bluuebunny/crossref_metadata_2025_split huggingface dataset:
Evaluation of a Therapeutic Conversion from Amlodipine to Felodipine
Authors: Manzo Bruce A. , Matalka Mazen S. , Ravnan Susan L. 
Published: May 2004

Study Objectives. To determine patient satisfaction with and tolerability of a conversion from a long‐acting calcium channel blocker, amlodipine, to felodipine. Secondary objectives were to compare the effect of the change on blood pressure and heart rate and the economic impact of the change.Design. Retrospective study.Setting. Veterans Affairs health care system.Patients. Two hundred eighty‐three men who were taking amlodipine to manage hypertension.Intervention. Patients who were converted to felodipine were mailed a survey quantifying subjective symptoms; the survey also included questions specific to the change program. Transitory blood pressure and heart rate measurements retrieved by electronic chart review were evaluated during therapy with both amlodipine and felodipine.Measurements and Main Results. Ninety‐five percent of patients were satisfied with the conversion process and tolerated the switch from amlodipine to felodipine. Mean systolic and diastolic blood pressures were reduced by 4.4 and 2.6 mm Hg, respectively (p=0.166 and 0.187, respectively). Heart rate was reduced significantly by 4.2 beats/minute (p=0.008). The conversion realized a net annual drug cost savings of approximately $16,000.Conclusion. Our patient population was satisfied with the conversion from amlodipine to felodipine, and the new drug was found to be effective, well tolerated, and associated with a modest cost reduction.
Epidemiology and Possible Causes of Autism
Authors: Jick Hershel , Kaye James A. 
Published: May 2004

Objectives. To review the recent literature on possible causes of the increase in frequency of diagnosed autism reported from three countries, and to compare the medical diagnoses and drug therapy from a new series of autistic boys and their mothers with that of comparable nonautistic boys and their mothers.Design. Case‐control evaluation.Participants. Members of over 250 general practices in the United Kingdom.Measurements and Main Results. Frequency of exposure to drugs and presence of preexisting clinical illnesses in autistic children and their mothers were compared with nonautistic children and their mothers over time. According to published studies, the incidence of boys diagnosed with autism rose dramatically in the 1990s. Numerous published studies have concluded that the measles‐mumps‐rubella vaccine is not responsible for the large rise in diagnosed autism. In our study, boys diagnosed with autism had medical and drug histories, such as vaccines, before diagnosis, that were closely similar to those of nonautistic boys, except that developmental and sensory disorders were far more common in autistic boys. No material differences during pregnancy were found between the mothers of autistic boys and those of nonautistic boys in relation to illness or drug therapy. In the early 1990s, boys with diagnosed developmental disorders were infrequently diagnosed with autism. In the later 1990s, such boys more often were diagnosed with autism.Conclusion. A major cause of the recent large increase in the number of boys diagnosed with autism probably is due to changing diagnostic practices.
Linezolid, Levofloxacin, and Vancomycin Against Vancomycin‐Tolerant and Fluoroquinolone‐Resistant Streptococcus pneumoniae in an In Vitro Pharmacodynamic Model
Authors: Cha Raymond , Akins Ronda L. , Rybak Michael J. 
Published: May 2004

Study Objective. To compare the pharmacodynamic profiles of linezolid, levofloxacin, and vancomycin against clinical strains of Streptococcus pneumoniae, including vancomycin‐tolerant and fluoroquinolone‐resistant isolates.Design. In vitro pharmacodynamic model.Setting. Biosafety level 2, university research laboratory.Bacterial Strains. Ciprofloxacin‐susceptible (79), ciprofloxacin‐resistant (R921), and vancomycin‐tolerant (P9802–020) clinical strains of S. pneumoniae.Intervention. An in vitro pharmacodynamic model was used to simulate standard dosing regimens of linezolid, levofloxacin, and vancomycin against the isolates 79, R921, and P9802–020.Measurements and Main Results. Bacterial density was profiled over 48 hours. Minimum inhibitory concentrations (MICs) for linezolid, levofloxacin, and vancomycin, respectively, were 1, 1, 0.5 μg/ml for isolate 79; 1, 4, 0.5 μg/ml for R921; and 0.5, 0.5, 0.5 μg/ml for P9802–020. Vancomycin minimum bactericidal concentration (MBC) values varied across large ranges for the tested strains. Linezolid achieved 99.9% kill against 79 and R921 by 24 and 28 hours, respectively. Levofloxacin achieved 99.9% kill against 79 and P9802–020 by 28 and 4 hours, respectively. Vancomycin achieved 99.9% kill against 79 and R921 by 8 and 24 hours, respectively. Levofloxacin did not demonstrate activity against R921 at the 48‐hour end point. Minimal kill (< 2 log) at 48 hours was noted for vancomycin and linezolid against P9802–020.Conclusion. Vancomycin tolerance appeared to be more reliably characterized by persistent viability in time‐kill analyses than by MBC:MIC ratios. Vancomycin exhibited bactericidal activity against the non‐vancomycin‐tolerant strains of S. pneumoniae. Linezolid exhibited both bactericidal and bacteriostatic activity against all three strains tested, whereas levofloxacin demonstrated bactericidal activity against the fluoroquinolone‐susceptible isolates. Further investigation of treatment alternatives for infections due to vancomycin‐tolerant S. pneumoniae are needed.
In Vitro Performance of Two Common Valved Holding Chambers with a Chlorofluorocarbon‐Free Beclomethasone Metered‐Dose Inhaler
Authors: Asmus Michael J. , Coowanitwong Intira , Kwon Soo Hun , Khorsand Nakisa , Hochhaus Günther 
Published: May 2004

Study Objective. To compare in vitro aerosol deposition from a beclomethasone dipropionate metered‐dose inhaler (MDI) containing hydrofluoroalkane propellant with that of the MDI in combination with two common valved holding chambers (VHCs) to evaluate how these VHCs affect the respirable dose of beclomethasone dipropionate.Design. In vitro aerosol deposition study.Setting. University research center.Devices. Beclomethasone dipropionate hydrofluoroalkane MDI alone, the MDI with OptiChamber VHC, and the MDI with AeroChamber‐Plus VHC.Intervention. The respirable dose (1–5‐um aerosol particles) of beclomethasone dipropionate was determined by sampling 10 80‐ug actuations from five runs with each configuration (MDI alone, MDI with OptiChamber, and MDI with AeroChamber‐Plus), using a well‐established in vitro cascade impactor method.Measurements and Main Results. Beclomethasone dipropionate aerosol was washed from the impactor with 50% methanol and quantified by means of high‐performance liquid chromatography. Differences among outcomes were determined by using analysis of variance. Mean beclomethasone dipropionate respirable dose from AeroChamber‐Plus (27.2 ± 10.0 μg/actuation) was not significantly different (p>0.05) from that of the MDI alone (29.0 ± 7.0 μg/actuation). OptiChamber respirable dose (12.8 ± 6.0 μg/actuation) was less than half that produced by either the AeroChamber‐Plus or the MDI alone (p=0.013).Conclusions. The OptiChamber and AeroChamber‐Plus VHCs do not demonstrate equivalent in vitro performance when used with a beclomethasone dipropionate MDI that contains hydrofluoroalkane propellant. The respirable dose of beclomethasone dipropionate aerosol from the hydrofluoroalkane MDI was decreased by only 6% when the MDI was mated to an AeroChamber‐Plus VHC and by 56% when used with an OptiChamber VHC.
Comparative Pharmacokinetic Analysis by Standard Two‐Stage Method versus Nonparametric Population Modeling
Authors: Tam Vincent H. , Preston Sandra L. , Drusano George L. 
Published: May 2004

Study Objective. To compare the two‐stage method, a widely used analytical method in pharmacokinetic studies, with nonparametric population modeling by using the same data set for determining the oral bioavailability of ribavirin.Design. Pharmacokinetic analysis.Setting. Clinical research center.Material. Oral bioavailability data of ribavirin determined previously in six healthy adults.Intervention. After13C3‐ribavirin 150 mg intravenously and unlabeled ribavirin 400 mg orally had been given 1 hour apart, serial serum and urine samples were obtained for up to 169 hours. Concentrations of13C3‐ribavirin and unlabeled ribavirin in serum and urine were determined by a high‐performance liquid chromatography tandem mass spectrometric method.Measurements and Main Results. Serum and urine concentration‐time profiles were comodeled with a three‐compartment model. The analysis was performed again by using the nonparametric population analysis technique. Serum ribavirin concentrations underwent Monte Carlo simulation for 1000 subjects receiving a single 600‐mg oral dose. Both methods were similar in determining the mean ± SD bioavailability (51.8 ± 21.8% by the two‐stage method vs 54.8 ± 16.4% by nonparametric modeling, p=0.79). However, the estimates of dispersion of model parameters and simulated drug exposures were substantially reduced by the population‐modeling technique, as it takes into account covariance among model parameters and intersubject variability.Conclusion. Although the study sample was small, our parallel analyses of the same data set clearly demonstrated that more precise parameter estimates are likely to result with the population‐modeling technique. Having accurate and precise estimation of population pharmacokinetic parameters and their true variances is crucial, as, at any dose, there will be a lower probability of encountering a concentration‐driven toxicity because of fewer outliers as the variance associated with the parameters decreases.
Correlation of Lamotrigine Concentrations Between Serum and Saliva
Authors: Ryan Melody , Grim Shellee A. , Miles Michael V. , Tang Peter H. , Fakhoury Toufic A. , Strawsburg Richard H. , DeGrauw Ton J. , Baumann Robert J. 
Published: May 2004

Study Objective. To compare the relationship between serum and salivary concentrations of lamotrigine in pediatric and adult epilepsy populations.Design. Paired‐sample pharmacokinetic study.Setting. University neurology clinic.Patients. Thirty‐seven patients with epilepsy, aged 2–60 years, who were taking lamotrigine and whose physicians had ordered a lamotrigine serum concentration.Measurements and Main Results. Patients spit a minimum of 0.25 ml into a cup to provide saliva samples. Blood samples were obtained by phlebotomy. Serum and salivary lamotrigine concentrations were determined by high‐performance liquid chromatography. Linear regression analysis was used to evaluate correlations. Six patients' results were omitted due to the lack of a serum or saliva specimen or clearly erroneous results, leaving 31 patients for analysis. There was a strong correlation between the serum results reported by two reference laboratories (coefficient of correlation [r] = 0.988). The correlations between salivary and serum lamotrigine concentrations were similar for reference laboratory A (r = 0.81) and reference laboratory B (r = 0.84). Saliva:serum concentration ratios ranged from 0.41–1.26 (mean ± SD 0.62 ± 0.19) for reference laboratory A and from 0.40–1.19 ((mean ± SD 0.64 ± 0.18) for reference laboratory B.Conclusion. There is a good correlation between salivary and serum concentrations for lamotrigine. However, there is wide interpatient variability in the saliva:serum ratio. The data suggest that salivary monitoring may play a role in the monitoring of lamotrigine for adult and pediatric patients.
Factors Associated with Long‐Term Antibody Production Induced by Hepatitis B Vaccine in Patients Undergoing Hemodialysis: A Retrospective Cohort Study
Authors: Elwell Rowland J. , Neumann Marianne , Bailie George R. 
Published: May 2004

Study Objective. To assess the influence of various clinical factors on antibody production induced by hepatitis B vaccine in patients receiving hemodialysis up to 24 months after vaccination.Design. Retrospective cohort study.Setting. Outpatient dialysis center.Patients. Adult patients undergoing hemodialysis who received a three‐dose series of intramuscular hepatitis B vaccine 40 ug at time 0, 1, and 6 months, according to protocol.Measurements and Main Results. Antibody to hepatitis B surface antigen (anti‐HBs) titers were monitored quarterly, and booster doses were given according to protocol. Patients with anti‐HBs of at least 10 mIU/ml were considered seropositive. Clinical variables—age, diabetes mellitus status, serum albumin level, and equilibrated Kt/V (eKt/V; Kt/V is a measure of urea clearance during dialysis, used to quantify the delivered dose of hemodialysis)—were compared between seropositive and seronegative patients 12 months (cohort 1) and 24 months (cohort 2) after vaccination. In cohort 1 (66 patients), 24 (36.4%) were seropositive at 12 months. In cohort 2 (40 patients), 15 (37.5%) were seropositive at 24 months. Comparison of seropositive and seronegative patients revealed no statistically significant differences in mean age, sex, serum albumin level, or eKt/V. However, at 24 months, patients with diabetes were 2.5 times more likely to demonstrate seropositivity than those without diabetes (60% vs 24%, respectively, p=0.02).Conclusion. Long‐term seroprevalence induced by hepatitis B vaccine was low in our patients 12 and 24 months after vaccination. These results were comparable to previously reported long‐term results. Larger, prospective studies would be needed to confirm the finding that patients with diabetes had superior hepatitis B vaccine‐induced antibody production at 24 months.
Clinical Pharmacy Specialist Implementation of Lisinopril Therapy in Patients with Coronary Artery Disease and Diabetes Mellitus
Authors:   For the Clinical Pharmacy Cardiac Risk Service Study Group, McConnell Karen J. , Humphries Tammy L. , Raebel Marsha A. , Merenich John A. 
Published: May 2004

Study Objective. As the results of the Heart Outcomes Prevention Evaluation trial suggested that patients with both coronary artery disease (CAD) and diabetes mellitus would benefit from angiotensin‐converting enzyme (ACE) inhibitor therapy, our objective was to increase the percentage of patients with both of these conditions receiving the goal dosage (20 mg/day) or highest tolerated dosage of the ACE inhibitor lisinopril through intervention of a clinical pharmacy service.Study Design. Prospective study with historic comparison (control group).Setting. Clinical Pharmacy Cardiac Risk Service.Patients. Hospitalized patients with CAD and type 2 diabetes mellitus.Measurements and Main Results. At hospital discharge, lisinopril 5 mg/day was started in eligible patients; the drug was titrated to a goal dosage of 20 mg/day or the highest tolerated dosage. Potassium level, serum creatinine level, and blood pressure were monitored at baseline, at each dosage titration, and 2 weeks after the goal or highest tolerated dosage was reached. The group receiving usual care (control group) consisted of 95 patients; the treatment group had 101 patients. At baseline, 19 patients (20%) in the control group were receiving the goal dosage of lisinopril, 34 (36%) were taking a suboptimal dosage, 16 (17%) were excluded from treatment, and 26 (27%) were eligible but were not receiving lisinopril therapy. After 9 months, ACE inhibitor dosages had changed minimally in the control group. In the treatment group, at baseline, 37 patients (36%) were at their goal dosage and therefore titration was not necessary; 15 (15%) were receiving a suboptimal dosage, 35 (35%) were excluded from treatment, and 14 (14%) were eligible but not receiving therapy. After the titration period, 55 (54%) treatment group patients were at the goal dosage, 11 (11%) were taking a suboptimal dosage, and 35 (35%) were not candidates for ACE inhibitor therapy. The most common reasons for exclusion were renal insufficiency, cough, and baseline hypotension. Changes in potassium level, serum creatinine level, and blood pressure were not significant during the study.Conclusion. The clinical pharmacy service more than doubled the number of patients with CAD and diabetes who achieved the goal dosage of an ACE inhibitor, a drug class that has been shown to decrease morbidity and mortality in this patient population.
A Structured Review of the Relationship Between Microalbuminuria and Cardiovascular Events in Patients with Diabetes Mellitus and Hypertension
Authors: Park Hayley Y. , Schumock Glen T. , Pickard A. Simon , Akhras Kasem 
Published: May 2004

Study Objective. To quantify the relative risk of cardiovascular events associated with microalbuminuria in patients with both diabetes mellitus and hypertension.Design. A structured literature search from January 1990‐December 2002 using MEDLINE, IPA, and CINAHL.Measurements and Main Results. We identified original studies that reported the presence or absence of microalbuminuria and estimates of risk associated with cardiovascular events in patients with both diabetes and hypertension. Abstracted information consisted of study design, patient demographics and risk factors, treatment regimens, and outcome variables. Point estimates and confidence intervals for relative risk were calculated from available data. Of 651 citations identified and reviewed based on title and abstract, 72 were selected for full review. Seven met the inclusion criteria. Because of lack of homogeneity among studies, the results were not conducive to pooling. Cardiovascular end points associated with the presence of microalbuminuria in these studies were all‐cause mortality, cardiovascular mortality, and composite cardiovascular morbidity. The relative risk of cardiovascular end points associated with the presence of microalbuminuria ranged from 1.6 (95% confidence interval [CI] 1.2–2.2) to 7.9 (95% CI 2.5–25.3).Conclusion. From the limited information available, the risk of cardiovascular events and mortality is estimated to be 2–8 times higher when microalbuminuria is present in patients with diabetes and hypertension. Point estimates in relative risk of cardiovascular morbidity and mortality in patients with diabetes and hypertension were generally higher compared with studies estimating risk in those with only diabetes. Studies that examine the relationship between microalbuminuria (scaled as a continuous or ordinal variable) and cardiovascular events are necessary to clarify potential benefits of pharmacotherapies that reduce levels of urinary albumin.
Impact of Long‐Acting Growth Factors on Practice Dynamics and Patient Satisfaction
Authors: Beveridge Roy A. , Rifkin Robert M. , Moleski Ronald J. , Milkovich Gary , Reitan John F. , Paivanas Thomas A. , Jacobs R. Jake 
Published: May 2004

Objective. To quantify time expended, patient satisfaction, and econometrics associated with short‐acting (sargramostim, epoetin alfa) and long‐acting (darbepoetin alfa, pegfilgrastim) growth factors.Design. Retrospective resource utilization and prospective two‐phase observational study.Methods. During week 1, time‐motion measurements related to patient treatment and drug preparation were collected for scheduling; check‐in; phlebotomy; laboratory; and drug preparation, administration, and recording. Drug utilization for one chemotherapy cycle during weeks 2 and 3 was assessed for sargramostim, pegfilgrastim, epoetin alfa, darbepoetin alfa, sargramostim plus epoetin alfa, and pegfilgrastim plus darbepoetin alfa. Patients completed a satisfaction survey.Results. Among 140 patients (mean age 58 yrs), mean chemotherapy cycle duration was 19 days. A total of 268 events were observed. Mean total staff time/patient visit for drug administration was 22.1 minutes, with most time spent on scheduling (5.5 min) and drug preparation, administration, recording (5.2 min). For sargramostim only versus pegfilgrastim only, pegfilgrastim resulted in a 37% reduction (p<0.01) in all visits and an 85% reduction (p<0.01) in mean number of doses. For epoetin alfa only versus darbepoetin alfa only, darbepoetin alfa resulted in a 48% reduction (p<0.01) in mean number of doses. The most common dosage of epoetin alfa was 40,000 U/week (63.6%) and that of darbepoetin alfa was 200 μg every other week (92%), but complete blood counts were obtained weekly. For pegfilgrastim plus darbepoetin alfa versus sargramostim plus epoetin alfa, a 45% reduction (p<0.01) in total visits and a 77% reduction (p<0.01) in mean number of doses were noted in the former group. In 69 patients converted to long‐acting drugs, 65 actual hours for a single treatment cycle were saved. For patients receiving pegfilgrastim plus darbepoetin alfa, there was a 45% reduction in total clinic visits, 77% reduction in doses, and staff time savings of 1.9 hours/patient/cycle of chemotherapy. Fifty‐four patients completed the survey and trended toward neutral in their responses, with moderate disagreement that receiving injections is painful.Conclusion. Long‐acting growth factors resulted in significant time savings for staff and providers by reducing the number of necessary office visits for drug administration. These time savings can significantly improve the quality of life for patients, as well as nurses, physicians, and caregivers.
Attitudes of deaf individuals towards genetic testing
Authors: Taneja Patricia Rubal , Pandya Arti , Foley Debra L. , Nicely Lauren Vanner , Arnos Kathleen S. 
Published: May 2004

AbstractRecent advances have made molecular genetic testing for several forms of deafness more widely available. Previous studies have examined the attitudes of the deaf towards genetic testing, including prenatal diagnosis. This study examines the attitudes of deaf college students towards universal newborn hearing screening, including molecular testing for specific forms of deafness, as well as the utilization of genetic test results for mate selection. We found that there may be differences in the attitudes of deaf individuals who associate closely with the deaf community (DC), and those who have equal involvement with both the deaf and hearing communities (EIC). The majority perceived newborn hearing screening for deafness to be helpful. However, more members of the EIC than the DC groups support newborn testing for genes for deafness. While there was reported interest in using genetic testing for partner selection, most participants reported they would not be interested in selecting a partner to have children with a specific hearing status. The results of this study point out important differences that genetic professionals should be aware of when counseling deaf individuals. © 2004 Wiley‐Liss, Inc.
Mutation analysis of the M6b gene in patients with Pelizaeus–Merzbacher‐like syndrome
Authors: Henneke Marco , Wehner Lars‐Erik , Hennies Hans Christian , Preuß Natalie , Gärtner Jutta 
Published: May 2004

Abstract“Pelizaeus–Merzbacher‐like syndrome” is an undetermined leukodystrophy disorder of diffuse hypomyelination. The patients' clinical phenotype is indistinguishable from classical Pelizaeus–Merzbacher disease (PMD), but the patients lack PLP1 gene duplications or mutations. They represent about 20% of all cases with a clinical PMD phenotype. The M6b gene has been localized to Xp22.2. The encoded M6B protein is a member of a novel proteolipid family that also includes other major brain myelin components like the proteolipid protein (PLP). Recent cotransfection experiments suggest a protein–protein interaction of M6B and mutant PLP1 that may contribute to oligodendrocyte dysfunction in PMD. Therefore, M6b has been considered a good candidate gene for Pelizaeus–Merzbacher‐like syndrome. However, our molecular analyses in eight thoroughly characterized patients make it unlikely that mutations in this gene are involved in this subgroup of human hypomyelination disorders. © 2004 Wiley‐Liss, Inc.