Patrones de tratamiento biológico en pacientes con enfermedades articulares inflamatorias. Estudio retrospectivo de 4 años de seguimiento / Biological treatment patterns in patients with inflammatory joint diseases. Retrospective study with 4 years follow-up

OBJETIVO: Describir el manejo terapéutico de la artritis reumatoide (AR), la artritis psoriásica (Aps) y la espondilitis anquilosante (EA) en pacientes que inician tratamiento con agentes biológicos. MATERIALES Y MÉTODOS: Estudio observacional, retrospectivo, longitudinal en 33 hospitales españoles. Se incluyeron pacientes con AR, Aps y EA que iniciaron tratamiento con agentes biológicos entre septiembre de 2009 y agosto de 2010, con un seguimiento de más de 3 años. Se analizaron las características clínico-demográficas, los fármacos, la supervivencia de la terapia biológica y las causas de cambio o interrupción. RESULTADOS: Se incluyeron 463 pacientes (183 AR, 119 Aps y 161 EA) con un seguimiento medio de 3,8 años. Al final del seguimiento una elevada proporción continuaba con el primer biológico prescrito (41,0% de AR, 59,7% de Aps y 51,6% de EA), precisando ajustes de dosis el 31,1%, 47,9% y 42,9% de pacientes con AR, Aps y EA, respectivamente. Hubo interrupción temporal en el 8,2%, 8,4% y 15,5% de los pacientes y se precisó cambio de biológico en el 37,7%, 26,1% y 24,2%. La interrupción definitiva ocurrió en el 13,1%, 5,9% y 8,7% de pacientes con AR, Aps y EA, respectivamente. El tiempo medio de cambio o interrupción fue de 30,1 meses para la AR y de 35,7 meses para la Aps y la EA. CONCLUSIONES: Nuestros resultados sugieren que, en la práctica, la mitad de los pacientes con AR y 2/3 con Aps o EA continúan con el primer biológico, pero con frecuentes ajustes de tratamiento

OBJECTIVES: To describe the therapeutic management of Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) and Ankylosing Spondylitis (AS) in patients initiating treatment with biological agents. MATERIALS AND METHODS: Observational, retrospective, longitudinal study in 33 Spanish hospitals. Patients with RA, PsA and AS starting treatment with biological agents between September 2009 and August 2010 and a follow-up longer than 3 years were included. Clinical-demographic characteristics, drugs, biological therapy survival, and reasons for discontinuation or switching were analyzed. RESULTS: Four hundred and sixty-three patients were included (183 RA, 119 PsA and 161 AS), with a mean follow-up of 3.8 years. At the end of follow-up, a high proportion continued with the first biological prescribed (41.0% of RA, 59.7% of PsA and 51.6% of AS), 31.1%, 47.9% and 42.9% of RA, PsA and AS patients requiring dosage adjustments, respectively. There was temporary discontinuation in 8.2%, 8.4% and 15.5% of patients, and a switch of biologic agent was required in 37.7%, 26.1% and 24.2%. Definitive discontinuation occurred in 13.1%, 5.9% and 8.7% of RA, PsA and AS patients, respectively. Mean time to discontinuation or switching was 30.1 months for RA and 35.7 months for PsA and AS. CONCLUSIONS: Our results suggest that, in practice, half of patients with RA and two thirds with PsA or AS maintained the first biological, but with frequent dose adjustments

Biological Treatment Patterns in Patients with Inflammatory Joint Diseases. Retrospective Study with 4 Years Follow-up. / Patrones de tratamiento biológico en pacientes con enfermedades articulares inflamatorias. Estudio retrospectivo de 4 años de seguimiento.

OBJECTIVES: To describe the therapeutic management of Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) and Ankylosing Spondylitis (AS) in patients initiating treatment with biological agents. MATERIALS AND METHODS: Observational, retrospective, longitudinal study in 33 Spanish hospitals. Patients with RA, PsA and AS starting treatment with biological agents between September 2009 and August 2010 and a follow-up longer than 3 years were included. Clinical-demographic characteristics, drugs, biological therapy survival, and reasons for discontinuation or switching were analyzed. RESULTS: Four hundred and sixty-three patients were included (183 RA, 119 PsA and 161 AS), with a mean follow-up of 3.8 years. At the end of follow-up, a high proportion continued with the first biological prescribed (41.0% of RA, 59.7% of PsA and 51.6% of AS), 31.1%, 47.9% and 42.9% of RA, PsA and AS patients requiring dosage adjustments, respectively. There was temporary discontinuation in 8.2%, 8.4% and 15.5% of patients, and a switch of biologic agent was required in 37.7%, 26.1% and 24.2%. Definitive discontinuation occurred in 13.1%, 5.9% and 8.7% of RA, PsA and AS patients, respectively. Mean time to discontinuation or switching was 30.1 months for RA and 35.7 months for PsA and AS. CONCLUSIONS: Our results suggest that, in practice, half of patients with RA and two thirds with PsA or AS maintained the first biological, but with frequent dose adjustments.

Short-term cost and efficiency analysis of raltegravir versus atazanavir/ritonavir or darunavir/ritonavir for treatment-naive adults with HIV-1 infection in Spain.

INTRODUCTION: The AIDS Clinical Trial Group (ACTG) 5257 clinical trial showed that raltegravir (RAL) was superior to atazanavir/ritonavir (ATV/r) and darunavir/ritonavir (DRV/r), when used in combination with emtricitabine/tenofovir DF (FTC/TDF), in a 96-week composite endpoint combining virologic efficacy and tolerability for treatment-naive adults with HIV-1 infection. This study aimed to estimate the efficiency associated with these three regimens in Spain. METHODS: An economic model was developed to estimate costs for antiretroviral drugs, adverse event management, and HIV care for individuals initiating first-line therapy. Antiretroviral drug costs were based on hospital costs with mandatory discounts applied. Adverse event management costs and HIV care costs were obtained from published sources and inflated to 2015 euros. Head-to-head efficacy and safety data (discontinuation rates, mean CD4 cell-count changes, adverse event incidence) up to 96 weeks for each regimen were obtained from the clinical trial. The efficiency of each regimen, as measured by the cost per successfully treated patient (i.e. on first-line therapy for 96 weeks), was estimated and examined in sensitivity analyses. All cost outcomes were discounted at 3.0% annually. RESULTS: Total costs per successfully treated patient were €22,377 for RAL, €26,629 for ATV/r, and €23,928 for DRV/r. These results were found to be robust in sensitivity analyses. DISCUSSION: RAL has the lowest cost per successfully treated patient when compared with DRV/r and ATV/r, each used in combination with FTC/TDF, for treatment-naive adults with HIV-1 infection in Spain. This economic evidence complements the clinical benefits of RAL reported in the ACTG 5257 clinical trial.

Patients' and rheumatologists' preferences for the attributes of biological agents used in the treatment of rheumatic diseases in Spain.

PURPOSE: To define importance values assigned to attributes of biological agents (BAs) by Spanish patients with rheumatic diseases (rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis) and rheumatologists. PATIENTS AND METHODS: This was an observational, cross-sectional design based upon a rank-based full-profile conjoint analysis. A literature review and four focus groups were undertaken to identify attributes and levels. An orthogonal matrix, combining the selected levels of attributes, was used to define scenarios. Participants ranked eight scenarios from 1 (most preferred) to 8 (least preferred). The relative importance (RI) of attributes was calculated. Multivariate regression analysis was performed to identify the characteristics that influenced the values of RI. A total of 488 patients (male 50.9%, mean age 50.6 [standard deviation {SD} 12.06] years, rheumatoid arthritis 33.8%, ankylosing spondylitis 32.4%, psoriatic arthritis 33.8%; mean time since diagnosis 12.6 [SD 8.2] years) and 136 rheumatologists (male 50.4%, mean age 46.4 [SD 9.1] years, mean time of practice 16.7 [SD 8.8] years) participated. RESULTS: The ideal BAs for patients and physicians, respectively, should allow pain relief and improvement of functional capacity (RI 39% and 44.7%), with low risk of adverse events (RI 24.9% and 30.5%), a long time prior to perceiving the need for a new dose (RI 16.4% and 12.4%), and self-administration at home (RI 19.7% and 12.5%), as identified through their preferences. CONCLUSION: Although efficacy and safety are paramount for patients and rheumatologists to make a choice regarding BAs, the need for a low frequency of administration and the administration method also play a role as preference attributes for BAs.

Impact of a Dynamic Microbiological Environment on the Clinical Efficacy of Ertapenem and Piperacillin/Tazobactam in the Treatment of Complicated Community-Acquired Intra-Abdominal Infection in Spain: A Cost-Consequence Analysis.

BACKGROUND AND OBJECTIVE: The microbial susceptibility of many antibiotics has been affected by prescribing patterns and their extensive use. The purpose of this evaluation was to assess how these changes could affect the initial efficacy of ertapenem and piperacillin/tazobactam in the treatment of complicated intra-abdominal infections (IAIs) acquired in the community and the potential consequences this may have in healthcare costs in Spain. METHODS: The Initial efficacy of ertapenem and piperacillin/tazobactam for patients with APACHE (Acute Physiology and Chronic Health Evaluation) II scores <10 was extracted from a multicenter randomized study and were combined with the current microbial susceptibilities obtained from the SMART study, a multinational surveillance program. Country-specific pathogens distribution was extracted from a national study in patients with community-acquired IAI. The estimated effectiveness was used in a decision-analytic model to compare total costs between ertapenem and piperacillin/tazobactam in the treatment of complicated IAI. The model performs extensive one-way and probabilistic sensitivity analyses. RESULTS: The model suggested a savings of €209 (year 2012 values) per patient when complicated IAIs acquired in the community (APACHE II <10) were treated with ertapenem instead of piperacillin/tazobactam. One-way sensitivity analyses showed length of stay as the key driver parameter. Further analysis of this parameter and probabilistic sensitivity analysis confirmed the robustness of our evaluation, with a 58% likelihood of ertapenem being dominant. CONCLUSIONS: Ertapenem appears to be a cost-saving strategy over piperacillin/tazobactam for the treatment of patients with complicated IAIs acquired in the community in Spain.

Antibiotic expected effectiveness and cost under real life microbiology: evaluation of ertapenem and ceftriaxone in the treatment of community-acquired pneumonia for elderly patients in Spain.

BACKGROUND: Clinical efficacy of antibiotics may be affected by changes in the susceptibility of microorganisms to antimicrobial agents. The purpose of this study is to assess how these changes could affect the initial efficacy of ertapenem and ceftriaxone in the treatment of community-acquired pneumonia (CAP) in elderly patients and the potential consequences this may have in health care costs. METHODS: Initial efficacy in elderly was obtained from a combined analysis of two multicenter, randomized studies. An alternative scenario was carried out using initial efficacy data according to the pneumonia severity index (PSI). Country-specific pathogens distribution was obtained from a national epidemiological study, and microbiological susceptibilities to first- and second-line therapies were obtained from Spanish or European surveillance studies. A decision analytic model was used to compare ertapenem versus ceftriaxone for CAP inpatient treatment. Inputs of the model were the expected effectiveness previously estimated and resource use considering a Spanish national health system perspective. Outcomes include difference in proportion of successfully treated patients and difference in total costs between ertapenem and ceftriaxone. The model performed one-way and probabilistic sensitivity analyses. RESULTS: First-line treatment of CAP with ertapenem led to a higher proportion of successfully treated patients compared with ceftriaxone in Spain. One-way sensitivity analysis showed that length of stay was the key parameter of the model. Probabilistic sensitivity analysis showed that ertapenem can be a cost-saving strategy compared with ceftriaxone, with a 59% probability of being dominant (lower costs with additional health benefits) for both, elderly patients (>65 years) and patients with PSI >3. CONCLUSION: The incorporation of the current antimicrobial susceptibility into the initial clinical efficacy has a significant impact in outcomes and costs in CAP treatment. The treatment with ertapenem compared with ceftriaxone resulted in better clinical outcomes and lower treatment costs for two segments of the Spanish population: elderly patients and patients with severe pneumonia (PSI >3).

Attainment of normal lipid levels among high cardiovascular risk patients: pooled analysis of observational studies from the United Kingdom, Sweden, Spain and Canada.

BACKGROUND: Although low-density lipoprotein cholesterol (LDL-C) is the primary lipid target for cardiovascular disease (CVD) risk reduction, high-density lipoprotein cholesterol (HDL-C) and triglycerides (TG) have also emerged as risk factors. This study evaluated attainment of goal/normal lipid levels in current clinical practice among high-risk patients following lipid-modifying therapy (LMT). METHODS: Data for patients aged ≥35years and on LMT for ≥12months were identified from electronic medical records (United Kingdom and Sweden) and extracted from medical charts (Canada and Spain). High CVD risk was defined according to the Adult Treatment Panel III guidelines. An index period was defined, from January 1995-July 2008, during which patients received an initial LMT prescription. Prevalence of lipid abnormalities was assessed 12months before and after the index date. Multivariate logistic regressions evaluated predictors of attaining goal/normal lipid levels. RESULTS: Among 12,768 high-risk patients, 75% had elevated LDL-C, 37% low HDL-C, and 30% elevated TG before LMT. Despite therapy (97% statins only), 23% had elevated LDL-C, 36% low HDL-C, 16% elevated TG, and 17% had ≥2 abnormal lipid levels. Framingham risk score >20% (Odds Ratio, 95% confidence interval: 0.37,0.31-0.43), diabetes (0.75,0.64-0.88), hypertension (1.26,1.09-1.46), current smoker (0.82,0.70-0.95) and increased body mass index (0.95,0.94-0.96) were associated with the likelihood of attaining ≥2 normal lipid levels (vs. LDL-C goal only). CONCLUSION: Current approaches to lipid management improve LDL-C goal attainment; however, control of multiple lipid risk factors remains poor. Patients may benefit from more comprehensive approaches to lipid management, which treat multiple lipid abnormalities, as suggested in clinical guidelines.

Calcium and vitamin D intake by postmenopausal women with osteoporosis in Spain: an observational calcium and vitamin D intake (CaVIT) study.

BACKGROUND: Osteoporotic fractures are important causes of morbidity, mortality, and increased health care costs. However, the risk of osteoporotic fractures can be decreased, with clinical studies supporting the use of calcium and vitamin D supplements to promote bone health. Vitamin D insufficiency is widespread, particularly among postmenopausal women with osteoporosis, and this indicates that dietary intake is suboptimal, even though vitamin D supplements are widely available. METHODS: We conducted an observational study, using telephone surveys, to estimate vitamin D and calcium intake and the use of prescription osteoporosis medications in Spanish women aged ≥ 50 years with osteoporosis. RESULTS: Among the study participants, mean dietary calcium intake was 1239 mg/day and generally appeared sufficient in terms of the recommended daily intake guidance documents. Participants aged ≥ 75 years had a significantly lower mean dietary calcium intake (988 mg/day), thus one-half were below the level advised by the World Health Organization. Daily calcium intake was also lower in participants who were not taking prescription medications for bone health. Dietary vitamin D intake was 167 IU/day, which is well below both the established target dose (400 IU/day) and the more recent, higher guideline recommended for postmenopausal women (800-1300 IU/day). Dietary vitamin D intake was even lower for participants aged ≥ 75 years (120 IU/day) and was not related to the use of bone health prescription medications. CONCLUSION: These results support the need for greater promotion of the benefits of higher vitamin D intake in Spanish women with osteoporosis.

Intensive care unit-related fluconazole use in Spain and Germany: patient characteristics and outcomes of a prospective multicenter longitudinal observational study.

BACKGROUND: Candida spp. are a frequent cause of nosocomial bloodstream infections worldwide. OBJECTIVE: To evaluate the use patterns and outcomes associated with intravenous (IV) fluconazole therapy in intensive care units in Spain and Germany. PATIENTS AND METHODS: The research reported here was a prospective multicenter longitudinal observational study in adult intensive care unit patients receiving IV fluconazole. Demographic, microbiologic, therapy success, length of hospital stay, adverse event, and all-cause mortality data were collected at 14 sites in Spain and five in Germany, from February 2004 to November 2005. RESULTS: Patients (n = 303) received prophylaxis (n = 29), empiric therapy (n = 140), preemptive therapy (n = 85), or definitive therapy (n = 49). A total of 298 patients (98.4%) were treated with IV fluconazole as first-line therapy. The treating physicians judged therapy successful in 66% of prophylactic, 55% of empiric, 45% of preemptive, and 43% of definitive group patients. In the subgroup of 152 patients with proven and specified Candida infection only, 32% suffered from Candida specified as potentially resistant to IV fluconazole. The overall mortality rate was 42%. CONCLUSION: Our study informs treatment decision makers that approximately 32% of the patients with microbiological results available suffered from Candida specified as potentially resistant to IV fluconazole, highlighting the importance of appropriate therapy.

Validation of a new tool to assess health-related quality of life in psoriasis: the PSO-LIFE questionnaire.

BACKGROUND: Several questionnaires have been used to measure health related quality of life (HRQoL) in patients with psoriasis, few have been adapted for use in Spain; none of them was developed specifically for the Spanish population. The purpose of the study was to validate and assess the sensitivity to change of a new questionnaire to measure HRQOL in patients with psoriasis (PSO-LIFE). METHODS: Observational, prospective, multicenter study performed in centers around Spain. Patients with active or inactive psoriasis completed the PSO-LIFE together with other Dermatology Quality of Life Index (DLQI) and Psoriasis Disability Index (PDI). A control group of patients with urticaria or atopic dermatitis was also included. Internal consistency and test-retest reliability of the PSO-LIFE were assessed by calculating Cronbach's alpha and Intraclass Correlation Coefficient (ICC). Validity was assessed by examining factorial structure, the capacity to discriminate between groups, and correlations with other measures. Sensitivity to change was measured using effect sizes. RESULTS: The final sample included for analysis consisted of 304 patients and 56 controls. Mean (SD) age of psoriasis patients was 45.3 (14.5) years compared to 38.8 (14) years for controls (p < 0.01). Cronbach's alpha for the PSO-LIFE was 0.95 and test-retest reliability using the ICC was 0.98. Factor analysis showed the questionnaire to be unidimensional. Mean (SD) PSO-LIFE scores differed between patients with psoriasis and controls (64.9 [22.5] vs 69.4 [17.3]; p < 0.05), between those with active and inactive disease (57.4 [20.4] vs 76.4 [20.6]; p < 0.01), and between those with visible and non-visible lesions (63.0 [21.9] vs. 74.8 [23.9]; p < 0.01). The correlation between PSO-LIFE and PASI scores was moderate (r = -0.43) while correlations with DLQI and PDI dimensions ranged from moderate to high (between 0.4 and 0.8). Effect size on the PSO-LIFE in patients reporting 'much improved' health status at study completion was 1.01 (large effect size). CONCLUSIONS: The present results provide substantial support for the reliability, validity, and responsiveness of the PSO-LIFE questionnaire in the population for which it was designed.

Pauta de tratamiento inicial en pacientes con osteoporosis: uso de antirresortivos y suplementos farmacológicos (calcio y vitamina D) en la práctica clínica / Initial treatment trends in patient with osteoporosis: use of antiresorptive agents and pharmacologic supplements (calcium and vitamin D) in clinical practice

Objetivo. Describir el porcentaje de prescripción de suplementos farmacológicos en pacientes que inician pauta de tratamiento con antirresortivos (TAR) en pacientes con osteoporosis y por especialidades médicas. Diseño. Estudio transversal, con recogida de información retrospectiva, naturalístico y multicéntrico. Emplazamiento. Participaron 88 médicos españoles de atención primaria (AP), unidades de metabolismo óseo y mineral (UMO)/reumatología y ginecología. Participantes. Mujeres con osteoporosis que inician tratamiento TAR en los 12-36 meses previos a la visita. Mediciones principales. Variables clínicas generales y relativas al tratamiento de la osteoporosis (TAR, suplementos farmacológicos) y encuesta de opinión sobre suplementos farmacológicos. Resultados. Se incluyó a 480 pacientes. La edad media ± DE era de 65,8 ± 9,2 años. Se prescribieron suplementos farmacológicos en el 69,6% de las pacientes, siendo más frecuente en aquellas pacientes tratadas en consultas de UMO/reumatología (89,1%) que en las pacientes tratadas en AP (60,3%) y en ginecología (55,6%). En la encuesta realizada a los médicos el 72% de los médicos de UMO/reumatología y el 66,7% de ginecólogos respondieron que los suplementos de vitamina D son necesarios en el tratamiento habitual de la osteoporosis frente al 38,5% de los médicos de AP (p=0,058). Conclusiones. El uso de suplementos farmacológicos en la pauta inicial de tratamiento con TAR representa más del 60% de la muestra, aunque se detectan diferencias según tipo de especialista, con un mayor porcentaje de pacientes con suplementos en las consultas de UMO/Reumatología que en AP y ginecología, pese a que las guías recomiendan el uso mayoritario de suplementos farmacológicos en estas pacientes (AU)

Initial treatment trends in patient with osteoporosis: use of antiresorptive agents and pharmacologic supplements (calcium and vitamin D) in clinical practice objetive To describe the percentage of prescription of pharmacologic supplements in patients starting antiresorptive treatment (ART) for osteoporosis by specialists. Design. Cross-sectional, naturalistic, multicenter study with retrospective data collection. Patients and methods. 88 Spanish primary care (PC) physicians participated as well as those from Bone Metabolism Unit / Rheumatology and Gynecology units. Patients were females with osteoporosis who started ART in the 12 to 36 months prior to the visit. Main outcomes. General clinical variables and those related to osteoporosis treatment (both ART and pharmacologic supplements) and an opinion survey on pharmacologic supplements. Results. 480 patients were included. Mean age (SD) was 65.8 (9.2) years. Pharmacologic supplements were prescribed in 69.6% of patients and were more frequent in patients treated in Bone Metabolism/Rheumatology Units (89.1%) than patients treated by PC (60.3%) and Gynecology (55.6%). In the physician survey, 72% of the Bone Metabolism / Rheumatology Unit physicians responded that the Vitamin D supplements were necessary for treatment of osteoporosis vs. 38.5% of PC physicians (p=0.058). Conclusions. The use of pharmacologic supplements in the onset of treatment with ART represents more than 60% of the sample, although differences were seen between specialists, with a greater percentage of patients with supplements in the Bone Metabolism/Rheumatology Units than in PC and Gynecology, despite guidelines primarily recommend the use of pharmacologic supplements in these patients (AU)

Observational study of treatment compliance in women initiating antiresorptive therapy with or without calcium and vitamin D supplements in Spain.

OBJECTIVE: The aims of this study were to evaluate the compliance with antiresorptive therapy (ART) and supplements in Spain and to analyze the validity of the different treatment compliance assessment methods. METHODS: A cross-sectional study with retrospective data collection was carried out in women starting ART, evaluating indirect objective compliance, self-reported compliance, and the Morisky-Green questionnaire. RESULTS: A total of 480 women with a mean (SD) age of 65.8 (9.2) years were studied. Of these women, 62.9% received calcium and/or vitamin D supplements in addition to ART. According to the objective compliance method, 76.9% of the women were compliers (≥80%) with bisphosphonates; 69.4%, with selective estrogen receptor modulators; and 61.8%, with supplements (P < 0.01). Using the self-reported compliance, we identified 91% compliers with antiresorptive drugs and 75% with supplements. Using the Morisky-Green test, we classified 60.8% of the women as compliers with antiresorptive drugs and 48.4% with supplements. Combining the objective and self-reported compliance, 29.5% of the women did not adequately comply with ART and 56% with the drug supplements. CONCLUSIONS: With all three compliance measures, supplements were the treatment yielding the lowest percentage of compliers. Bisphosphonates constituted the treatment offering the best objective compliance: 38.2% of the women with drug supplements and between 23.1% and 30.6% of the women with ART failed to exceed the theoretical value of 80% regarded as representing good compliance.

Reduction of urinary levels of N-telopeptide correlates with treatment compliance in women with postmenopausal osteoporosis receiving alendronate.

OBJECTIVE: The aim of this study was to assess the factors associated with the effectiveness of treatment with alendronate (ALN) quantified by a reduction in urinary excretion of N-telopeptide (NTx). METHODS: The study is an observational, prospective, multicenter trial, with a 6-month follow-up. Postmenopausal osteoporotic women (densitometric criteria), who initiated treatment with ALN (70 mg/weekly) without previous treatment with antiresorptive agents (12 month) and calcitonin (6 month), were included. The assessment of NTx levels (nmol bone collagen equivalents/mmol creatinine) in the urine was performed at baseline and after completion of follow-up. A logistic regression model included "achieving a reduction in urinary NTx of at least 30% (minimal clinically significant change [MCSC])" as a dichotomous dependent variable and the following as independent variables: baseline urinary NTx levels, treatment compliance, years since diagnosis of menopause, ALN treatment duration, and treatment with calcium and vitamin D. Treatment compliance was assessed as the percentage of days of medication prescribed as a function of the time between the beginning and end of treatment. Good compliance was defined as a percentage between 80% and 120%. RESULTS: The variables that reached statistical significance were baseline urinary NTx values (odds ratio, 1.052; 95% CI, 1.025-1.079) and compliance (odds ratio, 3.9; 95% CI, 1.5-10.1). Therefore, the women with good treatment compliance were almost 4 times more likely to achieve an MCSC in NTx levels, and the raise in one unit of urinary NTx baseline values increased by 5% of the probability of achieving MCSC. CONCLUSIONS: Treatment with ALN (70 mg/week) in women with postmenopausal osteoporosis effectively reduces the urinary excretion of the bone turnover biomarker NTx. The probability of achieving a clinically significant reduction is greater in those women with higher baseline levels of NTx and in women who comply with treatment.

[Initial treatment trends in patient with osteoporosis: use of antiresorptive agents and pharmacologic supplements (calcium and vitamin D) in clinical practice]. / Pauta de tratamiento inicial en pacientes con osteoporosis: uso de antirresortivos y suplementos farmacológicos (calcio y vitamina D) en la práctica clínica.

OBJECTIVE: To describe the percentage of prescription of pharmacologic supplements in patients starting antiresorptive treatment (ART) for osteoporosis by specialists. DESIGN: Cross-sectional, naturalistic, multicenter study with retrospective data collection. PATIENTS AND METHODS: 88 Spanish primary care (PC) physicians participated as well as those from Bone Metabolism Unit / Rheumatology and Gynecology units. Patients were females with osteoporosis who started ART in the 12 to 36 months prior to the visit. MAIN OUTCOMES: General clinical variables and those related to osteoporosis treatment (both ART and pharmacologic supplements) and an opinion survey on pharmacologic supplements. RESULTS: 480 patients were included. Mean age (SD) was 65.8 (9.2) years. Pharmacologic supplements were prescribed in 69.6% of patients and were more frequent in patients treated in Bone Metabolism/Rheumatology Units (89.1%) than patients treated by PC (60.3%) and Gynecology (55.6%). In the physician survey, 72% of the Bone Metabolism / Rheumatology Unit physicians responded that the Vitamin D supplements were necessary for treatment of osteoporosis vs. 38.5% of PC physicians (p=0.058). CONCLUSIONS: The use of pharmacologic supplements in the onset of treatment with ART represents more than 60% of the sample, although differences were seen between specialists, with a greater percentage of patients with supplements in the Bone Metabolism/Rheumatology Units than in PC and Gynecology, despite guidelines primarily recommend the use of pharmacologic supplements in these patients.

Association of hypoglycemic symptoms with patients' rating of their health-related quality of life state: a cross sectional study.

BACKGROUND: To evaluate the association between patient-reported hypoglycemic symptoms with ratings of their health-related quality of life state and patient-reported adverse events in patients with type 2 diabetes mellitus (T2DM). METHODS: This observational, multicenter, cross sectional study was based on a sample of patients with T2DM from seven European countries who added sulfonylurea or thiazolidinedione to metformin monotherapy between January 2001 and January 2006. Included patients were required to have at least one hemoglobin A1c (HbA1c) measurement in the 12 months before enrollment and to not be receiving insulin. Demographic and clinical data from medical records were collected using case report forms. Questionnaires measured patient-reported hypoglycemic symptoms, health-related quality of life (EuroQol visual analogue scale, EQ-5D VAS), and treatment-related adverse events. RESULTS: A total of 1,709 patients were included in the study. Mean patient age was 63 years, 45% were female, mean HbA1c was 7.06%, and 28% were at HbA1c goal (HbA1c < 6.5%). Hypoglycemic symptoms during the 12 months before enrollment were reported by 38% of patients; among whom 68% reported their most severe symptoms were mild, 27% moderate, and 5% severe. Adjusted linear regression analyses revealed that patients reporting hypoglycemic symptoms had significantly lower EQ-5D VAS scores indicating worse patient-reported quality of life (mean difference -4.33, p < 0.0001). Relative to those not reporting symptoms, the adjusted decrement to quality of life increased with greater hypoglycemic symptom severity (mild: -2.68, p = 0.0039; moderate: -6.42, p < 0.0001; severe: -16.09, p < 0.0001). Patients with hypoglycemia reported significantly higher rates of shakiness, sweating, excessive fatigue, drowsiness, inability to concentrate, dizziness, hunger, asthenia, and headache (p < 0.0001 for each comparison). CONCLUSIONS: Hypoglycemic symptoms and symptom severity have an adverse effect on patients' rating of their health related quality of life state. Hypoglycemic symptoms are correlated with treatment-related adverse effects. Minimizing the risk and severity of hypoglycemia may improve patients' quality of life and clinical outcomes. Results are subject to limitations associated with observational studies including the potential biases due to unobserved patient heterogeneity and the use of a convenience sample of patients.

Calcium and vitamin D intake by postmenopausal women with osteoporosis in France.

OBJECTIVE: To assess dietary calcium and vitamin D intake and their relationship with prescription medication and nutritional supplement use among postmenopausal women with osteoporosis in France. RESEARCH DESIGN AND METHODS: Telephone interviews were conducted with 207 postmenopausal women with osteoporosis referred by a random sample of physicians from a French national list. Based on a French food frequency questionnaire, patients reported their daily food intake and frequency as well as their use of prescription medications and nutritional supplements. RESULTS: Average daily dietary vitamin D intake was only 144.8 IU (SD 84.6, p < 0.01 compared to the recommended 800 IU), with 30% of the sample taking a vitamin D supplement. No participant had more than 500 IU vitamin D daily from food alone and 78% had less than 200 IU per day. A total of 51% of patients took no vitamin D supplements and had less than 5 hours of sun exposure in a week. Patients who were receiving osteoporosis medications and those who were not had comparable vitamin D intake. The average daily dietary calcium intake was 966.4 mg (SD 273.7, p < 0.01 compared to the 800 mg recommended). Calcium supplements were taken by 38% of participants and older patients tended to take more. Limitations of the study include convenience sampling and patient self-report. CONCLUSIONS: Daily vitamin D intake among this sample of postmenopausal osteoporotic women in France was significantly lower than recommended dosages. At least 50% of these patients might benefit by adding vitamin D to their current therapy.

Cost-effectiveness analysis of raltegravir in treatment-experienced HIV type 1-infected patients in Spain.

Raltegravir, a novel HIV-1 integrase inhibitor, has superior efficacy with optimized background treatment (OBT) vs. placebo + OBT in treatment-experienced HIV-1 patients. This study assessed the long-term cost effectiveness of raltegravir from a Spanish National Healthcare System perspective. A cohort-state-transition model was used to estimate clinical and economic outcomes associated with raltegravir + OBT vs. OBT alone. Subjects were stratified into health states according to HIV RNA level, CD4 count, and opportunistic infection (OI) history, and could transition into different health states over time based on projected long-term efficacy. Each health state was associated with a distinct treatment cost and utility (QoL) score. Model inputs for mortality, resource utilization, unit costs, OI risk, and long-term durability of viral suppression were obtained from clinical trials, published studies, and database analyses. Model outcomes were reported as incremental cost-effectiveness ratios (ICERs) in 2007 Euros per quality-adjusted life-year (euro/QALY) gained. Costs and QALYs were discounted at 6% per year based on Spanish cost-effectiveness guidelines. Extensive sensitivity analyses were conducted. Five years of treatment with raltegravir + OBT resulted in an additional 4.5 years of undiscounted life expectancy vs. OBT alone. The ICER of raltegravir + OBT vs. OBT alone was euro22,908/QALY and euro31,431/QALY for 3- and 5-year use, respectively. Lower ICERs were observed with lower discount rates (3%) for costs and benefits, lower raltegravir price (20%), and shorter treatment duration (3 years). ICER was also sensitive to analytical time horizon and alternative sources of QoL scores. In treatment-experienced Spanish patients, raltegravir was projected to provide survival benefits and be cost effective.

Consequences of inappropriate initial empiric parenteral antibiotic therapy among patients with community-acquired intra-abdominal infections in Spain.

To assess the association between inappropriate antibiotic therapy and clinical outcomes for complicated community-acquired intra-abdominal infections in Spain, patient records from October 1998 to August 2002 in 24 hospitals were reviewed. Initial empiric therapy was classified appropriate if all isolates were sensitive to at least 1 of the antibiotics administered. Multivariate analyses were performed to assess associations between appropriateness of therapy and patient outcomes. Healthcare resource use was measured as hospital length of stay (LOS) and d on intravenous antibiotic therapy. A total of 425 patients were included. Of these, 387 (91%) received appropriate initial empiric therapy. Patients on inappropriate therapy were less likely to have clinical success (79% vs 26%, p<0.001), more likely to require additional antibiotic therapy (40% vs 7%, p<0.01) and more likely to be re-hospitalized within 30 d of discharge (18% vs 3%, p<0.01). Multivariate analyses also showed that inappropriate therapy was associated with an almost 16% increase in LOS (p<0.05) and 26% in d of intravenous antibiotic therapy compared with appropriate therapy (p<0.05). Inappropriate initial antibiotic therapy was associated with a significantly higher proportion of unsuccessful patient outcomes (including death, re-operation, re-hospitalization or additional parental antibiotic therapies), increased length of stay and length on therapy.

Imipenem/cilastatin versus piperacillin/tazobactam plus amikacin for empirical therapy in febrile neutropenic patients: results of the COSTINE study.

BACKGROUND: Combinations of beta-lactams plus aminoglycosides have become standard therapy for suspected infections in patients with profound neutropenia. However, it is not clear whether such combinations are advantageous over therapy with a broad-spectrum antibiotic. OBJECTIVE: To assess the clinical effectiveness and the cost-effectiveness ratio of empirical therapy of febrile neutropenia with imipenem/cilastatin (I/C) versus piperacillin/tazobactam plus amikacin (P/T+A). RESEARCH DESIGN AND METHODS: Prospective, multicenter observational study with 2 matched parallel cohorts treated with I/C (500 mg/6 h iv) or P/T+A (P/T: 4 g/6 h iv; A: 20 mg/kg/day iv). MAIN OUTCOME MEASURES: Therapeutic success was defined as the resolution of fever following > or = 7 days of unchanged antibiotic treatment. An economic comparison was conducted focusing on the daily treatment costs, and the management of its toxicity. RESULTS: There were 343 eligible patients (180 I/C, 163 P/T+A), of whom 290 were evaluable for the primary clinical effectiveness analysis. Follow-up information beyond 7 days of study inclusion was only available for 52% of all evaluable patients. Treatment success was observed in 42% of I/C patients compared with 31% of P/T+A patients (95% CI: -0.01, 21.4). The incidence of drug-related adverse experiences was 13% for I/C and 6% for P/T+A, with no differences in moderate or severe adverse experiences nor in those causing discontinuation of antibiotic therapy. Treatment costs were 189.55 euros (95% CI: 127.46-251.46) lower per episode of febrile neutropenia for patients treated with I/C. CONCLUSIONS: The clinical effectiveness of I/C was similar to that of P/T+A. In both treatment groups toxicity was low and did not limit antibiotic therapy. Resource consumption was lower with I/C.

Validación de la versión española del Pediatric Quality of Life Questionnaire en la valoración de la calidad de vida del niño asmático / Validity of the Spanish version of the Pediatric Quality of Life Questionnaire for evaluating quality of life in asthma children

Fundamento: Analizar la utilidad clínica y validar el cuestionario de calidad de vida para niños asmáticos (PAQLQ) en situación de práctica clínica. Pacientes y método: Se incluyeron 1.012 niños entre 6 y 14 años, diagnosticados de asma leve o moderada, atendidos en 48 hospitales españoles. Además de recoger variables sociodemográficas y clínicas de los pacientes, se administraron los cuestionarios PAQLQ y EQ-5D en dos ocasiones: en la visita basal y a los 2-3 meses en pacientes con asma no controlada (grupo A), o en la visita basal y a los 15 días en pacientes con asma controlada (grupo B). Se valoró la factibilidad, la validez, la fiabilidad y la sensibilidad al cambio del PAQLQ. Resultados: El PAQLQ puede aplicarse sin dificultades en niños con asma leve o moderada a partir de los 7 años. Este cuestionario no presentó una relación estadísticamente significativa con las variables sociodemográficas ni con la mayoría de las clínicas, a excepción de la gravedad del asma, el número de exacerbaciones, los síntomas y el uso de agonistas de ß2 de corta duración a demanda. Las dimensiones más asociadas entre el PAQLQ y el EQ-5D fueron aquellas que medían aspectos similares de la calidad de vida. El coeficiente * de Cronbach de las puntuaciones del PAQLQ osciló entre 0,88 (limitación de las actividades) y 0,96 (puntuación global). El coeficiente de correlación intraclase de las puntuaciones del PAQLQ obtenido en el grupo B osciló entre 0,71 (limitación de las actividades) y 0,83 (puntuación global). La magnitud del efecto entre ambas visitas osciló entre 0,49 y 0,69. Conclusiones: La versión española del PAQLQ demostró ser factible y válida para su uso en niños con asma leve y moderada (AU)