RESUMEN
OBJECTIVE: The study objective was assessing patient adherence to a fixed-dose combination (FDC) of bisoprolol and amlodipine in daily practice in patients who had been switched from the free to the fixed-dose combination prior to recruitment. MATERIAL AND METHODS: The non-investigational study was carried out in Poland. Patients over 18 years of age with essential hypertension were recruited if they had already been switched from a free combination to the FDC at least 4 weeks prior to recruitment. Exclusion criteria included pregnancy, lactation, any contraindication to the FDC, and other antihypertensive treatment. Adherence was measured by tablet count (tablets taken divided by tablets prescribed, times 100) and defined as follows: excellent >90%, good 76-90%, moderate 51-75%, bad ≤50%. Other patient data, clinical findings and laboratory values were recorded upon availability at study start, after 3 months (voluntary) and after 6 months. RESULTS: Data of 4288 patients (mean age: 59 years; gender: 50% each) were documented. The average daily doses of the FDC were 5.8 mg bisoprolol and 6.4 mg amlodipine. These doses differ only slightly from those of the free combination. After 3 months' treatment with the FDC, a dose increase was carried out in 113 patients for bisoprolol and in 126 for amlodipine. After 6 months of FDC treatment, 82% of the participants of the study showed excellent adherence and for a further 15% the adherence could be considered good. This strong adherence may have led to the observed reduction in systolic and diastolic blood pressure of 11% (Cohen's D efficient size 1.23). In addition, pulse pressure decreased from 58.8 mm to 52.2 mm. Also in diabetic patients (21% of the cohort), further reduction of systolic blood pressure values could be achieved (mean before 150 mm, after 133), wherein the initial differences compared to patients without diabetes had disappeared. The pulse rate also changed from 75 b/min to 68 b/min under the FDC. CONCLUSION: These study results clearly show that the FDC leads to excellent patient adherence and therefore may result in better blood pressure control. Blood pressure control is crucial in the risk reduction of cardiovascular events. The key limitation of this study is that the study design does not allow a direct comparison of patient adherence under the free and the fixed-dose combination.
Asunto(s)
Amlodipino/uso terapéutico , Antihipertensivos/uso terapéutico , Bisoprolol/uso terapéutico , Hipertensión/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , Amlodipino/administración & dosificación , Antihipertensivos/administración & dosificación , Bisoprolol/administración & dosificación , Presión Sanguínea/efectos de los fármacos , Combinación de Medicamentos , Hipertensión Esencial , Femenino , Frecuencia Cardíaca/efectos de los fármacos , Humanos , Masculino , Persona de Mediana Edad , Polonia , Adulto JovenRESUMEN
BACKGROUND: This is a report on an international non-interventional study of patients exposed to fires with smoke development in closed rooms. The objective of the study was to document clinical symptoms, relevant laboratory values and blood cyanide concentrations from fire victims in order to confirm or rule out presumptive correlations between the individual parameters. MATERIALS AND METHODS: The study was conducted in five European countries with patients being included if they presented with the characteristic clinical signs, such as soot deposits and altered neurological status. Venous blood samples were taken from victims prior to administration of an antidote in all cases and determination of cyanide concentration was performed in a central laboratory using high performance liquid chromatography. RESULTS: Data from 102 patients (62 % male, average age 49 years) were included in the evaluation with no blood samples being available for analysis from 2 patients. In 25 patients the blood cyanide concentration was below the limit of detection of 1.2 µmol/l. Cyanide levels between 1.2 and 10 µmol/l were measured in 54 patients, 7 patients had values between 10 and 20 µmol/l, 4 patients between 20 and 40 µmol/l while levels above 40 µmol/l were determined in 10 patients. The results of the study could not demonstrate that the cyanide level was influenced either by the interval between smoke exposure and blood sampling or the duration presence at the fire scene. The following clinical signs or laboratory values were recorded as relevant for increased and possibly toxic cyanide levels: respiratory arrest, dyspnea, resuscitation requirement, tracheal intubation, respiratory support measures, low Glasgow coma scale (GCS) score and respiratory frequency. A correlation between cyanide concentration and the total amount of soot deposits on the face and neck, in the oral cavity and in expectoration was confirmed. A correlation between cyanide and carboxyhemoglobin (COHb) levels in the blood of fire victims was also confirmed. CONCLUSIONS: As long as it is not possible to immediately determine the blood cyanide concentration in patients exposed to fire with smoke development, a decreased GCS score, soot deposits particularly in expectoration, dyspnea and convulsions are to be regarded as risk markers for intoxication. In their presence immediate administration of hydroxocobalamin as an antidote is recommended.