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Arnal-Garcia C.,Hospital Virgen de Las Nieves | Garcia-Montero M.R.,Hospital Virgen de la Salud | Malaga I.,University of Oviedo | Millan-Pascual J.,Hospital Complex Mancha Centro | And 3 more authors.
European Journal of Paediatric Neurology | Year: 2013

Background: Not all pediatric patients with relapsing-remitting multiple sclerosis (MS) may respond to traditional disease-modifying therapies. Natalizumab has been shown to be effective but is currently only approved in adults. Objective: To analyze the safety and efficacy of natalizumab in patients under 18 years of age diagnosed with MS. Method: Data for pediatric patients with MS treated with natalizumab in a compassionate use setting were retrospectively collected and analyzed. Results: Valid data were obtained for nine patients under 18 years from seven different centers (mean age, 15 years 4 months [range 9.8-17.7]; 5 were boys). Patients received a median of 17 infusions of natalizumab (range, 2-31) and eight received at least 12 infusions. For these 8 patients, the median score on the Expanded Disability Status Scale decreased from 3.0 to 1.0 and the median annualized relapse rate decreased from 3.0 to 0. After 12 months, no patients reported gadolinium-enhancing lesions compared to seven at baseline. Four post-baseline adverse events occurred and one patient discontinued due to hypersensitivity reaction. Conclusion: Natalizumab is a highly effective treatment as a second-line option in pediatric patients. In as far as the limited numbers allowed comparisons, the safety and efficacy of natalizumab in children was in line with the experience published in adult populations. © 2012 European Paediatric Neurology Society. Published by Elsevier Ltd. All rights reserved.

Hernandez G.,Intensive Care Unit | Fernandez R.,Intensive Care Unit | Lopez-Reina P.,Intensive Care Unit | Cuena R.,Investigation Unit | And 3 more authors.
Chest | Year: 2010

Background: Guidelines for noninvasive mechanical ventilation (NIMV) recommend continuous positive airway pressure in patients with thoracic trauma who remain hypoxic despite regional anesthesia. This recommendation is rated only by level C evidence because randomized controlled trials in this specific population are lacking. Our aim was to determine whether NIMV reduces intubation in severe trauma-related hypoxemia. Methods: This was a single-center randomized clinical trial in a nine-bed ICU of a level I trauma hospital. Inclusion criteria were patients with PaO2/FIO2 < 200 for > 8 h while receiving oxygen by high-flow mask within the first 48 h after thoracic trauma. Patients were randomized to remain on high-flow oxygen mask or to receive NIMV. The interface was selected based on the associated injuries. Thoracic anesthesia was universally supplied unless contraindicated. The primary end point was intubation; secondary end points included length of hospital stay and survival. Statistical analysis was based on multivariate analysis. Results: After 25 patients were enrolled in each group, the trial was prematurely stopped for efficacy because the intubation rate was much higher in controls than in NIMV patients (10 [40%] vs 3 [12%], P = .02). Multivariate analysis adjusted for age, gender, chronic heart failure, and Acute Physiology and Chronic Health Evaluation II at admission revealed NIMV as the only variable independently related to intubation (odds ratio, 0.12; 95% CI, 0.02-0.61; P = .01). Length of hospital stay was shorter in NIMV patients (14 vs 21 days P = .001), but no differences were observed in survival or other secondary end points. Conclusion: NIMV reduced intubation compared with oxygen therapy in severe thoracic trauma-related hypoxemia. © 2010 American College of Chest Physicians.

Koopmans G.,Mundipharma Pharmaceuticals BV | Simpson K.,Glebe House | De Andres J.,Hospital Virgen de la Salud | Lux E.A.,Klinik fur Schmerz und Palliativmedizin | And 2 more authors.
Current Medical Research and Opinion | Year: 2014

Objective: The effects of combined oxycodone/naloxone prolonged release tablets (OXN PR) were investigated in patients with moderate-to-severe chronic cancer-related or non-cancer pain. All patients had opioid-induced constipation (OIC) which persisted despite substantial laxative therapy. Research design and methods: This pooled analysis included 75 patients with OIC at study entry that was refractory to at least two laxatives with different modes of action. Patients completed randomized, double-blind treatment with OXN PR 20-120mg/day for either 12 weeks (OXN 9001: non-cancer pain study) or 4 weeks (OXN 2001: cancer-related pain study). Analgesia and bowel function were assessed using the Brief Pain Inventory Short Form and Bowel Function Index (BFI), respectively. Use of laxative medication and safety were assessed throughout the studies. Clinical trial registration: NCT00513656, EudraCT 2005-002398-57, EudraCT 2005-003510-15. Results: Statistically and clinically significant improvements in bowel function were observed following double-blind treatment with OXN PR. Mean (SD) reduction in BFI score was 21.2 (28.8) and comparable in patients with cancer-related (19.0 [28.9]) and non-cancer pain (23.3.[29.0]; P≤0.0002). Furthermore, the proportion of patients with a BFI score within normal range (≤28.8) increased from 9.5% at screening to 43.1% at Day 15 of OXN PR. While all patients used ≥2 laxatives of different classes at screening, during study treatment 36% stopped using laxatives (P<0.001). OXN PR provided effective analgesia, evidenced by stable pain scores during study treatment, and there were no unanticipated adverse events. Conclusions: OXN PR significantly improved bowel function and reduced the use of laxatives in patients with OIC, previously unresponsive to at least two different classes of laxatives. OXN also provided effective analgesia for patients with moderate-to-severe cancer-related pain and non-cancer-related pain. © 2014 Informa UK Ltd.

Cohen B.,University of Castilla - La Mancha | Angel Organero J.,University of Castilla - La Mancha | Santos L.,University of Castilla - La Mancha | Rodriguez Padial L.,Hospital Virgen de la Salud | Douhal A.,University of Castilla - La Mancha
Journal of Physical Chemistry B | Year: 2010

Exploring the relationship between the structure and dynamics of a molecular system is fundamental to a better understanding of its function. Here, we report on studies of femtosecond dynamics of the most stable molecular structures of a cardiovascular drug, levosimendan (LSM), in water at three different pHs, in chemical (β-cyclodextrin, β-CD) and biological (human serum albumin protein, HSA) nanocavities, and in two organic solvents with different viscosities. In the used organic solvents, the structural dynamics, ranging from 50 fs to 3 ps, depends on the viscosity of the solvent, reflecting the involvement of a twisting motion in the excited molecule. In water solutions at pH 3 and 5, the excited neutral form is decaying in a time of ∼0.4 ps, undergoing an ultrafast (<50 fs) intramolecular charge transfer (ICT) to generate charge transfer species decaying in ∼1 ps. In neutral (pH 7) and alkaline water (pH 12), the LSM is present in its anion structure at the ground state. In these media, the experiments reveal, in addition to the ultrafast decay of the anionic structure (1.3 ps), the formation of an ICT state having (n, π*) character, produced in ∼0.3 ps and decaying in ∼0.5 ps. Encapsulation by β-CD and HSA protein leads to a 1:1 stoichiometry complex, which shows longer decaying times (4 and 7 ps, respectively) of the caged anionic forms due to the nanoconfinement. Our results show a structural diversity of the LSM dynamics, reflecting its intimate interaction with its surrounding. We believe that the reported findings and the related discussion and conclusions bring new knowledge for a better understanding of the molecular activity of this drug, taking into account its rich structural dynamics. Furthermore, the results might be relevant for a better drug design and nanodelivery involving CDs and proteins. © 2010 American Chemical Society.

Luque-Fernandez I.,Hospital Virgen de la Salud | Garcia-Martin A.,Hospital Comarcal del Noroeste | Luque-Pazos A.,Hospital Virgen de la Salud
Therapeutic Advances in Endocrinology and Metabolism | Year: 2013

Objectives: To assess the characteristics of patients with primary hyperparathyroidism (PHPT) treated with cinacalcet and to evaluate its efficacy in reducing serum calcium and parathyroid hormone (PTH) concentrations after 1 year of treatment. Methods: The study included 20 patients with PHPT who had completed at least 12 months of treatment with cinacalcet (eight patients for refusal of parathyroidectomy, three for surgery not possible due to comorbidities and nine for progressive hypercalcemia prior to surgery). We recorded clinical and biochemical data at baseline, and after 3, 6 and 12 months of treatment. We also monitored adverse events. Cinacalcet was administered in increasing doses until normal serum calcium was reached or side effects preventing a further increase occurred. Results: After 3 months of treatment, serum calcium significantly decreased (11.73 ± 0.85 versus 10.71 ± 1.63 mg/dl, p < 0.001) and serum phosphorus significantly increased (2.41 ± 0.48 versus 2.63 ± 0.70 mg/dl, p = 0.004) while no significant change occurred in PTH (181.91 ± 102.37 versus 195.47 ± 111.71 pg/ml, p = 0.695). No further variation was observed after 6 months compared with 3 months of follow up. However, after 12 months of treatment, there was a significant decrease in PTH concentrations compared with baseline (181.91 ± 102.37 versus 152.47± 70.16 pg/ml, p = 0.028) as well as serum calcium (11.73 ± 0.85 versus 10.20± 0.95 mg/dl, p < 0.001); serum phosphorus significantly increased (2.41 ± 0.48 versus 2.71 ± 0.43 mg/dl, p = 0.01). Normocalcemia (S-Ca < 10.2 mg/dl) was achieved in 55% of patients. The medication was usually well tolerated (83.4%). Most common adverse events were nausea and vomiting, especially at the beginning of therapy. Conclusion: Cinacalcet rapidly reduced serum calcium in patients with PHPT and this reduction remained stable after 1 year of treatment. We also observed a decrease in PTH. Cinacalcet is an effective alternative in nonsurgical treatment of PHPT and may be useful in the preoperative hypercalcemia management.© The Author(s), 2013.

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