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    133 results match your criteria BMC Clinical Pharmacology[Journal]

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    Statin therapy in critical illness: an international survey of intensive care physicians' opinions, attitudes and practice.
    BMC Clin Pharmacol 2012 Jun 28;12:13. Epub 2012 Jun 28.
    Division of Asthma, Allergy and Lung Biology, King's College London, London, UK.
    Background: Pleotropic effects of statins on inflammation are hypothesised to attenuate the severity of and possibly prevent the occurrence of the host inflammatory response to pathogen and infection-related acute organ failure. We conducted an international survey of intensive care physicians in Australia, New Zealand (ANZ) and United Kingdom (UK). The aims of the survey were to assess the current prescribing practice patterns, attitudes towards prescribing statin therapy in critically ill patients and opinions on the need for an interventional trial of statin therapy in critically ill patients. Read More

    Data for drugs available through low-cost prescription drug programs are available through pharmacy benefit manager and claims data.
    BMC Clin Pharmacol 2012 Jun 22;12:12. Epub 2012 Jun 22.
    Regenstrief Institute, Inc, Indianapolis, IN, USA.
    Background: Observational data are increasingly being used for pharmacoepidemiological, health services and clinical effectiveness research. Since pharmacies first introduced low-cost prescription programs (LCPP), researchers have worried that data about the medications provided through these programs might not be available in observational data derived from administrative sources, such as payer claims or pharmacy benefit management (PBM) company transactions.

    Method: We used data from the Indiana Network for Patient Care to estimate the proportion of patients with type 2 diabetes to whom an oral hypoglycemic agent was dispensed. Read More

    Population prevalence of high dose paracetamol in dispensed paracetamol/opioid prescription combinations: an observational study.
    BMC Clin Pharmacol 2012 Jun 18;12:11. Epub 2012 Jun 18.
    Department of Community Health and Epidemiology, Dalhousie University, Halifax, NS, Canada.
    Background: Paracetamol (acetaminophen) is generally considered a safe medication, but is associated with hepatotoxicity at doses above doses of 4.0 g/day, and even below this daily dose in certain populations.

    Methods: The Nova Scotia Prescription Monitoring Program (NSPMP) in the Canadian province of Nova Scotia is a legislated organization that collects dispensing information on all out-of-hospital prescription controlled drugs dispensed for all Nova Scotia residents. Read More

    Adherence to medication for the treatment of psychosis: rates and risk factors in an Ethiopian population.
    BMC Clin Pharmacol 2012 Jun 18;12:10. Epub 2012 Jun 18.
    Regulatory Unit, Beker Pharmaceuticals General Business Plc, Lideta Kifle Ketema, Addis Ababa, Ethiopia.
    Background: Medication-taking behavior, specifically non-adherence, is significantly associated with treatment outcome and is a major cause of relapse in the treatment of psychotic disorders. Non-adherence can be multifactorial; however, the rates and associated risk factors in an Ethiopian population have not yet been elucidated. The principal aim of this study was to evaluate adherence rates to antipsychotic medications, and secondarily to identify potential factors associated with non-adherence, among psychotic patients at tertiary care teaching hospital in Southwest Ethiopia. Read More

    Errors in medication history at hospital admission: prevalence and predicting factors.
    BMC Clin Pharmacol 2012 Apr 3;12. Epub 2012 Apr 3.
    eHealth Institute and School of Natural Sciences, Linnaeus University, Kalmar, Sweden.
    Background: An accurate medication list at hospital admission is essential for the evaluation and further treatment of patients. The objective of this study was to describe the frequency, type and predictors of errors in medication history, and to evaluate the extent to which standard care corrects these errors.

    Methods: A descriptive study was carried out in two medical wards in a Swedish hospital using Lund Integrated Medicines Management (LIMM)-based medication reconciliation. Read More

    Effect of exenatide on the pharmacokinetics of a combination oral contraceptive in healthy women: an open-label, randomised, crossover trial.
    BMC Clin Pharmacol 2012 Mar 19;12. Epub 2012 Mar 19.
    Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
    Background: Consistent with its effect on gastric emptying, exenatide, an injectable treatment for type 2 diabetes, may slow the absorption rate of concomitantly administered oral drugs resulting in a decrease in maximum concentration (Cmax). This study evaluated the drug interaction potential of exenatide when administered adjunctively with oral contraceptives, given their potential concomitant use.

    Methods: This trial evaluated the effect of exenatide co-administration on single- and multiple-dose pharmacokinetics of a combination oral contraceptive (ethinyl estradiol [EE] 30 μg, levonorgestrel [LV] 150 μg [Microgynon 30®]). Read More

    Adverse drug reactions to antiretroviral therapy (ARVs): incidence, type and risk factors in Nigeria.
    BMC Clin Pharmacol 2012 Feb 27;12. Epub 2012 Feb 27.
    Department of Operations Research, HIV/AIDS Program, Population Council, Nigeria, Plot 759, Cadastral Zone AO, Off Constitution Avenue, Central Business District, Abuja, Nigeria.
    Background: Data on adverse drug reactions (ADRs) related to antiretroviral (ARV) use in public health practice are few indicating the need for ART safety surveillance in clinical care.

    Objectives: To evaluate the incidence, type and risk factors associated with adverse drug reactions (ADRs) among patients on antiretroviral drugs (ARV).

    Methods: Patients initiated on ARVs between May 2006 and May 2009 were evaluated in a retrospective cohort analysis in three health facilities in Nigeria. Read More

    A cost effectiveness analysis of the preferred antidotes for acute paracetamol poisoning patients in Sri Lanka.
    BMC Clin Pharmacol 2012 Feb 22;12. Epub 2012 Feb 22.
    Department of Pharmacology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.
    Background: Acute paracetamol poisoning is a rapidly increasing problem in Sri Lanka. The antidotes are expensive and yet no health economic evaluation has been done on the therapy for acute paracetamol poisoning in the developing world. The aim of this study is to determine the cost effectiveness of using N-acetylcysteine over methionine in the management of acute paracetamol poisoning in Sri Lanka. Read More

    Quality and safety of medication use in primary care: consensus validation of a new set of explicit medication assessment criteria and prioritisation of topics for improvement.
    BMC Clin Pharmacol 2012 Feb 8;12. Epub 2012 Feb 8.
    Tayside Medicines Unit, NHS Tayside, Mackenzie Building, Kirsty Semple Way, Dundee, Scotland, DD2 4BF, UK.
    Background: Addressing the problem of preventable drug related morbidity (PDRM) in primary care is a challenge for health care systems internationally. The increasing implementation of clinical information systems in the UK and internationally provide new opportunities to systematically identify patients at risk of PDRM for targeted medication review. The objectives of this study were (1) to develop a set of explicit medication assessment criteria to identify patients with sub-optimally effective or high-risk medication use from electronic medical records and (2) to identify medication use topics that are perceived by UK primary care clinicians to be priorities for quality and safety improvement initiatives. Read More

    Pharmacokinetics of high-dose oral thiamine hydrochloride in healthy subjects.
    BMC Clin Pharmacol 2012 Feb 4;12. Epub 2012 Feb 4.
    Department of Emergency Medicine, Tufts University School of Medicine and Baystate Medical Center, Springfield, MA, USA.
    Background: High dose oral thiamine may have a role in treating diabetes, heart failure, and hypermetabolic states. The purpose of this study was to determine the pharmacokinetic profile of oral thiamine hydrochloride at 100 mg, 500 mg and 1500 mg doses in healthy subjects.

    Methods: This was a randomized, double-blind, single-dose, 4-way crossover study. Read More

    Mechanisms for an effect of acetylcysteine on renal function after exposure to radio-graphic contrast material: study protocol.
    BMC Clin Pharmacol 2012 Feb 3;12. Epub 2012 Feb 3.
    National Poisons Information Service (Edinburgh), Royal Infirmary of Edinburgh, Edinburgh, UK.
    Background: Contrast-induced nephropathy is a common complication of contrast administration in patients with chronic kidney disease and diabetes. Its pathophysiology is not well understood; similarly the role of intravenous or oral acetylcysteine is unclear. Randomized controlled trials to date have been conducted without detailed knowledge of the effect of acetylcysteine on renal function. Read More

    Validation of an LC-MS/MS method to determine five immunosuppressants with deuterated internal standards including MPA.
    BMC Clin Pharmacol 2012 Jan 11;12. Epub 2012 Jan 11.
    Division of Clinical Chemistry, Department of Medicine, University Medical Center Freiburg, Hugstetterstrasse 55, 79106 Freiburg, Germany.
    Background: Therapeutic drug monitoring of immunosuppressive drugs in organ-transplanted patients is crucial to prevent intoxication or transplant rejection due to inadequate dosage. The commonly used immunoassays have been gradually undergoing replacement by mass spectrometry, since this physical method offers both a higher sensitivity and specificity. However, a switch should be carefully considered because it is a challenging procedure and needs to be thoroughly validated. Read More

    Effects of paliperidone extended release on the symptoms and functioning of schizophrenia.
    BMC Clin Pharmacol 2012 Jan 6;12. Epub 2012 Jan 6.
    Institute of Biomedical Engineering, National Cheng Kung University, Tainan 70403, Taiwan.
    Background: We aimed to explore relations between symptomatic remission and functionality evaluation in schizophrenia patients treated with paliperidone extended-release (ER), as seen in a normal day-to-day practice, using flexible dosing regimens of paliperidone ER. We explored symptomatic remission rate in patients treated with flexibly dosed paliperidone ER by 8 items of Positive and Negative Syndrome Scale (PANSS) and change of Personal and Social Performance (PSP) scale.

    Method: This was a 12-week multicenter, open-label, prospective clinical study conducted in in-patient and out-patient populations. Read More

    The association between drospirenone and hyperkalemia: a comparative-safety study.
    BMC Clin Pharmacol 2011 Dec 30;11:23. Epub 2011 Dec 30.
    University of Florida, College of Pharmacy, Pharmaceutical Outcomes & Policy, 101 S. Newell Drive (HPNP), PO Box 100496, Gainesville FL, USA 32611.
    Background: Drospirenone/ethinyl-estradiol is an oral contraceptive (OC) that possesses unique antimineralocorticoid activity. It is conjectured that drospirenone, taken alone or concomitantly with spironolactone, may be associated with an increased risk of hyperkalemia.

    Methods: A retrospective cohort study was conducted evaluating women between 18-46 years of age in the Lifelink™ Health Plan Claims Database. Read More

    Etomidate and mortality in cirrhotic patients with septic shock.
    BMC Clin Pharmacol 2011 Dec 30;11:22. Epub 2011 Dec 30.
    Pharmaceutical Care Department, Clinical Pharmacy Division, King Abdulaziz Medical City, Riyadh, Saudi Arabia.
    Background: Clinical effects and outcomes of a single dose etomidate prior to intubation in the intensive care setting is controversial. The aim of this study is to evaluate the association of a single dose effect of etomidate prior to intubation on the mortality of septic cirrhotic patients and the impact of the subsequent use of low dose hydrocortisone.

    Methods: This is a nested-cohort study within a randomized double blind placebo controlled study evaluating the use of low dose hydrocortisone in cirrhotic septic patients. Read More

    Use of antipsychotic and antidepressant within the Psychiatric Disease Centre, Regional Health Service of Ferrara.
    BMC Clin Pharmacol 2011 Dec 20;11:21. Epub 2011 Dec 20.
    Department of Pharmacy, University Hospital of Ferrara, Corso Giovecca 203, 44123 Ferrara, Italy.
    Background: This study aimed at describing the type and dosage of psychopharmaceuticals dispensed to patients with psychiatric disorders and to assess the percentage of patients treated with antipsychotics and antidepressants, the associated therapies, treatment adherence, and dosages used in individuals registered at the Psychiatric Disease Center (PDC), Regional Health Service of Ferrara.

    Methods: The analysis focused on therapeutic programmes presented to the Department of Pharmacy of the University Hospital of Ferrara of 892 patients treated by the PDC (catchment area of 134605 inhabitants). All diagnoses were made according to International Classification of Diseases (ICD-9). Read More

    Price, familiarity, and availability determine the choice of drug - a population-based survey five years after generic substitution was introduced in Finland.
    BMC Clin Pharmacol 2011 Dec 15;11:20. Epub 2011 Dec 15.
    University of Eastern Finland, Faculty of Health Sciences, School of Pharmacy, Social Pharmacy, P.O.Box 1627, FI-70211 Kuopio, Finland.
    Background: Mandatory generic substitution (GS) was introduced in Finland at the beginning of April 2003. However, individual patients or physicians may forbid the substitution. GS was a significant change for Finnish medicine users. Read More

    Public perception on the role of community pharmacists in self-medication and self-care in Hong Kong.
    BMC Clin Pharmacol 2011 Nov 25;11:19. Epub 2011 Nov 25.
    School of Public Health and Primary Care, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, N.T., Hong Kong.
    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. Read More

    Knowledge, attitudes and practice survey about antimicrobial resistance and prescribing among physicians in a hospital setting in Lima, Peru.
    BMC Clin Pharmacol 2011 Nov 15;11:18. Epub 2011 Nov 15.
    Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Perú.
    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%). Read More

    Immunogenicity of panitumumab in combination chemotherapy clinical trials.
    BMC Clin Pharmacol 2011 Nov 9;11:17. Epub 2011 Nov 9.
    Amgen Inc, One Amgen Center Drive, Thousand Oaks, CA 91320, USA.
    Background: Panitumumab is a fully human antibody against the epidermal growth factor receptor that is indicated for the treatment of metastatic colorectal cancer (mCRC) after disease progression on standard chemotherapy. The purpose of this analysis was to examine the immunogenicity of panitumumab and to evaluate the effect of anti-panitumumab antibodies on pharmacokinetic and safety profiles in patients with mCRC receiving panitumumab in combination with oxaliplatin- or irinotecan-based chemotherapies.

    Methods: Three validated assays (two screening immunoassays and a neutralizing antibody bioassay) were used to detect the presence of anti-panitumumab antibodies in serum samples collected from patients enrolled in four panitumumab combination chemotherapy clinical trials. Read More

    What can we learn from consumer reports on psychiatric adverse drug reactions with antidepressant medication? Experiences from reports to a consumer association.
    BMC Clin Pharmacol 2011 Oct 25;11:16. Epub 2011 Oct 25.
    Nordic School of Public Health, Gothenburg, Sweden.
    Background: According to the World Health Organization (WHO) the cost of adverse drug reactions (ADRs) in the general population is high and under-reporting by health professionals is a well-recognized problem. Another way to increase ADR reporting is to let the consumers themselves report directly to the authorities. In Sweden it is mandatory for prescribers to report serious ADRs to the Medical Products Agency (MPA), but there are no such regulations for consumers. Read More

    Gastrointestinal adverse effects of varenicline at maintenance dose: a meta-analysis.
    BMC Clin Pharmacol 2011 Sep 28;11:15. Epub 2011 Sep 28.
    Centre of Studies in Primary Care, Queen's University, Kingston Ontario, K7L 5E9, Canada.
    Background: Tobacco smoking remains the leading modifiable health hazard and varenicline is amongst the most popular pharmacological options for smoking cessation. The purpose of this study is to critically evaluate the extent of gastrointestinal adverse effects of varenicline when used at maintenance dose (1 mg twice a day) for smoking cessation.

    Methods: We conducted a meta-analysis of randomised controlled trials published in PUBMED and EMBASE according to the PRISMA guidelines. Read More

    Impact of information letters on the reporting rate of adverse drug reactions and the quality of the reports: a randomized controlled study.
    BMC Clin Pharmacol 2011 Sep 7;11:14. Epub 2011 Sep 7.
    Department of Clinical Pharmacology and Regional Pharmacovigilance Centre, Sahlgrenska University Hospital, Gothenburg, Sweden.
    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). Read More

    Cognitive functioning in opioid-dependent patients treated with buprenorphine, methadone, and other psychoactive medications: stability and correlates.
    BMC Clin Pharmacol 2011 Aug 21;11:13. Epub 2011 Aug 21.
    Department of Psychiatry, Helsinki University Central Hospital, Finland.
    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. Read More

    Association between statin therapy and outcomes in critically ill patients: a nested cohort study.
    BMC Clin Pharmacol 2011 Aug 6;11:12. Epub 2011 Aug 6.
    Intensive Care Department, King Abdulaziz Medical City, Riyadh, Saudi Arabia.
    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. Read More

    An evaluation of ciprofloxacin pharmacokinetics in critically ill patients undergoing continuous veno-venous haemodiafiltration.
    BMC Clin Pharmacol 2011 Aug 4;11:11. Epub 2011 Aug 4.
    School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin, Dublin 2, Ireland.
    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. Read More

    The effects of polyunsaturated fatty acids in alcohol dependence treatment--a double-blind, placebo-controlled pilot study.
    BMC Clin Pharmacol 2011 Jul 26;11:10. Epub 2011 Jul 26.
    Psychobiology Department, Federal University of São Paulo, Edifício de Ciências Biomédicas, Rua Botucatu 862 - 1° Andar, São Paulo, Brasil.
    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'. Read More

    Comparative in vitro study of the antimicrobial activities of different commercial antibiotic products of vancomycin.
    BMC Clin Pharmacol 2011 Jul 21;11. Epub 2011 Jul 21.
    Universidad Nacional de Colombia, Facultad de Ciencias, Departamento de Farmacia, Laboratorio de Asesorías e Investigaciones en Microbiología, 472. Ciudad Universitaria. Carrera 30 Calle 45. A.A.14490. Bogotá D. C. Colombia.
    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. Read More

    Comparison of renal effects of ibuprofen versus indomethacin during treatment of patent ductus arteriosus in contiguous historical cohorts.
    BMC Clin Pharmacol 2011 Jun 30;11. Epub 2011 Jun 30.
    Division of Neonatology, Department of Pediatrics; Albany Medical Center 43 New Scotland Avenue, Albany, NY 12208 USA.
    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. Read More

    No relevant cardiac, pharmacokinetic or safety interactions between roflumilast and inhaled formoterol in healthy subjects: an open-label, randomised, actively controlled study.
    BMC Clin Pharmacol 2011 Jun 1;11. Epub 2011 Jun 1.
    Applied Clinical Pharmacology Services, Mainz-Kastel, Germany.
    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. Read More

    The future of pharmaceutical care in France: a survey of final-year pharmacy students' opinions.
    BMC Clin Pharmacol 2011 May 25;11. Epub 2011 May 25.
    Faculté de Médecine Paris-Sud Paris XI, Le Kremlin-Bicêtre, France.
    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). Read More

    Drug safety of rosiglitazone and pioglitazone in France: a study using the French PharmacoVigilance database.
    BMC Clin Pharmacol 2011 May 24;11. Epub 2011 May 24.
    Unité INSERM 1027, Equipe de Pharmacoépidémiologie, Université de Toulouse, Toulouse, France.
    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. Read More

    Use, tolerability and compliance of spironolactone in the treatment of heart failure.
    BMC Clin Pharmacol 2011 May 20;11. Epub 2011 May 20.
    Faculty of Pharmacy, University of Montreal, Montreal, Quebec, Canada.
    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. Read More

    Pharmacokinetics and tolerability of zibotentan (ZD4054) in subjects with hepatic or renal impairment: two open-label comparative studies.
    BMC Clin Pharmacol 2011 Mar 17;11. Epub 2011 Mar 17.
    AstraZeneca, Alderley Park, Macclesfield, UK.
    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. Read More

    Constipation and diarrhoea - common adverse drug reactions? A cross sectional study in the general population.
    BMC Clin Pharmacol 2011 Feb 18;11. Epub 2011 Feb 18.
    Department of Medicine, Innlandet Hospital Trust, Gjøvik, Norway.
    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. Read More

    Pharmacokinetics of phenoxodiol, a novel isoflavone, following intravenous administration to patients with advanced cancer.
    BMC Clin Pharmacol 2011 Feb 3;11. Epub 2011 Feb 3.
    Department of Pharmacology and Therapeutics, Griffith University, Gold Coast Hospital, Southport, Queensland, Australia.
    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. Read More

    Increasing polypharmacy - an individual-based study of the Swedish population 2005-2008.
    BMC Clin Pharmacol 2010 Dec 2;10:16. Epub 2010 Dec 2.
    eHealth Institute, Linnaeus University, Kalmar, Sweden.
    Background: An increase in the use of drugs and polypharmacy have been displayed over time in spite of the fact that polypharmacy represents a well known risk factor as regards patients' health due to the adverse drug reactions, drug-drug interactions, and low adherence to drug therapy arising from polypharmacy. For policymakers, as well as for clinicians, it is important to follow the developing trends in drug use and polypharmacy over time. We wanted to study if the prevalence of polypharmacy in an entire national population has changed during a 4-year period. Read More

    The impact of generic substitution on the activities of pharmaceutical companies - a survey from the companies' perspective one year and five years after the introduction of generic substitution in finland.
    BMC Clin Pharmacol 2010 Oct 22;10:15. Epub 2010 Oct 22.
    School of Pharmacy/Social Pharmacy, Faculty of Health Sciences, Kuopio Campus, University of Eastern Finland, POBox 1627, FI-70211 Kuopio, Finland.
    Background: Mandatory generic substitution (GS) was introduced in Finland on 1 April 2003. The aim of this study was to explore and compare the impacts of GS on the activities of pharmaceutical companies representing mainly original or generic pharmaceutical products in Finland. The self-reported impact of GS from pharmaceutical companies' perspective was explored with a focus on the number of employees, the range of sales packages on the market, the marketing activities, the research and development of new pharmaceutical products and storage of pharmaceuticals. Read More

    Comparison of the pharmacokinetics, safety and tolerability of two concentrations of a new liquid recombinant human growth hormone formulation versus the freeze-dried formulation.
    BMC Clin Pharmacol 2010 Oct 20;10:14. Epub 2010 Oct 20.
    Merck KGaA, Darmstadt, Germany.
    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. Read More

    Pharmacokinetic comparability of Prolastin®-C to Prolastin® in alpha₁-antitrypsin deficiency: a randomized study.
    BMC Clin Pharmacol 2010 Sep 30;10:13. Epub 2010 Sep 30.
    Department of Medicine, University of Texas Health Science Center at Tyler, 75708-3154, USA.
    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. Read More

    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.
    BMC Clin Pharmacol 2010 Sep 29;10:12. Epub 2010 Sep 29.
    Schmerzpraxis, Mainz, Germany.
    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. Patients with opioid-induced constipation were switched to oxycodone PR and then randomised to fixed doses of oxycodone PR/naloxone PR (n = 292) or oxycodone PR (n = 295) for 12 weeks (20-80 mg/day). Read More

    Knowledge and adherence to antiretroviral therapy among adult people living with HIV/AIDS treated in the health care centers of the association "Espoir Vie Togo" in Togo, West Africa.
    BMC Clin Pharmacol 2010 Sep 17;10:11. Epub 2010 Sep 17.
    Faculté Mixte de Médecine et de Pharmacie, Université de Lomé, BP 1515 Lomé, Togo.
    Background: The efficiency of antiretroviral therapy (ART) depends on a near perfect level of patients' adherence. The level of adherence of adults HIV-infected patients treated in the HIV/AIDS health care centres of the association "Espoir Vie Togo" in Togo, West Africa is not properly documented. The aim of the present study was to examine by means of self-reports the knowledge, the adherence level and associated factors to antiretroviral therapy (ART) among these patients. Read More

    The pharmacokinetic profile of a novel fixed-dose combination tablet of ibuprofen and paracetamol.
    BMC Clin Pharmacol 2010 Jul 5;10:10. Epub 2010 Jul 5.
    Simbec Research Ltd, Cardiff Road, Merthyr Tydfil, CF48 4DR, UK.
    Background: Ibuprofen and paracetamol differ in their mode of action and related therapeutic effects, suggesting that combined administration may offer improved analgesia. Reported here are the results of two studies on the pharmacokinetic properties of a novel ibuprofen (200 mg) and paracetamol (500 mg) fixed-dose combination tablet.

    Methods: Both studies were open-label, randomised studies in healthy volunteers: Study 1 was a four-way crossover, single-dose study; Study 2 was a two-way cross-over, repeat-dose study. Read More

    Traumeel S for pain relief following hallux valgus surgery: a randomized controlled trial.
    BMC Clin Pharmacol 2010 Apr 12;10. Epub 2010 Apr 12.
    The Center for Integrative Complementary Medicine, Shaare Zedek Medical Center, Jerusalem, Israel.
    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. Read More

    Assessing safety culture in pharmacies: the psychometric validation of the Safety Attitudes Questionnaire (SAQ) in a national sample of community pharmacies in Sweden.
    BMC Clin Pharmacol 2010 Apr 11;10. Epub 2010 Apr 11.
    Department of Pharmacy, Uppsala University, Box 570, S-751 23 Uppsala, Sweden.
    Background: Safety culture assessment is increasingly recognized as an important component in healthcare quality improvement, also in pharmacies. One of the most commonly used and rigorously validated tools to measure safety culture is the Safety Attitudes Questionnaire; SAQ. This study presents the validation of the SAQ for use in Swedish pharmacies. Read More

    Sodium pentosan polysulfate resulted in cartilage improvement in knee osteoarthritis--an open clinical trial.
    BMC Clin Pharmacol 2010 Mar 28;10. Epub 2010 Mar 28.
    Department of Pharmacology, Graduate School of Biomedical Sciences, Nagasaki University, 1-12-4, Sakamoto, Nagasaki city, Nagasaki prefecture, 852-8523, Japan.
    Background: Pentosan polysulfate sodium (pentosan) is a semi-synthetic drug manufactured from beech-wood hemicellulose by sulfate esterification of the xylopyranose hydroxyl groups. From in vitro and animal model studies, pentosan has been proposed as a disease modifying osteoarthritis drug (DMOAD). The objective of this study was to assess the efficacy, safety, and patient satisfaction in patients with mild radiographic knee osteoarthritis (OA) findings and OA-associated symptoms and signs. Read More

    Use of analgesics in intentional drug overdose presentations to hospital before and after the withdrawal of distalgesic from the Irish market.
    BMC Clin Pharmacol 2010 Mar 18;10. Epub 2010 Mar 18.
    National Suicide Research Foundation, 1 Perrott Avenue, College Road, Cork, Ireland.
    Background: Distalgesic, the prescription-only analgesic compound of paracetamol (325 mg) and dextropropoxyphene (32.5 mg) known as co-proxamol in the UK, was withdrawn from the Irish market as of January 2006. This study aimed to evaluate the impact of the withdrawal of distalgesic in terms of intentional drug overdose (IDO) presentations to hospital emergency departments (EDs) nationally. Read More

    EVITA: a tool for the early evaluation of pharmaceutical innovations with regard to therapeutic advantage.
    BMC Clin Pharmacol 2010 Mar 16;10. Epub 2010 Mar 16.
    Department of Pharmacology, Klinikum Bremen-Mitte gGmbH, Bremen, Germany.
    Background: New drugs are generally claimed to represent a therapeutic innovation. However, scientific evidence of a substantial clinical advantage is often lacking. This may be the result of using inadequate control groups or surrogate outcomes only in the clinical trials. Read More

    Characteristics of primary health care units with focus on drug information from the pharmaceutical industry and adherence to prescribing objectives: a cross-sectional study.
    BMC Clin Pharmacol 2010 Feb 15;10. Epub 2010 Feb 15.
    Department of Clinical Pharmacology, Sahlgrenska University Hospital, 413 45 Göteborg, Sweden.
    Background: Adherence to prescribing guidelines varies between primary health care units. The aim of the present study was to investigate correlations between characteristics of primary health care units and adherence to prescribing objectives for rational drug use with focus on drug information from the pharmaceutical industry.

    Methods: A cross-sectional study was performed in all 25 primary health care units in Göteborg, Sweden. Read More

    Comparative in vitro study of the antimicrobial activities of different commercial antibiotic products for intravenous administration.
    BMC Clin Pharmacol 2010 Jan 29;10. Epub 2010 Jan 29.
    UNIVERSIDAD NACIONAL DE COLOMBIA, FACULTAD DE CIENCIAS, DEPARTAMENTO DE FARMACIA, Laboratorio de Asesorías e Investigaciones en Microbiología. Postal Code: 472. Ciudad Universitaria. Carrera 30 Calle 45. A.A. 14490, Bogotá D. C., Colombia.
    Background: The antimicrobial resistance is a global problem, probably due to the indiscriminate and irrational use of antibiotics, prescriptions for incorrect medicines or incorrect determinations of dose, route and/or duration. Another consideration is the uncertainty of patients receiving antibiotics about whether the quality of a generic medicine is equal to, greater than or less than its equivalent brand-name drug. The antibiotics behaviors must be evaluated in vitro and in vivo in order to confirm their suitability for therapeutic use. Read More

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