use of mycologic tests can help achieve the correct diagnosis, when present. © 2011 Wiley Periodicals, Inc.
Perez-Ruiz E.,Hospital Costa del Sol
Tumour biology : the journal of the International Society for Oncodevelopmental Biology and Medicine | Year: 2012
The efficacy of epidermal growth factor-targeting therapies has been found to be limited in tumors with the wild-type K-RAS gene, suggesting a predictive value of K-RAS gene analysis in tumoral response. However, the prognostic value of K-RAS is controversial. This study included patients diagnosed with metastatic colorectal cancer. The presence of K-RAS mutations was analyzed, and the tumors positive for a K-RAS mutation were further analyzed to identify the mutation type. Similarly, the following clinical and pathological variables were also collected. The study was composed of 53.3 % of patients with wild-type K-RAS and 46.7 % of patients with mutated K-RAS (mutated codon 12 was the most frequent). With a mean follow-up of 15 months (range, 1-45), the median survival of patients with wild-type K-RAS was 31.6 months. The median survival was 24.8 months for patients with K-RAS mutated in codon 12 and 17.8 months for patients with mutated codon 13 (p = 0.37). In a univariate analysis, K-RAS was associated with stage IV at diagnosis (p < 0.005). When K-RAS was mutated, a lower overall survival was observed in cases of G → A transition compared with G → T transversion (19.5 vs. 24.2 months, respectively; p = 0.47). When the amino acid change resulted in an acidic substitution, survival was lower, but it increased when the substitution resulted in a polar or nonpolar amino acid (19.5 vs. 23.2 vs. 24.4 months, p = 0.79). The type of K-RAS mutation or amino acid changes may have prognostic implications in metastatic colon cancer patients. Further research is needed in patients treated in prospective controlled trials.
Martinez-Garcia M.-A.,Polytechnic University of Valencia |
Capote F.,Hospital Universitario Virgen Del Rocio |
Campos-Rodriguez F.,Hospital Universitario La Paz |
Lloberes P.,Hospital Universitario Vall Hebron |
And 21 more authors.
JAMA - Journal of the American Medical Association | Year: 2013
IMPORTANCE: More than 70% of patients with resistant hypertension have obstructive sleep apnea (OSA). However, there is little evidence about the effect of continuous positive airway pressure (CPAP) treatment on blood pressure in patients with resistant hypertension. OBJECTIVE: To assess the effect of CPAP treatment on blood pressure values and nocturnal blood pressure patterns in patients with resistant hypertension and OSA. DESIGN, SETTING, AND PARTICIPANTS: Open-label, randomized, multicenter clinical trial of parallel groups with blinded end point design conducted in 24 teaching hospitals in Spain involving 194 patients with resistant hypertension and an apnea-hypopnea index (AHI) of 15 or higher. Data were collected from June 2009 to October 2011. INTERVENTIONS: CPAP or no therapy while maintaining usual blood pressure control medication. MAIN OUTCOMES AND MEASURES: The primary end pointwas the change in 24-hour mean blood pressure after 12 weeks. Secondary end points included changes in other blood pressure values and changes in nocturnal blood pressure patterns. Both intention-to-treat (ITT) and per-protocol analyses were performed. RESULTS: A total of 194 patients were randomly assigned to receive CPAP (n = 98) or no CPAP (control; n = 96). The mean AHI was 40.4 (SD, 18.9) and an average of 3.8 antihypertensive drugs were taken per patient. Baseline 24-hour mean blood pressure was 103.4 mm Hg; systolic blood pressure (SBP), 144.2 mm Hg; and diastolic blood pressure (DBP), 83 mm Hg. At baseline, 25.8% of patients displayed a dipper pattern (a decrease of at least 10% in the average nighttime blood pressure compared with the average daytime blood pressure). The percentage of patients using CPAP for 4 or more hours per day was 72.4%. When the changes in blood pressure over the study period were compared between groups by ITT, the CPAP group achieved a greater decrease in 24-hour mean blood pressure (3.1 mm Hg [95% CI, 0.6 to 5.6]; P = .02) and 24-hour DBP (3.2 mm Hg [95% CI, 1.0 to 5.4]; P = .005), but not in 24-hour SBP (3.1 mm Hg [95% CI, -0.6 to 6.7]; P = .10) compared with the control group. Moreover, the percentage of patients displaying a nocturnal blood pressure dipper pattern at the 12-week follow-up was greater in the CPAP group than in the control group (35.9% vs 21.6%; adjusted odds ratio [OR], 2.4 [95% CI, 1.2 to 5.1]; P = .02). There was a significant positive correlation between hours of CPAP use and the decrease in 24-hour mean blood pressure (r = 0.29, P = .006), SBP (r = 0.25; P = .02), and DBP (r = 0.30, P = .005). CONCLUSIONS AND RELEVANCE: Among patients with OSA and resistant hypertension, CPAP treatment for 12 weeks compared with control resulted in a decrease in 24-hour mean and diastolic blood pressure and an improvement in the nocturnal blood pressure pattern. Further research is warranted to assess longer-term health outcomes. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00616265. Copyright 2013 American Medical Association. All rights reserved.