-- Back to Table of ContentsStudy Objective. To evaluate the antimicrobial properties of tigecycline, both alone and in combination with other antibiotics, against multidrug-resistant strains of Enterococcus faecium and Staphylococcus aureus.
Design. In vitro study.
Setting. University laboratory.
Measurements and Main Results. Tigecycline, both alone and in combination with other antimicrobial agents, was evaluated against two strains of vancomycin-resistant E. faecium (VREF), three glycopeptide- intermediately resistant S. aureus strains, and one methicillin-resistant S. aureus strain. Tigecycline’s activity was compared with that of vancomycin, gentamicin, rifampin, and doxycycline, using time-kill studies and analysis of minimum inhibitory concentrations and minimum bactericidal concentrations. Tigecycline also was evaluated in combination with vancomycin, gentamicin, rifampin, and doxycycline in time-kill studies. The number of log10 colony-forming units/ml at 24 hours was compared among treatment groups and growth control by analysis of variance. All isolates were susceptible to tigecycline, regardless of their susceptibilities to vancomycin or doxycycline. In time-kill studies, tigecycline significantly inhibited the bacterial inoculum of all isolates (p<0.05). Although none of the tigecycline combinations studied had enhanced killing activity against VREF, when gentamicin was combined with tigecycline, improved effects were found against both strains. Against three of the S. aureus strains tested, the combination of gentamicin and tigecycline demonstrated enhanced or improved activity independently of each strain’s susceptibility to gentamicin.
Conclusion. The multidrug-resistant, gram-positive bacteria tested, including doxycycline-resistant isolates, were susceptible to tigecycline. The combination of tigecycline and gentamicin may have improved or enhanced activity against strains of vancomycin-resistant enterococci and S. aureus.
(Pharmacotherapy 2002;22(12):1517-1523)
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Study Objectives. To describe the etiology and characteristics of patients with clinically diagnosed rhabdomyolysis in the United Kingdom General Practice Research Database (GPRD), and to estimate the risk of rhabdomyolysis in general and that associated with lipid-lowering agents in particular.
Design. Retrospective analysis.
Setting. The GPRD.
Patients. A base population of patients aged 20-75 years.
Intervention. Patients hospitalized with a computer-recorded code for acute myositis or myoglobinuria, or with “rhabdo” recorded in free text comments were reviewed for evidence of rhabdomyolysis. Lipid-lowering treatment among the base population also was calculated.
Measurements and Main Results. We identified 25 patients with rhabdomyolysis among 2.5 million in the base population between 1990 and 1999. Seven cases (28%) occurred after a drug overdose and 5 (20%) after septicemia. Among the 2935 concurrent users of statin and fibrate agents, one developed rhabdomyolysis.
Conclusion. Only 25 patients out of 2.5 million were found to have rhabdomyolysis. Of those, only one patient was taking a statin and fibrate concurrently, out of almost 3000 concurrent users. The free-text comments field in the GPRD helped to identify patients with rhabdomyolysis.
(Pharmacotherapy 2002;22(12):1524-1526)
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Study Objective. To compare the lipid-lowering effects of gemfibrozil and fenofibrate in patients with dyslipidemic coronary heart disease.
Design. Open label, fixed-dosage, retrospective-prospective, one-way crossover from gemfibrozil to fenofibrate.
Setting. University-affiliated outpatient clinics.
Patients. Eighty patients with coronary heart disease with a baseline low-density lipoprotein cholesterol (LDL) level above 130 mg/dl or a triglyceride level of 200 mg/dl or higher who had been receiving gemfibrozil 600 mg twice/day Thirty-nine (49%) patients had received concomitant therapy with a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin) for a minimum of 9 months.
Intervention. All patients received gemfibrozil 600 mg twice/day for at least 3 months before being switched to fenofibrate 201 mg/day. Patients receiving concomitant statin therapy before crossover continued the statin at the same dosage after crossover. Before crossover, a fasting lipid profile was determined and patients were queried about the side effects of lipid-lowering therapy. A repeat fasting lipid profile was obtained 12 weeks after the crossover.
Measurements and Main Results. Patients were stratified into those receiving versus those not receiving concomitant statin therapy. In both of these groups, fenofibrate was associated with significantly greater reductions in total cholesterol, LDL, and triglycerides than gemfibrozil (all p<0.001). In addition, fenofibrate was associated with a significantly greater increase in high-density lipoprotein cholesterol (HDL) than gemfibrozil (p<0.001). No patients reported new-onset adverse effects after the crossover.
Conclusions. Compared with gemfibrozil, fenofibrate produced significantly greater reductions in total cholesterol, LDL, and triglycerides and significantly greater increases in HDL. These changes were evident in patients receiving and not receiving concomitant statin therapy.
(Pharmacotherapy 2002;22(12):1527-1532)
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Objective. To determine whether pharmaceutical care provided by a pharmacist-managed hypertension clinic results in better treatment outcomes when compared with traditional health care from a primary care physician.
Design. Prospective, controlled study.
Setting. Veterans Affairs Medical Center, Philadelphia, Pennsylvania.
Patients. Fifty six patients with essential hypertension; 27 were randomly assigned to the intervention group and 29 to the control group.
Intervention. Patients in the intervention group were scheduled monthly to meet with a clinical pharmacist who made appropriate changes in prescribed drugs, adjusted dosages, and provided drug counseling in accordance with the hypertension guidelines in the sixth report of the Joint National Committee on the Detection, Evaluation, and Treatment of High Blood Pressure (JNC VI). Patients in the control group received standard care from their physicians. The study period was 6 months.
Measurements and Main Results. Treatment outcomes were measured by changes in compliance, blood pressure, and patient satisfaction. The Short Form-36 health survey and a patient satisfaction survey were used to measure changes in patient satisfaction, and a compliance evaluation survey measured compliance. Twenty-one (81%) patients in the intervention group attained their blood pressure goal of below 140/90 mm Hg at the completion of the study versus only eight (30%) in the control group (p<0.0001). Of 11 patients with diabetes in the intervention group, 10 (91%) attained their blood pressure goal (< 130/80 mm Hg) versus only two (12 %) of 16 patients with diabetes in the control group (p<0.0001). No significant differences in patient satisfaction or compliance were reported between the intervention and control groups.
Conclusions. Pharmaceutical care improves blood pressure control and results in more patients with hypertension reaching their blood pressure goal.
(Pharmacotherapy 2002;22(12):1533-1540)
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Study Objective. To assess whether clinicians are treating patients with both type 2 diabetes and hyperlipidemia according to national goals for blood pressure, low-density lipoprotein cholesterol (LDL), and glucose levels.
Design. Retrospective chart review.
Setting. University-based family medicine teaching practice.
Patients. One hundred twenty-four patients with both type 2 diabetes and hyperlipidemia.
Measurements and Main Results. Sixty-nine patients (58%) met the National Cholesterol Education Program Adult Treatment Panel II’s goals for LDL (< 130 mg/dl for primary prevention and < 100 mg/dl for secondary prevention). Only 47 patients (38%) were in compliance with national standards for both systolic and diastolic blood pressures. The mean hemoglobin A1c (A1C) level was 8.6%; 27 patients (21.8%) had A1C levels below 7.
Conclusion. A high percentage of patients in our family practice clinic met their goals for reducing lipid levels, but more aggressive therapy is necessary to attain glucose and blood pressure goals. Data from this study emphasize the need for understanding which factors influence clinicians’ treatment decisions.
(Pharmacotherapy 2002;22(12):1541-1546)
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Alzheimer’s disease is the most common type of dementia in older people. It is highly prevalent, affecting 35-45% of those aged 85 years or older. This disease has devastating consequences to patients, their families, caregivers, and the health care system. Much has been learned about its pathobiology, which has led to the b-amyloid (Ab) hypothesis. This hypothesis continues to be the predominant postulate of the pathobiology of Alzheimer’s disease. Under this hypothesis, abnormal accumulation of Ab is followed by a cascade of neurotoxic effects, which eventually result in neurodegeneration and development of Alzheimer’s disease. This is thought to be the result of altered processing of the amyloid precursor protein (APP), preferentially by b- and g-secretase enzymes rather than nonamyloidogenic processing by a-secretase. The growing body of knowledge regarding the processing of APP to various forms of Ab has resulted in new approaches to the investigation of putative anti-Alzheimer’s disease compounds, including immune-based therapies and various agents that can positively affect APP processing.
(Pharmacotherapy 2002;22(12):1547-1563)
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Each year millions of patients experience a venous thromboembolic event. Due to the significant morbidity and mortality associated with venous thromboembolism (VTE), prevention is critical. Several groups, such as those undergoing orthopedic or general surgery, and patients experiencing acute myocardial infarction, are known to be at high risk for VTE. General medical patients -- the medically ill -- are also at risk, but they receive insufficient prophylaxis, which may be due to underestimation or lack of assessment of their risk. The American College of Chest Physicians recommends either unfractionated heparin or low-molecular-weight heparin to prevent VTE in these patients. The different pharmacologic profiles and dosing methods of these two groups of agents suggest that efficacy and safety may not be equivalent. Due to heterogeneity of medically ill patients and variability in clinical trials, a detailed review of the literature was performed to assist clinicians in assessing risk and choice of a regimen to prevent VTE.
(Pharmacotherapy 2002;22(12):1564-1578)
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We sought to determine the demographics of pharmacists who were certified diabetes educators (CDEs) and information about their training, professional affiliations, and types of diabetes education services that they provide. We also queried these pharmacists about clinical activities, reimbursement, impact of certification, and intent to pursue CDE recertification. A list of pharmacists who were CDEs as of August 31, 2000, was obtained from the National Certification Board for Diabetes Educators. We then sent a six-page anonymous survey to 415 pharmacist CDEs; 233 surveys (56.1%) were returned. Of these respondents, 140 are women and 93 are men, with a mean age of 41.5 years. Most reside in Southern or Western states. Average time since pharmacist licensure was 17 years, and average time as a CDE was 5 years. Most had completed postgraduate training, including residencies and/or fellowships; 52.8% had faculty appointments; 46.7% stated they were billing for their services; and 45.9% were obtaining reimbursement. Most pharmacists (84.4%) stated that they intended to pursue CDE recertification. Providing details about pharmacist CDEs and their clinical activities may motivate other pharmacists to pursue this credential. Pharmacists are often the most accessible of all health care providers, and earning the CDE credential may be an important contribution to diabetes care and education.
(Pharmacotherapy 2002:22(12):1579-1593)
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Compilations of key articles and guidelines in a particular clinical practice area are useful not only to clinicians who practice in that area, but to all clinicians. We compiled pertinent articles and guidelines pertaining to drug therapy in the intensive care unit setting from the perspective of an actively practicing critical care pharmacist. This document also may serve to stimulate other experienced clinicians to undertake a similar endeavor in their practice areas.
(Pharmacotherapy 2002;22(12):1594-1610)
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Study Objective. To evaluate the ability of seven widely known herbal references and electronic databases to answer questions about herbal products asked at drug information centers.
Design. Cross-sectional study.
Setting. Five academic and institutional drug information centers.
Methods. Fifty-seven herbal-related questions were obtained from academic and institutional drug information centers. Seven herbal references and electronic databases were evaluated for their ability to answer these 57 questions: The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines, 1st edition; Physicians’ Desk Reference (PDR) for Herbal Medicines, 2001 edition; Tyler’s Honest Herbal: A Sensible Guide to the Use of Herbs and Related Remedies, 4th edition; The Lawrence Review of Natural Products, 2001; Natural Medicines Comprehensive Database (electronically updated, 2001); The Natural Pharmacist (electronically updated, 2001); and AltMedDex (electronically updated, 2001).
Results. Natural Medicines Comprehensive Database outperformed all other products evaluated, providing direct answers to 61% of questions. AltMedDex and The Natural Pharmacist performed similarly to one another, answering 49% and 44% of questions, respectively. The Lawrence Review of Natural Products, PDR for Herbal Medicines, The Complete German Commission E Monographs, and Tyler’s Honest Herbal were the least helpful in providing direct answers to the questions (24%, 21%, 11%, and 9%, respectively).
Conclusion. Natural Medicines Comprehensive Database, AltMedDex, and The Natural Pharmacist outperformed all other evaluated herbal references and electronic databases in their ability to answer questions about herbal products posed in clinical practice.
(Pharmacotherapy 2002;22(12):1611-1615)
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We assessed patients’ health-related quality of life after myocardial infarction and identified related variables. Clinical data were obtained retrospectively from medical records of consecutive patients admitted to a Midwestern university-affiliated medical center with diagnosis of myocardial infarction from July 1999-July 2000. Telephone interviews 7 months after discharge were made to administer the Short Form-12 (SF-12) and obtain patient, disease, drug, and intervention data. Complete information was obtained from 200 patients (mean age 63.4 ± 13.1 yrs, 68% men). The mean Physical Component Summary (PCS)-12 score was 40.6 ± 12.0, and the mean Mental Component Summary (MCS)-12 score was 52.1 ± 10.0. Based on univariate analyses, low PCS-12 scores were associated with women; non-Q-wave infarctions; greater number of illnesses; history of myocardial infarction, chronic heart failure (CHF), transient ischemic attack (TIA), renal disease, peripheral vascular disease, or percutaneous coronary intervention (PCI); rehospitalization during the interim period; and unscheduled PCI since index myocardial infarction. Low MCS-12 scores were associated with age below 65 years, low overall self-reported drug therapy compliance, low self-reported compliance with angiotensin-converting enzyme inhibitor and lipid-lowering therapy, no history of coronary artery bypass graft, and no stress test since index myocardial infarction. A multivariate regression model for PCS-12 kept the following variables: greater number of illnesses, history of CHF or TIA, and rehospitalization since index myocardial infarction. The MCS-12 model contained age below 65 years, low overall compliance, and low compliance with lipid-lowering therapy. Further work is necessary to determine noncardiovascular predictors of quality of life and whether interventions for these patients will result in improved quality of life.
(Pharmacotherapy 2002;22(12):1616-1622)
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Objectives. To describe some of the costs of providing a smoking-cessation program in a community pharmacy practice, and to model the program’s cost-effectiveness compared with that of a self-directed quit attempt.
Design and Setting. Data used were based primarily on results from a pharmacist-directed smoking-cessation program in a community pharmacy chain practice that achieved continuous abstinence for at least 1 year in 25% of patients. Baseline assumptions were formulated from a MEDLINE literature review and were varied in the sensitivity analysis. Overall costs were based on program costs and retail cost of the selected cessation method (cold turkey, nicotine patch, nicotine gum, or bupropion.
Patients. Forty-eight patients, more than two thirds of whom were women, aged 21-70 years, who had tried at least once to quit smoking.
Measurements and Main Results. Incremental cost-effectiveness was measured in terms of cost/successful quit attempt based on the payer’s perspective. Cost/life-year saved and cost/quality-adjusted life-year saved also were calculated for the societal perspective. Incremental cost for an additional patient to quit smoking using the pharmacist-directed program alternatives versus a self-directed quit attempt was $236 for the cold turkey method, $936 for nicotine patch, $1232 for nicotine gum, and $1150 for bupropion. Depending on the smoker’s age at the time of cessation, the incremental discounted cost-effectiveness was $720-1418/life-year saved.
Conclusion. This analysis demonstrates that a pharmacist-directed cessation program is a cost-effective alternative to a self-directed quit attempt with respect to payers and society. Additional analyses conducted in community pharmacy practice are necessary to corroborate our results.
(Pharmacotherapy 2002;22(12):1623-1631)
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A 25-year-old woman who was hospitalized for worsening endocarditis had a prolonged QT interval at baseline and developed monomorphic ventricular arrhythmias, which were managed successfully with pacing and antiarrhythmic therapy. Several days later, the patient started receiving high-dose fluconazole for fungemia and subsequently experienced episodes of torsades de pointes, a polymorphic ventricular arrhythmia associated with a prolonged QT interval or prominent U wave on the electrocardiogram. The arrhythmia developed in the presence of known risk factors. Clinicians should be aware of these risk factors and other relevant structural similarities with drugs that cause torsades de pointes so that they can recognize patients who may be at risk for fluconazole-associated arrhythmia.
(Pharmacotherapy 2002;22(12):1632-1637)
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Although intravenous immunoglobulin (IVIg) generally is considered a safe treatment for various autoimmune and inflammatory disorders, rare cases of thrombosis may occur. We describe two patients who experienced thrombotic complications associated with IVIg therapy. A 54-year-old woman with idiopathic thrombocytopenia received IVIg 1 g/kg/day for 2 days. While receiving her infusion on day 2, she had an ischemic stroke with hemiparesis; 3 days later she developed deep vein thrombosis. A 33-year-old woman with Evans’ syndrome received IVIg 400 mg/kg/day for 5 days and developed deep vein thrombosis 1 week after therapy was completed; she then received warfarin. Six months later, she received an additional course of IVIg for recurrent hemolytic anemia; 1 day later she died of pulmonary thromboembolism. We suggest that IVIg may promote thrombosis by increasing blood viscosity, activating platelets, or causing vasospasm and should be administered with caution.
(Pharmacotherapy 2002;22(12):1638-1641)
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Drug samples commonly are provided by physicians to patients in the outpatient setting. The use of drug samples, however, has come under scrutiny as critics argue that the practice is a marketing tool for the pharmaceutical industry.1-5 An additional problem facing the medical community is the growing rate of medication errors. Recently, there has been a national call for new methods of identifying and avoiding these frequently disabling events.6 We describe a case in which a medication error was averted through the use of drug samples.
(Pharmacotherapy 2002;22(12):1642-1643)
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