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.
Asunto(s)
Cianuros/sangre , Cianuros/envenenamiento , Incendios , Lesión por Inhalación de Humo/diagnóstico , Lesión por Inhalación de Humo/terapia , Antídotos/uso terapéutico , Biomarcadores , Dióxido de Carbono/sangre , Carboxihemoglobina/metabolismo , Cromatografía Líquida de Alta Presión , Intervalos de Confianza , Servicios Médicos de Urgencia , Ambiente , Escala de Coma de Glasgow , Hematínicos/uso terapéutico , Humanos , Hidroxocobalamina/uso terapéutico , Oxígeno/sangre , Medición de Riesgo , Lesión por Inhalación de Humo/sangre , HollínRESUMEN
OBJECTIVES: High-density lipoprotein (HDL) cholesterol elevation is associated with an improved outcome in patients with atherosclerotic disease. Niaspan, a prolonged-release nicotinic acid, was evaluated during the Niaspan-Induced HDL Elevation for Optimizing Risk Control (NEMO) study in The Netherlands. METHODS: NEMO was a 6-month, prospective, observational, multicentre, open-label study. Niaspan was prescribed in statin-treated patients with known or suspected atherosclerotic disease. The main outcome measures were treatment-related adverse drug reactions (ADRs) and effects on lipids and cardiovascular-risk score based on the algorithm derived from the Prospective Cardiovascular Münster study. RESULTS: 612 patients were included in The Netherlands. Flushing was the most common ADR (29% of patients during the first month of treatment). The main reasons for treatment discontinuation were flushing (10.5%), patient request (8.0%) and being lost to follow-up (6.0%). About half of all patients (52%) continued treatment after the study. Tolerability was rated 'good' or 'very good' in 54% of these patients. HDL cholesterol increased by 23% from baseline, and triglycerides were reduced by 16%, with little change in low-density lipoprotein or total cholesterol. Cardiovascular risk score was reduced by 3.3 points. CONCLUSIONS: The use of the prolonged-release nicotinic acid Niaspan in patients with or at risk for atherosclerotic disease showed good tolerability, a marked increase in HDL cholesterol and a reduced cardiovascular risk score.
Asunto(s)
Aterosclerosis/tratamiento farmacológico , Niacina/administración & dosificación , Adulto , Anciano , Enfermedades Cardiovasculares/prevención & control , HDL-Colesterol/sangre , Preparaciones de Acción Retardada , Femenino , Rubor/inducido químicamente , Humanos , Masculino , Persona de Mediana Edad , Niacina/efectos adversos , Estudios ProspectivosRESUMEN
OBJECTIVES: To investigate the effect of low-dose aspirin administered in the morning or evening on the rate of discontinuation of prolonged-release nicotinic acid (Niaspan) due to flushing in patients at elevated cardiovascular risk. RESEARCH DESIGN AND METHODS: This was an observational, non-interventional study in patients at elevated cardiovascular risk due to cardiovascular disease or type 2 diabetes. Patients received prolonged-release nicotinic acid and aspirin under the usual care of their physician for 15 weeks. MAIN OUTCOME MEASURES: The main outcome measure was the rate of treatment discontinuation for flushing. Other adverse drug reactions (ADRs) were also recorded. Lipid parameters were also measured. RESULTS: The patient population included 539 subjects (70% male); 36% had type 2 diabetes, 80% had prior cardiovascular disease, and 37% had a family history of cardiovascular disease. The rate of treatment discontinuation due to flushing did not differ (p = 0.3375) between the morning aspirin group (10.6%) and the evening aspirin group (13.8%). The overall incidence of flushing was 57%. Most flushes were of mild or moderate severity and decreases occurred over time in both frequency and intensity. ADRs unrelated to flushing occurred in 6.6% of the morning aspirin group and 7.4% of the evening aspirin group. HDL-cholesterol increased by +21.3% in the overall population, together with moderate improvements in other lipid parameters. CONCLUSIONS: Flushing was the most common ADR with prolonged-release nicotinic acid treatment, as expected. The timing of aspirin administration did not influence the rate of treatment discontinuations for flushing. Marked increases in HDL-cholesterol were observed.
Asunto(s)
Aspirina/administración & dosificación , Enfermedades Cardiovasculares/tratamiento farmacológico , Preparaciones de Acción Retardada/administración & dosificación , Hipolipemiantes/administración & dosificación , Niacina/administración & dosificación , Inhibidores de Agregación Plaquetaria/administración & dosificación , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Aspirina/efectos adversos , Enfermedades Cardiovasculares/sangre , HDL-Colesterol/sangre , Preparaciones de Acción Retardada/efectos adversos , Diabetes Mellitus Tipo 2/sangre , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Femenino , Rubor/sangre , Rubor/inducido químicamente , Humanos , Hipolipemiantes/efectos adversos , Masculino , Persona de Mediana Edad , Niacina/efectos adversos , Inhibidores de Agregación Plaquetaria/efectos adversos , Factores de RiesgoRESUMEN
BACKGROUND: Substantial residual cardiovascular risk persists despite effective LDL lowering treatment in populations at elevated risk for adverse cardiovascular outcomes. Low HDL cholesterol is an independent cardiovascular risk factor and occurs in about one-third of patients treated for dyslipidaemia in Europe. Moreover, randomised intervention studies have shown that increasing HDL cholesterol improves cardiovascular outcomes. Correcting low HDL cholesterol therefore presents a rational and proven strategy for intervention to produce further reductions in cardiovascular risk beyond those possible with a statin alone. Nicotinic acid (niacin in the USA) is the most effective agent currently available for increasing levels of HDL cholesterol. OVERALL STUDY RESULTS: A once-daily, prolonged-release formulation of nicotinic acid (Niaspan) is as effective on HDL cholesterol as the immediate-release formulation, and is equally effective at increasing HDL cholesterol whether or not patients are already taking a statin. Niaspan also shares the antiatherogenic benefit of nicotinic acid, and induced regression of atherosclerosis in patients with cardiovascular disease during a period of treatment of up to 2 years. The incidence of flushing, the principal side effect of nicotinic acid, is lower with Niaspan than with immediate-release nicotinic acid. Simple practical measures are available to minimise the incidence and impact of flushing, including careful dose titration and avoiding hot or spicy foods near the time of ingestion of Niaspan. The potential for hepatotoxicity, muscle toxicity or marked exacerbation of hyperglycaemia in diabetes with Niaspan is very low, with or without concomitant statin treatment. CONCLUSION: Niaspan provides a practical means of delivering the cardioprotective benefits associated with correction of low HDL cholesterol.
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Enfermedades Cardiovasculares/prevención & control , HDL-Colesterol/metabolismo , Dislipidemias/tratamiento farmacológico , Niacina/uso terapéutico , HDL-Colesterol/efectos de los fármacos , Preparaciones de Acción Retardada , Dislipidemias/complicaciones , Rubor/inducido químicamente , Humanos , Hipolipemiantes/efectos adversos , Niacina/efectos adversos , Resultado del TratamientoRESUMEN
OBJECTIVE: To evaluate the safety and tolerability of prolonged-release nicotinic acid (Niaspan) added to statin therapy in patients at increased cardiovascular risk. METHODS: This was a 6-month, prospective, observational, multicentre, open-label evaluation of prolonged-release nicotinic acid (maximum dose 2000 mg/day) in statin-treated patients with cardiovascular disease and/or type 2 diabetes. The primary endpoint was the safety and tolerability of prolonged-release nicotinic acid, with special regard to treatment-related adverse drug reactions (ADRs). Secondary endpoints were changes in lipids and 10-year cardiovascular risk (Prospective Cardiovascular Münster (PROCAM) score). RESULTS: The study population included 1053 patients: 50% had hypertension, diabetes and/or metabolic syndrome (National Cholesterol Education Program/Adult Treatment Panel III criteria) and 80% had cardiovascular disease. Flushing (mostly mild or moderate) occurred in 430 patients (40.8%). Other ADRs occurred in 125 patients (12.5%), most commonly pruritus (2.7%), gastro-intestinal symptoms (3.8%) and nervous system-related complaints (3.8%). Serious ADRs were uncommon (0.6%). All patients recovered completely from these ADRs after treatment discontinuation. In total, 11.1% of the patients discontinued study medication for flushing and 8.4% for other ADRs. There was no evidence of hepatotoxicity or myopathy. New-onset hyperglycaemia was negligible. Overall tolerability of prolonged-release nicotinic acid treatment (n = 734 patients at closeout) was 'very good' in 130 (17.7%), 'good' in 262 (35.7%), and 'acceptable' in 144 (19.6%) patients. High-density lipoprotein (HDL) cholesterol increased by 23%, triglycerides decreased by 15% and LDL-C decreased by 4%. CONCLUSIONS: Prolonged-release nicotinic acid was safe and generally well tolerated and effective in combination with statin therapy in patients at high risk of cardiovascular events, with a side-effect profile consistent with previous clinical experience.
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Enfermedades Cardiovasculares/tratamiento farmacológico , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Inhibidores de Hidroximetilglutaril-CoA Reductasas/uso terapéutico , Hipolipemiantes/efectos adversos , Niacina/efectos adversos , Preparaciones de Acción Retardada , Quimioterapia Combinada , Femenino , Rubor/inducido químicamente , Humanos , Hipolipemiantes/uso terapéutico , Masculino , Persona de Mediana Edad , Niacina/uso terapéutico , Estudios ProspectivosAsunto(s)
Anticolesterolemiantes/administración & dosificación , HDL-Colesterol/sangre , Enfermedad de la Arteria Coronaria/tratamiento farmacológico , Hipercolesterolemia/tratamiento farmacológico , Niacina/administración & dosificación , Sistemas de Registro de Reacción Adversa a Medicamentos , Anticolesterolemiantes/efectos adversos , LDL-Colesterol/sangre , Enfermedad de la Arteria Coronaria/sangre , Preparaciones de Acción Retardada , Esquema de Medicación , Alemania , Humanos , Hipercolesterolemia/sangre , Estudios Multicéntricos como Asunto , Niacina/efectos adversos , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del TratamientoRESUMEN
OBJECTIVE: The main objective was to evaluate the safety and tolerability of prolonged-release nicotinic acid (niacin; Niaspan) in an usual care setting with patients receiving treatment for dyslipidaemia in Germany: the multiceNtre, open, uncontrolled sAfety and tolerability stUdy of a modified-release nicoTinic acId formuLation in sUbjects with dySlipidaemia and low HDL-cholesterol (NAUTILUS). RESEARCH DESIGN AND METHODS: This was a multicentre, open-label, 15-week study. Eligible patients had a diagnosis of dyslipidaemia with lipids inadequately controlled by 4 weeks of diet treatment. Additionally, patients had low HDL-cholesterol (< 1.03 mmol/L [< 40 mg/dL]) in men and < 1.29 mmol/L [< 50 mg/dL] in women), and had triglycerides < 9.03 mmol/L (< 800 mg/dL). Exclusion criteria included uncontrolled diabetes (HbA(1C) > 9%), significant hepatic, vascular or renal disease. The target dose was 2000 mg once daily. MAIN OUTCOME MEASURES: The main objective was to evaluate the safety and tolerability of prolonged-release nicotinic acid [incidence of adverse events (AE) and serious AE] in the overall population (the safety population). Efficacy parameters (lipid parameters) were also measured in the intent-to-treat population. RESULTS: A total of 566 patients were recruited, mostly with metabolic syndrome (39.4%), mixed hypercholesterolaemia (31.6%), isolated low HDL-cholesterol and markedly elevated cardiovascular risk for other reasons (10.8%), and primary hypercholesterolaemia (8.8%), according to NCEP/ATP III guidelines. The target dose was achieved by 65% of patients. Flushing was the most common side-effect (42%), as expected, and 9.7% withdrew for flushing. Other drug-related AEs occurred at low frequency (18.6%), and 8.7% withdrew for an AE other than flushing. Most AEs were mild or moderate in severity. Serious AEs considered possibly related to treatment occurred in three patients (0.5%); all resolved following treatment withdrawal. There was no hepatotoxicity or serious muscle AE. CONCLUSIONS: Prolonged-release nicotinic acid was well tolerated, and these results support its use in the management of patients at elevated cardiovascular risk due to low HDL-cholesterol.
Asunto(s)
Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Hipolipemiantes/administración & dosificación , Niacina/administración & dosificación , Adulto , Anciano , Anciano de 80 o más Años , Preparaciones de Acción Retardada , Evaluación de Medicamentos , Dislipidemias/tratamiento farmacológico , Femenino , Alemania , Humanos , Hipolipemiantes/efectos adversos , Hipolipemiantes/uso terapéutico , Masculino , Persona de Mediana Edad , Niacina/efectos adversos , Niacina/uso terapéuticoRESUMEN
160 children aged 1 to 12 years with clinical diagnosis of bacterial pharyngitis and/or tonsillitis were treated either with cefixime ready-to-use-suspension or penicillin V in an open, controlled and randomized multicenter study. Before treatment a rapid antigen detection test was accomplished and throat swabs were taken. After randomization, the children were either treated for 5 days with 8 mg cefixime/kg bodyweight ready-to-use suspension once daily or with 20,000 I.U. penicillin V/kg bodyweight t.i.d. also administered as suspension. The data of 151 children could be evaluated for clinically efficacy. In the cefixime-group 86.7% of the children were cured and 9.3% significantly improved. After initial improvement, in one child (1.3%) a relapse occurred and in the two remaining children (2.7%) therapy failed. 90.8% of the patients treated with penicillin V were cured, 6.6% improved and in one child each a relapse was registered resp. therapy failed. Complete microbiological data were available in 137 patients. In the cefixime-group in 82.6% of the patients the pathogens were eradicated. The elimination rate in the penicillin-group was 88.2%. At the follow-up 3-4 weeks after end of treatment 6 relapses were seen in the cefixime-group, and 8 in the patients treated with penicillin. Both regimes were safe. Mild to moderate adverse events at least possibly related to the study medication were seen in only 4 children treated with cefixime and in 5 treated with penicillin. A 5 day treatment of bacterial pharyngitis and tonsillitis with cefixime was as effective as a ten day treatment with penicillin V.
Asunto(s)
Cefotaxima/análogos & derivados , Cefalosporinas/administración & dosificación , Penicilina V/administración & dosificación , Penicilinas/administración & dosificación , Faringitis/tratamiento farmacológico , Infecciones Estreptocócicas/tratamiento farmacológico , Streptococcus pyogenes , Tonsilitis/tratamiento farmacológico , Cefixima , Cefotaxima/administración & dosificación , Cefotaxima/efectos adversos , Cefalosporinas/efectos adversos , Niño , Preescolar , Relación Dosis-Respuesta a Droga , Esquema de Medicación , Femenino , Humanos , Lactante , Masculino , Penicilina V/efectos adversos , Penicilinas/efectos adversos , Streptococcus pyogenes/efectos de los fármacos , Resultado del TratamientoRESUMEN
In an open, controlled, randomized multicenter study, 160 children suffering from pharyngitis and/or tonsillitis were treated with either 8 mg cefixime/kg body weight once daily for 5 days or 20,000 I.U. penicillin V/kg body weight t.i.d. for 10 days. One hundred fifty-one children were evaluable for clinical efficacy. In the cefixime group, 65 (86.7%) children were cured, seven (9.3%) were significantly improved, one (1.3%) relapsed and in two (2.7%) therapy failed. Of the patients treated with penicillin V, 69 (90.8%) were cured, five (6.6%) improved, one (1.3%) relapsed and in one (1.3%) therapy failed. Elimination of initial pathogens occurred in 57 (82.6%) patients treated with cefixime and in 60 (88.2%) treated with penicillin V. At 3 to 4 weeks after the end of treatment, six relapses were seen in the cefixime group and eight in the penicillin V group. Mild-to-moderate adverse events that were possible related to the medication were seen in four children treated with cefixime and in five treated with penicillin V.
Asunto(s)
Cefotaxima/análogos & derivados , Cefalosporinas/uso terapéutico , Penicilina V/uso terapéutico , Penicilinas/uso terapéutico , Faringitis/tratamiento farmacológico , Infecciones Estreptocócicas/tratamiento farmacológico , Tonsilitis/tratamiento farmacológico , Cefixima , Cefotaxima/uso terapéutico , Niño , Preescolar , Femenino , Humanos , Lactante , MasculinoRESUMEN
28 myelomeningocele patients (aged 2-30 years) with clinical symptoms of acute UTI participated in this open uncontrolled clinical trial at the Orthopedic University Hospital of Heidelberg (Dir.: Prof. Dr. H. Cotta). 4 patients were treated with 200 mg cefixime tablets bid, 24 patients received 4 mg/kg body weight cefixime suspension bid, according to age and weight of the patients. The duration of treatment was 6-10 days. Clinical and microbiological examinations were carried out before therapy as well as 1 day and 5 to 9 days after the end of treatment. The data of 25 patients could be evaluated for bacteriological and clinical efficacy. 5-9 days after treatment in 22 patients (88%) complete recovery was stated. In 3 patients a reinfection occurred. In 24 patients (96%) the baseline pathogens were eliminated under cefixime therapy. 5-9 days after the end of treatment in 3 patients reinfection was observed. Clinical side effects could be detected in 1 patient (vomiting). These results indicate that the oral cephalosporin cefixime is efficient and well tolerated in complicated UTI of myelomeningocele patients.
Asunto(s)
Antiinfecciosos Urinarios/uso terapéutico , Cefotaxima/análogos & derivados , Meningomielocele/tratamiento farmacológico , Vejiga Urinaria Neurogénica/tratamiento farmacológico , Infecciones Urinarias/tratamiento farmacológico , Adolescente , Adulto , Antiinfecciosos Urinarios/efectos adversos , Antiinfecciosos Urinarios/farmacocinética , Bacteriuria/sangre , Bacteriuria/tratamiento farmacológico , Bacteriuria/microbiología , Cefixima , Cefotaxima/efectos adversos , Cefotaxima/farmacocinética , Cefotaxima/uso terapéutico , Niño , Preescolar , Relación Dosis-Respuesta a Droga , Esquema de Medicación , Femenino , Humanos , Masculino , Meningomielocele/sangre , Meningomielocele/microbiología , Pruebas de Sensibilidad Microbiana , Recurrencia , Vejiga Urinaria Neurogénica/sangre , Vejiga Urinaria Neurogénica/microbiología , Infecciones Urinarias/sangre , Infecciones Urinarias/microbiologíaRESUMEN
154 children aged 2 to 12 years with clinical diagnosis of bacterial pharyngitis and/or tonsillitis and--in most of the patients--a positive enzyme immunoassay for group A beta-hemolytic streptococci before therapy were enrolled in this open controlled randomized and multicenter trial. The children received either 8 mg/kg bodyweight cefixime once daily or 20,000 I.E. pencillin V/kg bodyweight t.i.d. Clinical evaluation and microbiological tests were carried out before treatment and 1-5 days after end of the treatment. 3-4 weeks after end of the treatment the rate of relapses was evaluated. The data of 149 children could be evaluated for clinical efficacy. In the cefixime group 93.3% of the children were cured and 6.7% improved compared to 89.2% and 10.8%, respectively, in the penicillin V group. Complete microbiological data were obtained from 136 patients. The eradication rate was 82.7% in the cefixime group and 77% in the group of patients treated with penicillin V. At follow up relapses were seen in 7 of the cefixime treated patients and in 6 of those receiving penicillin V. Mild side effects were reported by 4 patients in the cefixime group and by 3 children treated with penicillin V (1 drop out each). These results show that cefixime once daily is at least as effective as penicillin V t.i.d. in pharyngitis and tonsillitis in children. Both compounds are well tolerated.