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Castelló de la Plana, Spain

del Pino M.D.,Hospital Torrecardenas | Pons R.,Hospital de Castellon | Rodriguez-Carmona A.,Hospital Juan Canalejo | Rubio Liria M.,Sanofi S.A. | Subira R.,Sanofi S.A.
Pharmacoeconomics - Spanish Research Articles | Year: 2016

Objectives: In a 36-month, open-label randomized controlled trial (RCT) that involved 213 non-dialysis dependent chronic kidney disease (NDD-CKD) patients, INDEPENDENT-CKD study, sevelamer was compared with calcium carbonate (CC). The aim of this study was to assess the cost-effectiveness of sevelamer vs. CC in NDD-CKD patients with hyperphosphatemia adapting the results and costs of the INDEPENDENT-CKD study to the Spanish population. Methods: A cost-utility analysis was performed using a Markov model with three health states from a funder perspective and lifetime horizon. All-cause mortality, dialysis inception, hospitalization (frequency and length of stay [LOS]), and drug dosage data were taken from the INDEPENDENT-CKD study. Local costs were applied to pharmaceutical, hospitalization and dialysis utilization. Health utility data was taken from the published literature. Results: In the base case analysis sevelamer achieved 2.12 life years gained (LYG) and 1.61 quality-adjusted life years (QALY) gained vs. calcium carbonate. Increased survival implied more treatment time and dialysis sessions vs. calcium carbonate, resulting in an incremental cost of €28,139. The incremental cost per LYG for sevelamer vs. calcium carbonate was €13,280 and the incremental costs per QALY gained was €17,446. Sensitivity analysis showed that sevelamer was more effective and less costly (i.e., dominant) vs. calcium carbonate in time horizons < 6 years. Conclusions: The Spanish analysis showed that sevelamer is a cost-effective strategy vs. calcium carbonate for the treatment of hyperphosphatemia in patients with NDD-CKD, with cost-effectiveness ratios well below the accepted thresholds of €30,000–45,000/QALY gained. © 2016, Springer International Publishing Switzerland. Source

Samper Ots P.M.,Servicio de Oncologia Radioterapica | Munoz J.,Hospital Infanta Cristina | Biete A.,Hospital Clinic | Ortiz M.J.,Hospital Virgen del Rocio | And 18 more authors.
Clinical and Translational Oncology | Year: 2011

Introduction Anemia is the most common haematological complication in cancer patients. Objective Analysis of the incidence, prevalence and treatment of anemia in oncologic patients treated in Radiation Oncology Departments in Spain (ROD) and monitoring of the existing recommendations for the treatment of anemia. Material and methods Observational, prospective, multicenter study which involved 19 Spanish ROD. The study was approved by the CEIC Central Defense Hospital. 477 patients with solid tumors, subsidiary of RT with radical intent referred to such centers within a period of one month (5/5/09 to 5/6/09) and gave their consent to participate in the study. We gathered the main characteristics of patients and their oncologic disease. All patients underwent a determination of Hb levels before RT, upon reaching 25-35 Gy and at the end treatment. In patients with anemia we assessed the existence of related symptoms and its treatment. Results Basal situation: The prevalence of anemia was 34.8% (166 patients). Mean Hb in patients with anemia was 11.17±1.07 g/dl. Anemia-related symptoms were present in 34% of the patients. Anemia predisposing factors were: stage of the disease, previously received chemotherapy, and hormonal therapy. 39% (66 patients) received anemia treatment, with a mean Hb of 10.43±1.04 g/dl. During RT: The prevalence of anemia was 38.9% (182 patients) with a mean Hb of 11.24±1.21 g/dl. Predisposing factors for anemia during RT treatment were: age, male sex, chemotherapy prior to RT, basal anemia and chemotherapy during RT. 36.3% (66 patients) had anemia-related symptoms. 34.6% (63 patients) with a mean Hb of 10.5±1.37 g/dl received treatment for anemia. The prevalence of anemia at the end of the RT was 38.1% (177 patients) with a mean Hb of 11.19±1.18 g/dl. The predisposing factors for the appearance of anemia at the end of RT were: male sex, anemia at basal situation and during treatment and chemotherapy during RT. 34% (61 patients) had anemia-related symptoms and 73 patients (41.2%) with a mean Hb of 10.5±1.22 g/dl received treatment for anemia. The presence of anemia-related symptoms was signifi cantly correlated with the beginning of treatment for anemia. The incidence of anemia (new cases) during radiotherapy was 17.5%. Conclusion The prevalence of anemia in basal situation, during RT and at the end of RT is 34.8%, 38.9% and 38.1%. During RT the incidence of anemia is 17.5%. 39.8%-41.2% of patients with anemia and 64.2%-68% of patients with anemia-related symptoms received treatment. Treatment of anemia starts with Hb<11 g/dl and the goal is to achieve Hb 12 g/dl. In our Radiotherapy Oncology Departments, the treatment of anemia complies with the current recommendations and guidelines in use. Source

Provencio M.,Hospital Universitario Puerta Of Hierro | de Las Penas R.,Hospital de Castellon | Camps C.,Hospital General de Valencia | Artal A.,Hospital Miguel Servet | And 5 more authors.
Lung Cancer | Year: 2010

One of the standard treatments for metastatic non-small-cell lung cancer patients is the combination of cisplatin plus vinorelbine. This regimen is associated with a high rate of severe neutropenia, and a hemogram is therefore routinely performed on day 8 before the administration of vinorelbine. However, no study has ever examined the rate of neutropenia detected in this hemogram or the rate of discontinuation of chemotherapy as a result. Since one of the objectives in the treatment of advanced lung cancer is to maintain quality of life, we have retrospectively analyzed a Spanish Lung Cancer Group study of cisplatin plus vinorelbine to address the question of whether this hemogram on day 8 could be avoided, thus eliminating unnecessary venipunctures without endangering patient safety. Between April 2004 and January 2006, 180 chemotherapy-naïve, advanced NSCLC patients were included from 35 centers. They received intravenous doses of cisplatin 75mg/m2 on day 1 plus vinorelbine 25mg/m2 on days 1 and 8, every 3 weeks, for a maximum of six cycles. Median age was 62.5 years; 87.2% were males; 80.6% were smokers; 48.2% were adenocarcinomas and 36% were squamous cell carcinomas; 17.2% were stage IIIB and 82.8% stage IV. Of 750 cycles analyzed, vinorelbine was administered on day 8 in 661 (88.1%), and the dose was reduced or canceled in 15 (2%) due to hematological toxicity. Among patients aged<70 with no dose modification in previous cycles, the likelihood of observing hematological toxicity at day 8 was only 0.8% (95% CI, 0.1-3%). We speculate that the hemogram on day 8 could potentially be avoided in this subgroup of patients while still maintaining an acceptable safety margin. Prospective clinical studies to further examine this hypothesis are warranted. © 2009. Source

Miquel M.,Autonomous University of Barcelona | Miquel M.,CIBER ISCIII | Nunez O.,Hospital Universitario Infanta Sofia | Trapero-Marugan M.,Autonomous University of Madrid | And 7 more authors.
Annals of Hepatology | Year: 2013

This study aimed to evaluate the efficacy and safety of entecavir and/or tenofovir in compensated (CC) or decompensated (DC) hepatitis B cirrhotic patients in real-life clinical practice. Of the 48 patients, included between April 2007 and March 2010, 12 were DC. The mean age was 55 ± 12.2 years, 85.4% were Caucasians and 8 patients were HBeAg positive. Mean viral load was 5.2 ± 1.9 log10 UI/mL. HBV-DNA undetectability at 3, 6, 12 and 24 months were 53.3%, 78.3%, 83.7% and 97.1%, respectively, similar in CC and DC. At 6 and 12 months, ≥ 80% of CC achieved ALT normalization, while only 42.9% and 71.4% in DC. After a median follow-up of 27.1 (0.7-45.3) months, 43 patients were Child Pugh Turcotte (CPT) class A (n = 39 at entry). In DC, progressive improvement in the MELD scores was observed: 12.73 (SD 4.5), 10.4 (SD 3.6) and 8.2 (SD 2.6), at baseline, 12 and 24 months, respectively. During follow-up, 7 patients died, 4 received liver transplantation and 5 developed hepatocellular carcinoma. In three out of four DC who died due to hepatic causes, these events occurred between the first 0.7 and 6.7 months, and all were CPT class C. Cumulative survival in CC vs. DC at 12 and 24 months were 94.4% vs. 66.7%, and 88.2% vs. 57.1%, respectively (log rank p = 0.03). No severe adverse events associated with entecavir or tenofovir were reported. In conclusion, in compensated and decompensated cirrhotic patients, entecavir and tenofovir were effective and well tolerated. Source

Gomez-Iturriaga A.,Hospital Universitario Cruces | Cacicedo J.,Hospital Universitario Cruces | Navarro A.,Instituto Catalan Of Oncologia | Morillo V.,Hospital de Castellon | And 11 more authors.
BMC Palliative Care | Year: 2015

Background: Palliative radiotherapy (RT) is an effective treatment for symptomatic bone metastases. Pain flare, a transient worsening of the bone pain after RT, has been described in previous reports with different incidence rates. The aim of the study was to prospectively evaluate the incidence of pain flare following RT for painful bone metastases and evaluate its effects on pain control and functionality of the patients. Methods: Between June 2010 and June 2014, 204 patients were enrolled in this study and 135 patients with complete data were evaluable. Pain flare was defined as a 2- point increase in worst pain score as compared with baseline with no decrease in analgesic intake or a 25 % increase in analgesic intake as compared with baseline with no decrease in worst pain score. All pain medications and worst pain scores were collected before, daily during, and for 10 days after RT. The Brief Pain Inventory (BPI) was filled out on the pretreatment and at the 4 weeks follow-up visit. Results: There were 90 men (66.7 %) and 45 women (33.3 %). Mean age was 66 years (SD 9.8). The most common primary cancer site was lung in 42 patients (31.1 %), followed by prostate in 27 patients (20.0 %). Forty-two patients (31.1 %) patients received a single fraction of 8 Gy and 83 (61.5 %) received 20 Gy in five fractions. The overall pain flare incidence across all centers was 51/135 (37.7 %). The majority of pain flares occurred on days 1-5 (88.2 %). The mean duration of the pain flare was 3 days (SD: 3). There were no significant relationships between the occurrence of pain flare and collected variables. All BPI items measured four weeks after end of RT showed significant improvement as compared with pretreatment scores (p∈<∈0.001). No significant differences in BPI time trends were found between patients with and without flare pain. Conclusion: Pain flare is a common event, occurring in nearly 40 % of the patients that receive palliative RT for symptomatic bone metastases. This phenomenon is not a predictor for pain response. © 2015 Gomez-Iturriaga et al. Source

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