[Pharmacology]. / Farmaecología.

Two of the main characteristics of western societies in the last fifty years have been the medicalization of the human life and the environmental degradation. The first one has forced human being to consider medicines use related to what would be rational, reasonable and well-reasoned. The second one brought us to a new ecologist conscience. In relation to the "human social system", the effects of medication can be considered very positive as a whole, particularly those related to the amazing increase of expectative and quality of life. But, along with those unquestionable beneficial effects, medicines have also caused some negative effects for other biotic and abiotic systems, such as microbian alterations and their undesirable consequences which have involved the massive use of antibiotics in medicine and veterinary, the uncontrolled elimination of millions of doses of all kind of drugs, additives and excipients, etc., as well as atmospheric contamination and degradation of forests and deep oceans which can have been caused by investigation and production of determinated drugs. In this context Pharmacology appears as a scientific discipline that studies the research (R), development (D), production (P), and utilization (U) of drugs and medical substances in relation to the environment. From a farmaecologic perspective the drugs utilization has its development in three main contexts, all of them closely related: prescription quality, farmaceutical care, and patient's active participation in his own disease and treatment.

Farmaecología / Pharmaecology

Dos de los rasgos más característicos de las sociedades occidentales en el último medio siglo ha sido la medicalización de la vida entera y la degradación del medio ambiente. La primera ha llevado a plantearse el uso de los medicamentos en términos de uso racional, razonable y razonado. La segunda, a una nueva conciencia ecológica. En relación al “sistema social humano” los efectos de los medicamentos se pueden considerar como muy positivos en su conjunto, especialmente en lo que se refiere al aumento espectacular de la esperanza y la calidad de vida de las personas. Pero, junto a los indudables efectos beneficiosos, los medicamentos también han provocado algunos efectos negativos para otros sistemas bióticos y abióticos, como son las alteraciones microbianas y los efectos indeseables derivados de las mismas que han supuesto el empleo masivo de antibióticos en medicina y veterinaria, la eliminación incontrolada de millones de dosis de todo tipo de fármacos, aditivos y excipientes, etc., así como la contaminación atmosférica y la degradación de bosques y fondos marinos que han podido provocar la investigación y fabricación de determinados fármacos. En este contexto nace la farmaecología como disciplina científica que estudia la investigación (I), desarrollo (D), producción (P) y empleo (E) de los medicamentos y sustancias medicinales en su relación con el medio ambiente. En cuanto al empleo de los mismos, la farmaecología tiene su desarrollo en tres contextos fundamentales, íntimamente relacionados entre sí: la calidad de prescripción, la atención farmacéutica y la activación del paciente en su enfermedad y tratamiento(AU)

Two of the main characteristics of western societies in the last fifty years have been the medicalization of the human life and the environmental degradation. The first one has forced human being to consider medicines use related to what would be rational, reasonable and well-reasoned. The second one brought us to a new ecologist conscience. In relation to the “human social system”, the effects of medication can be considered very positive as a whole, particularly those related to the amazing increase of expectative and quality of life. But, along with those unquestionable beneficial effects, medicines have also caused some negative effects for other biotic and abiotic systems, such as microbian alterations and their undesirable consequences which have involved the massive use of antibiotics in medicine and veterinary, the uncontrolled elimination of millions of doses of all kind of drugs, additives and excipients, etc., as well as atmospheric contamination and degradation of forests and deep oceans which can have been caused by investigation and production of determinated drugs. In this context pharmaecology appears as a scientific discipline that studies the research (R), development (D), production (P), and utilization (U) of drugs and medical substances in relation to the environment. From a farmaecologic perspective the drugs utilization has its development in three main contexts, all of them closely related: prescription quality, farmaceutical care, and patient’s active participation in his own disease and treatment(AU)

Evaluación y tratamiento de la hipertensión arterial en España. Documento de consenso / No disponible

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Tolerability of high doses of lercanidipine versus high doses of other dihydropyridines in daily clinical practice: the TOLERANCE Study.

The TOLERANCE study was aimed to compare the tolerability of high doses of lercanidipine (20 mg) with that of other frequently used dihydropyridines (amlodipine 10 mg/nifedipine GITS 60 mg) in the treatment of essential hypertension in daily clinical practice. It was an observational, transversal, multicentre study performed in a Primary Care Setting. A total of 650 evaluable patients with essential hypertension and age > or = 18 years were included. They had been treated with high doses of lercanidipine (n= 446) or amlodipine/nifedipine GITS (n= 204) during at least 1 month and previously with low doses (10 mg, 5 mg, and 30 mg, respectively) of the same drugs. The main objective was to compare the rates of vasodilation-related adverse events between both groups. Rates of signs and symptoms related to vasodilation were significantly higher (P < 0.001) in the amlodipine/nifedipine GITS group (76.8%, CI 95%[70.7; 82.9]) than in lercanidipine group (60.8%, [56.1;65.5]). Blood pressure control (< 140/90 mmHg or <130/80 for diabetics) and type of concomitant antihypertensive medications were similar in both groups. Treatment compliance was good (around 93%) and fairly comparable in both groups. Most adverse events with lercanidipine were mild (74.5% vs. 64% in amlodipine/nifedipine GITS group, P= 0.035) whereas severe adverse event rates did not differ significantly between groups (2.8% vs. 3.6%). In conclusion, treatment with lercanidipine at high doses is associated with a lower rate of adverse events related to vasodilation compared to high doses of amlodipine or nifedipine GITS in clinical practice.

Microalbuminuria in hypertensive patients: evaluation of one-year treatment with irbesartan.

BACKGROUND: Microalbuminuria is an important cardiovascular risk factor, and appears to be a marker of early arterial disease in patients with and without diabetes and/or hypertension. The aim of this study was to investigate prevalence of albuminuria in hypertensive patients in clinical settings, as well as to assess the efficacy of the angiotensin receptor blocker irbesartan on the evolution of this risk marker in habitual clinical practice. METHODS: KORAL-HT is a prospective, multicenter 1-year follow-up study in inadequately controlled hypertensive patients. Demographic data, major cardiovascular risk factors, albuminuria, and clinical parameters were recorded at baseline and at 6-month and 12-month visits. During the year of follow-up, the patients received antihypertensive therapy with irbesartan in addition to their usual antihypertensive regimen. RESULTS: A total of 1657 [802 diabetics (48.4%) and 855 nondiabetics (51.6%)] hypertensive patients were studied. The prevalence of microalbuminuria in this sample was 62.5%. After 1-year treatment with irbesartan, the percentage of patients with normoalbuminuria grew from 17.1% at baseline to 40.9% at 1-year follow-up. Blood pressure (BP) decreased from 157.3 +/- 13.7/93.6 +/- 9.2 mm Hg at baseline to 139.8 +/- 13.12 mm Hg and 136.1 +/- 11.6/80.1 +/- 8 mmHg at 6- and 12-month visits, respectively. The percentage of patients who achieved BP targets increased progressively, 57.2% at 6 months, and 70.1% at the study end. CONCLUSION: This study shows that the population attending Spanish HT centers have high prevalence of microalbuminuria. The addition of irbesartan to the usual treatment in poorly controlled hypertensive patients significantly improved BP control, and reduced microalbuminuria both in diabetic and nondiabetic patients. Our study confirms that similar results can be obtained in normal clinical practice as in controlled clinical trials.

Pharmacoeconomic analysis of bemiparin and enoxaparin as prophylaxis for venous thromboembolism in total knee replacement surgery.

INTRODUCTION: Low molecular weight heparins are effective and have a good tolerability profile as first-line prophylaxis for venous thromboembolism (VTE) in major orthopaedic surgery. However, pharmacological inequivalence within the class could lead to differences in cost-effectiveness ratios. OBJECTIVE: To quantify the potential economic impact of subcutaneous bemiparin sodium 3500 IU/day compared with enoxaparin sodium 40 mg/day as prophylaxis for VTE in patients undergoing total knee replacement (TKR) surgery, considering both in-hospital and post-discharge outcomes and costs during 6 weeks of postoperative follow-up. METHODS: A cost-effectiveness analysis was performed using a decision modelling approach. The results were expressed in terms of costs and incremental cost effectiveness in Euro (2002 values). The treatment costs (hospital stay, physician services, drug administration) and costs incurred due to complications such as pulmonary embolism and/or proximal deep vein thrombosis, bleeding events, wound haematoma and thrombocytopenia were considered for this analysis. The target population comprised all adult patients undergoing TKR surgery included in a previous clinical trial (n = 381). The study was conducted in the setting of the Spanish National Health System. The time horizon chosen was 6 weeks. RESULTS: Bemiparin provided cost savings of Euro144.48 per patient compared with enoxaparin when costs derived from treatment and complications during the 6-week postoperative period were considered (Euro4675.01 vs Euro4819.49). Pharmacy costs per patient were lower for bemiparin during hospital stay (Euro43.34 vs Euro50.20; difference, Euro-6.86) and for post-discharge prophylaxis (Euro68.63 vs Euro87.78; difference Euro-19.15). Bemiparin was calculated to avoid 42 additional VTE events per 1000 patients treated at 6 weeks. The incremental cost-effectiveness analysis indicated that bemiparin was dominant over enoxaparin, producing better outcomes and cost savings. The sensitivity analysis supported the cost effectiveness of bemiparin in all the ranges tested for complications and costs. CONCLUSIONS: Our model suggests, based on its underlying assumptions and data, that bemiparin may be more cost effective than enoxaparin for thromboprophylaxis in total knee replacement surgery in the Spanish healthcare setting.

Therapeutic drug monitoring for sirolimus in whole blood of organ transplants by high-performance liquid chromatography with ultraviolet detection.

We developed and validated an accurate, sensitive, precise and rapid HPLC method with UV detection for the determination of sirolimus in blood samples from renal, cardiac and hepatic transplants. This method overcomes most of the problems related to previously published assays using a narrow-bore column with base deactivated C18 reversed phase. Whole blood samples were purified by a combination of a precipitating blood matrix with zinc sulphate and a single step liquid-liquid extraction with acetone and 1-chlorobutane. Calibration curves (range 2.5-150 ng/ml), were linear with coefficients of correlation better than 0.996. The relative standard deviation was determined to be less than 8%. The present method has also been validated by a reference laboratory (St. George's Hospital Medical School, London, UK). More of 300 clinical samples have been analysed with this method.

Primeras notificaciones espontáneas de sospechas de reacciones adversas a los nuevos antiinflamatorios selectivos sobre la ciclooxigenasa. Respuesta / First spontaneous reports of adverse drug reactions to the new selective COX-2 non-steroideal anti-inflammatory drugs. Reply

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