-- Back to Table of ContentsInternational adoptions have become increasingly common in the United States. Children awaiting international adoption and families traveling to adopt these children can be exposed to a variety of infectious diseases. Compared with the United States, foreign countries often have different immunization practices and methods of diagnosing, treating, and monitoring disease. Reporting of medical conditions can also differ from that of the United States. The prevalence of infectious diseases varies from country to country and may or may not be common among adopted children. The transmission of tuberculosis, hepatitis B, and measles from adopted children to family members has been documented. Furthermore, infectious organisms (e.g., intestinal parasites), bacterial pathogens (e.g., Bordetella pertussis and Treponema pallidum), and viruses (e.g., human immunodeficiency virus and hepatitis viruses) may cause clinically significant morbidity and mortality among infected children. Diseases such as severe acute respiratory syndrome or avian influenza have not been reported among international adoptees, but transmission is possible if infection is present. Family members may be infected by others during travel or by their adopted child after returning home. Families preparing to adopt a child from abroad should pay special attention to the infectious diseases they may encounter and to the precautions they should take on returning home.
Key Words: avian flu, hepatitis A, hepatitis B, hepatitis C, HIV, infectious disease, international adoption, intestinal parasites, lice, measles, mumps, pertussis, travel preparation, travel follow-up, rubella, SARS, scabies, syphilis, tuberculosis.
(Pharmacotherapy 2006;26(9):1207-1220)
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Study Objective. To develop and validate an instrument to assess nausea intensity in children aged 4-18 years.
Design. Prospective, descriptive study.
Setting. Tertiary-quaternary, university-affiliated pediatric hospital.
Patients. Four pediatric inpatient groups (177 patients): group 1 (107), those receiving cancer chemotherapy; group 2 (24), those receiving cancer chemotherapy before hematopoietic stem cell transplantation; group 3 (23), those with cancer who were not receiving cancer chemotherapy; and group 4 (23), those without cancer.
Intervention. We developed a scale with a standard script for administration, the Pediatric Nausea Assessment Tool (PeNAT). Revisions were made after face validity testing with clinicians and parents, and pilot testing with 15 inpatients undergoing chemotherapy.
Measurements and Main Results. The PeNAT scores were obtained 4-24 hours after chemotherapy in groups 1 and 2. Dietary intake scores and number of emetic episodes were recorded for the 4 hours before PeNAT administration for all patients in group 2 and 36 patients in group 1. Parents of a subset of patients made an independent assessment of their child’s nausea and pain intensities immediately before PeNAT administration. Reliability was evaluated in groups 1 and 2 by correlating the first and second (obtained 1 hr after the first) PeNAT scores. Construct validity was evaluated by comparing PeNAT scores in groups 1-4. Criterion-related validity was evaluated by correlating PeNAT scores with emetic episodes and dietary intake. Convergent and discriminant validity were evaluated by correlating PeNAT scores with parental assessments of nausea and pain. Significant differences in PeNAT scores were noted among the study groups (p=0.035). Moderate correlation was noted between the first and second PeNAT scores (Spearman r = 0.649). The PeNAT scores correlated modestly with emetic episodes (Spearman r = 0.322) but not with dietary intake (Spearman r = -0.217). Children’s PeNAT scores correlated moderately with their parents’ assessment of nausea (Spearman r = 0.442), whereas little correlation was seen between children’s PeNAT scores and parents’ assessment of pain (Spearman r = 0.167).
Conclusion. The PeNAT is a new instrument that can be used by children to assess nausea intensity.
Key Words: Pediatric Nausea Assessment Tool, PeNAT, nausea, children, antineoplastic-induced nausea, pediatric oncology.
(Pharmacotherapy 2006;26(9):1221-1231)
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Study Objective. To develop limited sampling strategies for estimation of mycophenolic acid exposure (by determining area under the concentration-time curve [AUC]) in lung transplant recipients by using sampling times within 2 hours after drug administration and a maximum of three plasma samples.
Design. Prospective, open-label clinical study.
Setting. Lung transplant clinic in Vancouver, British Columbia, Canada.
Patients. Nineteen adult (mean age 48.3 yrs) lung transplant recipients who were receiving mycophenolate mofetil therapy along with cyclosporine (9 patients) or tacrolimus (10 patients).
Intervention. Eleven blood samples were collected from each of the 19 patients over 12 hours: immediately before (0 hr) and 0.3, 0.6, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours after administration of mycophenolate mofetil.
Measurements and Main Results. Mycophenolic acid levels in plasma were determined by a high-performance liquid chromatography-ultraviolet detection method. The 19 patients were randomly divided into index (10 patients) and validation (9 patients) groups. Limited sampling strategies were developed with multiple regression analysis by using data from the index group. Data from the validation group were used to test each strategy. Bias and precision of each limited sampling strategy were determined by calculating the mean prediction error and the root mean square error, respectively. The correlation between AUC and single concen-trations was generally poor (r2 = 0.18-0.73). Two single-concentration strategies, eight two-concentration strategies, and eight three-concentration strategies matched our criteria. However, the best overall limited sampling strategies (and their predictive performance) were the following: log AUC = 0.241 log C0 + 0.406 log C2 + 1.140 (bias -5.82%, precision 5.97%, r2 = 0.828) and log AUC = 0.202 log C0 + 0.411 log C1.5 + 1.09 (bias -5.71%, precision 6.94%, r2 = 0.791), where Cx is mycophenolic acid concentration at time x hours.
Conclusion. Two-concentration limited sampling strategies provided minimally biased and highly precise estimation of mycophenolic acid AUC in lung transplant recipients. These optimal and most clinically feasible limited sampling strategies are based collectively on the number of blood samples required, r2 value, bias, and precision.
Key Words: limited sampling strategy, mycophenolic acid, lung transplantation, area under the concentration-time curve, AUC, drug exposure.
(Pharmacotherapy 2006;26(9):1232-1240)
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Study Objective. To determine the effect of an ephedra-containing thermogenic herbal compound (TrimSpa) on rate-corrected QT (QTc) interval duration and systolic blood pressure.
Design. Randomized, double-blind, placebo-controlled, crossover, intent-to-treat study.
Setting. Student laboratory at a college of pharmacy.
Subjects. Thirteen healthy volunteers (eight men, five women).
Intervention. Participants were given TrimSpa, which contains more than 30 ingredients including ephedra 15 mg and caffeine 60 mg, or matching placebo 3 times/day for 7 days in a crossover fashion with a 7-day washout period between treatments.
Measurements and Main Results. Each subject’s QTc interval and systolic blood pressure were measured on days 1, 4, and 7. These measurements were performed immediately before study drug ingestion (baseline) and 0.5, 1, and 3 hours after ingestion. No differences in these variables were found between the TrimSpa and placebo groups. In one subject taking TrimSpa, the QTc interval increased 96 msec from baseline, more than double the largest increase in the placebo group.
Conclusion. Standard doses of TrimSpa did not induce changes in subjects’ QTc intervals or systolic blood pressures. However, because the QTc interval dramatically changed in one subject taking TrimSpa, a large study is needed to determine if the effect is an artifact or if the subject represents a subset of people for whom the drug may pose a risk.
Key Words: blood pressure, ECG, ephedra, QTc interval, thermogenic herbal compound, THC, TrimSpa.
(Pharmacotherapy 2006;26(9):1241-1246)
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Study Objectives. To determine the correlation between ambulatory and clinic blood pressure in assessing antihypertensive response to b-blockade, to test whether blood pressure response to metoprolol is associated with the heart rate response, and to determine whether exercise and resting heart rate responses to metoprolol are correlated.
Design. Post hoc analysis of a prospective cohort study.
Setting. University-affiliated general clinical research center.
Patients. Fifty-one patients aged 35-65 years with uncomplicated hypertension.
Intervention. All patients received metoprolol at a dosage titrated to achieve a diastolic blood pressure below 90 mm Hg.
Measurements and Main Results. Clinic and 24-hour ambulatory blood pressure measurements were obtained and exercise treadmill testing was performed before and after metoprolol treatment. Based on ambulatory blood pressure data, 24 patients (47%) responded (defined as at least a 10% reduction in diastolic blood pressure) to metoprolol compared with 36 patients (71%) based on clinic blood pressure data (p=0.027). Clinic blood pressure was associated with a 67% false-positive rate (responsive blood pressure by clinic data that was actually nonresponsive by ambulatory data). Blood pressure responders and nonresponders exhibited similar reductions in exercise heart rate (24% and 23%, p=0.74). However, responses to metoprolol measured by exercise heart rate versus resting heart rate were not significantly correlated (r=0.24, p=0.105).
Conclusion. Reliance on clinic blood pressure or resting heart rate for making b-blocker treatment decisions may yield less than optimal assessment of the antihypertensive response or degree of b-blockade.
Key Words: b-blocker, metoprolol, clinic blood pressure, ambulatory blood pressure, heart rate, hypertension, measurement.
(Pharmacotherapy 2006;26(9):1247-1254)
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Study Objectives. To determine if quercetin, a bioflavonoid that inhibits p-glycoprotein, alters plasma saquinavir concentrations, and to explore the potential influence on intracellular concentrations.
Design. Prospective pharmacokinetic analysis.
Setting. University-affiliated general clinical research center.
Subjects. Ten healthy adults (four women, six men) with a mean ± SD age of 30.7 ± 9.4 years.
Intervention. All subjects received saquinavir 1200 mg 3 times/day with food on days 1-11 and quercetin 500 mg 3 times/day with food on days 4-11.
Measurements and Main Results. On days 4 and 11, nine blood samples and four peripheral blood mononuclear cell samples were drawn during a steady-state dosing interval. Pharmacokinetic parameters were calculated by using standard noncompartmental techniques. Plasma saquinavir concentrations were similar regardless of quercetin administration. Geometric mean ratios for the area under the concentration-time curve during an 8-hour dosing interval (AUC0-8), maximum concentration in the dosing interval, and minimum concentration in the dosing interval were 0.99 (95% confidence interval [CI] 0.65-1.50), 0.99 (95% CI 0.64-1.54), and 1.06 (95% CI 0.68-1.67), respectively. Intracellular saquinavir concentrations displayed substantial intra- and intersubject variability, which limited the ability to determine the influence of quercetin coadministration (geometric mean ratio for AUC0-8 = 0.51 [95% CI 0.14-1.95], six patients).
Conclusion. Quercetin coadministration did not influence plasma saquinavir concentrations. Because of substantial inter- and intrasubject variability, more study is necessary to determine if saquinavir intracellular concentrations are altered by coadministration of quercetin.
Key Words: quercetin, saquinavir, pharmacokinetics, plasma concentration, intracellular concentration, coadministration.
(Pharmacotherapy 2006;26(9):1255-1261)
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Study Objective. To determine whether lepirudin flushes are more effective than heparinized saline in preventing withdrawal occlusion of central venous access devices.
Design. Randomized, double-blind clinical trial.
Setting. Research institution-tertiary referral center.
Patients. Forty-nine adults undergoing bone marrow transplantation for hematologic malignancies or metastatic solid tumors.
Intervention. Twenty-four patients received heparin and 25 received lepirudin flushes. The heparin dose was 3 ml of porcine heparin 100 U/ml (300 U) per catheter lumen at least once/day; the lepirudin dose was 3 ml of lepirudin 100 µg/ml (300 µg) per catheter lumen at least once/day. After 3-4 weeks, all 49 patients received the heparin flushes.
Measurements and Main Results. Efficacy was assessed by the frequency with which the patients were treated with alteplase instillations for withdrawal occlusion of their central venous access devices during the first 4 months of catheterization. Three (12.5%) patients treated with heparin alone and five (20%) treated initially with lepirudin required alteplase instillations for an estimated relative risk with lepirudin versus heparin of 1.6 (95% confidence interval [CI] 0.40-13.86, p=0.70).
Conclusion. Lepirudin was not more effective than heparin, which may have been related to the conservative dose of lepirudin administered. However, higher lepirudin doses are likely to incur an unacceptable risk of systemic anticoagulation.
Key Words: lepirudin, heparin, venous access device, catheter function, withdrawal occlusion.
(Pharmacotherapy 2006;26(9):1262-1267)
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Study Objective. To determine the content of the hallucinogen salvinorin A in a variety of Salvia divinorum herbal products and to compare the content with the label claims of potency and purity.
Design. Laboratory analysis.
Setting. University-affiliated laboratory.
Samples. Five herbal products containing Salvia divinorum.
Measurements and Main Results. The samples were purchased from the Internet and local drug paraphernalia shops (“head shops”). High-performance liquid chromatography and thin-layer chromatography-gas chromatography-mass spectroscopy were used for the analysis. All five samples contained salvinorin A, a psychoactive compound found in Salvia divinorum; however, the salvinorin A concentrations we measured were much lower than those claimed on the product label. Vitamin E was also found in two samples and caffeine in one sample.
Conclusion. The five salvinorin A herbal products were found to be subpotent, and three products contained adulterants. Any discrepancy between the advertised salvinorin A concentration and their actual concentration may pose a potential risk of both misuse and overdose. These concerns, and the recently reported teenage suicide that could have been related to salvia consumption, underscore the need for practitioners to become familiar with the signs and symptoms of salvia use.
Key Words: Salvia divinorum, salvia, salvinorin A, psychoactive, psychotropic terpenoid, adolescent suicide, diterpene, hallucinogen, drugs of abuse.
(Pharmacotherapy 2006;26(9):1268-1272)
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Nausea and vomiting, common symptoms during pregnancy, often are regarded as an unpleasant but normal part of pregnancy during the first and early second trimesters. Nausea and vomiting of pregnancy (NVP) occurs in approximately 75-80% of pregnant women. The exact etiology and pathogenesis of NVP are poorly understood and are most likely multifactorial. Some theories for the etiology of NVP are psychological predisposition, evolutionary adaptation, hormonal stimuli, and Helicobacter pylori infection. Treatment ranges from dietary and lifestyle changes to vitamins, antiemetics, and hospitalization for intravenous therapy. Treatment generally begins with nonpharmacologic interventions; if symptoms do not improve, drug therapy is added. Although NVP has been associated with a positive pregnancy outcome, the symptoms can significantly affect a woman’s life, both personally and professionally. Given the substantial health care costs, as well as indirect costs, and the potential decrease in quality of life due to NVP, providers need to acknowledge the impact of NVP and provide appropriate treatment.
Key Words: nausea, vomiting, pregnancy, antiemetics, hyperemesis gravidarum.
(Pharmacotherapy 2006;26(9):1273-1287)
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Retrospective analyses of data from the Platelet Receptor Inhibition in Ischemic Syndrome Management (PRISM), the National Registry of Myocardial Infarction 4, and the Global Registry of Acute Coronary Events (GRACE) trials revealed that the benefits of 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) on acute coronary outcomes are rapidly lost and outcomes worsened if statins are discontinued during a patient’s hospitalization for an acute coronary syndrome. Withdrawal of statin therapy in the first 24 hours of hospitalization for non-ST-elevation myocardial infarction increased the hospital morbidity and mortality rate versus continued therapy (11.9% vs 5.7%, p<0.01). Data from the Treating New Targets (TNT) study, however, suggested that short-term discontinuation of statin therapy in patients with stable cardiac conditions may not substantially increase the risk of acute coronary syndromes. In patients with acute coronary syndromes who discontinue statins, the rapid increase in risk of an event may result not only from the lost benefits from the therapy, but also from rebound inhibition of vascular protective substances and activation of vascular deleterious substances. Statins inhibit cholesterol synthesis in vascular cells. By reducing levels of isoprenoid intermediates, statins increase the production of nitric oxide and downregulate angiotensin II AT1 receptors, endothelin-1, vascular inflammatory adhesion molecules, and inflammatory cytokines. These benefits are rapidly lost and often transiently reversed when statins are acutely discontinued. Acute removal of pleiotropic effects and rebound vascular dysfunction may be more important in an acute coronary event, where inflammation promotes rupture of atherosclerotic plaques and inflammatory and prothrombosis markers are present in high concentration, than in stable chronic vascular disease. In the absence of data from randomized controlled trials, current information suggests that statin therapy should be continued, and possibly boosted, during hospitalization for an acute coronary syndrome. Because statins are discontinued during the early hospitalization of many patients, practitioners must ensure that statins are not omitted, unless contraindicated, from the treatment of patients with acute coronary syndromes.
Key Words: statins, statin withdrawal, cardiovascular risk, 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors; HMG-CoA reductase inhibitors.
(Pharmacotherapy 2006;26(9):1288-1296)
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The rising prevalence and health burden of diabetes mellitus require that new approaches for prevention among high-risk populations be evaluated. Emerging evidence from the prospective evaluations of secondary and tertiary outcomes and from retrospective evaluations in randomized controlled trials suggests that angiotensin-converting enzyme (ACE) inhibitors and angiotensin II type 1 receptor blockers (ARBs) may reduce the occurrence of new-onset diabetes. Therefore, we each independently searched MEDLINE for randomized controlled trials from January 1966-October 2005 that used an ACE inhibitor or ARB as a primary intervention versus a control group not receiving an ACE inhibitor or ARB and that reported the occurrence of diabetes. Thirteen trials were identified. In each of the 13 studies, the frequency of diabetes in the ACE inhibitor or ARB groups was lower than that in the control groups. In addition, it was consistent in that no study significantly excluded any benefit from ACE inhibitors or ARBs on the rate of new-onset diabetes. The combined occurrence of new-onset diabetes in all 13 studies was 2249 cases among 31,283 patients (7.2%) in the ACE inhibitor or ARB group versus 3230 cases among 35,988 patients (9.0%) in the control group. The combined relative risk of diabetes was 0.80, with a 95% confidence interval of 0.76-0.84, based on a two-sided a of 0.05, in favor of ACE inhibitors and ARBs. This observation needs to be confirmed by randomized controlled trials with the frequency of diabetes as the primary prospective end point.
Key Words: angiotensin-converting enzyme inhibitor, ACE inhibitor, angiotensin II type 1 receptor blocker, ARB, diabetes mellitus, new-onset diabetes.
(Pharmacotherapy 2006;26(9):1297-1306)
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Objective. To evaluate the evidence of an interaction between selective serotonin reuptake inhibitors (SSRIs) and nonsteroidal antiinflammatory drugs (NSAIDs) producing an increased risk for gastrointestinal adverse outcomes such as bleeding.
Methods. We searched MEDLINE for English-language literature published between 1966 and August 2005. All studies examining gastrointestinal adverse effects from an SSRI-NSAID combination were included.
Data Synthesis. Four retrospective studies examined gastrointestinal adverse outcomes from the combination of SSRIs and NSAIDs. The risk ratio for an upper gastrointestinal bleed from this drug combination (compared with not receiving either agent) ranged from 3.3-15.6, and the risk ratio for gastrointestinal adverse effects was 12.4. Two studies found that the risk for an upper gastrointestinal bleed from the drug combination exceeded the additive risk of the agents alone. The risk ratio for an upper gastro-intestinal bleed from an SSRI-aspirin interaction was 1.9-7.2. In addition, the number needed to harm in terms of an upper gastrointestinal bleed from an SSRI-NSAID combination ranged from 62-75 patient-years, and the number needed to harm for gastrointestinal adverse effects was 2 patient-years.
Conclusion. Concurrent use of an SSRI and NSAID increases the risk of gastrointestinal adverse outcomes such as bleeding. Clinicians must take care to avoid these negative outcomes by altering NSAID or SSRI therapy, or by providing ulcer-protective drugs.
Key Words: selective serotonin reuptake inhibitors, SSRI, nonsteroidal antiinflammatory drugs, NSAID, ulcers, hemorrhage.
(Pharmacotherapy 2006;26(9):1307-1313)
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Warfarin is extensively used for anticoagulation to a target international normalized ratio of 2.0-3.0 for most indications or 2.5-3.5 for high-risk indications; however, many drugs and dietary supplements induce fluctuations in the international normalized ratio. Such fluctuations may lead to therapeutic failure or bleeding complications. Cranberry juice is increasingly used for the prevention and adjunctive treatment of urinary tract infections. The United Kingdom’s Committee on Safety of Medicines has alerted clinicians to a potential interaction between warfarin and cranberry juice and has advised that patients avoid their concurrent use. Review and analysis of the literature revealed that ingestion of large volumes of cranberry juice destabilize warfarin therapy. Small amounts of juice are not expected to cause such an interaction. Clinicians should be aware of this potential interaction and monitor and counsel patients accordingly.
Key Words: warfarin, drug-interaction, cranberry, cranberry juice, dietary supplements.
(Pharmacotherapy 2006;26(9):1314-1319)
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In recent years there have been tremendous strides in understanding the relationship between the pharmacodynamics of b-lactams and microbiologic response. For b-lactams, in vitro and animal studies suggest that the amount of time in which free or non-protein-bound antimicrobial concentration exceeds the minimum inhibitory concentration (MIC) of the organism (fT>MIC) is the best predictor of bacterial killing and microbiologic response. Using population pharmacokinetic modeling and Monte Carlo simulation, it is possible to integrate pharmacokinetics, a pharmacodynamic target, and microbiologic surveillance data to generate empiric b-lactam dosing strategies that maximize the likelihood of achieving fT>MIC associated with near-maximal bactericidal effect against the range of pathogens encountered in clinical practice. At Albany Medical Center Hospital, these mathematical modeling techniques were used to devise alternative dosing schemes for piperacillin-tazobactam, meropenem, and cefepime. These alternative schemes optimized fT>MIC at a lower total daily dose than would be employed with traditional dosing methods. Moreover, they achieved the targeted fT>MIC with less administration time/day than would be needed for continuous infusion.
Key Words: pharmacokinetics, pharmacodynamics, Monte Carlo simulation, antibiotics, b-lactams.
(Pharmacotherapy 2006;26(9):1320-1332)
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Study Objective. To assess the effectiveness of a pharmacist-managed service in improving hypertension control among patients with coronary artery disease.
Design. Prospective cohort study.
Setting. Health maintenance organization.
Patients. Three hundred seventy-six patients with uncontrolled hypertension and coronary artery disease.
Intervention. Pharmacist-managed, physician-supervised population-management approach to optimize evidence-based drug management.
Measurements and Main Results. Blood pressure reduction and control were evaluated, as well as the use of angiotensin-converting enzyme inhibitors and generic antihypertensive drugs during 7-month follow-up. At baseline, mean ± SD age was 70.4 ± 8.8 years, 247 (65.7%) were men, 201 (53.5%) had a history of myocardial infarction, and 237 (63.0%) had diabetes mellitus. Baseline mean systolic blood pressure was 151 mm Hg, and none had achieved their blood pressure goal. During follow-up, mean systolic blood pressure decreased 16.1 mm Hg overall (p<0.001), and 179 (47.6%) patients achieved their goal blood pressure (p<0.001). Blood pressure reductions were 14.7 and 18.4 mm Hg in patients with and patients without diabetes, respectively (p<0.001). The target dose for angiotensin-converting enzyme inhibitors was achieved in 252 (67.0%) patients compared with 102 (27.1%) at baseline (p<0.001). Generic fill rates for antihypertensive drugs continued to be higher than 95% during follow-up (p=0.723).
Conclusion. A pharmacist-managed, physician-supervised population-management approach in patients with coronary artery disease significantly improved blood pressure control. Clinically meaningful reductions in blood pressure were achieved by using evidence-based, cost-effective drug regimens.
Key Words: coronary artery disease, hypertension, pharmacist, angiotensin-converting enzyme inhibitor, ACE inhibitor, generic drug use, clinical pharmacy specialist.
(Pharmacotherapy 2006;26(9):1333-1341)
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Study Objective. To measure the effectiveness of a multifaceted educational intervention to improve ambulatory hypertension control.
Design. Cluster-randomized trial.
Setting. Academic health system using an ambulatory electronic medical record.
Subjects. A total of 10,696 patients with a diagnosis of hypertension cared for by 93 primary care providers.
Intervention. Academic detailing, provision of provider-specific data about hypertension control, provision of educational materials to the provider, and provision of educational and motivational materials to patients.
Measurements and Main Results. The primary outcome was blood pressure control, defined as a blood pressure measurement below 140/90 mm Hg, and was ascertained from electronic medical records over 6 months of follow-up. We determined the adjusted odds ratio for the association between the intervention and the achievement of controlled blood pressure. When we accounted for clustering by provider, this adjusted odds ratio was 1.13 (95% confidence interval 0.87-1.47). Adjusted odds ratios were 1.03 (95% confidence interval 0.78-1.36) in patients whose blood pressure was controlled at baseline and 1.25 (95% confidence interval 0.94-1.65) in those whose blood pressure was not. These odds ratios were not significantly different (p=0.11).
Conclusions. These results were consistent with no effect or, at best, a relatively modest effect of the intervention among patients with hypertension. Had we not included a concurrent control group, the data would have provided an unduly optimistic view of the effectiveness of the program. The effectiveness of future interventions may be improved by focusing on patients whose blood pressure is uncontrolled at baseline.
Key Words: hypertension, quality assurance, health care, randomized controlled trials, patient education, academic detailing.
(Pharmacotherapy 2006;26(9):1342-1347)
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The use of combined therapy with an angiotensin-converting enzyme (ACE) inhibitor and an angiotensin II receptor blocker (ARB) for treatment of proteinuria has been gaining support. Limited data are available regarding this treatment in the pediatric population. This report describes a case of acute compromise of renal function associated with hypotension in a 7-year-old boy treated with the ACE inhibitor lisinopril and the ARB losartan. It emphasizes the need for close surveillance of renal function and blood pressure during such therapy even in patients with relative preservation of renal function. Further investigation into the utility and safety of dual therapy with an ACE inhibitor plus an ARB in pediatric patients is warranted.
Key Words: renal failure, proteinuria, angiotensin-converting enzyme inhibitor, ACEI, angiotensin II receptor blocker, ARB.
(Pharmacotherapy 2006;26(9):1348-1351)
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According to premarketing studies, at least 1% of ziprasidone-treated patients exhibited hypertension; however, this figure is not necessarily attributable to the drug. A PubMed/MEDLINE search yielded no articles describing hypertension as a possible adverse event associated with oral ziprasidone therapy. We describe a 53-year-old African-American woman with hypertension and schizophrenia whose blood pressure increased during ziprasidone therapy. She experienced no similar blood pressure increases during therapy with four other atypical antipsychotics. Her mean systolic blood pressure during ziprasidone treatment (158 mm Hg) was significantly higher than before (141 mm Hg) and after (135 mm Hg) treatment. Also, her mean diastolic blood pressure during ziprasidone treatment (88 mm Hg) was significantly higher than after treatment (79 mm Hg). Linear regression analysis demonstrated that the patient’s systolic blood pressure increased significantly with ziprasidone dose (regression coefficient [B] = 0.22 mm Hg x day/mg, 95% confidence interval 0.10-0.34, p=0.001). Thus, after adjusting for the effect of antihypertensive doses, an increase of 40 mg/day in ziprasidone yielded an increase of 8.8 mm Hg in systolic blood pressure. For unknown (perhaps genetic) reasons, this patient may have been particularly sensitive to ziprasidone. Clinicians prescribing ziprasidone in patients with hypertension should be aware that their hypertension could worsen with the addition of ziprasidone. If this occurs, replacement of ziprasidone with a different antipsychotic should be considered.
Key Words: ziprasidone, hypertension, adverse drug reaction, schizophrenia.
(Pharmacotherapy 2006;26(9):1352-1357)
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Critical pathways represent comprehensive management plans that aim to optimize and streamline patient care.1 Critical pathways have been referred to in the medical literature by a number of different terms, including care path, care map, clinical pathway, critical path of care, case management plan, multidisciplinary action plan, collaborative care track, plan of care, clinical care plans, and care guides.2 These plans define key steps in disease management not only to improve the quality of health care, but also to reduce resource utilization. Some of the specific goals of critical pathways include providing continuous quality improvement, decreasing service fragmentation through managed care, optimizing cost-effectiveness of health care delivery, guiding the patient and family through expected treatment and progress, and increasing satisfaction of patients, families, staff, physicians, and third-party payers.3 Critical pathways create targeted patient outcomes and quality end points, which form a foundation for common expecta-tions, shared responsibility, regular communi-cation, and early problem detection and inter-vention among all members of the health care team.4 Further, they identify specific time frames and desired outcomes associated with each care step, with the goals of minimizing delays and maximizing resource utilization.3 The critical pathway can serve not only as a monitoring tool for identifying and addressing quality issues in a timely fashion, but also as a tool for educating health care providers to recognize the efficient and clinically appropriate use of resources. Although the importance of critical pathways remains somewhat controversial, since the first American College of Clinical Pharmacy (ACCP) White Paper was published in 19961 they have been shown to improve patient outcomes and to reduce health care expenses in various settings.5-23
Key Words: critical pathways, disease management, quality control, pharmacist’s role.
(Pharmacotherapy 2006;26(9):1358-1368)
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