journal
https://read.qxmd.com/read/21899766/impact-of-information-letters-on-the-reporting-rate-of-adverse-drug-reactions-and-the-quality-of-the-reports-a-randomized-controlled-study
#21
RANDOMIZED CONTROLLED TRIAL
Marie-Louise Johansson, Staffan Hägg, Susanna M Wallerstedt
BACKGROUND: Spontaneous reporting of adverse drug reactions (ADRs) is an important method for pharmacovigilance, but under-reporting and poor quality of reports are major limitations. The aim of this study was to evaluate if repeated one-page ADR information letters affect (i) the reporting rate of ADRs and (ii) the quality of the ADR reports. METHODS: All 151 primary healthcare units in the Region Västra Götaland, Sweden, were randomly allocated (1:1) to an intervention (n = 77) or a control group (n = 74)...
September 7, 2011: BMC Clinical Pharmacology
https://read.qxmd.com/read/21854644/cognitive-functioning-in-opioid-dependent-patients-treated-with-buprenorphine-methadone-and-other-psychoactive-medications-stability-and-correlates
#22
RANDOMIZED CONTROLLED TRIAL
Pekka Rapeli, Carola Fabritius, Hely Kalska, Hannu Alho
BACKGROUND: In many but not in all neuropsychological studies buprenorphine-treated opioid-dependent patients have shown fewer cognitive deficits than patients treated with methadone. In order to examine if hypothesized cognitive advantage of buprenorphine in relation to methadone is seen in clinical patients we did a neuropsychological follow-up study in unselected sample of buprenorphine- vs. methadone-treated patients. METHODS: In part I of the study fourteen buprenorphine-treated and 12 methadone-treated patients were tested by cognitive tests within two months (T1), 6-9 months (T2), and 12-17 months (T3) from the start of opioid substitution treatment...
August 21, 2011: BMC Clinical Pharmacology
https://read.qxmd.com/read/21819615/association-between-statin-therapy-and-outcomes-in-critically-ill-patients-a-nested-cohort-study
#23
RANDOMIZED CONTROLLED TRIAL
Shmeylan A Al Harbi, Hani M Tamim, Yaseen M Arabi
BACKGROUND: The effect of statin therapy on mortality in critically ill patients is controversial, with some studies suggesting a benefit and others suggesting no benefit or even potential harm. The objective of this study was to evaluate the association between statin therapy during intensive care unit (ICU) admission and all-cause mortality in critically ill patients. METHODS: This was a nested cohort study within two randomised controlled trials conducted in a tertiary care ICU...
August 6, 2011: BMC Clinical Pharmacology
https://read.qxmd.com/read/21816053/an-evaluation-of-ciprofloxacin-pharmacokinetics-in-critically-ill-patients-undergoing-continuous-veno-venous-haemodiafiltration
#24
JOURNAL ARTICLE
Almath M Spooner, Catherine Deegan, Deirdre M D'Arcy, Caitriona M Gowing, Maria B Donnelly, Owen I Corrigan
BACKGROUND: The study aimed to investigate the pharmacokinetics of intravenous ciprofloxacin and the adequacy of 400 mg every 12 hours in critically ill Intensive Care Unit (ICU) patients on continuous veno-venous haemodiafiltration (CVVHDF) with particular reference to the effect of achieved flow rates on drug clearance. METHODS: This was an open prospective study conducted in the intensive care unit and research unit of a university teaching hospital. The study population was seven critically ill patients with sepsis requiring CVVHDF...
August 4, 2011: BMC Clinical Pharmacology
https://read.qxmd.com/read/21787433/the-effects-of-polyunsaturated-fatty-acids-in-alcohol-dependence-treatment-a-double-blind-placebo-controlled-pilot-study
#25
RANDOMIZED CONTROLLED TRIAL
Marina N Fogaça, Ruth F Santos-Galduróz, Jaqueline K Eserian, José Carlos F Galduróz
BACKGROUND: The lipid fraction of cell membranes consists of polyunsaturated fatty acids (PUFAS), and chronic alcohol use alters it, modifying its permeability, what might contribute for the dysfunctional metabolism observed in the central nervous system of alcohol dependent patients. Therefore, the supplementation of PUFAS can be an important adjuvant in alcoholism treatment. METHODS: This was a placebo controlled, double blind, randomized study where, 80 alcohol dependent patients, according to DSM-IV, were allocated in four groups with 20 patient each: 'PUFAS', 'Naltrexone', 'Naltrexone + PUFAS' and 'Placebo'...
July 26, 2011: BMC Clinical Pharmacology
https://read.qxmd.com/read/21777438/comparative-in-vitro-study-of-the-antimicrobial-activities-of-different-commercial-antibiotic-products-of-vancomycin
#26
JOURNAL ARTICLE
Jorge A Diaz, Edelberto Silva, Maria J Arias, María Garzón
BACKGROUND: One of the most critical problems about antimicrobial therapy is the increasing resistance to antibiotics. Previous studies have shown that there is a direct relation between erroneous prescription, dosage, route, duration of the therapy and the antibiotics resistance. Other important point is the uncertainty about the quality of the prescribed medicines. Some physicians believe that generic drugs are not as effective as innovator ones, so it is very important to have evidence that shows that all commercialized drugs are suitable for therapeutic use...
July 21, 2011: BMC Clinical Pharmacology
https://read.qxmd.com/read/21718490/comparison-of-renal-effects-of-ibuprofen-versus-indomethacin-during-treatment-of-patent-ductus-arteriosus-in-contiguous-historical-cohorts
#27
COMPARATIVE STUDY
Alla Kushnir, Joaquim Mb Pinheiro
BACKGROUND: Ibuprofen treatment of patent ductus arteriosus (PDA) has been shown to be as effective as indomethacin in small randomized controlled trials, with possibly fewer adverse effects. However, adverse renal effects of ibuprofen have been noted in some trials and suspected in our practice.The purpose of this study was to examine whether ibuprofen and indomethacin treatment of PDA have comparable effects on renal function as evidenced by urine output and serum creatinine. METHODS: Retrospective chart review of 350 patients...
June 30, 2011: BMC Clinical Pharmacology
https://read.qxmd.com/read/21631929/no-relevant-cardiac-pharmacokinetic-or-safety-interactions-between-roflumilast-and-inhaled-formoterol-in-healthy-subjects-an-open-label-randomised-actively-controlled-study
#28
RANDOMIZED CONTROLLED TRIAL
Christian de Mey, Nassr Nassr, Gezim Lahu
BACKGROUND: Roflumilast is an oral, selective phosphodiesterase 4 inhibitor with anti-inflammatory effects in chronic obstructive pulmonary disease (COPD). The addition of roflumilast to long-acting bronchodilators improves lung function in patients with moderate-to-severe COPD. The present study investigated drug-drug interaction effects between inhaled formoterol and oral roflumilast. METHODS: This was a single-centre (investigational clinic), open, randomised, multiple-dose, parallel-group study...
June 1, 2011: BMC Clinical Pharmacology
https://read.qxmd.com/read/21609444/drug-safety-of-rosiglitazone-and-pioglitazone-in-france-a-study-using-the-french-pharmacovigilance-database
#29
JOURNAL ARTICLE
Stephanie Berthet, Pascale Olivier, Jean-Louis Montastruc, Maryse Lapeyre-Mestre
BACKGROUND: Thiazolidinediones (TZDs), rosiglitazone (RGZ) and pioglitazone (PGZ) are widely used as hypoglycemic drugs in patients with type 2 diabetes mellitus. The aim of our study was to investigate the profile of adverse drug reactions (ADRs) related to TZDs and to investigate potential risk factors of these ADRs. METHODS: Type 2 diabetic patients were identified from the French Database of PharmacoVigilance (FPVD) between 2002 and 2006. We investigated ADR related to TZD, focusing on 4 ADR: edema, heart failure, myocardial infarction and hepatitis corresponding to specific WHO-ART terms...
May 24, 2011: BMC Clinical Pharmacology
https://read.qxmd.com/read/21599961/use-tolerability-and-compliance-of-spironolactone-in-the-treatment-of-heart-failure
#30
JOURNAL ARTICLE
Jean Lachaine, Catherine Beauchemin, Elodie Ramos
BACKGROUND: Risk of morbidity and mortality in patients with severe heart failure (HF) is reduced by blockade of aldosterone receptors with spironolactone. However, benefits of spironolactone are potentially limited by treatment compliance and adverse events profile. The aim of this study was to estimate use of spironolactone by patients with HF, incidence of key adverse events, and patient compliance. METHODS: This study was performed using data from the Quebec provincial medical and drug plans (Régie de l'Assurance Maladie du Québec, RAMQ) for patients who had a diagnosis of HF...
May 20, 2011: BMC Clinical Pharmacology
https://read.qxmd.com/read/21414193/pharmacokinetics-and-tolerability-of-zibotentan-zd4054-in-subjects-with-hepatic-or-renal-impairment-two-open-label-comparative-studies
#31
MULTICENTER STUDY
Helen Tomkinson, John Kemp, Stuart Oliver, Helen Swaisland, Maria Taboada, Thomas Morris
BACKGROUND: Zibotentan (ZD4054) is a specific endothelin A (ETA) receptor antagonist being investigated for the treatment of prostate cancer. As zibotentan is eliminated by renal and metabolic routes, clearance may be reduced in patients with hepatic or renal impairment, leading to greater drug exposure. METHODS: Open-label studies investigated the PK and tolerability of zibotentan in subjects with hepatic or renal impairment, compared with those with normal organ function...
March 17, 2011: BMC Clinical Pharmacology
https://read.qxmd.com/read/22118309/public-perception-on-the-role-of-community-pharmacists-in-self-medication-and-self-care-in-hong-kong
#32
JOURNAL ARTICLE
Joyce H You, Fiona Y Wong, Frank W Chan, Eliza L Wong, Eng-Kiong Yeoh
BACKGROUND: The choices for self-medication in Hong Kong are much diversified, including western and Chinese medicines and food supplements. This study was to examine Hong Kong public knowledge, attitudes and behaviours regarding self-medication, self-care and the role of pharmacists in self-care. METHODS: A cross-sectional phone survey was conducted, inviting people aged 18 or older to complete a 37-item questionnaire that was developed based on the Thematic Household surveys in Hong Kong, findings of the health prorfessional focus group discussions on pharmacist-led patient self management and literature...
2011: BMC Clinical Pharmacology
https://read.qxmd.com/read/22085536/knowledge-attitudes-and-practice-survey-about-antimicrobial-resistance-and-prescribing-among-physicians-in-a-hospital-setting-in-lima-peru
#33
MULTICENTER STUDY
Coralith García, Liz P Llamocca, Krystel García, Aimee Jiménez, Frine Samalvides, Eduardo Gotuzzo, Jan Jacobs
BACKGROUND: Misuse of antimicrobials (AMs) and antimicrobial resistance (AMR) are global concerns. The present study evaluated knowledge, attitudes and practices about AMR and AM prescribing among medical doctors in two large public hospitals in Lima, Peru, a middle-income country. METHODS: Cross-sectional study using a self-administered questionnaire RESULTS: A total of 256 participants completed the questionnaire (response rate 82%). Theoretical knowledge was good (mean score of 6 ± 1...
2011: BMC Clinical Pharmacology
https://read.qxmd.com/read/21612642/the-future-of-pharmaceutical-care-in-france-a-survey-of-final-year-pharmacy-students-opinions
#34
JOURNAL ARTICLE
Clémence Perraudin, Françoise Brion, Olivier Bourdon, Nathalie Pelletier-Fleury
BACKGROUND: In the last decades, the provision of pharmaceutical care by community pharmacists has developed in OECD countries. These developments involved significant changes in professional practices and organization of primary care. In France, they have recently been encouraged by a new legal framework and favored by an increasing demand for health care (increase in the number of patients with chronic diseases) and reductions in services being offered (reduction in the number of general practitioners and huge regional disparities)...
2011: BMC Clinical Pharmacology
https://read.qxmd.com/read/21332973/constipation-and-diarrhoea-common-adverse-drug-reactions-a-cross-sectional-study-in-the-general-population
#35
JOURNAL ARTICLE
Gunvor S Fosnes, Stian Lydersen, Per G Farup
BACKGROUND: Constipation and diarrhoea are common complaints and often reported as adverse drug reactions. This study aimed at finding associations between drugs and constipation and diarrhoea in a general population. METHODS: A selection of inhabitants in Oppland County, Norway participated in a cross-sectional survey. Information about demographics, diseases including gastrointestinal complaints classified according to the Rome II criteria and use of drugs were collected on questionnaires...
2011: BMC Clinical Pharmacology
https://read.qxmd.com/read/21291562/pharmacokinetics-of-phenoxodiol-a-novel-isoflavone-following-intravenous-administration-to-patients-with-advanced-cancer
#36
JOURNAL ARTICLE
Jan B Howes, Paul L de Souza, Leanne West, Li Jiu Huang, Laurence G Howes
BACKGROUND: Phenoxodiol is a novel isoflavone currently being studied in clinical trials for the treatment of cancer. This study reports the pharmacokinetics of phenoxodiol in patients with cancer. METHODS: The pharmacokinetics of phenoxodiol was studied following a single intravenous (iv) bolus dose and during a continuous intravenous infusion. Three men with prostate cancer and 3 women with breast cancer received IV bolus phenoxodiol (5 mg/kg) and plasma was sampled for free and total phenoxodiol levels...
2011: BMC Clinical Pharmacology
https://read.qxmd.com/read/20961422/comparison-of-the-pharmacokinetics-safety-and-tolerability-of-two-concentrations-of-a-new-liquid-recombinant-human-growth-hormone-formulation-versus-the-freeze-dried-formulation
#37
RANDOMIZED CONTROLLED TRIAL
Bernd Liedert, Ulf Forssmann, Peter Wolna, Michaela Golob, Andreas Kovar
BACKGROUND: Somatropin is recombinant human growth hormone (GH) used for the treatment of growth failure in children and GH deficiency in adults. Two concentrations of a liquid formulation have been developed: 5.83 and 8.0 mg/mL. This trial compared the pharmacokinetics (PK), safety and tolerability of these two liquid concentrations against the freeze-dried (FD) formulation in healthy volunteers. METHODS: In an open-label, single-centre, three-way crossover study, volunteers (aged 18-45 years) were given subcutaneous injections of the reconstituted FD and two liquid formulations in random sequential order, each at 4 mg/dose, with a 1-week wash-out period between doses...
October 20, 2010: BMC Clinical Pharmacology
https://read.qxmd.com/read/20920295/pharmacokinetic-comparability-of-prolastin%C3%A2-c-to-prolastin%C3%A2-in-alpha%C3%A2-antitrypsin-deficiency-a-randomized-study
#38
RANDOMIZED CONTROLLED TRIAL
James M Stocks, Mark L Brantly, Laurene Wang-Smith, Michael A Campos, Kenneth R Chapman, Friedrich Kueppers, Robert A Sandhaus, Charlie Strange, Gerard Turino
BACKGROUND: Alpha1-antitrypsin (AAT) deficiency is characterized by low blood levels of alpha1-proteinase inhibitor (alpha₁-PI) and may lead to emphysema. Alpha₁-PI protects pulmonary tissue from damage caused by the action of proteolytic enzymes. Augmentation therapy with Prolastin® (Alpha₁-Proteinase Inhibitor [Human]) to increase the levels of alpha₁-PI has been used to treat individuals with AAT deficiency for over 20 years. Modifications to the Prolastin manufacturing process, incorporating additional purification and pathogen-reduction steps, have led to the development of an alpha₁-PI product, designated Prolastin®-C (Alpha₁-Proteinase inhibitor [Human])...
September 30, 2010: BMC Clinical Pharmacology
https://read.qxmd.com/read/20920236/efficacy-and-safety-of-combined-prolonged-release-oxycodone-and-naloxone-in-the-management-of-moderate-severe-chronic-non-malignant-pain-results-of-a-prospectively-designed-pooled-analysis-of-two-randomised-double-blind-clinical-trials
#39
RANDOMIZED CONTROLLED TRIAL
Oliver Löwenstein, Petra Leyendecker, Eberhard A Lux, Mark Blagden, Karen H Simpson, Michael Hopp, Björn Bosse, Karen Reimer
BACKGROUND: Two randomised 12-week, double-blind, parallel-group, multicenter studies comparing oxycodone PR/naloxone PR and oxycodone PR alone on symptoms of opioid-induced bowel dysfunction in patients with moderate/severe non-malignant pain have been conducted. METHODS: These studies were prospectively designed to be pooled and the primary outcome measure of the pooled data analysis was to demonstrate non-inferiority in 12-week analgesic efficacy of oxycodone PR/naloxone PR versus oxycodone PR alone...
September 29, 2010: BMC Clinical Pharmacology
https://read.qxmd.com/read/20380750/traumeel-s-for-pain-relief-following-hallux-valgus-surgery-a-randomized-controlled-trial
#40
RANDOMIZED CONTROLLED TRIAL
Shepherd R Singer, Michal Amit-Kohn, Samuel Weiss, Jonathan Rosenblum, Guy Maoz, Noah Samuels, Esther Lukasiewicz, Laurence Freedman, Ora Paltiel, Menachem Itzchaki, Meir Niska, Menachem Oberbaum
BACKGROUND: In spite of recent advances in post-operative pain relief, pain following orthopedic surgery remains an ongoing challenge for clinicians. We examined whether a well known and frequently prescribed homeopathic preparation could mitigate post-operative pain. METHOD: We performed a randomized, double blind, placebo-controlled trial to evaluate the efficacy of the homeopathic preparation Traumeel S in minimizing post-operative pain and analgesic consumption following surgical correction of hallux valgus...
April 12, 2010: BMC Clinical Pharmacology
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