Comparison of the Use of Desflurane vs. Propofol in Aortic Valve Replacement Surgery: Differences in Nephroprotection: An Explorative and Hypothesis-Generating Study.

Introduction: The cardioprotective effect of halogenated drugs in cardiac surgery has been the subject of several studies. However, there is scarcity of data on their potential nephroprotective effects. Aortic valve replacement and coronary revascularization are the most frequent cardiac surgery procedures. The objective of this explorative study was to examine the effect of desflurane vs. propofol on renal function, when administered in aortic valve replacement surgery, including the extracorporeal circulation period. Method: A quasi-experimental prospective study was performed in 60 patients, who were allocated to receive either desflurane or propofol intraoperatively during aortic valve replacement surgery. As a hypnotic, group 1 received propofol, whereas group 2 received desflurane. Markers of renal function and level of cardiac preservation were determined based on biochemical parameters (troponin I, NTProBNP). Results: In the propofol group, there were significant variations between postoperative values of urinary NGAL and creatinine and baseline values. In contrast, no variations were found in the desflurane group in terms of hemodynamic parameters and myocardial damage. Conclusions: The use of propofol vs. desflurane during aortic valve replacement surgery is associated with a decrease in renal function.

Prevalence and Clinical Conditions Related to Sarcopaenia among Older Persons Living in the Community.

(1) Background: In health care and in society at large, sarcopaenia is a disorder of major importance that can lead to disability and other negative health-related events. Our study aim is to determine the prevalence of sarcopaenia among older people attended in primary care and to analyse the factors associated with this age-related clinical condition; (2) Methods: A multicentre cross-sectional study was conducted of 333 community-dwelling Spanish adults aged 65 years or more. Sociodemographic, clinical, functional, anthropometric, and pharmacological data were collected. Sarcopaenia was defined following European Working Group on Sarcopaenia in Older People (EWGSOP) criteria; (3) Results: Sarcopaenia was present in 20.4% of the study sample, and to a severe degree in 6%. The intensity of the association between sarcopaenia and frailty was weak-moderate (Cramer V = 0.45). According to the multinomial logistic regression model performed, sarcopaenia was positively associated with age and with the presence of psychopathology (OR = 2.72; 95% CI = 1.30-5.70) and was inversely correlated with body mass index (OR = 0.73, 95% CI = 0.67-0.80; (4) Conclusions: Sarcopaenia commonly affects community-dwelling older persons and may be associated with age, body mass index, and psychopathology. The latter factor may be modifiable or treatable and is therefore a possible target for intervention.

Assessing Prevalence and Factors Related to Frailty in Community-Dwelling Older Adults: A Multinomial Logistic Analysis.

Frailty is an age-related clinical condition that typically involves a deterioration in the physiological capacity of various organ systems and heightens the patient's susceptibility to stressors. For this reason, one of the main research goals currently being addressed is that of characterising the impact of frailty in different settings. The main aim of this study is to determine the prevalence of Fried's frailty phenotype among community-dwelling older people and to analyse the factors associated with frailty. In this research study, 582 persons aged 65 years or more participated in this cross-sectional study that was conducted at primary healthcare centres in Málaga, Spain. Sociodemographic, clinical, functional and comprehensive drug therapy data were compiled. The relationship between the independent variables and the different states of frailty was analysed by using a multinomial logistic regression model. Frailty was present in 24.1% of the study sample (95% CI = 20.7-27.6) of whom 54.3% were found to be pre-frail and 21.6% were non-frail. The study variable most strongly associated with frailty was the female gender (OR = 20.54, 95% CI = 9.10-46.3). Other factors found to be associated with the state of frailty included age, dependence for the instrumental activities of daily living (IADL), polymedication, osteoarticular pathology and psychopathology. This study confirms the high prevalence of frailty among community-dwelling older people. Frailty may be associated with many factors. Some of these associated factors may be preventable or modifiable and, thus, provide clinically relevant targets for intervention. This is particularly the case for depressive symptoms, the clinical control of osteoarthritis and the use of polypharmacy.

Renal and Neurologic Benefit of Levosimendan vs Dobutamine in Patients With Low Cardiac Output Syndrome After Cardiac Surgery: Clinical Trial FIM-BGC-2014-01.

BACKGROUND: Low-cardiac output syndrome (LCOS) after cardiac surgery secondary to systemic hypoperfusion is associated with a higher incidence of renal and neurological damage. A range of effective therapies are available for LCOS. The beneficial systemic effects of levosimendan persist even after cardiac output is restored, which suggests an independent cardioprotective effect. METHODS: A double-blind clinical trial was conducted in patients with a confirmed diagnosis of LCOS randomized into two treatment groups (levosimendan vs. dobutamine). Monitoring of hemodynamic (cardiac index, systolic volume index, heart rate, mean arterial pressure, central venous pressure, central venous saturation); biochemical (e.g. creatinine, S100B protein, NT-proBNP, troponin I); and renal parameters was performed using acute kidney injury scale (AKI scale) and renal and brain ultrasound measurements [vascular resistance index (VRI)] at diagnosis and during the first 48 h. RESULTS: Significant differences were observed between groups in terms of cardiac index, systolic volume index, NT-proBNP, and kidney injury stage at diagnosis. In the levosimendan group, there were significant variations in AKI stage after 24 and 48 h. No significant differences were observed in the other parameters studied. CONCLUSION: Levosimendan showed a beneficial effect on renal function in LCOS patients after cardiac surgery that was independent from cardiac output and vascular tone. This effect is probably achieved by pharmacological postconditioning. CLINICAL TRIAL REGISTRATION: EUDRA CT, identifier 2014-001461-27. https://www.clinicaltrialsregister.eu/ctr-search/search?query=2014-001461-27.

Factors Associated with Health-Related Quality of Life in Community-Dwelling Older Adults: A Multinomial Logistic Analysis.

The main aim of this study was to determine the association of various clinical, functional and pharmacological factors with the physical (PCS) and mental (MCS) summary components of the health-related quality of life (HRQoL) of community-dwelling older adults. Design: Cross-sectional study. Patients and setting: Sample of 573 persons aged over 65 years, recruited at 12 primary healthcare centres in Málaga, Spain. Sociodemographic, clinical, functional, and comprehensive drug therapy data were collected. The main outcome was HRQoL assessed on the basis of the SF-12 questionnaire. A multinomial logistic regression model was constructed to study the relationship between independent variables and the HRQoL variable, divided into intervals. The average self-perceived HRQoL score was 43.2 (± 11.02) for the PCS and 48.5 (± 11.04) for the MCS. The factors associated with a poorer PCS were dependence for the instrumental activities of daily living (IADL), higher body mass index (BMI), number of medications, and presence of osteoarticular pathology. Female gender and the presence of a psychopathological disorder were associated with worse scores for the MCS. The condition that was most strongly associated with a poorer HRQoL (in both components, PCS and MCS) was that of frailty (odds ratio (OR) = 37.42, 95% confidence interval (CI) = 8.96-156.22, and OR = 20.95, 95% CI = 7.55-58.17, respectively). It is important to identify the determinant factors of a diminished HRQoL, especially if they are preventable or modifiable.

2015 Beers Criteria and STOPP v2 for detecting potentially inappropriate medication in community-dwelling older people: prevalence, profile, and risk factors.

PURPOSE: To comparatively assess the prevalence rates of potentially inappropriate medications (PIMs) obtained by the former and latest versions of American Geriatrics Society Beers Criteria (AGS BC) and screening tool of older person's potentially inappropriate prescriptions (STOPP), and analyze the factors of influence on PIM. METHODS: Cross-sectional study including 582 community-dwelling older adults over the age of 65. Sociodemographic, clinical, functional, and comprehensive drug therapy data were collected. The primary endpoint was the percentage of patients receiving at least one PIM. RESULTS: A total of 3626 prescriptions were analyzed. PIMs were detected in 35.4% and 47.9% of patients according to the STOPP v1 and the 2012 AGS BC, respectively. This percentage rose to 54% when 2015 AGS BC were used and reached 66.8% with STOPP v2. The kappa coefficient between STOPP v2 and its former version was lower than the one between the updated Beers Criteria and their former version (0.41 vs 0.85). The agreement was good (0.65) between both latest criteria. The number of medications, psychological disorders, and insomnia were predictors of PIM. A novel finding was that bone and joint disorders increased the odds for PIM by 78%. CONCLUSIONS: The 2015 AGS BC showed high sensitivity and good applicability to the European older patients. Both updated tools identified some pharmacological groups (benzodiazepines, PPIs, and opioids, among others) and certain health problems (insomnia, psychological disorders, and osteoarticular diseases) as factors of influence on PIM. Based on these findings, interventions aimed at promoting appropriate use of medications should be developed.

Are there intra-operative hemodynamic differences between the Coliseum and closed HIPEC techniques in the treatment of peritoneal metastasis? A retrospective cohort study.

BACKGROUND: Although two main methods of intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC) are currently accepted, the superiority of one over the other has not yet been demonstrated. The purpose of this study was to determine whether there are hemodynamic and temperature differences between patients who received HIPEC in two different techniques, open versus closed abdomen. METHODS: This retrospective study was conducted in our center between 2011-2015 in 30 patients who underwent surgery for peritoneal carcinomatosis secondary to colorectal cancer, in whom cytoreduction and HIPEC were performed by the Coliseum (15) or closed techniques (15). The main end points were morbidity, mortality, hemodynamic changes, and abdominal temperature. The comparative analysis of quantitative variables at different times was done with the parametric repeated measure ANOVA for those variables that fulfilled the suppositions of normality and independence and the Friedman non-parametric test for the variables that did not fulfill either of these suppositions. RESULTS: There were no deaths in either group. The incidence of postoperative complications in the Coliseum group was 53% (8 patients), grade II-III. The incidence of complications in the closed group was 13% (2 patients), grade II-III. The intra-operative conditions regarding the systolic and diastolic pressures were more stable using the closed abdomen technique (but not significantly so). We found statistically significant differences in abdominal temperature in favor of the closed technique (p = 0.009). CONCLUSIONS: Both HIPEC procedures are similar. In our series, the closed technique resulted in a more stable intra-abdominal temperature.

Assessing Potentially Inappropriate Prescribing in Community-Dwelling Older Patients Using the Updated Version of STOPP-START Criteria: A Comparison of Profiles and Prevalences with Respect to the Original Version.

Emerging and changing evidence made it necessary to update STOPP-START criteria, and version 2 was published recently. In this study the objectives were to determine the prevalence of potentially inappropriate medication prescribing (PIM) in primary care using STOPP versions 1 (v1) and 2 (v2), as well as 2012 AGS Beers criteria, and analyze the factors associated with inappropriate prescribing according to STOPP/START v2. A cross-sectional study was carried out including community-dwelling older adults over the age of 65. Sociodemographic, clinical, functional and comprehensive drug therapy data were collected. The primary endpoint was the percentage of patients receiving at least one PIM. This variable was measured using three tools: STOPP v1, 2012 AGS Beers criteria and STOPP v2. Similarly, the percentage of patients receiving at least one potential prescribing omission (PPO) was calculated using START versions 1 and 2. A total of 1,615 prescriptions were reviewed. The median number of medications per patient was 7.1 drugs (±3.8). The prevalence of elderly people exposed to polypharmacy (≥5 medications) was 72.9%, whereas 28.4% of the participants took ≥10 drugs regularly. PIM were present in 18.7%, 37.3% and 40.4% of participants, according to the STOPP v1, 2012 Beers criteria and STOPP v2, respectively. According to STOPP v2, the number of medications taken (OR: 1.14, 1.06-1.25), the presence of a psychological disorder (OR: 2.22, 1.13-4.37) and insomnia (OR: 3.35, 1.80-6.32) were risk factors for taking a PIM. The prevalence of PPOs was 34.7% and 21.8% according to version 1 and 2, respectively. In conclusion, STOPP-START criteria have been remarkably modified, which is evidenced by the different prevalence rates detected using version 2, as compared to version 1. In fact, the level of agreement between version 1 and the updated version is only moderate. Special attention should be paid on benzodiazepines, which keep being the most frequent PIM.

Exposure to tobacco, alcohol and drugs of abuse during pregnancy. A study of prevalence among pregnant women in Malaga (Spain).

The prevalence of substance abuse in women who become pregnant is similar to that of the general population, resulting in a high fetal exposure rate during the most vulnerable period regarding neurodevelopment and organogenesis. The present study was intended to assess the level of prenatal exposure to tobacco, alcohol or illicit drugs in the city of Málaga (Spain). It was designed as a cross-sectional study, and based on the anonymous self-reports of participants. A total of 451 pregnant women were recruited in the first, second or third trimester. The prevalence in each of the quarters respectively was 21.2%, 18.5% and 13.3% for smoking, 40.7%, 23.1% and 17.1% for alcohol and 4.8%, 1.9% and 1.2% for cannabis. We also found that a higher educational level was associated with a lower consumption of tobacco (RR 0.659 [0.537-0.810] p<0.0001) and greater exposure to alcohol (RR 1.87 [1.30-2.69] p<0.0007). These results, particularly in regard to alcohol intake, are sufficiently alarming to alert obstetric care providers about the need to implement preventive measures.

La prevalencia de hábitos tóxicos en la población de mujeres que quedan embarazadas es similar a la de la población general, por lo que la exposición fetal a tóxicos es elevada en el período de mayor vulnerabilidad, sobre todo en relación al neurodesarrollo y la organogénesis. El presente estudio ha sido desarrollado para conocer el nivel de exposición prenatal a tabaco, alcohol u otras drogas en la ciudad de Málaga (España). El trabajo responde a un diseño observacional de corte transversal sobre el consumo de tóxicos durante el embarazo, y se basa en la autodeclaración de las gestantes mediante la cumplimentación de un cuestionario. Se reclutaron 451 gestantes de primer, segundo y tercer trimestre. La prevalencia de consumo en cada uno de los trimestres resultó ser respectivamente del 21.2%, 18.5% y 13.3% para el tabaco, 40.7%, 23.1% y 17.1% para el alcohol y del 4.8%, 1.9% y 1.2% para cannabis. En los tres trimestres, un mayor nivel de estudios se asoció a un menor consumo de tabaco (RR 0,659 [0.537-0.810] p< 0.0001) y una mayor exposición al alcohol (RR 1.87 [1.30-2.69] p< 0.0007). Los resultados obtenidos, sobre todo en relación al consumo de alcohol, son suficientemente llamativos como para alertar a los proveedores de atención obstétrica sobre la necesidad de poner en marcha medidas preventivas.

Estudio de las prescripciones farmacológicas en niños a nivel de atención primaria: evaluación de los usos off-label o fuera de ficha técnica / Drug prescriptions study in the outpatient setting: assessment of off-label uses in children

OBJETIVO: Evaluar el perfil de prescripción y los usos off-label (fuera de ficha técnica [FT]) y unlicensed(medicamentos no autorizados específicamente para niños) de medicamentos a nivel ambulatorio. DISEÑO: Estudio transversal. Emplazamiento: Consultas de pediatría de 2 centros de salud urbanos y sala de urgencia general del Hospital Materno-Infantil de Málaga. PARTICIPANTES: Niños de 0-14 años que acudiesen a consulta y se les prescribiese al menos un medicamento. MEDICIONES PRINCIPALES: Variables sociodemográficas, motivo de consulta y medicación. Clasificación de las prescripciones según información contenida en FT. RESULTADOS: Se incluyeron un total de 388 niños, una submuestra de 105 (27%) atendidos en urgencias, y se valoraron 462 prescripciones, que involucraron 74 principios activos diferentes. Cada niño recibió un promedio de 1,7 fármacos (IC 95%: 1,6-1,9), siendo los más prescritos ibuprofeno, paracetamol, amoxicilina-clavulánico y budesonida. El grupo terapéutico más empleado y con mayor variedad de fármacos fue el respiratorio. El 27,4% de las prescripciones (IC 95%: 23,5-31) fueron off-label, constituyéndose como causa más frecuente el uso del fármaco para una edad distinta de la autorizada (60%; IC 95%: 54,1-63), seguida de distinta dosis (21,5%; IC 95%: 18-25), diferente indicación (12%; IC 95%: 9,2-15) y el 7% por distinta vía de administración (IC 95%: 5,4-10). CONCLUSIONES: La tasa de usos off-label presenta cifras intermedias, pudiendo recibir este tipo de prescripciones una tercera parte de los niños. Esto no significa que sean prescripciones incorrectas, pero es recomendable respaldarlas con la mejor evidencia, así como seguir las directrices de la normativa sobre medicamentos en situaciones especiales

OBJECTIVE: to evaluate the prescription profile and to assess the off-label and unlicensed uses of medicines among non-hospitalised pediatric PATIENTS: DESIGN: cross-sectional study. SETTING: pediatric units in two urban health centers and general emergency room (Hospital Materno-Infantil, Málaga). MAIN MEASUREMENTS: sociodemographics variables, reasons for consultation and information about therapeutic medications. The classification of prescriptions was established according to information requirements contained in the Summary of Products Characteristics (SPC). RESULTS: A total of 388 children were included (a subsample of 105 treated in the emergency room). Four hundred sixty-two prescriptions (involving 74 different active ingredients) were evaluated. Each infant received and average of 1,7 drugs (95% CI: 1,6-1,9). The most prescribed medicines were ibuprofen, paracetamol, amoxicillin-clavulanate and budesonide. The therapeutic group with the greatest variety of drugs was the respiratory group.27,4% (95% CI: 23,5-31) of prescriptions were off-label and the main cause was different age (60%; 95% CI: 54,1-63), followed by different dose (21,5%; 95% CI: 18-25), different indication (12%; 95% CI: 9,2-15) and different route of administration (7%; 95% CI: 5,4-10). CONCLUSIONS: The rate of off-label uses presents intermediate figures. Around one third of the paediatric outpatients in our sample are exposed to at least one off-label or unlicensed prescription. We should, however, point out that such usage is based on scant official, quality information, although it is not necessarily incorrect. Evidence-based medicine should be encouraged to improve drug therapy in children, as well as following the rules on drugs in special situations

Optimizing elderly pharmacotherapy: polypharmacy vs. undertreatment. Are these two concepts related?

PURPOSE: This study aimed to estimate the prevalence of polypharmacy and potential prescribing omissions (PPO) and their related factors in community-dwelling elderly patients and to examine any possible relationship between these two concepts. METHODS: A cross-sectional study was carried out including patients 65 years of age or over living on the island of Lanzarote (Spain). Sociodemographic, clinical and functional variables were collected, together with full data on drug therapy. The percentage of patients receiving ≥5 medications (polypharmacy) and the percentage of patients receiving at least one PPO according to Screening Tool to Alert doctors to Right Treatment (START) criteria (underprescription) were the two primary endpoints. RESULTS: A total of 1844 medications were prescribed to the 407 patients included in our study. The overall prevalence of polypharmacy was 45 %. The risk factors associated with polypharmacy were comorbidity (OR 1.98, 95 % CI 1.63-2.44), limitations in activities of daily living (ADL; OR 3.0, 95 % CI 1.51-6.11), and being prescribed a drug in the Anatomical Therapeutic Chemical classification (ATC) C group (OR 7.92, 95 % CI 4.10-16.25) or in the N group (OR 3.80, 95 % CI 2.25-6.55). START criteria identified a total of 303 PPO in 170 (41.8 %) subjects. The risk of PPO increased by 60 % for every additional point in the Charlson Comorbidity Index (OR 1.60, 95 % CI 1.35-1.91). Polypharmacy also independently predicted the odds of at least one PPO according to START criteria (OR 2.19, 95 % CI 1.36-3.55). CONCLUSION: Our findings show high rates of polypharmacy and PPO, as well as a clear relationship between these two concepts.

[Drug prescriptions study in the outpatient setting: assessment of off-label uses in children]. / Estudio de las prescripciones farmacológicas en niños a nivel de atención primaria: evaluación de los usos off-label o fuera de ficha técnica.

OBJECTIVE: to evaluate the prescription profile and to assess the off-label and unlicensed uses of medicines among non-hospitalised pediatric patients. DESIGN: cross-sectional study. SETTING: pediatric units in two urban health centers and general emergency room (Hospital Materno-Infantil, Málaga). MAIN MEASUREMENTS: sociodemographics variables, reasons for consultation and information about therapeutic medications. The classification of prescriptions was established according to information requirements contained in the Summary of Products Characteristics (SPC). RESULTS: A total of 388 children were included (a subsample of 105 treated in the emergency room). Four hundred sixty-two prescriptions (involving 74 different active ingredients) were evaluated. Each infant received and average of 1,7 drugs (95% CI: 1,6-1,9). The most prescribed medicines were ibuprofen, paracetamol, amoxicillin-clavulanate and budesonide. The therapeutic group with the greatest variety of drugs was the respiratory group. 27,4% (95% CI: 23,5-31) of prescriptions were off-label and the main cause was different age (60%; 95% CI: 54,1-63), followed by different dose (21,5%; 95% CI: 18-25), different indication (12%; 95% CI: 9,2-15) and different route of administration (7%; 95% CI: 5,4-10). CONCLUSIONS: The rate of off-label uses presents intermediate figures. Around one third of the paediatric outpatients in our sample are exposed to at least one off-label or unlicensed prescription. We should, however, point out that such usage is based on scant official, quality information, although it is not necessarily incorrect. Evidence-based medicine should be encouraged to improve drug therapy in children, as well as following the rules on drugs in special situations.

Exposición a tabaco, alcohol y drogas de abuso en gestantes. Estudio de prevalencia en gestantes de Málaga (España) / Exposure to tobacco, alcohol and drugs of abuse during pregnancy. A study of prevalence among pregnant women in Malaga (Spain)

La prevalencia de hábitos tóxicos en la población de mujeres que quedan embarazadas es similar a la de la población general, por lo que la exposición fetal a tóxicos es elevada en el período de mayor vulnerabilidad, sobre todo en relación al neurodesarrollo y la organogénesis. El presente estudio ha sido desarrollado para conocer el nivel de exposición prenatal a tabaco, alcohol u otras drogas en la ciudad de Málaga (España). El trabajo responde a un diseño observacional de corte transversal sobre el consumo de tóxicos durante el embarazo, y se basa en la autodeclaración de las gestantes mediante la cumplimentación de un cuestionario. Se reclutaron 451 gestantes de primer, segundo y tercer trimestre. La prevalencia de consumo en cada uno de los trimestres resultó ser respectivamente del 21.2%, 18.5% y 13.3% para el tabaco, 40.7%, 23.1% y 17.1% para el alcohol y del 4.8%, 1.9% y 1.2% para cannabis. En los tres trimestres, un mayor nivel de estudios se asoció a un menor consumo de tabaco (RR 0,659 [0.537-0.810] p< 0.0001) y una mayor exposición al alcohol (RR 1.87 [1.30-2.69] p< 0.0007). Los resultados obtenidos, sobre todo en relación al consumo de alcohol, son suficientemente llamativos como para alertar a los proveedores de atención obstétrica sobre la necesidad de poner en marcha medidas preventivas

The prevalence of substance abuse in women who become pregnant is similar to that of the general population, resulting in a high fetal exposure rate during the most vulnerable period regarding neurodevelopment and organogenesis. The present study was intended to assess the level of prenatal exposure to tobacco, alcohol or illicit drugs in the city of Málaga (Spain). It was designed as a cross-sectional study, and based on the anonymous self-reports of participants. A total of 451 pregnant women were recruited in the first, second or third trimester. The prevalence in each of the quarters respectively was 21.2%, 18.5% and 13.3% for smoking, 40.7%, 23.1% and 17.1% for alcohol and 4.8%, 1.9% and 1.2% for cannabis. We also found that a higher educational level was associated with a lower consumption of tobacco (RR 0.659 [0.537-0.810] p<0.0001) and greater exposure to alcohol (RR 1.87 [1.30-2.69] p<0.0007). These results, particularly in regard to alcohol intake, are sufficiently alarming to alert obstetric care providers about the need to implement preventive measures