Abstract:
PURPOSE:The aim of this study was to analyze the cases of gynecomastia associated with α1A-adrenergic receptor antagonists (α1-ARAs) in the Italian spontaneous reporting system database (Rete Nazionale di Farmacovigilanza or RNF) and in the World Health Organization ICSRs database (VigiBase(™)), focusing on tamsulosin use. METHODS:We analyzed the spontaneous reports of gynecomastia related to the use of α1-ARAs and collected from the RNF and from VigiBase(™) up to December 2012. Cases of gynecomastia have been defined as reports associated with gynecomastia according with Medical Dictionary for Regulatory Activities (MedDRA). Reporting odds ratio (ROR) and Information Component (IC) were calculated as measures of disproportionality in RNF and VigiBase(™), respectively. RESULTS:Up to December 2012, about 186,000 reports were recorded in the RNF. Among these, 902 reports of adverse drug reaction (ADR) have been associated with the use of at least one α1-ARAs. Of these, in 15 cases, gynecomastia was a listed ADR: in 10, the suspected drug was tamsulosin (in eight, it was the sole suspect); in two, doxazosin and alfuzosin, respectively; and in one, terazosin. ROR for tamsulosin was 5.3 (95% CI 1.8, 15.7). In VigiBase(™), 84 reports of gynecomastia indicated tamsulosin as suspected drug. Tamsulosin-associated gynecomastia showed the highest IC value within this class of drugs (IC 95% 2.43). CONCLUSION:In this study, we highlight a possible association between gynecomastia and tamsulosin use. To our knowledge, this association has not been described before and could represent a potential signal.
journal_name
Eur J Clin Pharmacoljournal_title
European journal of clinical pharmacologyauthors
Viola E,Opri S,Moretti U,Leone R,Casini ML,Ruggieri S,Minore C,Conforti Adoi
10.1007/s00228-014-1700-3subject
Has Abstractpub_date
2014-08-01 00:00:00pages
1003-9issue
8eissn
0031-6970issn
1432-1041journal_volume
70pub_type
杂志文章abstract:AIM:To describe and evaluate spontaneous reports of suspected adverse reactions (ARs) associated with herbal laxatives received by the Italian Medicines Agency and the Italian National Institute of Health between April 2002 and January 2011. METHODS:Spontaneous reports of suspected ARs were individually analyzed by a ...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/s00228-011-1128-y
更新日期:2012-03-01 00:00:00
abstract:PURPOSE:The survival of esophageal and gastric cancer patients treated with chemotherapy is rarely assessed outside of clinical trials. Therefore, we compared the effectiveness of various curative or palliative chemotherapy regimens on the survival of esophageal and gastric cancer patients in a "real world" clinical se...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/s00228-020-02883-3
更新日期:2020-07-01 00:00:00
abstract::In a double-blind, placebo-controlled cross-over study, the plasma atrial natriuretic peptide (ANP) levels of nine young and ten elderly hypertensive patients were compared after placebo and after treatment with 120 mg verapamil given three times daily over 4 weeks. During placebo, plasma ANP levels proved to be highe...
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/BF01409206
更新日期:1990-01-01 00:00:00
abstract::Migraine is the most common cause of vascular headache and a highly prevalent illness. In the last 20 years, the discovery of new agents has increased clinical research on migraine. In most of clinical trials that have been conducted, the efficacy was established using a placebo as a control treatment. The objective o...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章,meta分析
doi:10.1007/s00228-005-0088-5
更新日期:2006-03-01 00:00:00
abstract::The effect of cimetidine and ranitidine on doxepin pharmacokinetics was studied in 6 healthy volunteers. Each subject completed 3 study phases: Treatment A, 9 consecutive doses of 50 mg doxepin (once daily); Treatment B, same as Treatment A but co-administration of cimetidine 600 mg b.i.d. starting after the sixth dox...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/BF00542189
更新日期:1987-01-01 00:00:00
abstract:OBJECTIVE:A prospective study was undertaken to determine the transcorneal penetration of three topically applied fluoroquinolones into aqueous humour. METHODS:Two hundred and twenty-four patients undergoing cataract extraction received 0.3% ciprofloxacin, norfloxacin or ofloxacin eye drops by two different administra...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/s002280050371
更新日期:1997-01-01 00:00:00
abstract::The aim of the study was to examine the effect of chronic angiotensin converting enzyme inhibition on haemodynamics and left ventricular performance during long-lasting exercise at the anaerobic threshold. For this purpose exercise haemodynamics and left ventricular performance were assessed in 14 physically trained h...
journal_title:European journal of clinical pharmacology
pub_type: 临床试验,杂志文章
doi:10.1007/BF00194331
更新日期:1995-01-01 00:00:00
abstract::The antihypertensive effect of a new vasodilator with betablocking properties (SK & F 92657) was investigated in 10 patients with mild to moderate essential hypertension. After a mean treatment period of 26,5 weeks (6,5-49 weeks) blood pressure was significantly reduced, from 168 +/- 22/106 +/- 6 mmHg to 144 +/- 19/94...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/BF00605990
更新日期:1982-01-01 00:00:00
abstract:OBJECTIVES:To study the frequency of corticosteroid therapy and the use of inpatient care for preschool children with wheezing in two regions in Finland. METHODS:The Finnish Social Insurance Institution database on refundable asthma medication indicated that 1.18% of children in Tampere and 2.37% in Turku used inhaled...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/s002280000199
更新日期:2000-11-01 00:00:00
abstract:PURPOSE:To assess the influence of the P450 oxidoreductase 28 SNP (POR 28) on tacrolimus pharmacokinetics in the Chinese population. METHODS:Seventy-one healthy Chinese volunteers enrolled in the study received an oral dose of 2 mg of tacrolimus after providing written informed consent. CYP3A5 3 was genotyped by polym...
journal_title:European journal of clinical pharmacology
pub_type: 临床试验,杂志文章
doi:10.1007/s00228-012-1432-1
更新日期:2013-04-01 00:00:00
abstract::The maternofetal transfer of the beta 1-selective adrenergic antagonist celiprolol has been studied in four hypertensive pregnant women. Fetal plasma concentrations were about 25-50% of the levels found on the maternal side. There was no significant difference between the plasma concentrations of the two enantiomers i...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/BF00316477
更新日期:1993-01-01 00:00:00
abstract:PURPOSE:The aim of this study was to examine whether educational meetings and group detailing could increase the use of drugs from the ward lists or the drug formulary in hospitals. METHODS:Twelve medical wards from two hospitals were randomized into three groups: control, basic and extended intervention. All wards ha...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章,随机对照试验
doi:10.1007/s00228-013-1589-2
更新日期:2014-01-01 00:00:00
abstract::The pharmacokinetics of IV meropenem (500 mg over 30 min) has been studied in 6 healthy volunteers and 26 patients with various degrees of renal impairment. Blood samples were taken at different times over 24 h in healthy subjects and 36 to 48 h in uraemic patients, and four or five urine samples were collected over 2...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/BF00314864
更新日期:1992-01-01 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::The role of mental stress in the development of hypertension and coronary heart disease remains uncertain. Its effects are likely to depend on an interaction of at least three factors: the nature of the stressor, its perception by the individual, and the individual's physiological susceptibility. This type of interact...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:
更新日期:1990-01-01 00:00:00
abstract:OBJECTIVE:The aim of this study was to evaluate the pharmacokinetics of vancomycin in patients with severe acute pancreatitis (SAP). METHODS:Sixty-seven patients with SAP were included. The FPIA method was used to measure vancomycin serum trough concentrations, and the pharmacokinetic parameters were calculated using ...
journal_title:European journal of clinical pharmacology
pub_type: 临床试验,杂志文章
doi:10.1007/s00228-016-2018-0
更新日期:2016-06-01 00:00:00
abstract:AIM:The aim of this study was to quantify the reasons and opinions of patients who reported adverse drug reactions (ADRs) in the Netherlands to a pharmacovigilance centre. METHOD:A web-based questionnaire was sent to 1370 patients who had previously reported an ADR to a pharmacovigilance centre. The data were analysed...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/s00228-010-0865-7
更新日期:2010-11-01 00:00:00
abstract::The systemic availability of oral zidovudine has been studied in 13 patients with the acquired immunodeficiency syndrome (AIDS) dosed either fasting or with breakfast. The mean peak plasma concentration and AUC of zidovudine were significantly 2.8- and 1.4-times higher in fasting patients than in those treated during ...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/BF00315215
更新日期:1991-01-01 00:00:00
abstract:PURPOSE:The aim of this study was to investigate the contributions of non-genetic and genetic factors on the variability of stable warfarin doses in Thai patients. METHODS:A total of 250 Thai patients with stable warfarin doses were enrolled in the study. Demographics and clinical data, e.g., age, body mass index, ind...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/s00228-017-2265-8
更新日期:2017-08-01 00:00:00
abstract:OBJECTIVE:After liver transplantation (LT), genotypic differences between the recipient and the transplanted liver, medications and post-LT complications may all affect drug metabolism. We have studied the effect of two CYP2D6 mutations in the donor and the recipient on post-LT CYP2D6 phenotype. METHOD:The CYP2D6 phen...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/s002280050419
更新日期:1998-03-01 00:00:00
abstract::Eighty patients recovering from major operations were investigated to evaluate the influence of naloxone on the analgesic and respiratory depressant properties of buprenorphine. They were randomly assigned to two groups to self-administer either buprenorphine (Group B) or a mixture of buprenorphine and naloxone (fract...
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/BF00542434
更新日期:1988-01-01 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:BACKGROUND:Anti-tumor necrosis factor-alpha (TNF-α) agents have considerable advances in treating inflammatory bowel disease (IBD). These drugs carry possible risk of adverse symptoms, and no meta-analysis has examined this issue and the potential duration-response relationship. PURPOSE:The purpose of this study was t...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章,meta分析,评审
doi:10.1007/s00228-015-1877-0
更新日期:2015-08-01 00:00:00
abstract::The pharmacokinetics of isosorbide-5-mononitrate (IS-5-MN) has been studied in two groups of healthy volunteers after oral (n = 20) and intravenous (n = 11) administration of 20 mg, which had previously been proved to be as effective as 20 mg sustained-release isosorbide dinitrate (ISDN). IS-5-MN in serum was measured...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/BF00618777
更新日期:1981-01-01 00:00:00
abstract:OBJECTIVES:The study was conducted to investigate whether oral co-administration with citrus juices significantly affects the pharmacokinetics and/or pharmacodynamics of pranidipine, a new 1,4-dihydropyridine calcium antagonist, in healthy male subjects. Grapefruit juice and orange juice, which were both commercially a...
journal_title:European journal of clinical pharmacology
pub_type: 临床试验,杂志文章
doi:10.1007/s002280050547
更新日期:1998-11-01 00:00:00
abstract::Natural and synthetic steroids and mineralocorticoids were tested for their in vitro suppressive activity on phytohemagglutinin (PHA) stimulated lymphocytes. Three different (p less than 0.05) groups were identified. Methylprednisolone and betamethasone were very potent, dexamethasone, hydrocortisone and prednisolone ...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/BF00542111
更新日期:1983-01-01 00:00:00
abstract::The effect of AS-4370 on gastric emptying was investigated in healthy adults using 99mTc-DTPA. Single doses of AS-4370 2.5, 5 or 10 mg or placebo were administered to 12 subjects in a controlled, double-blind, cross-over study. Tests were performed twice weekly in each subject. Thirty min after administration of test ...
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/BF00314963
更新日期:1991-01-01 00:00:00
abstract:OBJECTIVE:This study was performed to investigate whether it is possible to use saliva instead of blood usually used for therapeutic drug monitoring (TDM) of disopyramide. METHODS:Six healthy male volunteers ingested 200 mg of disopyramide base, and the disopyramide concentrations in saliva and plasma (total and unbou...
journal_title:European journal of clinical pharmacology
pub_type: 临床试验,杂志文章
doi:10.1007/s002280050250
更新日期:1997-01-01 00:00:00
abstract::The systemic effects of single and multiple doses of inhaled fluticasone propionate (FP) and budesonide were examined in 24 healthy male volunteers (age range 18-29 years). The study was of an open, placebo-controlled, randomized, three-way crossover design. On each study day, multiple blood samples were taken over a ...
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/BF00195931
更新日期:1996-01-01 00:00:00
abstract:AIM:It has been reported that verapamil and atorvastatin are inhibitors of both P-glycoprotein (P-gp) and microsomal cytochrome P450 (CYP) 3A4, and verapamil is a substrate of both P-gp and CYP3A4. Thus, it could be expected that atorvastatin would alter the absorption and metabolism of verapamil. METHODS:The pharmaco...
journal_title:European journal of clinical pharmacology
pub_type: 临床试验,杂志文章
doi:10.1007/s00228-007-0447-5
更新日期:2008-05-01 00:00:00