bluuebunny/crossref_metadata_2025_split huggingface dataset:
Intravenous Valproate in Status Epilepticus
Authors: Hodges Brian M , Mazur Joseph E 
Published: June 2003

OBJECTIVE: To evaluate the role of intravenous valproate sodium (IV VPA) in the treatment of status epilepticus (SE). DATA SOURCES: A literature search of the English language was performed (MEDLINE 1966–July 2000). Search terms included valproate, valproic acid, and status epilepticus. Bibliographies of articles chosen were reviewed to identify other possible sources. DATA SYNTHESIS: A review of the medical literature was conducted to evaluate the safety and efficacy of IV VPA in the treatment of SE. CONCLUSIONS: Experience with IV VPA in the treatment of SE is too limited to recommend its use as a first-line agent. IV VPA may represent a third- or fourth-line option in cases of SE when other agents are ineffective or contraindicated.
Intermittent Dosing of Alendronate
Authors: Tsun Ellen C , Heck Amy M 
Published: June 2003

OBJECTIVE: To review data describing use of intermittent dosing of alendronate. DATA SOURCES: A comprehensive literature search was conducted using MEDLINE (1966–May 2001) and EMBASE (1974–May 2001) databases to identify all information regarding intermittent dosing of alendronate. DATA SYNTHESIS: A small number of clinical studies have evaluated the use of intermittent alendronate dosing in an attempt to improve patient compliance and adverse events. CONCLUSIONS: Evidence from more controlled clinical trials and postmarketing data are needed to demonstrate the therapeutic efficacy and tolerability of intermittent alendronate dosing. The definitive role of intermittent dosing in patients with postmenopausal osteoporosis remains to be determined.
Use of Infliximab in Pediatric Patients with Inflammatory Bowel Disease
Authors: Serrano Maria-Stella , Schmidt-Sommerfeld Eberhard , Kilbaugh Todd J , Brown Raynorda F , Udall John N , Mannick Elizabeth E 
Published: June 2003

BACKGROUND: The concentration of tumor necrosis factor, a proinflammatory cytokine, is increased in the gastrointestinal mucosa of patients with active Crohn's disease (CD) and ulcerative colitis (UC). Neutralization of tumor necrosis factor decreases the mucosal inflammatory response of adults with CD. Little information is available on the use of monoclonal antibody to tumor necrosis factor (infliximab) in children and adolescents with CD or UC. OBJECTIVE: To evaluate the clinical response and side effects of patients to infliximab. METHODS: A retrospective review of data regarding 18 pediatric and adolescent patients with active CD (n = 15) and UC (n = 3) poorly controlled with conventional therapy. All patients received one to six intravenous infusions of infliximab 5 mg/kg, while receiving their usual medications. RESULTS: All patients experienced clinical improvement, including decrease in the frequency of stooling and resolution of extraintestinal symptoms such as arthropathy, malaise, and skin manifestations after treatment with infliximab. All but one patient had a documented decrease in the erythrocyte sedimentation rate. Prednisone dosage was tapered in all but two patients, and discontinued in seven patients. Intravenous infusion of infliximab was well tolerated. One patient developed a rash several days after the infusion. A patient who received six infliximab infusions developed recurrent Staphylococcus aureus infections, as well as septic arthritis and chronic osteomyelitis during the follow-up period, raising the issue of the long-term safety of infliximab. CONCLUSIONS: Treatment of our patients with refractory CD and UC with infliximab was associated with remarkable clinical improvement. Although the drug may have an important role in their management, further assessment of long-term safety and efficacy is needed.
Mifepristone
Authors: DeHart Renee M , Morehead M Shawn 
Published: June 2003

OBJECTIVE: To review the efficacy and safety of mifepristone (with misoprostol) for the termination of early pregnancy. DATA SOURCES: A MEDLINE search (1966–October 2000) was conducted, and additional references listed in articles were included; unpublished data obtained from the manufacturer were used to identify data from the scientific literature. Studies evaluating mifepristone were considered for inclusion. STUDY SELECTION: Human clinical studies in the English language were reviewed and evaluated. Clinical trials selected for detailed review were limited to those including the regimens of mifepristone and misoprostol, recently approved by the Food and Drug Administration for early pregnancy termination. DATA SYNTHESIS: Mifepristone is an antiprogestin available for pregnancy termination in combination with a prostaglandin such as misoprostol. Mifepristone offers efficacy similar to, if not better than, other drugs used for pregnancy termination, but appears less efficacious overall than surgical termination of pregnancy. Mifepristone in combination with misoprostol commonly causes adverse effects such as abdominal pain and, less commonly, can cause serious adverse effects such as incomplete abortion; endometritis; and bleeding warranting transfusion, hospitalization, or surgery. Mifepristone is metabolized by the cytochrome P450 system. Thus, the potential for drug interactions with this agent exists, although this has not been well studied. Data are included from clinical trials evaluating the safety, tolerability, efficacy, and pharmacoeconomics of mifepristone combined with misoprostol for early pregnancy termination. Data comparing the use of these agents with surgical abortion and other drugs used for pregnancy termination are included where available. CONCLUSIONS: Mifepristone in combination with misoprostol for the termination of early pregnancy (amenorrhea of ⩽49 d) is effective in 92–95% of women. Incomplete abortion requiring surgical abortion after the fact occurs in 3–5% of women, and pregnancy continues 1–2% of the time. Mifepristone with misoprostol treatment is not without significant risks, including hemorrhage, infection, and potential for long-term emotional consequences.
Prescribing Patterns and Therapeutic Implications for Diabetic Hypertension in Bahrain
Authors: Al Khaja Khalid AJ , Sequeira Reginald P , Mathur Vijay S 
Published: June 2003

OBJECTIVE: To determine drug prescription patterns and the extent of conformity with World Health Organization/International Society of Hypertension (WHO/ISH) guidelines in diabetic hypertension. DESIGN: Retrospective prescription-based survey. SETTING: Seven primary-care health centers, comprising approximately one-third of primary-care health centers in Bahrain. PATIENTS: Patients with type 2 diabetes and hypertension. MAIN OUTCOME MEASURE: The prescribing pattern of antihypertensive and antidiabetic drugs. RESULTS: Among a study sample of 1463 patients with type 2 diabetes and hypertension, antidiabetic agents were prescribed as monotherapy in the following descending order: glyburide, gliclazide, insulin, and metformin. As combinations, sulfonylureas plus metformin was most popular, followed by metformin plus insulin, and sulfonylureas plus insulin. Sulfonylurea and metformin with insulin was rarely used. There was no significant difference in prescribing of glyburide and metformin between the elderly and young middle-aged diabetic patients; many patients older than 65 years were treated with a β-blocker along with a long-acting sulfonylurea. Both as monotherapy and in overall use, β-blockers, angiotensin-converting enzyme (ACE) inhibitors, and calcium-channel blockers were most often prescribed. Among 35.5% patients treated with antihypertensive combinations, various two- and three-drug combinations of β-blockers, ACE inhibitors, calcium-channel blockers, and diuretics were often used. The proportion of patients taking atenolol 100 mg/d was higher with combination regimens. Hydrochlorothiazide 25 mg or equivalent thiazide diuretics were extensively used. CONCLUSIONS: The prescribing pattern of antihypertensives in diabetic hypertension differs in many instances from WHO/ISH guidelines, especially regarding the choice of antihypertensive drugs and their combinations. The appropriateness of antidiabetic drug choice is questionable in relation to the antihypertensive used.
Appropriateness of Nitrate Use in a General Medicine Population
Authors: Shilo Lotan , Hadari Ruth , Kovatz Susy , Qasim Mahmud , Shenkman Louis 
Published: June 2003

BACKGROUND: Nitrates are one of the most commonly prescribed drug groups for cardiac disease, especially for angina pectoris and congestive heart failure. The chronic efficacy of nitrates is limited by the development of tolerance, which can be attenuated by use of sustained-release preparations or administration of regular-release preparations asymmetrically. OBJECTIVE: To determine whether patients receiving isosorbide 5-mononitrate (ISMN) use the drug in a pharmacologically appropriate manner and whether they had been instructed in the prophylactic use of sublingual nitrates prior to effort. METHODS: We administered a questionnaire regarding details of nitrate use to 229 patients with ischemic heart disease using oral ISMN, prescribed prior to their current admission. The study was conducted in a 600-bed university-affiliated hospital. RESULTS: We found that only 15% of patients receiving regular-release ISMN were taking the drug asymmetrically. In contrast, 82.6% of the patients receiving sustained-release ISMN were using the drug properly. Only 38.1% of the patients treated with regular-release ISMN were treated with the dose recommended in the literature. Furthermore, of the 190 patients who reported experiencing effort angina, only 17.9% had been instructed in the prophylactic use of nitrates prior to effort. CONCLUSIONS: The majority of patients (85%) using regular-release ISMN were taking the medication in an inappropriate fashion, while most patients taking sustained-release preparations were using them properly. More than half the patients treated with regular-release ISMN were treated with doses exceeding the recommended dose. In addition, most patients experiencing effort angina had not been instructed regarding the prophylactic use of nitrates. These findings suggest that both physicians and pharmacists must be reminded of the continuing need to properly counsel patients regarding appropriate drug use. TRASFONDO: Los nitratos representan uno de los grupos de medicamentos que más se prescriben para enfermedad cardíaca, especialmente angina de pecho e insuficiencia cardíaca congestiva. La eficacia crónica de los nitratos está limitada por el desarrollo de tolerancia, la cual puede ser atenuada mediante el uso de preparaciones de liberación sostenida o la administración asimétrica de preparaciones de liberación regular.
Potential Adverse Drug Events in an Indigent and Homeless Geriatric Population
Authors: Spiker Erin C , Emptage Ruth E , Giannamore Martin R , Pedersen Craig A 
Published: June 2003

OBJECTIVE: To identify potential adverse drug events (ADEs) in a geriatric ambulatory population using the modified Beers criteria. METHODS: This is a cross-sectional study of an indigent and homeless geriatric population served by a network of six primary healthcare clinics with clinical pharmacy services. Medical records of patients ≥65 years old visiting the clinics between December 1999 and April 2000 were retrospectively reviewed by a clinical pharmacist. Medications meeting the modified Beers criteria were evaluated for the most common drug classes involved, severity potential, and dose or disease state restrictions. Following the identification of medications meeting Beers criteria, the pharmacist left a written recommendation regarding use of alternative drugs or doses in the medical record. Physician acceptance of pharmacy recommendations was also evaluated. RESULTS: Medical records of 146 patients (71.9% women, average age 72.6 ± 6.7 y) were reviewed. Overall, 52 patients (35.6%) had 70 medications with the potential for causing an ADE based on the modified Beers criteria. The most commonly identified medication classes were narcotic analgesics (20.0%), antihypertensives (20.0%), and antihistamines (14.3%). Fifteen of these medications (21.4%) had a high severity potential. Identified medications met the following modified Beers criteria: 41.4% were inappropriate in a specific disease state, 38.6% were inappropriate for the elderly, 10.0% exceeded maximum dosage guidelines, and 10.0% were inappropriate for both the elderly and the patient's disease state. Approximately 60% of pharmacy recommendations were accepted by physicians. CONCLUSIONS: The modified Beers criteria are a useful tool for reviewing medical records to identify potential ADEs in an ambulatory geriatric population.
Managing the Pharmaceutical Industry—Health System Interface
Authors: Zarowitz Barbara J , Muma Bruce , Coggan Peter , Davis Glenn , Barkley Gregory L 
Published: June 2003

BACKGROUND: Direct-to-consumer advertising, media, and Internet marketing to physicians and patients, as well as enticing marketing strategies, are used by the pharmaceutical industry to ensure market share growth of new drugs. Our health system adopted a strict vendor policy governing detailing and sampling activities of pharmaceutical representatives, but realized that further analysis of vendor influence in our system was needed. OBJECTIVE: An assessment of tangible benefits, ethical concerns, and financial liabilities and gains was conducted to reassess the need for further vendor restriction. CONCLUSIONS: Based on our findings, several recommendations have been made. Medical practices and health systems are encouraged to establish and enforce explicit vendor policies, measure their effectiveness, partner proactively with representatives to deliver a drug-detailing message consistent with system initiatives, monitor and regulate continuing medical education funding, and implement strategies to ensure appropriate drug use.
Serotonin Syndrome Induced by Fluvoxamine and Mirtazapine
Authors: Demers Jason C , Malone Margaret 
Published: June 2003

OBJECTIVE: To document a case of serotonin syndrome associated with the combined use of fluvoxamine and mirtazapine, and to discuss the pharmacodynamic and pharmacokinetic interactions that were the likely causes of this potentially serious adverse drug reaction (ADR). CASE SUMMARY: A 26-year-old white woman with a 12-year history of anorexia nervosa was being treated with fluvoxamine. After mirtazapine was added to her therapy, she developed tremors, restlessness, twitching, flushing, diaphoresis, and nausea, symptoms that are consistent with serotonin syndrome. DISCUSSION: The possible causes of this ADR are discussed, including the effects of fluvoxamine and mirtazapine alone, the possible pharmacodynamic and pharmacokinetic interactions of these two drugs, and the patient's underlying anorexia nervosa. CONCLUSIONS: An increasing number of drugs that affect serotonin are available and are indicated for various disorders. Since there is a significant likelihood of these agents being prescribed concomitantly, clinicians must be aware of possible interactions that could lead to serotonin syndrome.
Sudden Cardiac Death with Clozapine and Sertraline Combination
Authors: Hoehns James D , Fouts Michelle M , Kelly Michael W , Tu Katie B 
Published: June 2003

OBJECTIVE: To report a case of sudden cardiac death in a patient receiving combination therapy with clozapine and sertraline. CASE SUMMARY: A 26-year-old white man was discovered dead at his residence. His medical history included chronic paranoid schizophrenia, obsessive—compulsive disorder, major depressive disorder, obstructive sleep apnea, and akathisia. He had no prior history of cardiovascular disease. His medication regimen included clozapine 100 mg twice daily (started 4 y prior to his death), risperidone 3 mg twice daily, sertraline 200 mg once daily, atenolol 50 mg twice daily, and lorazepam 0.5 mg four × daily. Autopsy and toxicology studies revealed cardiomegaly suggestive of idiopathic cardiomyopathy, single-vessel coronary artery disease, sertraline and clozapine blood concentrations in the expected range, undetectable lorazepam and risperidone blood concentrations, obesity, and moderate fatty changes to the liver. The most likely cause of death was sudden cardiac death due to acute cardiac arrhythmia. DISCUSSION: Clozapine is structurally similar to the tricyclic antidepressants, which have type 1A antiarrhythmic properties. Case reports have described electrocardiographic abnormalities, cardiomyopathy, and fatal myocarditis associated with its use. Unexplained death in patients on clozapine therapy has also been reported. Sertraline appears to have less cardiac effect; however, one report has observed clinically significant QT prolongation during sertraline therapy. CONCLUSIONS: Clozapine-induced cardiomyopathy and cardiac arrhythmia from clozapine and/or sertraline use may have contributed to this man's death.
Clinical Use of Fluoroquinolones in Children
Authors: Alghasham Abdullah A , Nahata Milap C 
Published: June 2003

OBJECTIVE: To review the pharmacokinetics, efficacy, and safety of fluoroquinolones in children. DATA SOURCES: A MEDLINE search (January 1966–March 1998) was conducted for relevant literature. STUDY SELECTION AND DATA EXTRACTION: Data from compassionate use and published studies were reviewed for the assessment of pharmacokinetics, efficacy, and safety of fluoroquinolones in children. DATA SYNTHESIS: Fluoroquinolones have a broad spectrum coverage of gram-positive and gram-negative bacteria, including Pseudomonas aeruginosa and intracellular organisms. Fluoroquinolones are well absorbed from the gastrointestinal tract, have excellent tissue penetration, low protein binding, and long elimination half-lives. These antibiotics are effective in treating various infections and are well tolerated in adults. However, the use of fluoroquinolones in children has been restricted due to potential cartilage damage that occurred in research with immature animals. Fluoroquinolones have been used in children on a compassionate basis. Ciprofloxacin is the most frequently used fluoroquinolone in children, most often in the treatment of pulmonary infection in cystic fibrosis as well as salmonellosis and shigellosis. Other uses include chronic suppurative otitis media, meningitis, septicemia, and urinary tract infection. Safety data of fluoroquinolones in children appear to be similar to those in adults. Fluoroquinolones are associated with tendinitis and reversible arthralgia in adults and children. However, direct association between fluoroquinolones and arthropathy remains uncertain. CONCLUSIONS: Fluoroquinolones have been found to be effective in treating certain infections in children. Additional research is needed to define the optimal dosage regimens in pediatric patients. Although fluoroquinolones appear to be well tolerated, further investigations are needed to determine the risk of arthropathy in children. However, their use in children should not be withheld when the benefits outweigh the risks.
Transdermal Nitroglycerin for the Prevention of Intravenous Infusion Failure Due to Phlebitis and Extravasation
Authors: Tjon James A , Ansani Nicole T 
Published: June 2003

OBJECTIVE: To evaluate the clinical use of transdermal nitroglycerin for the prevention of intravenous infusion failures due to phlebitis or extravasation. DATA SOURCES: Clinical literature was accessed through a MEDLINE search (1966–May 2000). Key search terms included nitroglycerin, transdermal, phlebitis, extravasation, intravenous, and infusion. DATA SYNTHESIS: Common and serious consequences of intravenous therapy include the occurrence of postinfusion phlebitis and failure to maintain intravenous therapy due to intravenous fluid extravasation. Transdermal application of nitroglycerin has been evaluated as a treatment and preventive method for intravenous infusion failures related to phlebitis or extravasation. An evaluation of studies focusing on transdermal nitroglycerin in the prevention of infusion failures due to phlebitis or extravasation was conducted. CONCLUSIONS: Use of transdermal nitroglycerin as a prophylactic measure for intravenous infusion failures is a therapeutic option for patients requiring long-term intravenous therapy (i.e., >50 h).
Tamsulosin for the Treatment of Benign Prostatic Hypertrophy
Authors: Lee Mary 
Published: June 2003

OBJECTIVE: To review the information necessary to assess the efficacy and safety of tamsulosin compared with other adrenergic antagonists for treatment of symptomatic benign prostatic hyperplasia. DATA SOURCES: A search was conducted of Cumulated Index Medicus, January 1993–August 1999, which was restricted to human trials and English-language journals. STUDYSELECTION AND DATAEXTRACTION: Efficacy studies were included if the design was randomized and included a control group. Drug safety was assessed using data from any patient series or controlled study. DATA SYNTHESIS: Tamsulosin, a uroselective α1A-adrenergic receptor antagonist, relaxes smooth muscle in the prostate and bladder neck, thereby enhancing bladder emptying. In randomized, controlled clinical trials using standardized instruments, tamsulosin improves obstructive voiding symptoms by at least 25% in 65–80% of patients with symptomatic benign prostatic hyperplasia. Tamsulosin also improves peak urinary flow rate by 1.4–3.6 mL/sec in various studies and reduces post-void residual urine volume. The usual dosage of tamsulosin was 0.4 or 0.8 mg orally once a day in the studies performed in the US and Europe; daily doses of 0.1–0.4 mg were used in studies performed in Japan. The beneficial effects of tamsulosin on voiding symptoms, peak urinary flow rate, and bladder emptying appear to be dose-related, up to a ceiling dose of 0.4 mg. The most common adverse effects are headache, asthenia, dizziness, and rhinitis-like complaints. Retrograde or delayed ejaculation occurs in 4.5–14.0% of patients and has required discontinuation of treatment in a minority of these patients. At the usual dose of 0.4–0.8 mg/d, tamsulosin does not appear to significantly reduce blood pressure, increase heart rate, or cause first-dose syncope; therefore, dosage titration is not necessary when initiating treatment. Use of nifedipine, enalapril, atenolol, furosemide, or digoxin does not require dosage modification when tamsulosin is initiated concomitantly; hypotension has not been reported with combined use of tamsulosin and these commonly used agents. CONCLUSIONS: Tamsulosin is an improvement over other a-adrenergic antagonists for the management of symptoms of benign prostatic hyperplasia. It is a more convenient alternative that does not require initial dosage titration, has a fast onset of action, and has a low potential to cause hypotension when used alone or in combination with commonly used antihypertensive agents. It is more costly than some of the other second-generation α-adrenergic antagonists.