RESUMEN
STUDY OBJECTIVE: To compare 24-hour blood pressure control and adverse effects in patients with essential hypertension who were switched from amlodipine to nisoldipine. DESIGN: Open-label, one-way crossover study. SETTING: Cardiac clinic and patients' homes. PATIENTS: Twenty-five patients with stage I or II essential hypertension stabilized with amlodipine for at least 3 months, of whom 21 patients completed the study. INTERVENTION: All patients underwent 24-hour ambulatory blood pressure monitoring while receiving amlodipine 5 or 10 mg/day. Patients then were switched to nisoldipine 10 mg/day (> or = 65 yrs old) or 20 mg/day (< 65 yrs old) and returned to the clinic at 2-week intervals to assess cuff blood pressure, heart rate, adverse effects, and compliance. No adverse effects were experienced in 15 of the 25 patients. Lower extremity edema was the most commonly reported adverse effect (four patients). Two patients discontinued treatment because of pulmonary edema in one and chest pain in the other. Two patients were lost to follow-up. After a mean of 10.6 weeks, repeat 24-hour ambulatory monitoring was performed to evaluate blood pressure control with nisoldipine. Systolic and diastolic ambulatory results for daytime, nighttime, and total 24 hours were calculated. For amlodipine versus nisoldipine, no significant differences existed in any of the blood pressure parameters (p>0.05) in the 21 patients who completed the study, except for 24-hour diastolic pressure (p<0.05); however, this latter difference was only 2 mm Hg (nisoldipine 77 mm Hg, amlodipine 75 mm Hg). CONCLUSION: Both amlodipine and nisoldipine have similar 24-hour ambulatory blood pressure profiles. The frequency of lower extremity edema was no different after the switch to nisoldipine than when the patients were taking amlodipine.
Asunto(s)
Amlodipino/uso terapéutico , Presión Sanguínea/efectos de los fármacos , Bloqueadores de los Canales de Calcio/uso terapéutico , Hipertensión/tratamiento farmacológico , Nisoldipino/uso terapéutico , Adulto , Anciano , Amlodipino/efectos adversos , Amlodipino/economía , Monitoreo Ambulatorio de la Presión Arterial , Bloqueadores de los Canales de Calcio/efectos adversos , Bloqueadores de los Canales de Calcio/economía , Estudios Cruzados , Femenino , Frecuencia Cardíaca/efectos de los fármacos , Humanos , Masculino , Persona de Mediana Edad , Nisoldipino/efectos adversos , Nisoldipino/economía , Cooperación del Paciente , Factores de TiempoRESUMEN
STUDY OBJECTIVE: To evaluate the effectiveness of a posthospital discharge intervention that prompted physicians to increase the use and effectiveness of statins (3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors) in patients with coronary heart disease (CHD). METHODS: Participants were 612 patients with CHD who were admitted to a coronary care unit. The control group (303 patients admitted from October 1-December 31, 1998) received no follow-up intervention. The intervention group (309 patients admitted fromJanuary 1-March 31, 1999) had follow-up letters sent or phone calls made to their primary care physicians with patient-specific recommendations concerning assessment of lipid profiles and statin therapy. Over a 2-year follow-up period, assessment of lipid profiles, use of therapy, and adverse clinical outcomes were compared between the control and intervention groups. RESULTS: At hospital discharge, there was no significant difference in the use of statins between the groups. At each reported follow-up interval, the percentages of patients having lipid profiles measured, being treated with a statin, receiving titrated dosages of a statin, and achieving low-density lipid (LDL) cholesterol goals set by the National Cholesterol Education Program (NCEP) were significantly greater in the intervention group compared with the control group (all p<0.05). At the end of the 2-year follow-up period, nearly three-fourths (72%) of the intervention group were receiving a statin, compared with 43% of the control group. In addition, 55% of the intervention group achieved their NCEP LDL goal, compared with only 10% of the control group. Recurrent myocardial infarction, hospitalization for myocardial ischemia, coronary revascularization, and cardiovascular mortality were significantly reduced in the intervention group compared with the control group (all p<0.05). CONCLUSION: A relatively simple physician-prompting intervention significantly increased assessment of lipid status, frequency of statin use, achievement of LDL treatment goals, and titration of lipid drug dosages. In addition, the improved use of statins significantly reduced adverse cardiovascular outcomes. This intervention tool should be more broadly applied in patient populations eligible to receive these agents.
Asunto(s)
Enfermedad Coronaria/tratamiento farmacológico , Inhibidores de Hidroximetilglutaril-CoA Reductasas/uso terapéutico , Pacientes/estadística & datos numéricos , Médicos/estadística & datos numéricos , Anciano , LDL-Colesterol/sangre , Enfermedad Coronaria/economía , Enfermedad Coronaria/mortalidad , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Médicos/economía , Resultado del TratamientoRESUMEN
OBJECTIVE: To determine the significance of timing of low-density lipoprotein (LDL) cholesterol evaluation in patients with chest pain as it relates to subsequent National Cholesterol Education Program (NCEP) treatment decisions. DESIGN: Prospective, observational study. SETTING: A university-affiliated tertiary care hospital. PATIENTS: Sixty-two patients with coronary heart disease who were not receiving lipid-lowering therapy and whose LDL levels were obtained 25-48 hours after onset of chest pain. INTERVENTION: We evaluated laboratory test results of patients with chest pain admitted to the cardiac care unit to determine risk to patients when LDL levels obtained inappropriately are used to make decisions regarding antihyperlipidemic therapy. MEASUREMENTS AND MAIN RESULTS: Inpatient and outpatient LDL levels were compared, and changes in NCEP treatment decisions analyzed. Differences between inpatient and outpatient LDL levels were significant (p<0.05), which frequently resulted in changes in therapy using the NCEP guidelines. The LDL levels of most inpatients were consistent with NCEP goals for patients with coronary heart disease, whereas the outpatient levels showed a need for drug therapy. CONCLUSION: Lipid values obtained 25-48 hours after hospital admission in patients with acute coronary syndromes do not represent baseline values and may significantly alter the treatment approach; thus, they should not be used to direct drug therapy.
Asunto(s)
LDL-Colesterol/sangre , Enfermedad de la Arteria Coronaria/sangre , Enfermedad Aguda , Adolescente , Anciano , Anciano de 80 o más Años , Errores Diagnósticos , Femenino , Estudios de Seguimiento , Guías como Asunto , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Factores de TiempoRESUMEN
OBJECTIVE: To evaluate the diagnostic and prognostic significance of ST-segment deviation detected by ambulatory Holter monitoring in unselected chest pain patients referred for coronary angiography. METHODS: Two hundred seventy-seven patients (71% were men) who underwent coronary angiography for evaluation of chest pain were studied with 24-h ambulatory Holter monitoring within 72 h of angiography. A lumen diameter reduction of > or = 50% was considered coronary artery disease. The ST-segment deviation was defined as > or = 1-mm deviation from the baseline lasting > or = 1 min separated by a minimum of 1 min. The patients were followed up for 65 +/- 21 months (mean +/- SD) for occurrences of death, myocardial infarction, hospitalization for unstable angina, and need for revascularization. RESULTS: Of the 277 patients, 223 (80%) had coronary artery disease. The prevalence of coronary artery disease was not significantly different in patients with (43 of 48 patients; 90%) and without (180 of 229 patients; 79%) Holter-detected ST-segment deviation. The diagnostic accuracy of Holter-detected ST-segment deviation in predicting the presence of coronary artery disease was poor (33%), with a sensitivity of 19% and a specificity of 91%. The presence of Holter-detected ST-segment deviation was not predictive of future cardiac events or death. CONCLUSION: The ST-segment changes detected on ambulatory Holter monitoring are of limited value in identifying coronary artery disease and predicting the future adverse cardiac events or death in unselected patients with chest pain.
Asunto(s)
Angina de Pecho/diagnóstico , Electrocardiografía Ambulatoria , Adulto , Anciano , Anciano de 80 o más Años , Angina de Pecho/diagnóstico por imagen , Estudios de Seguimiento , Humanos , Persona de Mediana Edad , Pronóstico , Estudios Prospectivos , Radiografía , Sensibilidad y EspecificidadRESUMEN
BACKGROUND: Recent hypertension trials have demonstrated the importance of achieving goal blood pressures to reduce the risk of target organ damage. In patients with moderate to severe hypertension, the use of high-dose monotherapy and/or combinations of drugs are necessary to achieve these goals. Fixed-dose combination products may be useful in these patients by reducing the number of daily doses required to control blood pressure. OBJECTIVE: The objective of the present study was to evaluate the efficacy and safety of a therapeutic interchange between high-dose calcium channel blocker therapy and a fixed-dose combination of amlodipine/ benazepril (Lotrel; Novartis Pharmaceuticals, USA) in patients with moderate to severe hypertension. METHODS: A total of 75 patients were switched from amlodipine (n = 25), felodipine (n = 25), and nifedipine-GITS (n = 25) to amlodipine/benazepril. Twenty-eight of the 75 patients (37%) were taking either a beta-blocker or a diuretic in addition to the high-dose calcium channel blocker prior to the switch. Blood pressure control, side effects and the cost of the therapeutic interchange were evaluated in the year following the therapeutic interchange. RESULTS: Sixty-six of the 75 (88%) patients were successfully switched with maintenance of blood pressure control and without the development of new dose-limiting side effects. Reasons for treatment failure after the therapeutic interchange included loss of blood pressure control in five patients and the development of new dose-limiting side effects in four patients. These side effects included cough in three patients and rash in one patient. After accounting for differences in drug acquisition cost and costs related to the switch (clinic and emergency room and laboratory tests), a cost savings of $16030 for all 75 patients was realised in the first year. The per patient-per year cost savings was $214. CONCLUSIONS: Our data indicate that a therapeutic interchange from selected high-dose calcium channel blockers to a fixed-dose combination of amlodipine/ benazepril can be successfully accomplished in the majority of patients.
Asunto(s)
Amlodipino/uso terapéutico , Antihipertensivos/uso terapéutico , Benzazepinas/uso terapéutico , Bloqueadores de los Canales de Calcio/uso terapéutico , Hipertensión/tratamiento farmacológico , Adulto , Anciano , Amlodipino/efectos adversos , Amlodipino/economía , Antihipertensivos/efectos adversos , Antihipertensivos/economía , Benzazepinas/efectos adversos , Benzazepinas/economía , Presión Sanguínea/efectos de los fármacos , Bloqueadores de los Canales de Calcio/efectos adversos , Bloqueadores de los Canales de Calcio/economía , Costos y Análisis de Costo , Relación Dosis-Respuesta a Droga , Quimioterapia Combinada , Felodipino/efectos adversos , Felodipino/economía , Felodipino/uso terapéutico , Femenino , Humanos , Hipertensión/economía , Masculino , Persona de Mediana Edad , Nifedipino/efectos adversos , Nifedipino/economía , Nifedipino/uso terapéutico , Resultado del TratamientoRESUMEN
Myocardial infarction, stroke, heart failure and end-stage renal disease have all been linked to inadequate control of blood pressure. Despite overwhelming evidence that uncontrolled hypertension is responsible for a sizeable number of adverse health-related outcomes, control of the disease remains considerably suboptimal. Available data demonstrate that in order to achieve adequate blood pressure control, a large number of patients require therapy with more than one medication. Fixed dose combination antihypertensive therapy has many advantages over other treatment options. Positive effects on blood pressure control, rates of adherence, adverse effects and cost have been identified. Amlodipine/benazepril (Lotrel), Novartis) is a fixed dose combination product indicated for the treatment of hypertension. Although not currently recommended as first-line therapy, studies confirm that this combination of a long-acting calcium antagonist and an angiotensin-converting enzyme (ACE) inhibitor possesses substantial blood pressure lowering capabilities. Whereas adverse events tend to become more frequent with increasing doses of antihypertensive monotherapy, the rate of adverse events attributed to amlodipine/benazepril in clinical trials often correlates with rates ascribed to placebo. Amlodipine/benazepril is capable of sustaining blood pressure control over a 24 h period and appears to be minimally affected by an occasional dose omission. Unlike the older calcium antagonists, amlodipine is unlikely to cause alterations in myocardial contractility. Additionally, the amlodipine/benazepril combination product costs less than the same therapy administered as the individual components. It is, therefore, reasonable to consider therapy with amlodipine/benazepril in appropriate patients after an adequate trial of antihypertensive monotherapy.
Asunto(s)
Amlodipino/uso terapéutico , Antihipertensivos/uso terapéutico , Benzazepinas/uso terapéutico , Hipertensión/tratamiento farmacológico , Amlodipino/administración & dosificación , Amlodipino/efectos adversos , Amlodipino/farmacocinética , Antihipertensivos/administración & dosificación , Antihipertensivos/efectos adversos , Antihipertensivos/farmacocinética , Benzazepinas/administración & dosificación , Benzazepinas/efectos adversos , Benzazepinas/farmacocinética , Presión Sanguínea/efectos de los fármacos , Ensayos Clínicos como Asunto , Combinación de Medicamentos , Humanos , Resultado del TratamientoRESUMEN
OBJECTIVE: To review literature relating to significant changes in drug therapy recommendations in the 1999 American College of Cardiology (ACC)/American Heart Association (AHA) guidelines for treating patients with acute myocardial infarction (AMI). DATA SOURCES: 1999 ACC/AHA AMI guidelines, English-language clinical trials, reviews, and editorials researching the role of drug therapy and primary angioplasty for AMI that were referenced in the guidelines were included. Additional data published in 2000 or unpublished were also included if relevant to interpretation of the guidelines. STUDY SELECTION: The articles selected influence AMI treatment recommendations. DATA SYNTHESIS: Many clinicians and health systems use the ACC/AHA AMI guidelines to develop treatment plans for AMI patients. This review highlights important changes in AMI drug therapy recommendations by reviewing the results of recent clinical trials. Insights into evolving drug therapy strategies that may impact future guideline development are also described. CONCLUSIONS: Several changes in drug therapy recommendations were included in the 1999 AMI ACC/AHA guidelines. There is emphasis on administering fibrin-specific thrombolytics secondary to enhanced efficacy. Selection between fibrin-specific agents is unclear at this time. Low response rates to thrombolytics have been noted in the elderly, women, patients with heart failure, and those showing left bundle-branch block on the electrocardiogram. These patient groups should be targeted for improved utilization programs. The use of glycoprotein (GP) IIb/IIIa receptor inhibitors in non-ST-segment elevation MI was emphasized. Small trials combining reduced doses of thrombolytics with GP IIb/IIIa receptor inhibitors have shown promise by increasing reperfusion rates without increasing bleeding risk, but firm conclusions cannot be made until the results of larger trials are known. Primary percutaneous coronary intervention (PCI) trials suggest lower mortality rates for primary PCI when compared with thrombolysis alone. However, primary PCI, including coronary angioplasty, is only available at approximately 13% of US hospitals, making thrombolysis the preferred strategy for most patients. Clopidogrel has supplanted ticlopidine as the recommended antiplatelet agent for patients with aspirin allergy or intolerance following reports of a better safety profile. The recommended dose of unfractionated heparin is lower than previously recommended, necessitating a separate nomogram for patients with acute coronary syndromes. Routine use of warfarin, either alone or in combination with aspirin, is not supported by clinical trials; however, warfarin remains a choice for antithrombotic therapy in patients intolerant to aspirin. Beta-adrenergic receptor blockers continue to be recommended, and emphasis is placed on improving rates of early administration (during hospitalization), even in patients with moderate left ventricular dysfunction. New recommendations for drug treatment of post-AMI patients with low high-density lipoprotein cholesterol and/or elevated triglycerides are included, with either niacin or gemfibrozil recommended as an option. Supplementary antioxidants are not recommended for either primary or secondary prevention of AMI, with new data demonstrating lack of efficacy vitamin E in primary prevention. Estrogen replacement therapy or hormonal replacement therapy should not be initiated solely for prevention of cardiovascular disease, but can be continued in cardiovascular patients already taking long-term therapy for other reasons. Bupropion has been added as a new treatment option for smoking cessation. As drug therapy continues to evolve in treating AMI, more frequent updates of therapy guidelines will be necessary.
Asunto(s)
Angioplastia Coronaria con Balón , Fibrinolíticos/uso terapéutico , Infarto del Miocardio/tratamiento farmacológico , Guías de Práctica Clínica como Asunto , Terapia Trombolítica , Antagonistas Adrenérgicos beta/uso terapéutico , Anciano , American Heart Association , Cardiología , Clopidogrel , Contraindicaciones , Femenino , Heparina/uso terapéutico , Humanos , Masculino , Infarto del Miocardio/terapia , Inhibidores de Agregación Plaquetaria/uso terapéutico , Complejo GPIIb-IIIa de Glicoproteína Plaquetaria/antagonistas & inhibidores , Sociedades Médicas , Stents , Terapia Trombolítica/estadística & datos numéricos , Ticlopidina/análogos & derivados , Ticlopidina/uso terapéutico , Estados UnidosRESUMEN
Sudden cardiac death (SCD) accounts for more than half of all cardiac deaths occurring each year in the United States. Although it has several causes, patients at greatest risk are those with coronary artery disease and impaired left ventricular function, heart failure secondary to ischemia or idiopathic dilated cardiomyopathy, hypertrophic cardiomyopathy, documented sustained ventricular tachycardia or ventricular fibrillation, and survivors of cardiac arrest. The presence of asymptomatic ventricular arrhythmias, positive signal-averaged electrocardiogram (ECG), low heart rate variability index, or inducible ventricular tachycardia or ventricular fibrillation increases the risk. In primary prevention trials in patients with ischemic heart disease, beta-blockers reduced both total mortality and SCD, whereas class I antiarrhythmic drugs, especially class IC, increased mortality. Among class III agents, d,l-sotalol and dofetilide have a neutral effect on mortality, whereas d-sotalol increases mortality. Amiodarone has a neutral effect on total and cardiac mortality but does reduce the risk of arrhythmic death and cardiac arrest. Three primary prevention trials in patients with ischemic heart disease were conducted with implantable cardioverter-defibrillators (ICDs). Patients with low ejection fractions (EFs), asymptomatic ventricular arrhythmias, and inducible ventricular tachycardia or ventricular fibrillation had significant reductions in total, cardiac, and arrhythmic death with ICDs compared with either no drug therapy or conventional antiarrhythmic agents. The ICDs did not reduce mortality in patients with low EFs and a positive signal-averaged ECG undergoing coronary bypass graft. In those with heart failure, beta-blockers reduced total and SCD mortality, but dofetilide and amiodarone had a neutral effect on mortality. In the secondary prevention of SCD, antiarrhythmic drugs alone generally are not thought to improve survival. In three trials in patients with documented sustained ventricular tachycardia or ventricular fibrillation, or survivors of SCD, ICDs reduced cardiac and arrhythmic mortality. Total mortality, however, was significantly reduced in only one of these trials. The role of antiarrhythmic drugs in secondary prevention of SCD is limited to patients in whom ICD is inappropriate or in combination with ICD. Antiarrhythmics can be given selectively with ICDs to decrease episodes of ventricular tachycardia or fibrillation to reduce ICD discharges, to suppress episodes of nonsustained ventricular tachycardia that trigger ICD discharges, to slow the rate of ventricular tachycardia to increase hemodynamic stability, to allow effective antitachycardia pacing, or to suppress supraventricular arrhythmias.
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Antiarrítmicos/uso terapéutico , Muerte Súbita Cardíaca/prevención & control , Medicina Basada en la Evidencia/estadística & datos numéricos , Isquemia Miocárdica/terapia , Muerte Súbita Cardíaca/epidemiología , Desfibriladores Implantables/estadística & datos numéricos , Medicina Basada en la Evidencia/métodos , Insuficiencia Cardíaca/epidemiología , Insuficiencia Cardíaca/terapia , Humanos , Isquemia Miocárdica/epidemiología , Factores de RiesgoRESUMEN
STUDY OBJECTIVE: To evaluate short-term outcomes when atorvastatin was substituted for pravastatin or simvastatin in patients with coronary artery disease. DESIGN: Open-label, fixed-dosage, one-way crossover from pravastatin and simvastatin to atorvastatin. SETTING: University-affiliated hospital and outpatient clinics. PATIENTS: Eighty patients with coronary artery disease with a minimum baseline low-density lipoprotein (LDL) above 130 mg/dl: 20 were treated with pravastatin 20 mg/day, 20 with pravastatin 40 mg/day, 20 with simvastatin 20 mg/day, and 20 with simvastatin 40 mg/day for a minimum of 6 months, with a prescription refill rate of 80% or greater. Intervention. Before crossover, patients had a fasting lipid profile determined and were questioned about side effects of pravastatin and simvastatin. All patients were switched to atorvastatin 10 mg/day. After 12 weeks of atorvastatin therapy, a repeat fasting lipid profile was obtained and patients were questioned about side effects with the drug. MEASUREMENTS AND MAIN RESULTS: Baseline demographic and clinical characteristics of the treatment groups were not significantly different with the exception of a lower baseline LDL in patients receiving pravastatin 20 mg/day. Baseline LDL values were as follows: pravastatin 20 mg/day, 158+/-26 mg/dl; pravastatin 40 mg/day, 176+/-22 mg/dl; simvastatin 20 mg/day, 177+/-27 mg/dl; and simvastatin 40 mg/day, 177+/-27 mg/dl. Reductions in LDL after treatment with pravastatin or simvastatin were as follows: pravastatin 20 mg/day, 22%; pravastatin 40 mg/day, 32%; simvastatin 20 mg/day, 33%; and simvastatin 40 mg/day, 38%. Patients achieving LDL goal with initial therapy were as follows: pravastatin 20 mg/day, 5%; pravastatin 40 mg/day, 5%; simvastatin 20 mg/day, 20%; and simvastatin 40 mg/day, 30%. After the switch to atorvastatin 10 mg/day, reductions in LDL were as follows: pravastatin 20 mg/day, 39% (p<0.001); pravastatin 40 mg/day, 38% (p<0.01); simvastatin 20 mg/day, 39% (p=0.04); and simvastatin 40 mg/day, 38% (p=0.83). Patients achieving LDL goals with atorvastatin 10 mg/day were as follows: pravastatin 20 mg/day, 60%; pravastatin 40 mg/day, 30%; simvastatin 20 mg/day, 25%; and simvastatin 40 mg/day, 30%. The frequency of side effects was similar for all three statins. Based on annual average wholesale price, atorvastatin 10 mg/day was more cost-effective than all pravastatin and simvastatin regimens. CONCLUSIONS: Therapeutic interchange from pravastatin 20 and 40 mg/day and simvastatin 20 mg/day to atorvastatin 10 mg/day was associated with both cost savings and significant reductions in LDL. The change from simvastatin 40 mg/day to atorvastatin 10 mg/day was associated with cost savings and an equivalent reduction in LDL.
Asunto(s)
Enfermedad Coronaria/tratamiento farmacológico , Ácidos Heptanoicos/uso terapéutico , Inhibidores de Hidroximetilglutaril-CoA Reductasas/uso terapéutico , Pravastatina/uso terapéutico , Pirroles/uso terapéutico , Simvastatina/uso terapéutico , Atorvastatina , LDL-Colesterol/sangre , Estudios de Cohortes , Análisis Costo-Beneficio , Estudios Cruzados , Esquema de Medicación , Femenino , Ácidos Heptanoicos/administración & dosificación , Ácidos Heptanoicos/economía , Humanos , Inhibidores de Hidroximetilglutaril-CoA Reductasas/administración & dosificación , Inhibidores de Hidroximetilglutaril-CoA Reductasas/economía , Masculino , Persona de Mediana Edad , Pravastatina/administración & dosificación , Pravastatina/economía , Pirroles/administración & dosificación , Pirroles/economía , Simvastatina/administración & dosificación , Simvastatina/economía , Resultado del TratamientoRESUMEN
The incidence, morbidity and mortality of chronic obstructive pulmonary disease (COPD) is rising throughout the world. The total economic cost of COPD in the US in 1993 was estimated to be over $US15.5 billion, with $US6.1 billion for hospitalisation, $US4.4 billion for physician and other fees, $US2.5 billion for drugs, $US1.5 billion for nursing home care and $US1.0 billion for home care. Office visits, hospital outpatient visits and emergency department visits accounted for 17.3% of the direct costs for COPD in the US. When stratified by severity, COPD treatment costs strongly correlate with disease severity. The American Thoracic Society, the European Respiratory Society and the British Thoracic Society have developed guidelines for the pharmacological treatment of COPD. However, the guidelines establish inhaled bronchodilators (anticholinergic agents and beta 2-adrenergic agonists) as the mainstay of therapy for patients with COPD. The guidelines were not based on cost analyses and thus are not a priori cost-effective guidelines. Since the publication of these guidelines, several new pharmacological products have been approved for use in patients with COPD including a combination of an anticholinergic and selective beta 2-adrenergic agonist [ipratropium/salbutamol (albuterol)] and a long-acting beta 2-adrenergic agonist (salmeterol). Both products are effective bronchodilators in COPD. The purpose of this report is to place these new agents in an updated pharmacological guideline scheme, utilising recently published data on clinical efficacy as well as pharmacoeconomics. The annualised healthcare costs were computed to be $US788/patient/year for the combination ipratropium/salbutamol inhaler and $US1059/patient/year for salmeterol (1999 values). Based upon an improved understanding of the complexity of COPD, the response of patients to newer bronchodilators (given individually or in combination), and recent pharmacoeconomic data for COPD treatment, a new treatment algorithm with associated costs is proposed. The use of an algorithm, based on medical and pharmacoeconomic data, will improve lung function in patients with COPD, improve patient satisfaction (e.g. quality of life, dyspnoea) and outcomes (e.g. exacerbations). It will also result in a positive effect on healthcare costs.
Asunto(s)
Costo de Enfermedad , Enfermedades Pulmonares Obstructivas/economía , Algoritmos , Costos de la Atención en Salud , Humanos , Enfermedades Pulmonares Obstructivas/tratamiento farmacológicoRESUMEN
OBJECTIVE: To describe the pharmacology, pharmacokinetics, efficacy, and safety of a fixed-dose combination of aspirin and extended-release (ER) dipyridamole indicated for the secondary prevention of stroke. DATA SOURCES: Published articles and abstracts were identified from a MEDLINE search (1966-December 1999) using the search terms dipyridamole, aspirin, antiplatelet, antiaggregation, and stroke prevention. Pertinent articles written in English were considered for review. Additional articles were identified from the references of retrieved literature. STUDY SELECTION AND DATA EXTRACTION: Studies including a combination of aspirin/dipyridamole in human subjects were evaluated. Emphasis was placed on randomized, controlled trials. DATA SYNTHESIS: Aspirin is a platelet inhibitor that works by inhibiting platelet cyclooxygenase, which reduces the production of thromboxane A2. Dipyridamole is a platelet inhibitor that is thought to work in part by inhibiting platelet cyclic-3',5'-adenosine monophosphate and cyclic-3',5'-guanosine monophosphate phosphodiesterase. The active metabolite of aspirin, salicylic acid, is highly bound to plasma protein and has a plasma half-life of two to three hours. Dipyridamole is also highly bound to plasma proteins, and the ER formulation has a plasma half-life of 13 hours. The first European Stroke Prevention Study (ESPS-1) found the combination of aspirin/dipyridamole to be superior to placebo in the prevention of stroke and transient ischemic attack (TIA). The ESPS-1, however, did not include an aspirin-only treatment arm. Therefore, it was unclear whether the combination of aspirin/dipyridamole was superior to aspirin alone. As a result, a second trial was conducted that included treatment arms of aspirin alone, ER dipyridamole alone, combination therapy, and placebo. The combination of aspirin 25 mg plus ER dipyridamole 200 mg twice daily was shown in the ESPS-2 to be significantly better than either agent given individually in preventing stroke and TIAs (p < 0.001). CONCLUSIONS: The American College of Chest Physicians (ACCP) recommends aspirin 50-325 mg/d to be the initial antiplatelet of choice for the prevention of atherothrombotic cerebral ischemic events. However, with the favorable results of the ESPS-2, it may be appropriate to substitute aspirin/ER dipyridamole for aspirin alone as the drug of choice. This combination appears to have a favorable adverse effect profile. The relative effectiveness of aspirin/ER dipyridamole compared with clopidogrel and ticlopidine has yet to be determined. If alternative antiplatelet therapy is needed, the ACCP recommends clopidogrel rather than ticlopidine because of its lower incidence of adverse effects. The ACCP further states that the combination of aspirin plus dipyridamole may be more effective than clopidogrel; these agents have a similarly favorable adverse effect profile.
Asunto(s)
Antiinflamatorios no Esteroideos , Aspirina , Dipiridamol , Combinación de Medicamentos , Inhibidores de Agregación Plaquetaria , Accidente Cerebrovascular/prevención & control , Antiinflamatorios no Esteroideos/efectos adversos , Antiinflamatorios no Esteroideos/farmacocinética , Antiinflamatorios no Esteroideos/uso terapéutico , Aspirina/efectos adversos , Aspirina/farmacocinética , Aspirina/farmacología , Aspirina/uso terapéutico , Combinación Aspirina y Dipiridamol , Ensayos Clínicos como Asunto , Dipiridamol/efectos adversos , Dipiridamol/farmacocinética , Dipiridamol/farmacología , Dipiridamol/uso terapéutico , Humanos , Inhibidores de Agregación Plaquetaria/efectos adversos , Inhibidores de Agregación Plaquetaria/farmacocinética , Inhibidores de Agregación Plaquetaria/farmacología , Inhibidores de Agregación Plaquetaria/uso terapéuticoRESUMEN
STUDY OBJECTIVES: The clinical outcomes and health-care costs of a cohort of 413 patients with COPD are reported. DESIGN: This study was a retrospective pharmacoeconomic analysis. SETTING: University teaching hospital and affiliated clinics. PATIENTS: COPD patients with an FEV(1) < 65% of predicted and an FEV(1)/FVC ratio < 70% were eligible to be included in this analysis. INTERVENTIONS: Health-care resource utilization and costs were identified through chart review and were stratified according to the severity of COPD using the American Thoracic Society stages I, II, and III. The pharmacoeconomic analysis was a cost-of-illness evaluation that included the acquisition costs of initially prescribed pulmonary drugs, acquisition cost of pulmonary drugs added during the follow-up period, oxygen therapy, laboratory and diagnostic test costs, clinic visit costs, and emergency department and hospital costs. RESULTS: Total treatment cost was highly correlated with disease severity, with stage I COPD having the lowest cost ($1,681 per patient per year), stage III COPD having the highest cost ($10, 812 per patient per year), and stage II COPD having a cost intermediate to stage I and stage III ($5,037 per patient per year). With the exception of add-on drug acquisition cost, all cost variables were the highest in stage III COPD, the lowest in stage I COPD, and intermediate in stage II COPD. Hospitalization was the most important cost variable for all three stages of COPD severity. When stratified by both disease severity and initial bronchodilator drug selection, ipratropium alone in stage I COPD patients and the combination of ipratropium plus a ss-agonist (with or without steroid therapy) in stage II and stage III COPD patients had the lowest total costs. Reasons for the lower total cost of the ipratropium and ipratropium plus ss-agonist treatment groups included lower add-on drug costs, fewer diagnostic and laboratory tests, and a lower utilization rate for clinic visits, emergency department visits, and hospitalizations. CONCLUSIONS: Our study demonstrates a strong correlation between disease severity and total treatment cost in COPD. In addition, the type of bronchodilator therapy impacts total cost in COPD. In stage I COPD, ipratropium alone had the lowest total cost, while in stage II and stage III COPD, a combination of ipratropium plus a ss-agonist had the lowest total cost. These data support the concept that adherence to published treatment guidelines will result in lower health-care costs due to COPD.
Asunto(s)
Enfermedades Pulmonares Obstructivas/economía , Fármacos del Sistema Respiratorio/economía , Adulto , Anciano , Anciano de 80 o más Años , Técnicas de Laboratorio Clínico/economía , Estudios de Cohortes , Costo de Enfermedad , Economía Farmacéutica , Servicio de Urgencia en Hospital/economía , Femenino , Estudios de Seguimiento , Volumen Espiratorio Forzado/fisiología , Costos de la Atención en Salud , Instituciones de Salud/economía , Recursos en Salud/estadística & datos numéricos , Hospitalización/economía , Humanos , Enfermedades Pulmonares Obstructivas/clasificación , Enfermedades Pulmonares Obstructivas/tratamiento farmacológico , Masculino , Persona de Mediana Edad , Terapia por Inhalación de Oxígeno/economía , Estudios Retrospectivos , Estadísticas no Paramétricas , Resultado del Tratamiento , Capacidad Vital/fisiologíaRESUMEN
Therapeutic goals for the treatment of hypertension and the ability of various angiotensin-converting-enzyme (ACE) inhibitors to meet these goals are presented. The 1997 Sixth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC-VI) does not recommend ACE inhibitors for first-line therapy in the treatment of hypertension; however, these guidelines do identify compelling indications for ACE inhibitor therapy, including diabetes mellitus (type 1) with proteinuria, heart failure, or previous myocardial infarction with systolic dysfunction. Since the JNC-VI guidelines were developed, the results of a prospective randomized clinical trial in patients with uncomplicated hypertension have demonstrated that ACE inhibitor therapy is as effective as conventional treatment in the prevention of cardiovascular morbidity and mortality. In hypertensive patients with diabetes, therapy with captopril, enalapril, fosinopril, or ramipril has resulted in significant reductions in cardiovascular events. In addition, tight blood pressure control with an ACE inhibitor has resulted in a greater reduction in the risk of macrovascular and microvascular complications of diabetes than was seen with less tight control. Recent study results support broader use of ACE inhibitors for hypertension than was recommended in the JNC-VI guidelines.
Asunto(s)
Inhibidores de la Enzima Convertidora de Angiotensina/uso terapéutico , Hipertensión/tratamiento farmacológico , Enfermedades Cardiovasculares/prevención & control , Complicaciones de la Diabetes , Humanos , Hipertensión/complicaciones , Guías de Práctica Clínica como Asunto , Insuficiencia Renal/prevención & controlAsunto(s)
Electrocardiografía/efectos de los fármacos , Estrógenos Conjugados (USP)/farmacología , Posmenopausia/fisiología , Administración Oral , Anciano , Esquema de Medicación , Ecocardiografía , Estrógenos Conjugados (USP)/administración & dosificación , Prueba de Esfuerzo , Reacciones Falso Positivas , Femenino , Humanos , Medroxiprogesterona/administración & dosificación , Medroxiprogesterona/farmacología , Persona de Mediana Edad , Congéneres de la Progesterona/administración & dosificación , Congéneres de la Progesterona/farmacologíaRESUMEN
Dofetilide is a new antiarrhythmic agent recently approved for conversion and maintenance of sinus rhythm in patients with atrial fibrillation (AF) and atrial flutter (AFl). It is a class III antiarrhythmic that works by selectively blocking the rapid component of the delayed rectifier outward potassium current. Dofetilide prolongs the effective refractory period in accessory pathways, both anterograde and retrograde. This can be seen on the electrocardiogram through a dose-dependent prolongation of the QT and QTc intervals, with parallel increases in ventricular refractoriness. Approximately 80% of drug is excreted in urine, so dosing must be based on creatinine clearance. The elimination half-life is approximately 10 hours. In clinical trials dofetilide was superior to flecainide in converting patients with AFl to normal sinus rhythm (NSR; 70% vs 9%, p<0.01). It also was more effective than sotalol in converting patients with both AF and AFl to NSR (29% vs 6%, p<0.05) and maintaining them in NSR for up to 1 year. Most patients converted within 24-36 hours. Dofetilide has a favorable risk:benefit profile. Torsades de pointes is the most serious side effect; it occurs in 0.3-10.5% of patients and is dose related. To minimize the risk of induced arrhythmia, patients who start or restart the drug should be hospitalized a minimum of 3 days for creatinine clearance measurements, continuous electrocardiographic monitoring, and cardiac resuscitation, if necessary.
Asunto(s)
Antiarrítmicos/uso terapéutico , Arritmias Cardíacas/tratamiento farmacológico , Fenetilaminas/uso terapéutico , Sulfonamidas/uso terapéutico , Animales , Antiarrítmicos/efectos adversos , Antiarrítmicos/farmacología , Humanos , Fenetilaminas/efectos adversos , Fenetilaminas/farmacología , Sulfonamidas/efectos adversos , Sulfonamidas/farmacologíaRESUMEN
Heart failure is a symptom complex of varied etiology associated with substantial mortality. Approximately 5 million Americans have the disease, with 400,000 new cases diagnosed each year. Despite better understanding of its pathophysiology, therapeutic options remain suboptimal and the syndrome remains associated with high rates of hospitalization and loss of economic productivity. Management traditionally included vasodilators, diuretics, and digoxin, with a focus on controlling symptoms and improving ejection fraction and exercise capacity. Drug therapy now is focused on improving survival, with a reduction in health care costs related to hospitalizations. Drugs with a proven benefit in reducing morbidity and mortality are angiotensin-converting enzyme inhibitors, beta-blockers, and the combination of hydralazine plus a nitrate. Diuretics, digoxin, dihydropyridine calcium channel blockers, phosphodiesterase inhibitors, catecholamine infusions, amiodarone, left ventricular assist devices, and transplantation are also options.
Asunto(s)
Fármacos Cardiovasculares/uso terapéutico , Insuficiencia Cardíaca/terapia , Insuficiencia Cardíaca/tratamiento farmacológico , Insuficiencia Cardíaca/cirugía , HumanosRESUMEN
We conducted a post hoc pharmacoeconomic analysis of a multicenter, open-label, randomized, parallel-group, 8-week efficacy-safety comparison of five HMG-CoA reductase inhibitors-atorvastatin, fluvastatin, lovastatin, pravastatin, and simvastatin. The 534 patients requiring cholesterol-lowering therapy took the drugs for 8 weeks with 15 different regimens. Low-density lipoprotein (LDL) was measured after 6 weeks of diet (baseline) and after 8 weeks of treatment with a study drug. At dosages of 10, 20, and 40 mg/day, atorvastatin was associated with significantly greater reductions in LDL than equivalent dosages of the other agents. Cost-effectiveness calculated as the annual acquisition cost/percentage LDL reduction was greatest with atorvastatin 10 mg ($17.96), fluvastatin 40 mg ($19.83), atorvastatin 20 mg ($22.85), and atorvastatin 40 mg ($24.96). All other dosages were above $25.00/year/percentage LDL reduction. Atorvastatin was the most cost-effective HMG-CoA reductase inhibitor. Fluvastatin 40 mg/day also had a favorable cost:effectiveness ratio but lowered LDL only by 23%.
Asunto(s)
Anticolesterolemiantes/economía , Anticolesterolemiantes/uso terapéutico , Inhibidores de Hidroximetilglutaril-CoA Reductasas/economía , Inhibidores de Hidroximetilglutaril-CoA Reductasas/uso terapéutico , Hipercolesterolemia/tratamiento farmacológico , Hipercolesterolemia/economía , Adulto , Anciano , Anciano de 80 o más Años , Anticolesterolemiantes/efectos adversos , LDL-Colesterol/sangre , Análisis Costo-Beneficio , Femenino , Humanos , Inhibidores de Hidroximetilglutaril-CoA Reductasas/efectos adversos , Lípidos/sangre , Masculino , Persona de Mediana EdadRESUMEN
BACKGROUND: Supraventricular tachyarrhythmias are common after open heart surgery. Possible causative factors for these arrhythmias include operative trauma, atrial ischemia, electrolyte imbalances, pericardial irritation, and excess catecholamines. Two agents commonly used to control ventricular rate in atrial fibrillation or atrial flutter (AF/AFL) are beta-blockers and calcium channel blockers. METHODS AND RESULTS: This randomized study was designed to compare the safety and efficacy of intravenous diltiazem versus intravenous esmolol in patients with postoperative AF/AFL after coronary bypass surgery and/or valve replacement surgery. A comparative cost analysis was also performed. Thirty patients received either esmolol (n = 15) or diltiazem (n = 15) for AF/AFL. During the first 6 hours of treatment, 66.6% of esmolol-treated patients converted to sinus rhythm compared with 13.3% of the diltiazem-treated patients (P <.05). At 24 hours, 66.6% of the diltiazem group converted to SR compared with 80% of the esmolol group (not significant). Drug-induced side effects, time to rate control (<90 beats/min), number of patients requiring cardioversion, and length of hospitalization were similar for the two groups. The drug cost/successfully treated patient for esmolol versus diltiazem was $254 versus $437 at 6 hours and $529 versus $262 at 24 hours. CONCLUSIONS: Although this is a small study, it suggests that esmolol is more effective in converting patients to normal sinus rhythm than diltiazem during the initial dosing period. No differences in conversion rates were observed between the two groups after 24 hours. Additional studies are needed to confirm whether esmolol is the initial drug of choice in patients with postoperative AF/AFL after coronary bypass surgery.
Asunto(s)
Fibrilación Atrial/tratamiento farmacológico , Aleteo Atrial/tratamiento farmacológico , Puente de Arteria Coronaria/efectos adversos , Diltiazem/administración & dosificación , Propanolaminas/administración & dosificación , Antagonistas Adrenérgicos beta/uso terapéutico , Adulto , Anciano , Fibrilación Atrial/etiología , Fibrilación Atrial/mortalidad , Aleteo Atrial/etiología , Análisis Costo-Beneficio , Diltiazem/economía , Femenino , Humanos , Infusiones Intravenosas , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/tratamiento farmacológico , Probabilidad , Pronóstico , Propanolaminas/economía , Valores de Referencia , Tasa de Supervivencia , Resultado del TratamientoRESUMEN
This randomized, controlled trial evaluated the impact of personalized follow-up on compliance rates in high-risk patients receiving combination lipid-lowering therapy over 2 years. A random sample of 30 patients 7-30 days after cardiac surgery had baseline fasting low-density lipoprotein levels higher than 130 mg/dl. All patients received lovastatin 20 mg/day and colestipol 5 g twice/day. Weekly telephone contact was made with each patient for 12 weeks. Short- and long-term compliance was assessed by pill and packet counts and refill records. Compliance and lipid profile results were significantly better in the intervention group (p<0.05) up to 2 years after the start of therapy than in the control group for all parameters except high-density lipoprotein. However, this effect was not apparent during the first 12 weeks of therapy. Short-term telephone follow-up favorably affected compliance and lipid profile results up to 2 years after start of therapy.
Asunto(s)
Enfermedad Coronaria/terapia , Consejo/métodos , Hipolipemiantes/uso terapéutico , Cooperación del Paciente/estadística & datos numéricos , Farmacéuticos , Anciano , Colesterol/sangre , Colestipol/uso terapéutico , Enfermedad Coronaria/sangre , Enfermedad Coronaria/psicología , Quimioterapia Combinada , Femenino , Estudios de Seguimiento , Humanos , Lipoproteínas HDL/sangre , Lipoproteínas HDL/efectos de los fármacos , Lipoproteínas LDL/sangre , Lipoproteínas LDL/efectos de los fármacos , Lovastatina/uso terapéutico , Masculino , Persona de Mediana Edad , Revascularización Miocárdica/métodos , Factores de Tiempo , Resultado del Tratamiento , Triglicéridos/sangreRESUMEN
STUDY OBJECTIVE: This study reports a comparison of the time to treatment and cost of administration of alteplase (tPA) and reteplase (rPA) in patients with acute myocardial infarction (MI). DESIGN: Retrospective chart review. SETTING: Hospital emergency department. INTERVENTIONS: A retrospective chart review of 500 MI patients who received alteplase or reteplase was performed. A comparison of time from presentation in the emergency department to start of treatment was performed, and the cost of administration of drugs, including cost of supplies, monitoring time, and IV line complications, was calculated for each drug. RESULTS: The time from presentation to start of treatment was significantly shorter for reteplase than alteplase (51 vs 34 min). This difference resulted from a shorter decision to treat to start of treatment time for reteplase (11 min) compared to alteplase (31 min). The cost of administration of alteplase ranged from $136 to $184 per patient, while the cost of administration of reteplase ranged from $87 to $120 per patient. DISCUSSION: Given the similar safety and efficacy profiles of these thrombolytic agents, the advantages of reteplase in speed of administration and the reduction in cost should be considered when making formulary and drug product selection decisions.). Abbreviated Abstract. Alteplase (tPA) and reteplase (rPA) were compared in a retrospective review of 500 patients. rPA was associated with 17 minute time savings from presentation-to-treatment compared to tPA. rPA was also associated with a per patient cost savings $49 to $64 compared to tPA. The time and cost advantages of rPA should be considered when making drug product selection decisions.