Prognostic Impact of Active Cigarette Smoking on Mortality in Patients with Acute Venous Thromboembolic Events, Findings from Real World Data.

Background and Objectives: The influence of smoking habits on mortality, VTE recurrence, and major bleeding in patients receiving anticoagulant therapy for venous thromboembolism (VTE) has not been consistently evaluated. Materials and Methods: We used data from the RIETE (Registro Enfermedad TromboEmbólica) registry to compare mortality, VTE recurrence, and major bleeding risk in smoking versus non-smoking patients with acute VTE. Results: 50,881 patients (43,426 non-smoking and 7455 smoking patients) were included. After a median follow-up of 8.8 months, 7110 patients died (fatal PE 292 and fatal bleeding 281), 3243 presented VTE recurrence, and 1579 had major bleeding. At multivariate analysis, smoking behavior was associated with a higher hazard of death, (HR: 1.28; 95% CI: 1.19-1.40). The risk of VTE recurrence was marginally increased in smoking patients compared to non-smoking patients (1.14; 95% CI: 1.02-1.27). Major bleeding did not differ in smoking and non-smoking patients (1.15; 95% CI: 0.96-1.38). The presence of cancer did not appear to influence the association between smoking habits and death (HR: 1.34; 95% CI: 1.22-1.47 in cancer patients and HR: 1.23; 95% CI: 1.04, 1.45 in non-cancer patients, respectively) Conclusions: the risk of death after an acute episode of VTE appeared to be higher in smoking than in non-smoking patients and this risk is higher between patients presenting PE at the onset of symptoms.

Functional gastrointestinal disorders: real-life results of a multidisciplinary non-pharmacological approach based on group-consultations.

INTRODUCTION: functional gastrointestinal disorders are prevalent and resource consuming. The use of group-consultations in these diseases is limited and no specific multidisciplinary programs have been developed. METHODS: a multidisciplinary approach was used in patients with diverse functional gastrointestinal disorders attending group-consultations (group A). Five two-hour sessions were scheduled over a four-month period. Sessions consisted of a theoretical introduction (Pathophysiology, Low fodmap diet, Over the counter medications, Mediterranean diet, and Laughter therapy workshop) followed by relaxation techniques. This group was compared to a similar group of patients who received written information covering the topics discussed during the group-consultations (group B). Severity of digestive and psychological symptoms, use of drugs and adherence to the diet were the main outcomes measured. RESULTS: the mean age of participants was 43 (± 1.38) years, 78 % were female and 73 % had at least two functional gastrointestinal disorders. Sixty-two patients were included in group A and 17 in group B. The severity of gastrointestinal and psychological symptoms at baseline was similar in both groups. Globally, there was an improvement in all symptoms in both groups. The proportion of participants with severe baseline gastrointestinal symptoms or pathologic anxiety scores that showed improvement was significantly higher in group A (74 % vs 23 %, p = 0.005; 47 % vs 8 %, p = 0.02, respectively). Symptoms were reassessed at six and 12 months after the intervention in participants from group A who attended ≥ 80 % sessions and a sustained response was observed. CONCLUSIONS: group-consultations are useful and efficient to alleviate gastrointestinal and psychological symptoms in patients with functional gastrointestinal disorders.

How continuous monitoring changes the interaction of patients with a mobile telemedicine system.

BACKGROUND: The combination of telemedicine systems integrating mobile technologies with the use of continuous glucose monitors improves patients' glycemic control but demands a higher interaction with information technology tools that must be assessed. In this article, we analyze patients' behavior from the use-of-the-system point of view, identifying how continuous monitoring may change the interaction of patients with the mobile telemedicine system. METHODS: Patients' behavior were evaluated in a clinical experiment consisting of a 2-month crossover randomized study with 10 type 1 diabetes patients. During the entire experiment, patients used the DIABTel telemedicine system, and during the intervention phase, they wore a continuous glucose monitor. Throughout the experiment, all user actions were automatically registered. This article analyzes the occurrence of events and the behavior patterns in blood glucose (BG) self-monitoring and insulin adjustments. A subjective evaluation was also performed based on the answers of the patients to a questionnaire delivered at the end of the study. RESULTS: The number of sessions established with the mobile Smart Assistant was considerably higher during the intervention period than in the control period (29.0 versus 18.8, p < .05), and it was also higher than the number of Web sessions (29.0 versus 22.2, p < .01). The number of daily boluses was higher during the intervention period than in the control period (5.27 versus 4.40, p < .01). The number of daily BG measurements was also higher during the intervention period (4.68 versus 4.05, p < .05) and, in percentage, patients increased the BG measurements not associated to meals while decreasing the percentage of preprandial measurements. The subjective evaluation shows that patients would recommend the use of DIABTel in routine care. CONCLUSIONS: The use of a continuous glucose monitor changes the way patients manage their diabetes, as observed in the increased number of daily insulin bolus, the increased number of daily BG measurements, and the differences in the distribution of BG measurements throughout the day. Continuous monitoring also increases the interaction of patients with the information system and modifies their patterns of use. We can conclude that mobile technologies are especially useful in scenarios of tight monitoring in diabetes, and they are well accepted by patients.

Formulación de soluciones oftálmicas de ciclosporina en colirio al 2 por 100 para la práctica clínica / Formulation of cyclosporine 2% eyedrops solutions for clinical practice

Los colirios de ciclosporina existentes en la práctica farmacéuticapresentan deficiencias que hacen que su calidad y seguridad no seaaceptable, máxime cuando se emplea como fuente de materia primaun medicamento comercializado. En el presente trabajo se definela fuente de principio activo, los excipientes empleados, los métodosde elaboración de las formulaciones y su evaluación que incluye susolubilización, fabricación y estabilidad física, así como la toleranciade los vehículos en voluntarios sanos. Se han elaborado formulacionesacuosas y oleosas de colirios de ciclosporina al 2 por 100 convehículos como miristato de isopropilo, macrogolglicéridos de oleilo,triglicéridos de cadena media, aceite de oliva y suero fisiológico. Lafórmula de ciclosporina y miristato de isopropilo resulta la más adecuadapor lo que se propone al Formulario Nacional español(AU)

The cyclosporine eyedrops in the current pharmaceutical practicedisplay deficiencies that cause their quality and safety not acceptable,especially when a commercialized made up drug is used like sourceof raw material. In the present investigation, the source of activeprinciple is defined, the ingredients, the methods of making-upof the formulations and their evaluation that includes solving,manufacturing and physical stability as well as the tolerance of thevehicles in healthy volunteers. Aqueous and oily formulationscyclosporine 2% eyedrops have been manufactured using vehicleslike isopropyl myristate, oleoyl macrogolglycerides, medium chaintriglycerides, olive oil and saline solution. Cyclosporine and isopropylmyristate formula is the most suitable and it is proposed to beincluded into the Spanish National Formulary(AU)

Design, methods, and evaluation directions of a multi-access service for the management of diabetes mellitus patients.

Recent advances in information and communication technology allow the design and testing of new models of diabetes management, which are able to provide assistance to patients regardless of their distance from the health care providers. The M2DM project, funded by the European Commission, has the specific aim to investigate the potential of novel telemedicine services in diabetes management. A multi-access system based on the integration of Web access, telephone access through interactive voice response systems, and the use of palmtops and smart modems for data downloading has been implemented. The system is based on a technological platform that allows a tight integration between the access modalities through a middle layer called the multi-access organizer. Particular attention has been devoted to the design of the evaluation scheme for the system: A randomized controlled study has been defined, with clinical, organizational, economic, usability, and users' satisfaction outcomes. The evaluation of the system started in January 2002. The system is currently used by 67 patients and seven health care providers in five medical centers across Europe. After 6 months of usage of the system no major technical problems have been encountered, and the majority of patients are using the Web and data downloading modalities with a satisfactory frequency. From a clinical viewpoint, the hemoglobin A1c (HbA1c) of both active patients and controls decreased, and the variance of HbA1c in active patients is significantly lower than the control ones. The M2DM system allows for the implementation of an easy-to-use, user-tailored telemedicine system for diabetes management. The first clinical results are encouraging and seem to substantiate the hypothesis of its clinical effectiveness.