bluuebunny/crossref_metadata_2025_split huggingface dataset:
Relationship between Asthma Drug Therapy Patterns and Healthcare Utilization
Authors: Shireman Theresa I , Heaton Pamela C , Gay Wendy E , Cluxton Robert J , Moomaw Charles J 
Published: June 2003

BACKGROUND AND OBJECTIVE: Asthma drug therapy problems contribute significantly to preventable hospitalizations and increased healthcare use in asthmatics. Since asthma patients often require >1 medication for control of symptoms, concurrent asthma drug therapies may be important in predicting excessive healthcare utilization. The purpose of this study was to link inappropriate asthma drug therapy patterns and selected patient demographics to healthcare utilization. METHODS: This study was a retrospective, cross-sectional analysis of Ohio Medicaid medical, institutional, and prescription claims. We included ambulatory patients aged 15–65 years who had ≥2 claims for asthma (493.x) and who were continuously enrolled in the Medicaid fee-for-service program for the 12-month period from April 1998 through March 1999. We examined age, race, gender, metropolitan residence, presence of gastroesophageal reflux disease, and the usage patterns of inhaled corticosteroids, short-acting β2-agonists, long-acting β2-agonists, theophylline, and leukotriene receptor modifiers to identify asthma drug therapy problems based on national guidelines. The primary outcomes included the number of asthma-related hospitalizations, asthma-related emergency department visits, and oral steroid bursts. RESULTS: Among 10 959 asthma patients, only 46.8% of the study patients received >1 puff of inhaled corticosteroid per day. Forty-four percent of the patients received >3 puffs of short-acting β2-agonists per day. The most common outcome was an oral steroid burst (46.5%). Patients on high doses of short-acting β2-agonists had the greatest odds of receiving an oral steroid burst and were most likely to be hospitalized. African Americans were more likely to incur a hospitalization or emergency department visit. Women had greater odds of any undesirable asthma outcome. Higher use of short-acting β2-agonists led to higher odds of receiving a steroid burst or being hospitalized. Leukotriene receptor modifier use was related to higher levels of all outcomes. CONCLUSIONS: A large percentage of Ohio Medicaid patients were not receiving asthma medications in compliance with the National Heart, Lung, and Blood Institute guidelines. Despite nearly a decade of national efforts, asthma drug therapy patterns still have substantial room for improvement and continue to be associated with excess healthcare utilization.
Blood Pressure as a Surrogate End Point for Hypertension
Authors: Carter Barry L 
Published: June 2003

OBJECTIVE: To review relevant literature and provide opinions regarding the use of blood pressure as a surrogate measure to predict cardiovascular risk. DATA SOURCES: Primary and review articles were identified by MEDLINE search (1990–January 2001) and through secondary sources. STUDY SELECTION AND DATA EXTRACTION: Studies and review articles that related to the interpretation of blood pressure as a surrogate measure were reviewed. Information that was relevant to this topic was included. DATA SYNTHESIS: The measurement of blood pressure is subject to numerous sources of error and bias. Patients who perform home blood pressure testing and self-report these values frequently leave out high values and add ghost values into logbooks. Additionally, analysis of recent data suggests that at any given level of blood pressure that is achieved, cardiovascular risk reduction may not be the same with different therapeutic agents. It is also now recommended that systolic blood pressure be used in preference to diastolic blood pressure to determine risk and to assess management strategies. Although 24-hour blood pressure measurements may be the best predictors of cardiovascular risk, this has not been demonstrated in a long-term morbidity trial. CONCLUSIONS: Blood pressure is a relatively poor surrogate measure. Unfortunately, no alternatives are available at this time. Therefore, every attempt must be made to accurately determine blood pressure and to assess risk and benefit from specific antihypertensive agents. Systolic blood pressure should be the predominant blood pressure measure used to evaluate patients, especially middle-aged and elderly individuals.
Hydroxymethylglutaryl-Coenzyme A Reductase Inhibitors in Osteoporosis Management
Authors: Coons James C 
Published: June 2003

OBJECTIVE: To evaluate the use and potential benefit of hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins) in the management of osteoporosis. DATA SOURCES: Clinical literature accessed through MEDLINE (1994–May 2001) using the key search terms HMG-CoA reductase inhibitors, statins, osteoporosis, and fractures. DATA SYNTHESIS: Osteoporosis is the most common bone disease, affecting millions of people worldwide and leading to significant morbidity and high expenditures, especially when it is not adequately managed. Recent data have documented a potential association between statin use and improvement in fracture risk profile. Therefore, an evaluation of studies investigating the effect of HMG-CoA reductase inhibitors on bone and fracture risk was conducted. CONCLUSIONS: Observational studies suggest an association between HMG-CoA reductase inhibitors and reduction in fracture risk. However, large randomized controlled studies are needed to confirm this association.
Idiopathic Paresthesia Reaction Associated with Rofecoxib
Authors: Daugherty Kimberly K , Gora-Harper Mary Lea 
Published: June 2003

OBJECTIVE: To report a case of a paresthesia-type reaction due to the use of rofecoxib in standard doses for the treatment of osteoarthritis. CASE SUMMARY: A 55-year-old white woman was receiving rofecoxib for treatment of osteoarthritis. The patient began to have tongue numbness and hand tingling and numbness shortly after starting therapy with rofecoxib. The occurrence and resolution of her symptoms correlated with the start and end of the therapy. DISCUSSION: An adverse reaction with rofecoxib is a likely explanation for the patient's symptoms. Paresthesias have been reported in 0.1–1.9% of patients who took rofecoxib during premarketing studies, but no causality has been established. One case report of paresthesias occurring in a 59-year-old white man who took one 20-mg dose of piroxicam is available. Information on when the reaction occurred in relation to the dose and resolution of the reaction was not recorded in this study. Our patient's reaction is best classified as idiopathic. CONCLUSIONS: We report the first case of a paresthesia-type reaction to rofecoxib in a patient receiving the drug in standard doses for treatment of osteoarthritis. Although the reaction is rare, clinicians should be aware of its potential.
Therapeutic Dilemma of Fluconazole Prophylaxis in Intensive Care
Authors: Sypula William T , Kale-Pradhan Pramodini B 
Published: June 2003

OBJECTIVE: To review the data concerning the use of prophylactic fluconazole in intensive care patients who are not immunocompromised. DATA SOURCE: Literature identified through MEDLINE (1966–March 2001) and recent abstracts of data presented at scientific meetings. DATA SYNTHESIS: The use of fluconazole as a prophylactic antifungal agent is well documented in patients who are immunocompromised or undergoing bone marrow or solid organ transplantation, with supportive results. Recently published data suggest that the use of fluconazole in high-risk surgical patients can be safe and effective for preventing certain candida infections. However, there is growing evidence that the use of fluconazole may be contributing to the higher prevalence of fluconazole-resistant fungal infections. CONCLUSIONS: The use of prophylactic fluconazole in nonneutropenic patients is controversial. Retrospective and surveillance studies of nosocomial fungal infections suggest that the use of fluconazole may be contributing to the shift in fungal flora causing these infections and that the isolates are more fluconazole resistant. Fluconazole prophylaxis in surgical patients may be justified in patients who are at the greatest risk of developing fungal infections, those requiring multiple intraabdominal surgeries, or those with recurrent gastrointestinal perforations or anastomotic leakages, but there is a lack of randomized controlled trials to recommend its widespread use at this time.
Safety of Zaleplon in the Treatment of Insomnia
Authors: Israel Andrew Glenn , Kramer Jeffrey A 
Published: June 2003

OBJECTIVE: To evaluate the safety of zaleplon, a quick-acting, rapidly eliminated nonbenzodiazepine (non-BZD) hypnotic, as described in clinical investigations of adult and/or elderly subjects. DATA SOURCES: Published and presented studies evaluating zaleplon, a novel non-BZD, were identified via MEDLINE (1995–July 2001), Current Contents (ISI database), bibliographic reviews, and consultation with sleep specialists who also identified published abstracts containing data not yet published in peer-reviewed journals. DATA SYNTHESIS: Transient and chronic insomnia are common problems that should be clinically evaluated and appropriately treated. BZDs have been a primary pharmacotherapy for treating insomnia, despite their disadvantages. Newer hypnotics, characterized by increased receptor-binding specificity and favorable pharmacokinetics, provide potentially better alternatives to BZDs. Assessments included residual sedation, psychomotor impairment, or cognitive dysfunction during treatment, as well as the occurrence of rebound insomnia and withdrawal effects after discontinuation of therapy. CONCLUSIONS: Zolpidem, the first non-BZD hypnotic, appears to have short- and long-term safety profiles similar to those of the BZD triazolam. Zaleplon, a newer non-BZD sleep medication, has a quick onset of action and undergoes rapid elimination, which results in a better safety profile than previously available agents. Additionally, rebound insomnia and other withdrawal effects have not been demonstrated with zaleplon, and the drug is well tolerated in both young and elderly patients. These characteristics may be clinically advantageous for patients who should not receive BZDs.
Outcomes and Secondary Prevention Strategies for Male Hip Fractures
Authors: Riley Rebecca L , Carnes Molly L , Gudmundsson Adalsteinn , Elliott Mary E 
Published: June 2003

OBJECTIVE: To assess clinical outcomes and determine whether osteoporosis assessment and secondary prevention strategies were performed for male veterans hospitalized for hip fractures. DESIGN: Retrospective chart review for male veterans hospitalized for hip fracture from January 1993 through July 1999. SETTING: The Veterans Affairs Medical Center, Madison, WI. RESULTS: Medical charts were available for 46 of 53 male patients admitted for hip fracture during the study period. Three subjects were excluded because hip fracture was associated with high-impact trauma. Mean age of the 43 study patients was 72 years (range 43–91 y), and mean length of hospitalization was 16 days (median 11 d, range 3–108 d). Thirty-two (82%) of 39 veterans whose disposition was documented were discharged to a nursing home. Eleven (26%) of 43 men died within 12 months after fracture. Twelve (28%) had fractured previously. Four (10%) subsequently had another fracture. Three of 9 patients with documented ambulation status were ambulatory at 1 year. Three patients received a bone mass measurement within a prespecified time interval of 6 months subsequent to fracture. No patient's records included a diagnosis of osteoporosis either before or within 6 months after fracture. One-third of the patients had documentation of calcium or multivitamin supplementation at discharge. One patient was receiving calcitonin at the time of fracture and continued to receive it afterward. No other patient was prescribed antiresorptive therapy by the time of hospital discharge. CONCLUSIONS: Male veterans with hip fractures received inadequate evaluation and treatment for osteoporosis, although a substantial portion had documentation of recurrent fractures. Education of clinicians and creation of algorithms for management of established osteoporosis may improve outcomes for these individuals.
Role of Budesonide Inhalation Suspension in Children with Asthma
Authors: West Kelly M , Culhane Nicole S 
Published: June 2003

OBJECTIVE: To evaluate the role of budesonide inhalation suspension (BIS) in the treatment of children with asthma. DATA SOURCES: Literature identified through Medline (1966–November 2000) and references obtained from selected articles. Search terms included budesonide and asthma. DATA SYNTHESIS: Asthma is a chronic inflammatory disease that affects approximately 4.8 million children in the US. By reducing inflammation, corticosteroids decrease symptoms and improve lung function. As the first nebulized corticosteroid, BIS offers an important treatment option for children with persistent asthma. CONCLUSIONS: BIS is effective in reducing symptoms and improving lung function in children with asthma. It should be used in children ages 1–8 years with moderate to severe persistent asthma who are unable to effectively use a metered-dose inhaler with or without a spacer or a dry-powder inhaler.
Esomeprazole for Acid Peptic Disorders
Authors: Kale-Pradhan Pramodini B , Landry Heather K , Sypula William T 
Published: June 2003

OBJECTIVE: To review the pharmacology, pharmacokinetics, clinical efficacy, and safety of esomeprazole, a new proton-pump inhibitor (PPI). DATA SOURCES: A MEDLINE search (1966–March 2001) was conducted for relevant literature using the terms esomeprazole, Nexium, and H199/18. Abstracts from the XXXII Nordic Meeting of Gastroenterology and journal articles provided by AstraZeneca were reviewed. STUDY SELECTION AND DATA EXTRACTION: All available studies on the pharmacology, pharmacokinetics, clinical efficacy, and safety of esomeprazole were reviewed. DATA SYNTHESIS: Esomeprazole is a new PPI and is the S—isomer of racemic omeprazole. Esomeprazole has demonstrated acid control comparable to that of the other PPIs currently available. Esomeprazole undergoes less hepatic metabolism compared with omeprazole, and thus may result in less interpatient variability among slow and fast metabolizers of CYP2C19. The oral bioavailability of esomeprazole is approximately 89% with a dose of 40 mg, and the half-life is approximately 1.5 hours. Esomeprazole is effective in the healing of erosive esophagitis, with a rate of healing at week 8 of 93.7% (p < 0.001). In maintenance therapy of healed erosive esophagitis, esomeprazole maintained healing rates <90% (6-mo trial). Esomeprazole is comparable with omeprazole (both in combination with appropriate antibiotics) in the eradication of Helicobacter pylori, with eradication rates of 89.7% and 87.8%, respectively. The drug is well tolerated. The few adverse effects associated with esomeprazole are diarrhea, headache, nausea, abdominal pain, respiratory infection, and sinusitis. CONCLUSIONS: Esomeprazole is a safe and effective PPI. It is effective in the treatment of peptic ulcer disease and gastroesophageal reflux disease.
Interrupted Time Series Analysis in Clinical Research
Authors: Matowe Lloyd K , Leister Cathie A , Crivera Concetta , Korth-Bradley Joan M 
Published: June 2003

OBJECTIVE: To demonstrate the usefulness of interrupted time series analysis in clinical trial design. METHODS: A safety data set of electrocardiographic (ECG) information was simulated from actual data that had been collected in a Phase I study. Simulated data on 18 healthy volunteers based on a study performed in a contract research facility were collected based on single doses of an experimental medication that may affect ECG parameters. Serial ECGs were collected before and during treatment with the experimental medication. Data from 7 real subjects receiving placebo were used to simulate the pretreatment phase of time series; data from 18 real subjects receiving active treatment were used to simulate the treatment phase of the time series. Visual inspection of data was performed, followed by tests for trend, seasonality, and autocorrelation by use of SAS. RESULTS: There was no evidence of trend, seasonality, or autocorrelation. In 11 of 18 simulated individuals, statistically significant changes in QTc intervals were observed following treatment with the experimental medication. A significant time of day and treatment interaction was observed in 4 simulated patients. CONCLUSIONS: Interrupted time series analysis techniques offer an additional tool for the study of clinical situations in which patients must act as their own controls and where serial data can be collected at evenly distributed intervals.
Risedronate for the Prevention and Treatment of Corticosteroid-Induced Osteoporosis
Authors: Dougherty John A 
Published: June 2003

OBJECTIVE: To evaluate the role of risedronate in corticosteroid-induced osteoporosis. DATA SOURCES: Clinical literature was accessed through MEDLINE (1966–February 2001). Key search terms included risedronate, corticosteroid, osteoporosis, and bisphosphonate. DATA SYNTHESIS: Corticosteroid-induced osteoporosis (CIO) is clinically challenging and can lead to fractures. Risedronate, an oral bisphosphonate, has been studied for use in CIO. Trials focusing on the use of risedronate in these patients were reviewed. CONCLUSIONS: Risedronate 5 mg/d increased bone mineral density at lumbar, femoral neck, and trochanter skeletal sites in patients recently initiated on or receiving long-term corticosteroid therapy. Further investigation is needed to determine risedronate's effects on fracture prevention. The drug was well tolerated.
High-Dose Methylprednisolone Therapy in Pure Red Cell Aplasia
Authors: Kadikoylu Gurhan , Bolaman Zahit , Barutca Sabri 
Published: June 2003

OBJECTIVE: To report our experience using high-dose methylprednisolone (HDMP) treatment in a patient with primary acquired pure red cell aplasia (PRCA) who failed to respond to conventional prednisone therapy. CASE SUMMARY: A 29-year-old woman reported weakness, was easily fatigued, and had developed palpitations. On physicial examination, pallor and splenomegaly were detected. On blood smear, mild macrocytic anemia was seen. Bone marrow aspiration and biopsy revealed normocellularity, erythroid hypoplasia (E/M:1/10), reduction in erythroid precursors, and normal megakaryocytes and myeloid series. No disease associated with secondary PRCA was detected. Oral prednisone 1 mg/kg (total 60 mg/d) was started as conventional treatment. However, the patient's status deteriorated and the hemoglobin concentration fell from 6.5 to 5.5 g/dL within the first week of hospitalization. HDMP was then begun. Treatment protocol consisted of methylprednisolone 30 mg/kg for 4 days, 20 mg/kg for 3 days, 10 mg/kg for 3 days, 5 mg/kg for 4 days, and 1 mg/kg for 2 weeks. The patient's hemoglobin concentration increased from 5.5 to 14.2 g/dL over a period of 9 weeks. Transient hyperglycemia and cushingoid appearance were seen during prednisone treatment. DISCUSSION: Exactly how steroids enhance erythropoiesis in PRCA is unknown. It seems likely that steroids render abnormal erythroid progenitors more sensitive to marrow growth factors, thereby permitting them to differentiate to functional precursors. HDMP treatment had been rarely used in patients with primary acquired PRCA. Limited studies using HDMP have shown variable results. CONCLUSIONS: HDMP treatment may be considered safe and effective in patients with primary acquired PRCA who do not respond to conventional steroid therapy.
Viral Load as a Surrogate End Point in HIV Disease
Authors: Smith Curtis L , Stein Gary E 
Published: June 2003

OBJECTIVE: To examine the role of viral load as a surrogate end point for HIV disease progression and death. DATA SOURCES: A MEDLINE search was conducted for the years 1990–March 2001. In addition, relevant articles were cross-referenced to screen for additional information. STUDY SELECTION AND DATA EXTRACTION: Data regarding the validity of viral load as a surrogate end point for disease progression or death are cited. Emphasis was placed on randomized, controlled trials, but descriptive studies are also included. DATA SYNTHESIS: Recently, viral load has emerged as an important biomarker for monitoring HIV disease and antiretroviral therapy. Both baseline viral load and changes in viral load with time predict HIV disease progression and death. In fact, disease progression increases consistently once viral load exceeds 10 000 copies/mL, and AIDS and death primarily occur in patients with viral loads >100 000 copies/mL. Changes that occur in viral load after initiation of antiretroviral therapy, however, do not fully explain the entire treatment effect. Also, separate comparisons of antiretroviral regimens may demonstrate similar differences in viral load changes but not similar differences in disease progression. CONCLUSIONS: Viral load is an important monitoring parameter for HIV disease and antiretroviral therapy. However, changes in viral load do not explain the entire clinical improvement that occurs after initiation of therapy. Although viral load is a clinically important surrogate end point for HIV disease, it cannot fully account for all associated treatment effects.
Broth Microdilution and E-Test for Determining Fluoroquinolone Activity against Streptococcus Pneumoniae
Authors: Kays Michael B , Graff Melissa A 
Published: June 2003

OBJECTIVE: To compare broth microdilution and E-test minimum inhibitory concentrations (MICs) of 4 fluoroquinolones against Streptococcus pneumoniae and to determine the effect of these in vitro MIC methods on the calculation of AUC0–24/MIC ratios. METHODS: Levofloxacin, gatifloxacin, moxifloxacin, and gemifloxacin MICs were determined by broth microdilution (incubated in air) and E-test (incubated in CO2) for 100 clinical isolates of S. pneumoniae. MIC50, MIC90, and geometric mean MIC were calculated. Steady-state serum concentration—time profiles were simulated for once-daily, oral dosing of levofloxacin 500 mg, gatifloxacin 400 mg, moxifloxacin 400 mg, and gemifloxacin 320 mg. After correcting for protein binding, AUC0–24 of unbound drug was calculated for each regimen, and AUC0–24/MIC ratios were calculated using MIC data from both in vitro methods. Differences in MICs between methods were determined for each agent using the paired t-test (after logarithmic transformation of MICs) and the Wilcoxon signed-rank test. Differences in AUC0–24/MIC ratios were also determined using the paired t-test and the Wilcoxon signed-rank test. The level of significance for all analyses was p < 0.05. RESULTS: Broth microdilution and E-test MICs were within ± 1 log2 dilution for 94%, 93%, 61%, and 35% of the isolates for levofloxacin, gatifloxacin, moxifloxacin, and gemifloxacin, respectively. Broth microdilution MICs were significantly lower than E-test MICs for all 4 agents (p < 0.001). However, a categorical change in susceptibility was seen for only 1 isolate with gatifloxacin and moxifloxacin (intermediate by broth microdilution, resistant by E-test). AUC0–24/MIC ratios were significantly higher for each regimen when MICs were determined by broth microdilution compared with E-test (p < 0.001). CONCLUSIONS: There is a significant difference in the activity of the newer fluoroquinolones against S. pneumoniae when MICs are determined by broth microdilution and E-test. When evaluating fluoroquinolone activity and pharmacodynamics against this organism, clinicians must be aware that MIC testing methodology may have a significant impact on the results.