RESUMEN
Nimodipine, an L-type cerebroselective calcium channel antagonist, is the only drug approved by the US Food and Drug Administration for the neuroprotection of patients with aneurysmal subarachnoid hemorrhage (aSAH). Four randomized, placebo-controlled trials of nimodipine demonstrated clinical improvement over placebo; however, these occurred before precision medicine with pharmacogenomics was readily available. The standard enteral dose of nimodipine recommended after aSAH is 60 mg every 4 h. However, up to 78% of patients with aSAH develop systemic arterial hypotension after taking the drug at the recommended dose, which could theoretically limit its neuroprotective role and worsen cerebral perfusion pressure and cerebral blood flow, particularly when concomitant vasospasm is present. We investigated the association between nimodipine dose changes and clinical outcomes in a consecutive series of 150 patients (mean age, 56 years; 70.7% women) with acute aSAH. We describe the pharmacogenomic relationship of nimodipine dose reduction with clinical outcomes. These results have major implications for future individualized dosing of nimodipine in the era of precision medicine.
Asunto(s)
Bloqueadores de los Canales de Calcio , Nimodipina , Farmacogenética , Hemorragia Subaracnoidea , Humanos , Nimodipina/administración & dosificación , Nimodipina/efectos adversos , Hemorragia Subaracnoidea/tratamiento farmacológico , Hemorragia Subaracnoidea/genética , Hemorragia Subaracnoidea/complicaciones , Persona de Mediana Edad , Femenino , Masculino , Bloqueadores de los Canales de Calcio/administración & dosificación , Bloqueadores de los Canales de Calcio/efectos adversos , Bloqueadores de los Canales de Calcio/uso terapéutico , Anciano , Farmacogenética/métodos , Resultado del Tratamiento , Relación Dosis-Respuesta a Droga , Adulto , Medicina de Precisión/métodos , Vasoespasmo Intracraneal/tratamiento farmacológicoRESUMEN
In the Caribbean there is limited data on orthostatic hypertension (OHT) in elderly hypertensive patients with atherosclerotic disease who are at risk for cardiovascular events. The authors examined the association of antihypertensive classes of drugs with diastolic OHT in patients 60 year and older with hypertension and hyperlipidemia attending public primary care facilities. These relationships were evaluated in a cross-sectional study of hypertensive hyperlipidemic older patients (n = 400) to determine orthostatic changes in blood pressure based on seated to standing measurements. OHT was defined as an increase in systolic blood pressure of ≥20 mm Hg and/or increase in diastolic blood pressure of ≥10 mm Hg upon orthostasis at 3 min. Patients were categorized based on their orthostatic blood pressure response: orthostatic normotensive (n = 200) and blood pressure dysregulated (n = 200) of which 168 were diastolic OHT. Multivariable logistic regression models were used to examine associations of antihypertensive classes and diastolic OHT. Renin-angiotensin-aldosterone-system (RAAS) blockers were the most commonly prescribed (79.3%), followed by diuretics (DIUs) (61.6%), dihydropyridine calcium channel blockers (dCCBs) (53.8%), and beta-blockers (BBs) (19.3%). Most normotensive (76.0%) and diastolic OHT (75.0%) patients were prescribed two or more antihypertensive medications. Pharmaceutical prescription of triple combination RAAS blockers + dCCBs + DIUs (OR, 0.55; 95% CI, 0.31-0.99) or RAAS blockers + dCCBs + BBs (OR, 0.23; 95% CI, 0.06-0.92) showed a protective effect of diastolic OHT in analyses adjusted for age, sex, sitting diastolic blood pressure, and comorbidities. Our study suggests prescription of triple combination antihypertensive drugs of RAAS blockers + dCCBs + DIUs or RAAS blockers + dCCBs + BBs may reduce the likelihood of diastolic OHT.
Asunto(s)
Antihipertensivos , Hipertensión , Humanos , Adulto , Anciano , Antihipertensivos/farmacología , Hipertensión/tratamiento farmacológico , Hipertensión/epidemiología , Hipertensión/inducido químicamente , Estudios Transversales , Presión Sanguínea/fisiología , Bloqueadores de los Canales de Calcio/efectos adversos , Diuréticos/uso terapéutico , Región del Caribe/epidemiologíaRESUMEN
Systemic medications categorized as diphenylhydantoin, calcineurin inhibitor and calcium channel blocker may have effects on the oral cavity by modifying the inflammatory and immune response and causing undesired tissue proliferative reactions. Calcineurin inhibitors are medications commonly used for long periods in patients undergoing allogeneic hematopoietic stem cell transplant (HSCT) and solid organ transplantation. Medication-related fibrovascular hyperplasia (MRFH) is an extra gingival hyperplastic nodular growth associated with medications use. This study reports five cases of pediatric patients (6 to 12-years-old) diagnosed with Fanconi anemia (FA) after HSCT who presented similar oral mucosal lesions associated with the use of cyclosporine, phenobarbital and amlodipine. After excision of the lesions, histopathological analysis described them as pyogenic granuloma (PG). As the aetiology of the lesions manifested by the patients was associated with the use of medications, the final diagnosis was MRFH. Despite the clinical and histopathological similarity between PG and MRFH, it is fundamental to know the aetiological agent for achieving definitive diagnosis and correct management. Considering the etiologic agent (medication) and histopathological findings, it is suggested that the most appropriate term for this manifestation should be "medication-related fibrovascular hyperplasia". The correct nomenclature related to extra gingival hyperplastic lesions identified in patients on medications with potential to induce hyperplastic reactions should be adopted to facilitate scientific communication and improve the treatment.
Asunto(s)
Bloqueadores de los Canales de Calcio/efectos adversos , Anemia de Fanconi/terapia , Granuloma Piogénico/inducido químicamente , Trasplante de Células Madre Hematopoyéticas , Inmunosupresores/efectos adversos , Enfermedades de la Boca/inducido químicamente , Amlodipino/efectos adversos , Niño , Ciclosporina/efectos adversos , Femenino , Humanos , Hiperplasia/inducido químicamente , Masculino , Fenobarbital/efectos adversosRESUMEN
OBJECTIVE: To determine if the use of magnesium sulphate postdelivery reduces the risk of eclampsia in women with severe pre-eclampsia exposed to at least 8 hours of magnesium sulphate before delivery. DESIGN: Randomised multicentre controlled trial. SETTING: Latin America. POPULATION: Women with severe pre-eclampsia that had received a 4-g loading dose followed by 1 g per hour for 8 hours as maintenance dose before delivery. METHODS: In all, 1113 women were randomised; 555 women were randomised to continue the infusion of magnesium sulphate for 24 hours postpartum and 558 were randomised to stopping the magnesium sulphate infusion immediately after delivery. OUTCOME MEASURES: Primary outcome was the incidence of eclampsia in the first 24 hours postdelivery. Secondary outcomes included maternal death, maternal complications, time to start ambulation and time to start lactation. RESULTS: The maternal characteristics at randomisation between the groups were not different. There were no differences in the rate of eclampsia; 1/555 (0.18%) versus 2/558 (0.35%) [relative risk (RR 0.7, 95% CI 0.1-3.3; P = 0.50] or maternal complications between the groups (RR 1.0, 95% CI 0.8-1.2; P = 0.76). Time to start ambulation was significantly shorter in the no magnesium sulphate group (18.1 ± 10.6 versus 11.8 ± 10.8 hours; P = 0.0001) and time to start lactation was equally shorter in the no magnesium sulphate group (24.1 ± 17.1 versus 17.1 ± 16.8 hours; P = 0.0001). CONCLUSIONS: Women with severe pre-eclampsia treated with a minimum of 8 hours of magnesium sulphate before delivery do not benefit from continuing the magnesium sulphate for 24 hours postpartum. TWEETABLE ABSTRACT: No benefit of continuing magnesium sulphate postpartum in severe pre-eclampsia exposed to this drug for a minimum of 8 hours before delivery.
Asunto(s)
Parto Obstétrico , Sulfato de Magnesio , Complicaciones del Trabajo de Parto/prevención & control , Preeclampsia , Adulto , Bloqueadores de los Canales de Calcio/administración & dosificación , Bloqueadores de los Canales de Calcio/efectos adversos , Parto Obstétrico/efectos adversos , Parto Obstétrico/métodos , Relación Dosis-Respuesta a Droga , Monitoreo de Drogas/métodos , Femenino , Humanos , Sulfato de Magnesio/administración & dosificación , Sulfato de Magnesio/efectos adversos , Periodo Posparto/efectos de los fármacos , Preeclampsia/tratamiento farmacológico , Preeclampsia/prevención & control , Embarazo , Medición de Riesgo , Resultado del TratamientoRESUMEN
OBJECTIVE: The aim of the current study was to assess the association between 3 different calcium channel blockers (CCBs) (nifedipine, amlodipine and felodipine) and gingival overgrowth in patients with a diagnosis of severe refractory hypertension. METHODS: One hundred and sixty-two patients with severe refractory hypertension, taking CCBs, were selected. Gingival overgrowth was graded and periodontal measurements were recorded (probing pocket depth, clinical attachment level, plaque index and bleeding on probing). Unconditional multivariable binary logistic regression analyses were performed to assess the association between CCB intake and gingival overgrowth after adjusting for potential confounders. RESULTS: Of the 162 patients, 26 (16.0%) were current smokers and 101 (62.3%) were females. The mean age (SD) was 54.1 (8.5) years and the median age (range) 52.5 (39-78) years. Gingival overgrowth was observed in 55 patients (34.0%). Nifedipine was the most common medication (35.2%; 57 of 162). The results of multiple binary logistic regression showed statistically significant associations between CCB intake (exposure) and gingival overgrowth (outcome) after adjusting for the variables treatment time with antihypertensive and plaque index. Patients with gingival overgrowth were 2.5 (odds ratio = 2.46; 95% confidence interval: 1.04-5.82) and 4.0 (odds ratio = 3.90; 95% confidence interval: 1.47-10.35) times more likely to be taking nifedipine and amlodipine, respectively, than patients without gingival overgrowth. On the other hand, this significant association was not observed for felodipine. CONCLUSION: Nifedipine and amlodipine, but not felodipine, were associated with gingival overgrowth in patients with severe refractory hypertension.
Asunto(s)
Bloqueadores de los Canales de Calcio/efectos adversos , Sobrecrecimiento Gingival/inducido químicamente , Hipertensión/tratamiento farmacológico , Adulto , Anciano , Amlodipino/efectos adversos , Brasil , Felodipino/efectos adversos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Nifedipino/efectos adversos , Índice PeriodontalRESUMEN
BACKGROUND: Drug-induced gingival overgrowth (DIGO) is attributed mainly to the prolonged use of calcium channel blocking agents, anticonvulsants, and anti-calcineurin inhibitors . The management of DIGO depends on the severity of the disease and includes surgical intervention and plaque control. Compared to conventional surgical treatment, the recent literature data have shown that gingivectomy using a high-power laser (HPL) is a short and easy procedure, which results in minimal postoperative discomfort and greater patient accep- tance. OBJECTIVE AND METHODS: The purpose of this study was to report two cases of recurrent DIGO treated surgically using HPL (λ 808nm, 1.5W). RESULTS: Minimal bleeding and discomfort were observed during surgery, and patients reported no pain or bleeding after the procedure. After 1 year of follow-up, patients presented a minimal increase of gingival volume, indicating that laser technology can improve the efficiency and prognosis of DIGO. CONCLUSIONS: The HPL was able to preventing hemorrhage and improving the patient's collaboration with the treatment and quality of life.
Asunto(s)
Sobrecrecimiento Gingival/cirugía , Gingivectomía/métodos , Láseres de Semiconductores/uso terapéutico , Adolescente , Amlodipino/efectos adversos , Bloqueadores de los Canales de Calcio/efectos adversos , Niño , Femenino , Estudios de Seguimiento , Sobrecrecimiento Gingival/inducido químicamente , Gingivoplastia , Humanos , Masculino , Factores de TiempoRESUMEN
BACKGROUND: In a recent case-control study, long-term use of calcium channel blocking drugs was associated with a greater-than-twofold increased breast cancer risk. If prospectively collected data confirm that calcium channel blocker use increases breast cancer risk, this would have major implications for hypertension treatment. The objective of this study was to determine whether women using calcium channel blockers for 10 years or more were at increased risk of developing breast cancer compared with women not using calcium channel blockers. METHODS: The Sister Study is a prospective volunteer cohort study of women from the USA and Puerto Rico designed to evaluate environmental and genetic risk factors for breast cancer. Beginning in 2003, women between the ages of 35 and 74 were recruited. They were eligible to participate if they had a sister with breast cancer but had not been diagnosed with breast cancer themselves. In total, 50,884 women enrolled in the cohort between 2003 and 2009; 50,757 women with relevant baseline data and available follow-up data are included in this study. The exposure of interest is current use of calcium channel blocking drugs and the reported duration of use at entry into the cohort. Secondary exposures of interest were the duration and frequency of use for all other subclasses of antihypertensive drugs. Our main outcome is a self-reported diagnosis of breast cancer during the study follow-up period. With patient permission, self-reported diagnoses were confirmed using medical records. RESULTS: Results showed 15,817 participants were currently using an antihypertensive drug, and 3316 women were currently using a calcium channel blocker at study baseline; 1965 women reported a breast cancer diagnosis during study follow-up. Using Cox proportional hazards modeling, we found no increased risk of breast cancer among women who had been using calcium channel blockers for 10 years or more compared with never users of calcium channel blockers (HR 0.88, 95 % CI 0.58-1.33). CONCLUSIONS: We saw no evidence of increased risk of breast cancer from 10 years or more of current calcium channel blocker use. Our results do not support avoiding calcium channel blocking drugs in order to reduce breast cancer risk.
Asunto(s)
Antihipertensivos/efectos adversos , Neoplasias de la Mama/epidemiología , Neoplasias de la Mama/etiología , Bloqueadores de los Canales de Calcio/efectos adversos , Anciano , Neoplasias de la Mama/patología , Femenino , Estudios de Seguimiento , Terapia de Reemplazo de Hormonas , Humanos , Incidencia , Persona de Mediana Edad , Vigilancia de la Población , Modelos de Riesgos Proporcionales , Estudios Prospectivos , Puerto Rico/epidemiología , Riesgo , Factores de Riesgo , Estados Unidos/epidemiologíaRESUMEN
The aging population is rapidly increasing, and is mainly due to medical advances and the control of chronic diseases, with a real worldwide increase in the elderly population. Special emphasis has been placed on the management of hypertension in the geriatric patient, since its long-term benefits have been shown to prevent both cerebral and cardiac infarctions. Calcium channel blockers have been shown to be effective in this condition in the elderly. Their success depends on their mechanism of action, as well as on the physiological changes observed, and on the aging process itself, which include cardiac hypertrophy, calcification of cardiac valves, and a decrease in the excitation-conduction system. There is thickening of the tunica intima of the arteries, and the production of nitric oxide at cellular level decreases with age, along with an increase in endothelin 1, which leads to vascular endothelium dysfunction. In the kidneys, there is a decrease in prostacyclin, endothelial hyperpolarization factor, as well as the Klotho anti-aging protein, which leads to an increase in blood pressure. Calcium channel blocker drugs have been shown to be effective in any age group for the management of hypertension, and are safe in the elderly patients. These drugs block L-type calcium channels, with the long-acting or latest generation dihydropyridines being the most effective of this group. Several studies, including SYST-EUR2, NORDIL, and STOP-2, have demonstrated the effectiveness of these drugs in the geriatric patient. The prescribing of long-acting calcium channel blocker drugs in a single dose is the most recommended. The safety in the use of this drug group has been demonstrated in the treatment of hypertension in the elderly patient, with a level of effectiveness similar to other widely used drugs.
Asunto(s)
Antihipertensivos/uso terapéutico , Bloqueadores de los Canales de Calcio/uso terapéutico , Hipertensión/tratamiento farmacológico , Anciano , Envejecimiento/fisiología , Animales , Antihipertensivos/efectos adversos , Antihipertensivos/farmacología , Bloqueadores de los Canales de Calcio/efectos adversos , Bloqueadores de los Canales de Calcio/farmacología , Interacciones Farmacológicas , Humanos , Hipertensión/fisiopatologíaRESUMEN
OBJECTIVE: To identify patients who were being treated for hypertension with conventional release verapamil (CRV), and to notify the professional responsible for their health care on cardiovascular risk to which they are exposed and achieve a reduction in the number of patients who are treated with this drug. METHODS: A quasi-experimental prospective before and after study without a control group was conducted on 7289 patients diagnosed with hypertension who were on treatment with CRV, between October 1, 2012 and December 31, 2012 in 8 Colombian cities, collected from a database for dispensing medicines. Socio-demographic and pharmacological variables were evaluated. A total of 108 educational interventions were performed on those responsible for their health care, and evaluated within three months with the proportion of suspension of the prescriptions of CRV being evaluated. Multivariate analysis was performed using SPSS 22.0. RESULTS: The mean age of patients was 67.9±11.8 years (range: 26-96 years), of which 70.6% were men. Withdrawal of treatment with CRV was achieved in a total of 1922 patients (26.3% of users), distributed as follows: 1160 (60.4%) were the presentation of 120mg, while 762 (39.6%) the 80mg. The variable being treated in the city of Medellin (OR: 17.6; 95% CI: 11.949 to 25.924; P<.01) was statistically significantly associated with the replacement of CRV for another antihypertensive. CONCLUSIONS: A relatively moderate adherence to recommendations about the proper use of CRV in hypertensive patients, was found. Intervention programs that reduce inappropriate prescribing of potential risks to patients of insurance companies and cities where the change was not achieved, must be enforced.
Asunto(s)
Antihipertensivos/uso terapéutico , Bloqueadores de los Canales de Calcio/uso terapéutico , Prescripciones de Medicamentos/estadística & datos numéricos , Hipertensión/tratamiento farmacológico , Prescripción Inadecuada/prevención & control , Pautas de la Práctica en Medicina/estadística & datos numéricos , Verapamilo/uso terapéutico , Adulto , Anciano , Anciano de 80 o más Años , Antihipertensivos/efectos adversos , Antihipertensivos/farmacocinética , Bloqueadores de los Canales de Calcio/efectos adversos , Bloqueadores de los Canales de Calcio/farmacocinética , Enfermedades Cardiovasculares/inducido químicamente , Enfermedades Cardiovasculares/prevención & control , Colombia , Sustitución de Medicamentos , Femenino , Adhesión a Directriz , Humanos , Masculino , Persona de Mediana Edad , Guías de Práctica Clínica como Asunto , Estudios Prospectivos , Verapamilo/efectos adversos , Verapamilo/farmacocinéticaRESUMEN
PURPOSE: The proposal of this study was to determine the prevalence and the associated factors of erectile dysfunction (ED) among hemodialysis (HD) patients. MATERIALS AND METHODS: This was a cross-sectional study based on data collected from HD male patients. Clinical, demographic and laboratory data of all patients were collected in three HD clinics from December 2010 to June 2011. Patients answered questions of erectile function domain from International Index of Erectile Function. Data were evaluated by descriptive analysis and by univariate (ULRA) and multivariate logistic regression analysis (MLRA). RESULTS: Three hundred and five patients participated of the study. The prevalence of ED was 68.19%. ED was associated with diabetes (DM), benign prostatic hyperplasia, glomerulonephritis as cause of chronic renal failure (CRF), smoking habits, lower creatinine levels (ULRA), use of calcium channel blocker (MLRA), aging, lower education level, alcohol consumption, DM (as cause of CRF) and coronary insufficiency (ULRA and MLRA). CONCLUSIONS: ED was highly prevalent in the HD men. It was independently associated with aging, current use of alcohol, long alcohol use (even for those who do not drink more), lower education level, diabetes as cause of CRF, coronary insufficiency and use of channel blockers calcium.
Asunto(s)
Disfunción Eréctil/epidemiología , Fallo Renal Crónico/complicaciones , Diálisis Renal/efectos adversos , Adulto , Anciano , Consumo de Bebidas Alcohólicas/efectos adversos , Brasil/epidemiología , Bloqueadores de los Canales de Calcio/efectos adversos , Creatinina/sangre , Estudios Transversales , Disfunción Eréctil/etiología , Humanos , Masculino , Persona de Mediana Edad , Análisis Multivariante , Prevalencia , Factores de Riesgo , Fumar/efectos adversos , Factores Socioeconómicos , Encuestas y CuestionariosRESUMEN
Purpose: The proposal of this study was to determine the prevalence and the associated factors of erectile dysfunction (ED) among hemodialysis (HD) patients. Materials and Methods: This was a cross-sectional study based on data collected from HD male patients. Clinical, demographic and laboratory data of all patients were collected in three HD clinics from December 2010 to June 2011. Patients answered questions of erectile function domain from International Index of Erectile Function. Data were evaluated by descriptive analysis and by univariate (ULRA) and multivariate logistic regression analysis (MLRA). Results: Three hundred and five patients participated of the study. The prevalence of ED was 68.19%. ED was associated with diabetes (DM), benign prostatic hyperplasia, glomerulonephritis as cause of chronic renal failure (CRF), smoking habits, lower creatinine levels (ULRA), use of calcium channel blocker (MLRA), aging, lower education level, alcohol consumption, DM (as cause of CRF) and coronary insufficiency (ULRA and MLRA). Conclusions: ED was highly prevalent in the HD men. It was independently associated with aging, current use of alcohol, long alcohol use (even for those who do not drink more), lower education level, diabetes as cause of CRF, coronary insufficiency and use of channel blockers calcium. .
Asunto(s)
Adulto , Anciano , Humanos , Masculino , Persona de Mediana Edad , Disfunción Eréctil/epidemiología , Fallo Renal Crónico/complicaciones , Diálisis Renal/efectos adversos , Consumo de Bebidas Alcohólicas/efectos adversos , Brasil/epidemiología , Estudios Transversales , Bloqueadores de los Canales de Calcio/efectos adversos , Creatinina/sangre , Disfunción Eréctil/etiología , Análisis Multivariante , Prevalencia , Factores de Riesgo , Factores Socioeconómicos , Encuestas y Cuestionarios , Fumar/efectos adversosRESUMEN
A hipertensão arterial é a doença cardiovascular mais prevalentee, para se atingir a meta de controle ideal, a maioriados pacientes necessita de mais de uma classe terapêutica.Além disso, devido à presença de muitas comorbidades associadas,é comum o uso de outras medicações associadas.O entendimento das interações benéficas e indesejáveisdos medicamentos anti-hipertensivos entre si e com outrostipos de medicamentos, é muito importante para se obter umtratamento adequado do paciente hipertenso. Neste artigo,abordamos as principais interações das diferentes classesde anti-hipertensivos que apresentam benefícios na melhorobtenção do efeito anti-hipertensivo e na redução de efeitoscolaterais. Também são apresentadas as interações que podematrapalhar o efeito anti-hipertensivo das medicações, assimcomo aumentar a chance de efeitos colaterais...
Hypertension is the most prevalent cardiovascular disease,and to achieve the goal of optima! contrai, most patients requiremore than one therapeutic c1ass. In addition, due to thepresence of several associated co-morbidities it is common touse other associated medications. Understanding beneficialand undesirable interactions of antihypertensive medicationsamong themselves and with other types of drugs, it is veryimportant to get a proper treatment of the hypertensive patient.In this article we discuss the main interactions of differentclasses of antihypertensive drugs which are beneficial inobtaining better antihypertensive effect and reducing sideeffects. We also presented the interactions that could disruptthe antihypertensive effect of the drugs as well as increasethe risk of side effects...
Asunto(s)
Humanos , Anciano , Interacciones Farmacológicas , Enfermedades Cardiovasculares/metabolismo , Hipertensión/complicaciones , Hipertensión/metabolismo , Hipertensión/terapia , Antagonistas Adrenérgicos beta/efectos adversos , Bloqueadores de los Canales de Calcio/efectos adversos , Comorbilidad , Enfermedad Crónica/tratamiento farmacológico , Peptidil-Dipeptidasa A/efectos adversosRESUMEN
Standard drug monographs (SDMs) have been described as deficient in providing information in a manner simplified enough for patient reading. The aim of this study was to design patient information leaflets for hydrochlorothiazide, nifedipine and enalapril with content indicated by patients as relevant and to evaluate them against the SDM. Patient information leaflet (PIL) for each drug was designed to contain information on name, use of drug, how it works, how it is to be taken, common side effects, storage, missed dose action, things to avoid and when to contact the physician. Appropriateness was assessed by 10 practising pharmacists. For each drug, 40 patients were recruited, of which 20 were given SDM and 20 PIL. The knowledge of each participant was examined before and after exposure to SDM or PIL, as well as opinion on ease of reading and attractiveness using Pearson s Chi-square analysis. The results showed that both SDM and PIL improved knowledge of common side effects when compared with responses before exposure (chi2 = 24.26 for SDM and 27.64 for PIL, p < 0.001) with no difference between the groups. Respondents receiving PILs were better able to recall "things to avoid" after exposure to PIL (chi2 =10.85, p < 0.001). After exposure to SDM or PIL, the respondents who received PIL were more aware of when to contact the physician, compared to the SDM group (chi2 = 8.41, p < 0.01). When compared with SDM, respondents receiving PIL were more likely to indicate that PIL was easy to read (chi2 = 20.00, p < 0.001), attractive (chi2 = 12.45, p < 0.001) and they were more likely to recommend distribution of their reading material to other patients (chi2 = 22.11, p < 0.001). We conclude that there is benefit in designing information leaflets that simplify language and medication information contained in SDMs, including better understanding of precautions to take while on medication and when to consult physicians.
Asunto(s)
Antihipertensivos/uso terapéutico , Bloqueadores de los Canales de Calcio/uso terapéutico , Diuréticos/uso terapéutico , Etiquetado de Medicamentos , Enalapril/uso terapéutico , Hidroclorotiazida/uso terapéutico , Nifedipino/uso terapéutico , Folletos , Educación del Paciente como Asunto , Prioridad del Paciente , Antihipertensivos/efectos adversos , Bloqueadores de los Canales de Calcio/efectos adversos , Diuréticos/efectos adversos , Femenino , Humanos , Masculino , Persona de Mediana EdadRESUMEN
BACKGROUND: Hypertension guidelines recommend the use of 2 agents with synergistic action when >1 agent is needed to achieve blood pressure goals. Newer antihypertensive treatment combinations include fixed-dose combinations of an angiotensin receptor blocker and a calcium channel blocker. OBJECTIVE: The I-ADD study aimed to demonstrate whether the antihypertensive efficacy of fixed-dose combination irbesartan 300 mg/amlodipine 5 mg (I300/A5) was superior to that of irbesartan (I300) monotherapy in lowering home systolic blood pressure after 10 weeks' treatment. METHODS: The I-ADD study was a 10-week, multicenter, Phase III, prospective, randomized, parallel-group, open-label with blinded-end point study. The main inclusion criterion was essential uncontrolled hypertension (systolic blood pressure ≥145 mm Hg at office after at least 4 weeks of irbesartan 150 mg [I150] monotherapy administered once daily). Patients continued to receive I150 for 7 to 10 days and were randomized to either monotherapy with I150 for 5 weeks then I300 for the next 5 weeks, or to a fixed-dose combination therapy (I150/A5, then I300/A5). Safety profile was assessed by recording adverse events reported by patients or observed by the investigator. RESULTS: Following enrollment, 325 patients were randomized to treatment, and 320 (mean [SD] age, 56.7 [11.4] years; 41% male) were included in the intention-to-treat analysis: 155 patients treated with I150/A5 then I300/A5, and 165 patients treated with I150 then I300. At randomization, mean home systolic blood pressure was similar in both groups: 152.7 (11.8) mm Hg in the I150/A5 group and 150.4 (10.1) mm Hg in the I150 group. At week 10, the adjusted mean difference in home systolic blood pressure between groups was -8.8 (1.1) mm Hg (P < 0.001). The percentage of controlled patients (mean home blood pressure <135 and 85 mm Hg) was nearly 2-fold higher in the I300/A5 group versus the I300 group (P < 0.001). Treatment-emergent adverse events were experienced by 10.5% of I300/A5-treated patients and 6.6% of I300-treated patients during the second 5-week period. Three serious adverse events were reported; 2 with monotherapy (1 with I150 and 1 with I300) and 1 with fixed-dose combination I300/A5. All patients affected by serious adverse events made a full recovery. CONCLUSIONS: These 10-week data from this patient population suggest a greater antihypertensive efficacy of the fixed-dose combination I300/A5 over I300 alone in lowering systolic blood pressure. Both treatments were well tolerated throughout the study. ClinicalTrials.gov identifier: NCT00957554.
Asunto(s)
Amlodipino/administración & dosificación , Bloqueadores del Receptor Tipo 1 de Angiotensina II/administración & dosificación , Antihipertensivos/administración & dosificación , Compuestos de Bifenilo/administración & dosificación , Presión Sanguínea/efectos de los fármacos , Bloqueadores de los Canales de Calcio/administración & dosificación , Hipertensión/tratamiento farmacológico , Tetrazoles/administración & dosificación , Adulto , África del Norte , Anciano , Anciano de 80 o más Años , Amlodipino/efectos adversos , Análisis de Varianza , Bloqueadores del Receptor Tipo 1 de Angiotensina II/efectos adversos , Antihipertensivos/efectos adversos , Compuestos de Bifenilo/efectos adversos , Bloqueadores de los Canales de Calcio/efectos adversos , Distribución de Chi-Cuadrado , Combinación de Medicamentos , Femenino , Humanos , Hipertensión/diagnóstico , Hipertensión/fisiopatología , Irbesartán , Líbano , Masculino , México , Persona de Mediana Edad , Estudios Prospectivos , Arabia Saudita , América del Sur , Tetrazoles/efectos adversos , Factores de Tiempo , Resultado del Tratamiento , Adulto JovenRESUMEN
BACKGROUND: Hypertension guidelines recommend the use of 2 agents with synergistic action when >1 agent is needed to achieve blood pressure goals. Newer antihypertensive treatment combinations include fixed-dose combinations of an angiotensin receptor blocker and a calcium channel blocker. OBJECTIVE: The I-COMBINE study aimed to determine whether the antihypertensive efficacy of the fixed-dose combination irbesartan 150 mg/amlodipine 5 mg (I150/A5) was superior to that of amlodipine 5 mg (A5) monotherapy in lowering home systolic blood pressure (HSBP) after 5 weeks' treatment. METHODS: The I-COMBINE study was a 10-week, multicenter, Phase III, prospective, randomized, parallel-group, open-label with blinded-endpoint study. The main inclusion criterion was essential uncontrolled hypertension (SBP ≥145 mm Hg at office, after at least 4 weeks of A5 monotherapy administered once daily). Patients continued to receive A5 for 7 to 10 days and were randomized to either monotherapy with A5 for 5 weeks then amlodipine 10 mg (A10) for the next 5 weeks or to a fixed-dose combination therapy (I150/A5 then I150/A10). Safety profile was assessed by recording adverse events reported by patients or observed by the investigator. RESULTS: Following enrollment, 290 patients were randomized to treatment, and 287 (mean [SD] age, 57.3 [11.2] years; 48% male) were included in the intention-to-treat analysis: 144 patients treated with I150/A5 then I150/A10, and 143 patients treated with A5 then A10. At randomization, mean HSBP was similar in both groups: 148.5 (10.3) mm Hg in the I150/A5 group and 149.2 (9.7) mm Hg in the A5 group. At week 5, the adjusted mean difference in HSBP between groups was -6.2 (1.0) mm Hg (P < 0.001). The proportion of controlled patients (mean home blood pressure <135 and 85 mm Hg) was significantly higher in the I150/A5 group than in the A5 group (P < 0.001). Treatment-emergent adverse events were experienced by 13.8% of I150/A5-treated patients and 11.9% of A5-treated patients during the first 5-week period, and by 15.8% of I150/A10-treated patients and 17.0% of A10-treated patients during the second 5-week period. Two serious adverse events were reported with the fixed-dose combination; both patients recovered. CONCLUSIONS: Data from this adult population with essential hypertension suggest greater efficacy with the fixed-dose combination I150/A5 over A5 monotherapy in lowering SBP after 5 weeks. Both treatment regimens were well tolerated throughout the study. ClinicalTrials.gov identifier: NCT00956644.
Asunto(s)
Amlodipino/administración & dosificación , Bloqueadores del Receptor Tipo 1 de Angiotensina II/administración & dosificación , Antihipertensivos/administración & dosificación , Compuestos de Bifenilo/administración & dosificación , Presión Sanguínea/efectos de los fármacos , Bloqueadores de los Canales de Calcio/administración & dosificación , Hipertensión/tratamiento farmacológico , Tetrazoles/administración & dosificación , Adulto , África del Norte , Anciano , Anciano de 80 o más Años , Amlodipino/efectos adversos , Análisis de Varianza , Bloqueadores del Receptor Tipo 1 de Angiotensina II/efectos adversos , Antihipertensivos/efectos adversos , Compuestos de Bifenilo/efectos adversos , Bloqueadores de los Canales de Calcio/efectos adversos , Combinación de Medicamentos , Femenino , Humanos , Hipertensión/diagnóstico , Hipertensión/fisiopatología , Irbesartán , Líbano , Masculino , México , Persona de Mediana Edad , Estudios Prospectivos , Arabia Saudita , América del Sur , Tetrazoles/efectos adversos , Factores de Tiempo , Resultado del TratamientoRESUMEN
Standard drug monographs (SDMs) have been described as deficient in providing information in a manner simplified enough for patient reading. The aim of this study was to design patient information leaflets for hydrochlorothiazide, nifedipine and enalapril with content indicated by patients as relevant and to evaluate them against the SDM. Patient information leaflet (PIL) for each drug was designed to contain information on name, use of drug, how it works, how it is to be taken, common side effects, storage, missed dose action, things to avoid and when to contact the physician. Appropriateness was assessed by 10 practising pharmacists. For each drug, 40 patients were recruited, of which 20 were given SDM and 20 PIL. The knowledge of each participant was examined before and after exposure to SDM or PIL, as well as opinion on ease of reading and attractiveness using Pearson's Chi-square analysis. The results showed that both SDM and PIL improved knowledge of common side effects when compared with responses before exposure (ϲ = 24.26for SDM and 27.64 for PIL, p < 0.001) with no difference between the groups. Respondents receiving PILs were better able to recall "things to avoid" after exposure to PIL (ϲ =10.85, p < 0.001). After exposure to SDM or PIL, the respondents who received PIL were more aware of when to contact the physician, compared to the SDM group (ϲ = 8.41, p < 0.01). When compared with SDM, respondents receiving PIL were more likely to indicate that PIL was easy to read (ϲ = 20.00, p < 0.001), attractive (ϲ = 12.45, p < 0.001) and they were more likely to recommend distribution of their reading material to other patients (ϲ = 22.11, p < 0.001). We conclude that there is benefit in designing information leaflets that simplify language and medication information contained in SDMs, including better understanding of precautions to take while on medication and when to consult physicians.
Las monografías de medicamentos estandarizadas se han considerado deficientes a la hora de proporcionar información de manera suficientemente simple para que el paciente pueda entenderlas. El objetivo de este estudio fue disenar prospectos con información sobre la hidroclorotiazida, la nifedipina y el analapril con contenidos indicados como relevantes por los pacientes, y evaluarlos en comparación con las monografías estandarizadas de medicamentos (MEM). El prospecto de información para el paciente (PIP) fue disenado de modo que apareciera información sobre el nombre del medicamento, su uso, modo de operar, manera de tomarse, efectos secundarios comunes, almacenamiento, qué hacer en caso de perder una dosis, cosas que deben evitarse, y cuando debe contactarse el médico. Se evaluó la adecuación por parte de 10 farmacéuticos practicantes. Para cada medicamento, se reclutaron 40 pacientes, a 20 de los cuales se les dio monografías (MEM), en tanto que a 20 se les ofreció prospectos (PIP). El conocimiento de cada participante se examinó antes y después de la exposición a MEM o PIP, así como la opinión en cuanto a facilidad de lectura y grado de atracción, usando el análisis del Chi-cuadrado de Pearson. Los resultados mostraron que tanto MEM como PIP mejoraron el conocimiento sobre los efectos secundarios comunes, cuando se hacía una comparación con las respuestas antes de la exposición (ϲ = 24.26para MEMy 27.64para PIP, p < 0.001) sin diferencia entre los grupos. Los encuestados que recibieron prospectos pudieron recordar mejor las "cosas a evitar" luego de la exposición a PIP (ϲ =10.85, p < 0.001). Después de la exposición a MEM o PIP, los encuestados con PIP tenían mayor conciencia en cuanto a cuando contactar a un médico, en comparación con el grupo MEM (ϲ = 8.41, p < 0.01). Cuando se les comparó con el grupo MEM, los encuestados que recibieron PIP mostraron por una parte mayor probabilidad de indicar que PIP era más fácil de leer (ϲ = 20.00, p < 0.001) y atractivo (ϲ = 12.45, p < 0.001), y por otra, una mayor tendencia a recomendar la distribución de su material de lectura a otros pacientes (ϲ = 22.11, p < 0.001). Se llegó a la conclusión de que es beneficioso disenar prospectos que simplifiquen el lenguajey la información médica contenida en las monografias estándar del medicamento, incluyendo una mejor comprensión de las precauciones a tomar mientras se está bajo medicación, y sobre cuándo consultar al médico.
Asunto(s)
Femenino , Humanos , Masculino , Persona de Mediana Edad , Antihipertensivos/uso terapéutico , Bloqueadores de los Canales de Calcio/uso terapéutico , Diuréticos/uso terapéutico , Etiquetado de Medicamentos , Enalapril/uso terapéutico , Hidroclorotiazida/uso terapéutico , Nifedipino/uso terapéutico , Folletos , Educación del Paciente como Asunto , Prioridad del Paciente , Antihipertensivos/efectos adversos , Bloqueadores de los Canales de Calcio/efectos adversos , Diuréticos/efectos adversosRESUMEN
Many patients with hypertension will require multiple antihypertensive drugs to achieve blood pressure (BP) control. This double-blind study evaluated the efficacy and safety of aliskiren/amlodipine single-pill combinations (SPCs) in patients with mild-to-moderate hypertension who were non-responsive to aliskiren monotherapy. After a 4-week run-in with aliskiren 300 mg, patients with mean sitting diastolic BP (msDBP) ≥ 90 and < 110 mmHg were randomized to oncedaily aliskiren/ amlodipine 300/10 mg or 300/5 mg, or aliskiren 300 mg for 8 weeks. Aliskiren/amlodipine SPCs provided significantly greater mean reductions in mean sitting systolic BP/msDBP (300/10 mg, 18.0/13.1 mmHg; 300/5 mg, 14.4/10.5 mmHg) than aliskiren 300 mg (6.4/5.8 mmHg) at week 8 endpoint. This represents additional mean reductions of 11.6/7.2 mmHg (300/10 mg) and 8.0/4.7 mmHg (300/5 mg) over aliskiren alone (both p < 0.0001). Significantly more patients achieved BP control ( < 140/90 mmHg) with aliskiren/amlodipine 300/10 mg (65.5%) and 300/5 mg (56.6%) than with aliskiren (31.5% both p < 0.0001). Aliskiren, alone and in combination with amlodipine, was well tolerated, with a slightly higher incidence of adverse events with SPCs (29.0-30.1%) than with monotherapy (22.7%). In conclusion, aliskiren/amlodipine SPCs offer an effective next step for patients who have an inadequate BP response to aliskiren alone.
Asunto(s)
Amidas/uso terapéutico , Amlodipino/uso terapéutico , Antihipertensivos/uso terapéutico , Presión Sanguínea/efectos de los fármacos , Bloqueadores de los Canales de Calcio/uso terapéutico , Fumaratos/uso terapéutico , Hipertensión/tratamiento farmacológico , Vasodilatadores/uso terapéutico , Administración Oral , Adulto , Anciano , Amidas/administración & dosificación , Amidas/efectos adversos , Amlodipino/administración & dosificación , Amlodipino/efectos adversos , Antihipertensivos/administración & dosificación , Antihipertensivos/efectos adversos , Bloqueadores de los Canales de Calcio/administración & dosificación , Bloqueadores de los Canales de Calcio/efectos adversos , Método Doble Ciego , Esquema de Medicación , Combinación de Medicamentos , Resistencia a Medicamentos , Europa (Continente) , Femenino , Fumaratos/administración & dosificación , Fumaratos/efectos adversos , Humanos , Hipertensión/diagnóstico , Hipertensión/fisiopatología , India , Análisis de los Mínimos Cuadrados , Modelos Logísticos , Masculino , Persona de Mediana Edad , República de Corea , Comprimidos , Factores de Tiempo , Resultado del Tratamiento , Vasodilatadores/administración & dosificación , Vasodilatadores/efectos adversos , VenezuelaRESUMEN
Most patients with hypertension will require treatment with at least two antihypertensive agents to achieve blood pressure (BP) control. This double-blind study evaluated the efficacy and safety of aliskiren/amlodipine single-pill combination (SPC) therapy in patients with mild-to-moderate hypertension who are inadequately responsive to amlodipine monotherapy. Patients with mean sitting diastolic BP (msDBP) ≥ 90 and < 110 mmHg 110 mmHg after 4 weeks' treatment with amlodipine 10 mg were randomized to once-daily aliskiren/amlodipine 300/10 mg (n = 279) or 150/10 mg (n = 285) or amlodipine 10 mg monotherapy (n = 283) for 8 weeks. Aliskiren/amlodipine 300/10 and 150/10 mg SPCs provided significantly greater reductions in mean sitting systolic BP/msDBP (14.4/11.0 and 11.0/9.0 mmHg, respectively) than amlodipine 10 mg (8.2/7.2 mmHg) at week 8 endpoint. This represents additional mean reductions of 6.2/3.8 mmHg (300/10 mg) and 2.8/1.7 mmHg (150/10 mg) over amlodipine alone (all P < 0.01). Significantly more patients achieved BP control (< 140/90 mmHg) with aliskiren/amlodipine 300/10 mg (58.8%) than amlodipine 10 mg (38.4%; P < 0.0001). Aliskiren/amlodipine SPCs were generally well tolerated. In conclusion, aliskiren/amlodipine SPCs offers an effective option for management of patients who have an inadequate BP response to amlodipine alone.
Asunto(s)
Amidas/uso terapéutico , Amlodipino/uso terapéutico , Antihipertensivos/uso terapéutico , Presión Sanguínea/efectos de los fármacos , Bloqueadores de los Canales de Calcio/uso terapéutico , Fumaratos/uso terapéutico , Hipertensión/tratamiento farmacológico , Vasodilatadores/uso terapéutico , Administración Oral , Adulto , Anciano , Amidas/administración & dosificación , Amidas/efectos adversos , Amlodipino/administración & dosificación , Amlodipino/efectos adversos , Antihipertensivos/administración & dosificación , Antihipertensivos/efectos adversos , Argentina , Bloqueadores de los Canales de Calcio/administración & dosificación , Bloqueadores de los Canales de Calcio/efectos adversos , Método Doble Ciego , Esquema de Medicación , Combinación de Medicamentos , Resistencia a Medicamentos , Europa (Continente) , Femenino , Fumaratos/administración & dosificación , Fumaratos/efectos adversos , Humanos , Hipertensión/diagnóstico , Hipertensión/fisiopatología , Modelos Logísticos , Masculino , Persona de Mediana Edad , Comprimidos , Factores de Tiempo , Resultado del Tratamiento , Turquía , Vasodilatadores/administración & dosificación , Vasodilatadores/efectos adversosRESUMEN
Objetivos Determinar los posibles resultados negativos asociados a la medicación mediante la metodología de búsqueda activa de posibles interacciones medicamentosas en bases de datos de pacientes afiliados al Sistema General de Seguridad Social en Salud. Métodos A partir de las bases de datos de dispensación de medicamentos de Audifarma S.A a unos 4 millones de usuarios del país, se hizo una revisión sistemática de estadísticas de una serie de medicamentos identificados por presentar interacciones de riesgo, dosis diferentes a las recomendadas o dispensación irregular. Los casos son socializados con las EPS responsables. Resultados Se encontró un caso de nefrotoxicidad por ácido zoledrónico; el 37,0 por ciento de los usuarios de clopidogrel recibían concomitantemente omeprazol, que reduce la efectividad del primero; el 29,9 por ciento de los pacientes que toman losartan están recibiendo dosis superiores a las recomendadas para su indicación; el 2,0 por ciento de los pacientes que toman metoprolol o verapamilo, los recibe simultáneamente, con riesgo de generar bradicardia sinusal, bloqueos auriculoventriculares o disfunción sistólica. Todos los casos fueron notificados a los responsables en la EPS que atienden estos pacientes. Discusión La farmacovigilancia activa permite optimizar recursos, prevenir eventos adversos que puedan potencialmente causar morbilidad importante o incluso letalidad o determinar problemas que podrían ser responsables del fracaso terapéutico. Este tipo de estrategia se anticipa a la aparición de posibles riesgos para el paciente por lo que se recomienda considerarla para reforzar los programas de vigilancia de uso de medicamentos en el país.
Objectives Determining negative results associated with medication through an active search of possible drug interactions in databases for patients affiliated to the Colombian general social security/health system. Methods Statistics related to Audifarma S.A. dispensation drug databases for about 4 million Colombian users were systematically reviewed for identifying drugs having known interactions involving risk, doses different from recommended ones or irregular dispensation. The pertinent health-care providing services were made aware of the above. Results There was one case of nephrotoxicity being caused by zoledronic acid. 37 percent of clopidogrel users concomitantly received omeprazole which reduces the former's effectiveness. 29.9 percent of patients who were taking losartan were receiving doses higher than the recommended ones. 2.0 percent of patients who were taking metoprolol or verapamil were simultaneously receiving them, at the risk of generating first-degree heart block, bradycardia, or systolic dysfunction. All these cases were notified to the pertinent health-care services. Conclusions Active pharmacosurveillance leads to resources being optimised, adverse events which can potentially cause morbidity or lethality being prevented or even determining problems which could be responsible for therapeutic failure. This type of strategy anticipates the appearance of possible risks for patients, meaning that drug use monitoring programmes in Colombia should be reinforced.
Asunto(s)
Humanos , Sistemas de Registro de Reacción Adversa a Medicamentos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Sistemas de Medicación/estadística & datos numéricos , Programas Nacionales de Salud/estadística & datos numéricos , Sistemas de Registro de Reacción Adversa a Medicamentos/organización & administración , Sistemas de Registro de Reacción Adversa a Medicamentos/estadística & datos numéricos , Bloqueadores de los Canales de Calcio/administración & dosificación , Bloqueadores de los Canales de Calcio/efectos adversos , Bloqueadores de los Canales de Calcio/farmacocinética , Colombia , Difosfonatos/efectos adversos , Interacciones Farmacológicas , Imidazoles/efectos adversos , Losartán/efectos adversos , Sistemas de Medicación/organización & administración , Metoprolol/administración & dosificación , Metoprolol/efectos adversos , Metoprolol/farmacocinética , Omeprazol/administración & dosificación , Omeprazol/farmacocinética , Estudios Retrospectivos , Seguridad Social , Programas Informáticos , Ticlopidina/administración & dosificación , Ticlopidina/efectos adversos , Ticlopidina/análogos & derivados , Ticlopidina/farmacocinéticaRESUMEN
AIM: To assess the prevalence and variables associated with gingival overgrowth (GO) in renal transplant recipients medicated with cyclosporine (CsA), tacrolimus (Tcr), or sirolimus (Sir). MATERIALS AND METHODS: One hundred and thirty-five eligible subjects were divided in CsA, Tcr, and Sir groups comprising 45 subjects each. GO was visually assessed and subjects were assigned as GO+ or GO- in a post hoc definition. Saliva samples were collected and the presence of periodontal pathogens was assessed through polymerase chain reaction. Variables of interest were compared between GO+ and GO- subjects through univariate and multivariate analysis. RESULTS: Prevalence of GO was of 60.0% for CsA, 28.9% for Tcr, and 15.6% for Sir groups. Within the CsA group, GO was associated with papillary bleeding index (p=0.001); within the Tcr group, GO was associated with CsA previous use (p=0.013), and calcium channel blockers (CCB) use (p=0.003); within the Sir group, GO was associated with papillary bleeding index (p=0.018), and CCB use (p=0.020). A higher frequency of Tannerella forsythia was observed among GO+ subjects medicated with Tcr. CONCLUSION: Pharmacological and periodontal variables were associated with GO in different immunosuppressive regimens. Integration between the medical and the dental team may be an important approach in the post-transplant maintenance routine.