Characterisation of the management of patients with migraine in the primary care setting in Spain. Analysis of the results of the European My-LIFE anamnesis project.

INTRODUCTION: Migraine affects more than 4.5 million people in Spain, resulting in a considerable socioeconomic impact. Although national and international guidelines have been published, the management of patients with migraine, especially those with chronic migraine, is inadequate. SUBJECTS AND METHODS: We conducted a survey among 40 primary care (PC) physicians in Spain as part of a European project involving 201 physicians from 5 countries. RESULTS: Most participants issued diagnoses of episodic migraine and chronic migraine (93% vs 65%); 82.5% indicated that they did not refer these patients to specialists, and 100% of PC physicians stated that they were responsible for patient follow-up. The main tools used in PC for diagnosis and follow-up were clinical interviews, medical histories, and the patient diaries. Our data revealed that the treatments prescribed were not in accordance with the national and international guidelines. Participants who did not refer patients estimated that only 48% of patients received preventive treatment, and that the assessment of efficacy was based on patient perception. Seventy percent of respondents indicated a need for migraine training. Finally, 100% of participants considered that a guide for medical history taking and referral would be essential or useful for the management of migraine in PC. CONCLUSIONS: The survey results revealed a need for training and guidance in PC to improve the diagnosis and management of patients with migraine, particularly chronic migraine.

Evaluation and management of chemotherapy-induced cardiotoxicity in breast cancer: a Delphi study

Purpose. While much progress has been made in the treatment of breast cancer, cardiac complications resulting from therapy remain a significant concern. Both anthracyclines and novel targeted agents can inflict cardiac damage. The present study aimed to evaluate the difference between what it is currently done and what standards of care should be used to minimizing and managing cardiac toxicity in breast cancer survivors. Methods. A two-round multicenter Delphi study was carried out. The panel consisted of 100 oncologists who were asked to define the elected therapies for breast cancer patients, the clinical definition and patterns of cancer drug-derived cardiac toxicity, and those protocols focused on early detection and monitoring of cardiovascular outcomes. Results. Experts agreed a more recent definition of cardiotoxicity. Around 38 % of patients with early-stage disease, and 51.3 % cases with advanced metastatic breast cancer had preexisting risk factors for cardiotoxicity. Among risk factors, cumulative dose of anthracycline ≥450 mg/m2 and its combination with other anticancer drugs, and a preexisting cardiovascular disease were considered the best predictors of cardiotoxicity. Echocardiography and radionuclide ventriculography have been the proposed methods for monitoring changes in cardiac structure and function. Breast cancer is generally treated with anthracyclines (80 %), so that the panel strongly stated about the need to plan a strategy to managing cardiotoxicity. A decline of left ventricular ejection fraction (LVEF) >10 %, to an LVEF value <53 % was suggested as a criterion for changing the dose schedule of anthracyclines, or suspending the treatment of chemotherapy plus trastuzumab until the normalization of the left ventricular function. The use of liposomal anthracyclines was strongly suggested as a treatment option for breast cancer patients. Conclusions. The present report is the first to produce a set of statements on the prevention, evaluation and monitoring of chemotherapy-induced cardiac toxicity in breast cancer patients (AU)

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Evaluation and management of chemotherapy-induced cardiotoxicity in breast cancer: a Delphi study.

PURPOSE: While much progress has been made in the treatment of breast cancer, cardiac complications resulting from therapy remain a significant concern. Both anthracyclines and novel targeted agents can inflict cardiac damage. The present study aimed to evaluate the difference between what it is currently done and what standards of care should be used to minimizing and managing cardiac toxicity in breast cancer survivors. METHODS: A two-round multicenter Delphi study was carried out. The panel consisted of 100 oncologists who were asked to define the elected therapies for breast cancer patients, the clinical definition and patterns of cancer drug-derived cardiac toxicity, and those protocols focused on early detection and monitoring of cardiovascular outcomes. RESULTS: Experts agreed a more recent definition of cardiotoxicity. Around 38 % of patients with early-stage disease, and 51.3 % cases with advanced metastatic breast cancer had preexisting risk factors for cardiotoxicity. Among risk factors, cumulative dose of anthracycline ≥450 mg/m2 and its combination with other anticancer drugs, and a preexisting cardiovascular disease were considered the best predictors of cardiotoxicity. Echocardiography and radionuclide ventriculography have been the proposed methods for monitoring changes in cardiac structure and function. Breast cancer is generally treated with anthracyclines (80 %), so that the panel strongly stated about the need to plan a strategy to managing cardiotoxicity. A decline of left ventricular ejection fraction (LVEF) >10 %, to an LVEF value <53 % was suggested as a criterion for changing the dose schedule of anthracyclines, or suspending the treatment of chemotherapy plus trastuzumab until the normalization of the left ventricular function. The use of liposomal anthracyclines was strongly suggested as a treatment option for breast cancer patients. CONCLUSIONS: The present report is the first to produce a set of statements on the prevention, evaluation and monitoring of chemotherapy-induced cardiac toxicity in breast cancer patients.

Consensus and controversies in the definition, assessment, treatment and monitoring of BTcP: results of a Delphi study

Introduction. There is no unanimous consensus on the clinical features to define breakthrough cancer pain (BTcP). The current project aimed to investigate the opinion of a panel of experts on cancer pain on how to define, diagnose, assess, treat and monitor BTcP. Materials and methods. A two-round Spanish multi-centre exploratory Delphi study was conducted with medical experts (n = 90) previously selected from Medical Oncology Services, Radiation Oncology, Palliative Care/Home Care Teams, and Pain Units. The study intended to seek experts’ consensus and to define a set of recommendations for the management of BTcP. Results. It was generally agreed that, definition of BTcP implies that baseline pain should be controlled (84 %), although not necessarily with opioids (only 30 %); there must be exacerbations (98.9 %); the duration of each episode should last < 1 h (70 %); the intensity of pain ≥7 out of 10 (67.8 %); and the number of flares per day should not be less than four. All participants supported the use of the Davies algorithm for the diagnosis. The use of a ‘Patient Diary’ was highly recommended. The optimal treatment should have a rapid onset, a short-acting analgesic effect (1-2 h) and transmucosal nasal or oral administration. It was considered very important to develop protocols for the management of cancer pain. Conclusions. The present Delphi study identified a set of recommendations to define, assess and monitor BTcP (AU)

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Consensus and controversies in the definition, assessment, treatment and monitoring of BTcP: results of a Delphi study.

INTRODUCTION: There is no unanimous consensus on the clinical features to define breakthrough cancer pain (BTcP). The current project aimed to investigate the opinion of a panel of experts on cancer pain on how to define, diagnose, assess, treat and monitor BTcP. MATERIALS AND METHODS: A two-round Spanish multi-centre exploratory Delphi study was conducted with medical experts (n = 90) previously selected from Medical Oncology Services, Radiation Oncology, Palliative Care/Home Care Teams, and Pain Units. The study intended to seek experts' consensus and to define a set of recommendations for the management of BTcP. RESULTS: It was generally agreed that, definition of BTcP implies that baseline pain should be controlled (84 %), although not necessarily with opioids (only 30 %); there must be exacerbations (98.9 %); the duration of each episode should last <1 h (70 %); the intensity of pain ≥7 out of 10 (67.8 %); and the number of flares per day should not be less than four. All participants supported the use of the Davies algorithm for the diagnosis. The use of a 'Patient Diary' was highly recommended. The optimal treatment should have a rapid onset, a short-acting analgesic effect (1-2 h) and transmucosal nasal or oral administration. It was considered very important to develop protocols for the management of cancer pain. CONCLUSIONS: The present Delphi study identified a set of recommendations to define, assess and monitor BTcP.

Long-term effectiveness of glatiramer acetate in clinical practice conditions.

Glatiramer acetate currently represents one of the main treatments for relapsing-remitting multiple sclerosis (RRMS). However, the information available about its long-term effect in clinical practice is still limited. Thus, this multicenter retrospective cohort study aimed to assess the long-term effectiveness of glatiramer acetate in this setting. The study population included RRMS patients treated with glatiramer acetate for at least 5 years after its marketing authorization and the primary endpoint was long-term clinical effectiveness, defined as absence of disability progression for at least five consecutive years. A total of 149 patients were included into the study, who had received glatiramer acetate for a mean of 6.9 ± 1.4 years (5 years, n=149; 6 years, n=112; 7 years, n=63; 8 years, n=32; 9 years, n=21). More than 85% of patients remained free from disability progression through years 1 to 9 of glatiramer acetate treatment, and 75.2% showed absence of disability progression for at least five consecutive years. Expanded Disability Status Scale (EDSS) scores were maintained, with most patients showing stable/improved EDSS and 92.6% sustaining EDSS <6. Decreased annual relapse rates and increased proportion of relapse-free patients were maintained during the whole glatiramer acetate treatment compared to the year prior to its authorization (p<0.001). The number of gadolinium-enhanced T1-weighted lesions also decreased from pre-glatiramer-acetate assessment to last follow-up whilst on glatiramer acetate (p<0.05). In conclusion, administration of glatiramer acetate shows long-term clinical effectiveness for RRMS treatment; its effect under clinical practice conditions slowed disability progression and reduced relapse occurrence for up to 9 years.

Análisis del impacto presupuestario del tratamiento en primera línea de la esclerosis múltiple remitente recurrente en España. Réplica / No disponible

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Spasticity improvement in patients with relapsing-remitting multiple sclerosis switching from interferon-ß to glatiramer acetate: the Escala Study.

BACKGROUND: A recent pilot study suggested spasticity improvement during glatiramer acetate (GA) treatment in multiple sclerosis (MS) patients who previously received interferon-ß (IFN-ß). OBJECTIVE: To evaluate changes in spasticity in MS patients switching from IFN-ß to GA. METHODS: Observational, multicentre study in patients with relapsing-remitting MS (RRMS) and spasticity switching from IFN-ß to GA. The primary endpoint comprised changes on Penn Spasm Frequency Scale (PSFS), Modified Ashworth Scale (MAS), Adductor Tone Rating Scale (ATRS), and Global Pain Score (GPS) at months 3 and 6 after starting GA. RESULTS: Sixty-eight evaluable patients were included (mean age,41.7±9.5 years; female,70.6%; mean time from MS diagnosis to starting GA,7.6±5.7 years). Previous treatments were subcutaneous IFN-ß1a in 42.6% patients, intramuscular IFN-ß1a in 41.2% and IFN-ß1b in 32.4%, whose mean durations were 3.5±3.3, 2.7±2.5 and 4.4±3.6 years, respectively. Statistically significant reductions in mean scores on all spasticity measurements were observed from baseline to month 3 (PSFS, 1.7±0.9 vs 1.4±0.6, p<0.01; MAS, 0.7±0.5 vs 0.6±0.5, p<0.01; highest MAS score, 1.9±0.8 vs 1.7±0.8, p<0.01; ATRS, 1.6±0.6 vs 1.4±0.6, p<0.01; GPS, 29.4±22.1 vs 24.7±19.4, p<0.01) and from baseline to month 6 (PSFS, 1.7±0.9 vs 1.3±0.6, p<0.01; MAS, 0.7±0.5 vs 0.5±0.5, p<0.01; highest MAS score, 1.9±0.8 vs 1.5±0.9, p<0.01; ATRS, 1.6±0.6 vs 1.3±0.6, p<0.01; GPS, 29.4±22.1 vs 19.1±14.8, p<0.01). CONCLUSION: Spasticity improvement in terms of spasm frequency, muscle tone and pain can be noted after three months and prolonged for six months of GA treatment.

[Budget impact analysis of the first-line treatment of relapsing remitting multiple sclerosis in Spain]. / Analisis del impacto presupuestario del tratamiento en primera linea de la esclerosis multiple remitente recurrente en Espana.

AIM: To assess the budget impact of the treatment for relapsing remitting multiple sclerosis (RRMS), interferons, and glatiramer acetate, from the National Health System perspective in Spain. PATIENTS AND METHODS: A budget impact model was designed to compare the cost of RRMS treatment in different settings, using a five year time-horizon, considering different percentages of administration of each medication. A reference setting o base case using all the available first line treatments (interferons and glatiramer acetate) was compared with five alternatives scenarios excluding each one of these treatments. The cost analysis (euros, year 2010) includes direct medical resources (drugs, administration, visits, disease management, diagnostic tests). Unitary cost data was obtained from the health costs database e-Salud and drugs catalogue. RESULTS: Considering a cohort of 22 255 patients with RRMS, the mean global budget impact per year would be 260 775 470 euros in the base case. The setting that excluded glatiramer acetate increases the budget impact in a 3.23% (372 euros per patient per year). Pharmacological costs were the key drivers of total cost (90%). CONCLUSION: The use of glatiramer acetate in the first-line-treatment of RRMS patients is a cost-saving strategy, which may decrease the budget impact from the National Health System perspective in Spain.

Protection against woodchuck hepatitis virus (WHV) infection by gene gun coimmunization with WHV core and interleukin-12.

Woodchuck hepatitis virus (WHV) and hepatitis B virus (HBV) are closely similar with respect to genomic organization, host antiviral responses, and pathobiology of the infection. T-cell immunity against viral nucleocapsid (HBcAg or WHcAg) has been shown to play a critical role in viral clearance and protection against infection. Here we show that vaccination of healthy woodchucks by gene gun bombardment with a plasmid coding for WHcAg (pCw) stimulates proliferation of WHcAg-specific T cells but that these cells do not produce significant levels of gamma interferon (IFN-gamma) upon antigen stimulation. In addition, animals vaccinated with pCw alone were not protected against WHV inoculation. In order to induce a Th1 cytokine response, another group of woodchucks was immunized with pCw together with another plasmid coding for woodchuck interleukin-12 (IL-12). These animals exhibited WHcAg-specific T-cell proliferation with high IFN-gamma production and were protected against challenge with WHV, showing no viremia or low-level transient viremia after WHV inoculation. In conclusion, gene gun immunization with WHV core generates a non-Th1 type of response which does not protect against experimental infection. However, steering the immune response to a Th1 cytokine profile by IL-12 coadministration achieves protective immunity. These data demonstrate a crucial role of Th1 responses in the control of hepadnavirus replication and suggest new approaches to inducing protection against HBV infection.

[Assessment of paclitaxel treatment of non-small-cell lung cancer]. / Evaluación del tratamiento con paclitaxel del cáncer de pulmón no microcítico.

BACKGROUND: Our goal was to assess the effectiveness of paclitaxel therapy in patients with non-small-cell lung cancer (NSCLC) by means of a meta-analysis of published clinical trials. MATERIAL AND METHOD: We carried out a search of controlled and randomized clinical trials which evaluated treatment with paclitaxel in patients with NSCLC from January 1996 to April 2001, regardless of any other associated therapy and without restrictions in the publication language. We also performed a sensitivity analysis and an analysis of sample heterogeneity. RESULTS: Six randomized and controlled studies fulfilled the inclusion criteria. Results from the analysis of effectiveness favoured significantly treatment with paclitaxel (OR 95% total responders: 1.42 [1.16-1.74]; p = 0.07). These results remained unchanged with the sensitivity analysis. Analysis of survival after 1 year of treatment was not significant (OR 95% 0.96 [0.79-1.17]; p = 0.2) CONCLUSIONS: Paclitaxel in patients with NSCLC offers a therapeutic advantage over other chemotherapy regimes with an overall OR of 1.42. However, this therapy does not appear to offer a significant survival advantage after 1 year.

¿Podemos utilizar el clopidogrel en pacientes a los que se ha implantado un stent coronario? / Clopidogrel can be utilized in patients with coronary stent?

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[Epidemiological surveillance of patients treated with digoxin]. / Aportes en la vigilancia epidemiológica de los pacientes tratados con digoxina.

In the present study we assess that the etiology of digitalis intoxication. We try to identify factors and intensity of each association. One thousand fifty patients form Havana City, Cuba were selected, under digitalis therapy. Two groups were made Cases and Controls. Each patient was evaluated by direct interview. There was a significative association (P < 0.01) among digitalis intoxication and; older persons who use high doses of digoxin, other risk factors were underweight, lack of potassium supplement, some associated diseases, combination therapy between digoxin, and furosemide, thyazides, dipyridamole, amiodarone, quinidine, nifedipine or verapamil, cigar smoking, alcohol intake and prior history of digitalis intoxication. The odds ratio (OR) was calculated for each association. We conclude: some factors are responsible for digitalis intoxication, each one contribute partially.