Abstract：
BACKGROUND:Fexofenadine is the active metabolite of the non-sedating anti-histamine terfenadine. Pre-licensing clinical trials in over 6000 patients suggested it was effective and well tolerated. OBJECTIVE:To assess the tolerability and safety of fexofenadine immediately after its availability on the UK market in March 1997. METHODS:Post-marketing non-interventional observational cohort study using the methodology of prescription-event monitoring. Exposure data derived from dispensed prescription details supplied in confidence by the Prescription Pricing Authority. Outcome data derived from questionnaires returned by general practitioners (GPs) in England between March and August 1997. RESULTS:Of the 35,817 questionnaires sent, 18,238 (50.9%) were returned, of which 16,638 contained useful data. These included 40% male (mean age 36+/-19 years) and 59% female (mean age 39+/-19 years). Most common indications were allergic rhinitis (55%), not specified (28%), urticaria, pruritus or rash (10%) and other indications (7%). There were 40 reports of adverse drug reactions in 27 patients. Less than 2% of patients stopped the drug because of side effects. Events reported after exposure to fexofenadine were uncommon and already reported in clinical trials. There were eight reports of possible cardiac side effects (palpitations, three; chest pain, three; arrhythmia, one; and chest tightness, one). None was felt to be serious. There were no drug interactions reported. None of the 30 deaths was related to fexofenadine. None of the three adverse outcomes from the 47 pregnancies reported was related to fexofenadine. CONCLUSION:Within the limitations for an observational cohort study, fexofenadine was found to be well tolerated and safe in 16,638 users in general practice in England.
journal_name
Eur J Clin Pharmacoljournal_title
European journal of clinical pharmacologyauthors
Craig-McFeely PM,Acharya NV,Shakir SAdoi
10.1007/s002280100292subject
Has Abstractpub_date
2001-07-01 00:00:00pages
313-20issue
4eissn
0031-6970issn
1432-1041journal_volume
57pub_type
杂志文章abstract：:The purpose of this study was to examine the influence of cigarette smoking and gender on the pharmacokinetics of metoprolol. Eighteen volunteers with no evidence of clinical disease each randomly received the following doses of metoprolol tartrate: 100 mg orally, 200 mg orally and 20 mg as a constant-rate intravenous...
journal_title：European journal of clinical pharmacology
pub_type： 临床试验,杂志文章,随机对照试验
doi：10.1007/BF00637630
更新日期：1987-01-01 00:00:00
abstract：:The pharmacokinetics of melatonin during the day-time has been studied in 4 healthy subjects after a bolus i.v. injection of 5 or 10 micrograms/person and after a 5 h infusion of 20 micrograms per person in 6 healthy subjects. In addition, a pinealomectomized patient whose nocturnal plasma melatonin had been abolished...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00315035
更新日期：1990-01-01 00:00:00
abstract：OBJECTIVE:To study, in a large cohort, the association between the use of anti-asthmatic drugs during pregnancy and pregnancy complications. METHODS:Using the Swedish Medical Birth Register, we identified 24,369 women who reported the use of anti-asthmatic drugs in early pregnancy and 7778 women who were prescribed su...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-006-0257-1
更新日期：2007-04-01 00:00:00
abstract：:Differences in the plasma concentrations of drugs after oral administration are caused by two main factors: variation in absorption ratios and in the distribution processes in the body. A new method for the dissection of both types of factors is discussed. The method uses a reference regression of the AUC-values to th...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00545226
更新日期：1982-01-01 00:00:00
abstract：PURPOSE:The aims of this study were to quantify the behavioural determinants of health professional reporting of medication errors in the United Arab Emirates (UAE) and to explore any differences between respondents. METHODS:A cross-sectional survey of patient-facing doctors, nurses and pharmacists within three major ...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-016-2124-z
更新日期：2016-11-01 00:00:00
abstract：:Plasma renin concentration (PRC) was measured in 46 patients with essential hypertension before and after treatment for 4 weeks with alprenolol 600-1200 mg daily. In 27 of these patients PRC was measured after 4 weeks of combined treatment with alprenolol and hydralizine. During alprenolol treatment PRC and blood pres...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00645128
更新日期：1977-10-14 00:00:00
abstract：PURPOSE:To investigate statin use in the elderly by age (≥ 80 vs. 65-79 years) in relation to established indications. METHODS:A population-based cohort, including data from four registers, encompassing inhabitants in Region Västra Götaland, Sweden, was used. Statin users were defined as those filling statin prescript...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-019-02645-w
更新日期：2019-07-01 00:00:00
abstract：:The pharmacokinetics of i.v. chloramphenicol succinate and oral chloramphenicol palmitate were studied in Ethiopian children with different nutritional states. In children with kwashiorkor the plasma clearance of chloramphenicol was significantly lower than in children of normal weight (4.16 ml/min/kg versus 7.53 ml/m...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00607094
更新日期：1983-01-01 00:00:00
abstract：OBJECTIVE:To determine the effects of late pregnancy and also oestrogen supplementation on the CYP2C19-mediated biotransformation of proguanil (PG) to its active antifol triazine metabolite cycloguanil (CG). METHODS:Case control study conducted on the NW border of Thailand; a single dose of PG (4 mg/kg) was administer...
journal_title：European journal of clinical pharmacology
pub_type： 临床试验,杂志文章
doi：10.1007/s00228-003-0651-x
更新日期：2003-10-01 00:00:00
abstract：PURPOSE:We assessed reported associations of CYP3A5 *1 allele with a delay in achieving target tacrolimus concentrations, and occurrence of biopsy-confirmed subclinical acute rejection (SAR) and chronic allograft nephropathy (CAN) in Japanese subjects. METHODS:Forty-one renal allograft recipients were studied. The tar...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-008-0606-3
更新日期：2009-05-01 00:00:00
abstract：PURPOSE:Pre-clinical experiments have shown that almorexant, a dual orexin receptor antagonist, is able to inhibit cytochrome P450 3A4 (CYP3A4). Therefore, a study was conducted to investigate the effects of multiple-dose almorexant on the pharmacokinetics of midazolam and simvastatin, two CYP3A4 model substrates. MET...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章,随机对照试验
doi：10.1007/s00228-012-1403-6
更新日期：2013-03-01 00:00:00
abstract：:The relation between plasma concentration of theophylline and number of apnea preterm infants was studied in six patients. The apnea frequency was monitored after cessation of theophylline treatment and plotted against the log plasma concentration of theophylline. It was calculated that at an average plasma concentrat...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00561480
更新日期：1980-07-01 00:00:00
abstract：:A study, using non-invasive techniques, was carried out in ten patients with essential hypertension to examine the mechanism of the hypotensive effect of propranolol when used in combination with a potent vasodilator antihypertensive - minoxidil. The hypotensive effect of minoxidil, a mean (+/- SEM) decrease of 42.4 +...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00606548
更新日期：1976-03-22 00:00:00
abstract：OBJECTIVE:The efficacy of beta-adrenergic blocking agents and acetylsalicylic acid in the secondary prevention of myocardial infarction has been well recognized since the beginning of the 1980s. In a previous paper, however, we reported a lower than expected use of these drugs during the period 1982 1988. In 1989 the r...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s002280050446
更新日期：1998-05-01 00:00:00
abstract：:The use of bioelectrical impedance (BI) analysis as a non-invasive approach for individualizing gentamicin therapy in newborn infants has been investigated in a two phase study. In Phase I, 1/impedance and length were identified as statistically significant predictors of the distribution volume of gentamicin (Adj R2 =...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00271367
更新日期：1993-01-01 00:00:00
abstract：:We have studied the pharmacokinetics of fluconazole in five patients on long-term haemodialysis. The single-pass extraction rate of the dialyzer was 59 (3.5)% (n = 4), and the serum concentration was reduced by haemodialysis for 3 or 4 h by 26 (3.2)% (n = 5) and 39 (2.2)% (n = 9) respectively. The estimated amount ext...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00265934
更新日期：1992-01-01 00:00:00
abstract：OBJECTIVE:To study the effect of cisplatin on plasma concentrations and urinary excretion of carnitine in ten patients with different malignancies treated with chemotherapy. METHODS:Carnitine concentrations were determined using a radioenzymatic assay and other metabolites by routine methods of clinical chemistry. Ren...
journal_title：European journal of clinical pharmacology
pub_type： 临床试验,杂志文章
doi：10.1007/s002280050504
更新日期：1998-09-01 00:00:00
abstract：:The haemodynamic effects of prenalterol, a new beta-1 agonist, were studied in 10 patients with chronic heart failure. Following intravenous prenalterol infusions of 1 mg, 2.5 mg and 5 mg at 15 min intervals, oral slow release prenalterol 20 mg, 30 mg and 50 mg was given at 2 h intervals and then 50-100 mg bid for one...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00542125
更新日期：1983-01-01 00:00:00
abstract：PURPOSE:To illustrate the interface of pharmacogenetics and therapeutic drug monitoring and to estimate target blood level for imatinib in the treatment of chronic myelogenous leukemia METHODS:A literature review to provide the evidence and necessary data to support the case for the interface, and quantitative analysi...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-009-0779-4
更新日期：2010-04-01 00:00:00
abstract：PURPOSE:Gefitinib is one of the standard treatments for non-small cell lung cancer (NSCLC) with epidermal growth factor receptor mutations. It has been reported that acid suppressants (AS) decrease the anti-tumor effect of gefitinib by reducing its solubility. AS is sometimes necessary in cancer patients; however, prev...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-020-03013-9
更新日期：2020-10-07 00:00:00
abstract：PURPOSE:To assess, with all available trial information, whether the assessment of the PRECIS-2 nine domains could provide a clear distinction between medicine masked pragmatic randomized controlled trials (pRCTs) and open-label pRCTs. METHODS:A search was conducted of participant-level pRCTs on medicines published on...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-020-03030-8
更新日期：2020-10-26 00:00:00
abstract：INTRODUCTION:Regulation EU 536/2014 EU introduces a separation between two parts (technical-scientific aspects and locally relevant ethical aspects) in the assessment of applications for approval of trials and provides for each 'Member State concerned' to arrive at 'one single decision' regarding the application for au...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-016-2009-1
更新日期：2016-04-01 00:00:00
abstract：OBJECTIVE:Knowledge about the metabolism of anti-parasitic drugs (APDs) will be helpful in ongoing efforts to optimise dosage recommendations in clinical practise. This study was performed to further identify the cytochrome P(450) (CYP) enzymes that metabolise major APDs and evaluate the possibility of predicting in vi...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-003-0636-9
更新日期：2003-09-01 00:00:00
abstract：:An analytical procedure for the simultaneous determination of pethidine and its N-Demethylated metabolite, norpethidine, in plasma is described. Pethidine and norpethidine are separated by partition chromatography, converted to the trichloroethyl carbamate with trichloroethyl chloroformate and determined by electron c...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00561790
更新日期：1977-01-01 00:00:00
abstract：:Guidelines presented previously for the analysis of plasma concentration versus time data for a drug exhibiting concentration-dependent plasma protein binding were successfully applied to the distributional parameters of a new cephalosporin, ceftriaxone. This approach provided several striking observations when the ph...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF01037956
更新日期：1983-01-01 00:00:00
abstract：:The metabolism of hydralazine in a group of slow acetylator patients with the drug-induced lupus syndrome was compared with the metabolism in asymptomatic control subjects. There were no toxicologically significant difference in metabolite excretion between the groups which reached statistical significance, although t...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00556891
更新日期：1984-01-01 00:00:00
abstract：OBJECTIVE:High-density lipoprotein (HDL)-associated antioxidant paraoxonase (PON) may reduce low-density lipoprotein (LDL) oxidation and prevent atherosclerosis. The aim of this present study was to investigate the effect of the 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor atorvastatin on hydroge...
journal_title：European journal of clinical pharmacology
pub_type： 临床试验,杂志文章
doi：10.1007/s00228-004-0820-6
更新日期：2004-12-01 00:00:00
abstract：:Eight patients were given flunitrazepam 2 mg orally, once daily for 28 consecutive days. The time-course of the plasma concentration of unchanged flunitrazepam and its principal metabolites were studied in detail after the first and last doses. Additional blood samples were collected immediately before administration ...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00561899
更新日期：1980-01-01 00:00:00
abstract：OBJECTIVES:To analyse reports of drug-induced myocardial infarction and chest pain sent to a national reporting centre. To review which drugs were suspected of exhibiting these adverse events and what mechanisms were involved. METHODS:During the 20-year period 1975 through 1994, a total of 19,141 reports on adverse re...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章,评审
doi：10.1007/s002280050346
更新日期：1997-01-01 00:00:00
abstract：PURPOSE:Intravenous (IV) magnesium sulfate (MgSO4) is used as adjunct therapy to treat acute asthma exacerbations. Despite its clinical use, there is a limited understanding of the disposition of magnesium in children. METHODS:To explore the pharmacokinetics (PK) of IV MgSO4 in this population, we collected retrospect...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-016-2165-3
更新日期：2017-03-01 00:00:00
