bluuebunny/crossref_metadata_2025_split huggingface dataset:
A Comparison of Clinical Outcome Studies among Cholesterol-Lowering Agents
Authors: Lousberg Tammy R , Denham Anne M , Rasmussen Jon R 
Published: June 2003

OBJECTIVE: To review and compare clinical trials of cholesterol-lowering agents that evaluated clinical end points as the primary outcome measure; specifically, to determine whether all agents that decrease cholesterol impact clinical outcomes similarly. DATA SOURCES: Primary articles were identified through a MEDLINE search (1966–February 2001) and through secondary sources. STUDY SELECTION AND DATA EXTRACTION: All of the articles identified from the data sources were evaluated. Articles that included clinical end points as the primary outcome measure were included in this review. DATA SYNTHESIS: Clinical trials were assessed according to study population (primary vs. secondary prevention of coronary artery disease), baseline and follow-up lipid profiles, and clinical outcome data. Both cardiac and noncardiac morbidity and mortality were evaluated. The differences in study populations, study methods, and changes in lipid values were compared and contrasted between trials to evaluate their effect on outcomes. CONCLUSIONS: Niacin and bile acid sequestrants should be considered as add-on therapy when therapeutic goals cannot be attained with a hydroxymethyl glutaryl—coenzyme A reductase inhibitor (statin). Estrogen therapy cannot be recommended solely for cardioprotection. Fibrates are most effective in patients with high baseline triglycerides, low baseline high-density lipoprotein cholesterol, and low to average low-density lipoprotein cholesterol (LDL). Statins are considered first line for the treatment of elevated LDL in both the primary and secondary prevention of coronary heart disease. They are well tolerated, have the strongest data to support their use, and have been shown to decrease total mortality.
Bupropion versus Selective Serotonin-Reuptake Inhibitors for Treatment of Depression
Authors: Nieuwstraten Carmine E , Dolovich Lisa R 
Published: June 2003

OBJECTIVE: To compare the benefits and risks of bupropion and selective serotonin-reuptake inhibitors (SSRIs) in adults with depression. DATA SOURCES: MEDLINE (1966–September 1999), Embase (1980–August 1999), PsycINFO (1887–August 1999), International Pharmaceutical Abstracts (1970–August 1999), and CIANHL databases were searched. References from the selected citations, review articles, and the manufacturer were also screened. STUDY SELECTION: Included studies were randomized, double-blind, controlled trials evaluating bupropion versus SSRIs for depression in adults. Studies were assessed independently in duplicate. Discrepancies were resolved by consensus. DATA ANALYSIS: Data are reported as absolute weighted mean differences or relative risks and 95% confidence intervals comparing bupropion relative to SSRIs. Data not combined are presented qualitatively. DATA SYNTHESIS: Six full-length studies were included of 257 citations identified. SSRI comparators were fluoxetine, sertraline, and paroxetine. No differences in Hamilton Rating Scale for Depression (HAM-D) and Clinical Global Impressions Scale for Improvement of Illness (CGI-I) were found, but data were not able to be quantitatively combined. The absolute weighted mean differences were 0.10 (95% CI −0.2 to 0.4) for the CGI for Severity of Illness and 0.37 (95% CI −0.85 to 1.6) for the Hamilton Rating Scale for Anxiety measurements. Relative risks of bupropion compared with SSRIs were 0.6 (95% CI 0.41 to 0.89), 0.31 (95% CI 0.16 to 0.57), and 0.27 (95% CI 0.15 to 0.48) for nausea, diarrhea, and somnolence, respectively. Sexual arousal disorder, orgasmic dysfunction, and sexual desire disorder occurred less with bupropion than with SSRIs, with relative risks of 0.46 (95% CI 0.26 to 0.83), 0.22 (95% CI 0.12 to 0.40), and 0.65 (95% CI 0.51 to 0.84), respectively. CONCLUSIONS: Bupropion and SSRIs have similar effectiveness; however, bupropion was associated with less nausea, diarrhea, somnolence, and sexual dysfunction.
Use of Metformin in Polycystic Ovary Syndrome
Authors: Koch Yvonne De Sloover , Ernst Michael E 
Published: June 2003

OBJECTIVE: To review the use of the insulin-sensitizing agent metformin in women with polycystic ovary syndrome (PCOS). DATA SOURCES: Biomedical literature was accessed through MEDLINE (1996–March 2001) and the Iowa Drug Information Service. Key terms included metformin and polycystic ovary syndrome. DATA SYNTHESIS: A number of small clinical studies have examined the use of metformin in the treatment of PCOS. Women treated with metformin demonstrated normalization of endocrine function with minimal adverse effects. CONCLUSIONS: Metformin can be beneficial in normalizing menstrual irregularities and stimulating ovulation in previously anovulatory women. Metformin therapy is well tolerated by the majority of patients and should be considered for use in women with PCOS.
Stability of Piperacillin and Ticarcillin in AutoDose Infusion System Bags
Authors: Zhang Yanping , Trissel Lawrence A 
Published: June 2003

OBJECTIVE: To evaluate the physical and chemical stability of piperacillin sodium 3 and 4 g/100 mL and ticarcillin disodium 3 g/100 mL each admixed in NaCl 0.9% injection packaged in AutoDose Infusion System bags. DESIGN: Triplicate test samples of the penicillin antibiotics in NaCl 0.9% injection were packaged in ethylene vinyl acetate (EVA) plastic containers, AutoDose bags, designed for use in the AutoDose Infusion System. Samples were stored protected from light and evaluated at appropriate intervals for up to seven days at 23 °C and up to 30 days at 4 °C. Physical stability was assessed using turbidimetric and particulate measurement as well as visual inspection. Chemical stability was assessed by HPLC. RESULTS: All of the penicillin admixtures initially were clear when viewed in normal fluorescent room light and with a Tyndall beam. Measured turbidity and particulate content were low initially and exhibited little change in the ticarcillin disodium samples throughout the study. The piperacillin sodium samples exhibited small increases in measured haze throughout the study, but no accompanying increase in particulates ≥1.04 μm was found. All samples were essentially colorless throughout the study. HPLC analysis found some decomposition in the samples. Piperacillin sodium exhibited a 9–10% loss after five days at 23 °C. In the samples stored at 4 °C, piperacillin sodium exhibited acceptable stability through 21 days of storage, but losses exceeded 10% after 30 days. Ticarcillin disodium exhibited a 7% loss after three days, but 14% after five days at 23 °C. Less than 7% loss occurred after 21 days, but 12% loss after 30 days at 4 °C. CONCLUSIONS: Piperacillin sodium and ticarcillin disodium exhibited physical and chemical stability consistent with previous studies on these drugs. The AutoDose Infusion System bags were not found to adversely affect the physical and chemical stability of these penicillin antibiotics.
Olanzapine-Induced Diabetic Ketoacidosis
Authors: Ragucci Kelly R , Wells Brian J 
Published: June 2003

OBJECTIVE: To report the case of a patient taking olanzapine who developed diabetic ketoacidosis (DKA). CASE SUMMARY: A 46-year-old African American woman with no previous history of diabetes mellitus was admitted to the hospital and subsequently diagnosed with DKA and acute pancreatitis. The patient had been taking olanzapine, valproic acid, carbamazepine, hydrochlorothiazide/triamterene, and conjugated estrogens prior to admission. Olanzapine was the last medication added to the regimen. In addition to clinicians treating the DKA with appropriate interventions, olanzapine (due to possible association with hyperglycemia and DKA) as well as valproic acid (due to possible association with pancreatitis) were discontinued from the medication regimen. The patient was discharged home and her most recent glycosylated hemoglobin and fasting glucose concentrations have been within the normal range. DISCUSSION: Atypical antipsychotics, such as olanzapine, have been associated with hyperglycemia and possibly DKA. We believe that this occurred in our patient who had no previous history of diabetes mellitus. Possible mechanisms of action and potential confounding variables are discussed. CONCLUSIONS: Clinicians should monitor blood glucose concentrations periodically in patients taking olanzapine, especially in those patients with risk factors for diabetes mellitus.
Multiple Antipsychotic Medication Prescribing Patterns
Authors: Schumacher Jennifer E , Makela Eugene H , Griffin Holly R 
Published: May 2003

OBJECTIVE: To assess current prescribing practices regarding concomitant use of antipsychotic medications and summarize the reasons clinicians may prescribe >1 scheduled agent. METHODS: The pharmacy identified patients at William R Sharpe Jr Hospital currently receiving antipsychotic therapy. All patients receiving ≥2 scheduled antipsychotic agents concomitantly were included in the study. Data regarding the demographics, current medication combinations used, history of therapeutic regimens tried, and prescriber rationale were prospectively evaluated for a 60-day period beginning December 13, 2000, and ending February 10, 2001. Prescriber rationale for using >1 antipsychotic simultaneously and other drug therapy regimens that had been tried were compared with chart documentation and published therapeutic guidelines for schizophrenia. RESULTS: Over a 60-day surveillance period, 206 patients were placed on scheduled antipsychotic medications, with 85 (41%) receiving at least 2 agents. Responders to a prescriber questionnaire (59%) indicated the most common rationale for combination therapy was augmentation; the least likely rationale was cross-titration. Survey responses also indicated a belief that there was questionable therapeutic benefit in more than half of the patients being treated with multiple antipsychotic combinations. Additionally, chart documentation showed that the majority of these patients did not receive an adequate trial of monotherapy with other atypical or typical agents, or clozapine prior to the combination antipsychotic regimen. Fifty-one percent of medical records did not document the rationale for concomitant therapy. CONCLUSIONS: Due to the lack of published data, the practice of using multiple antipsychotic agents is considered to be a gray area that requires the prescriber to be at a heightened level of awareness in assessing effectiveness and safety. Documentation of rationale, adverse effects, and response to the treatment regimen is essential in providing optimal care for the patient.
Direct-to-Consumer Marketing of Osteoporosis Drugs and Bone Densitometry
Authors: Hollon Matthew F , Larson Eric B , Koepsell Thomas D , Downer Ann E 
Published: May 2003

OBJECTIVE: To determine whether there is an association between a woman's exposure to direct-to-consumer (DTC) advertisements for 2 osteoporosis drugs and presentation for bone densitometry. METHODS: A matched case–control study was conducted between October and December 1998 at an academic primary care clinic in Seattle, WA. Seventeen women from the study population (aged ≥18 y, seen in the previous 2 y at the academic primary care clinic) presented for bone densitometry. All 51 women completed a self-administered questionnaire. RESULTS: Women familiar with 1 of 2 osteoporosis drugs due to exposure to advertisements had 9 times the odds of densitometry (unadjusted OR 9.3, 95% CI 1.0 to 86). Multivariate analysis, including confounders such as education level and whether a woman had previously had 3 screening tests (mammography, Pap smear, serum cholesterol), revealed a significant and strong association between exposure to advertisements and densitometry (adjusted OR 29, 95% CI 1.6 to 511). CONCLUSIONS: DTC marketing may increase health services utilization. Further independent evaluation of DTC marketing based on available observational evidence is feasible and warranted.
Peripheral Neuropathy Associated with Fluoroquinolones
Authors: Cohen Jay S 
Published: June 2003

OBJECTIVE: To survey cases of fluoroquinolone-associated adverse events that included peripheral nervous system (PNS) symptoms posted on Internet Web sites. METHODS: Cases were obtained with the assistance of members of Web sites formed by people sustaining fluoroquinolone-related events. Information obtained met the standards of MedWatch, and each reported case was assessed using the Naranjo probability scale. RESULTS: In contrast to previous reports suggesting that fluoroquinolone-associated PNS events are mild and short-term, 36 of the 45 cases reported severe events that typically involved multiple organ systems. Although many newer cases are still evolving, symptoms had lasted more than three months in 71% of cases and more than one year in 58%. Onset of adverse events was usually rapid, with 15 (33%) events beginning within 24 hours of initiating treatment, 26 (58%) within 72 hours, and 38 (84%) within one week. Sixty courses of fluoroquinolones were prescribed: levofloxacin (n = 33 cases), ciprofloxacin (n = 11), ofloxacin (n = 6), lomefloxacin (n = 1), trovafloxacin (n = 1); in eight cases the same antibiotic was prescribed twice. CONCLUSIONS: These cases suggest a possible association between fluoroquinolone antibiotics and severe, long-term adverse effects involving the PNS as well as other organ systems. The severity of these cases may reflect a different population than typically reported to drug companies or MedWatch, which often originate from healthcare providers. In contrast, Internet Web sites may provide a forum for patients experiencing adverse effects that have not resolved promptly. Further study is warranted. Meanwhile, the occurrence of PNS symptoms during fluoroquinolone therapy should prompt immediate discontinuation of the agent used.
Sertraline-Induced Hypoglycemia
Authors: Pollak P Timothy , Mukherjee Som D , Fraser Albert D 
Published: June 2003

OBJECTIVE: To report a case of hypoglycemia that occurred in a patient treated with the selective serotonin-reuptake inhibitor, sertraline. CASE SUMMARY: An 82-year-old white woman with mild cardiovascular disease and no history of glucose intolerance was seen in the emergency department for a presyncopal episode associated with a blood glucose of 32 mg/dL as measured by the ambulance attendant. She had similar symptoms the day before. Despite repeated administration of oral and intravenous glucose, the patient had recurrent episodes of hypoglycemia and was hospitalized for four days. She had started taking sertraline 50 mg once daily for mild depression 25 days prior to presentation. Other medications included furosemide 20 mg/d, ramipril 5 mg/d, clopidogrel 75 mg/d, nitroglycerin patch 0.4 mg/h, and lorazepam 1 mg taken occasionally for agitation. She had never been prescribed any oral hypoglycemic agents. Serum sertraline and desmethylsertraline concentrations measured two, three, and four days after discontinuing sertraline were within the expected range, but the rate of decline was consistent with a moderately prolonged half-life. DISCUSSION: Sertraline has been shown to blunt postprandial hyperglycemia in rats and to potentiate the hypoglycemic effects of sulfonylurea agents in humans. It has not been reported to cause hypoglycemia independently, but in this case, a nondiabetic patient experienced multiple episodes of hypoglycemia that resolved after discontinuation of sertraline. CONCLUSIONS: This report and another implicating fluoxetine in a case of hypoglycemia suggest that healthcare professionals should consider these medications among the possible causes of hypoglycemia occurring in patients receiving selective serotonin-reuptake inhibitors.
Effects of Risperidone on Gonadal Axis Hormones in Schizophrenia
Authors: Kaneda Yasuhiro 
Published: June 2003

OBJECTIVE: To investigate the effects of risperidone on the hypothalamo—pituitary—gonadal (HPG) axis of chronic schizophrenic male inpatients medicated regularly. METHODS: Subjects included six inpatients who were diagnosed according to the Diagnostic and Statistical Manual, Fourth Edition, criteria for schizophrenia, and were termed treatment-refractory. Each patient gave informed consent for the research involved in this study. The neuroendocrine studies were done before and during risperidone administration. Patients took a mean dose of risperidone 9.5 mg/d for a mean period of 64.2 days. Psychotic symptoms were assessed using the Brief Psychiatric Rating Scale (BPRS). RESULTS: Prolactin (PRL) increased significantly during risperidone administration. However, luteinizing hormone, follicle-stimulating hormone, and testosterone did not show significant difference between blood concentrations before and during risperidone administration. Scores of the BPRS total, thought disturbance factor, and tension decreased significantly during risperidone administration. Throughout the study, none of the patients experienced clinically significant problems associated with elevated PRL concentrations including gynecomastia and/or sexual dysfunction. CONCLUSIONS: Addition of risperidone produced significant improvement of psychotic symptoms in treatment-resistant schizophrenic patients, and an increase in basal blood PRL concentrations, but not in basal blood HPG axis hormone concentrations. This preliminary result warrants further double-blind evaluation with a larger sample.
Ofloxacin: A Probable Cause of Toxic Epidermal Necrolysis
Authors: Melde Stephen L 
Published: June 2003

OBJECTIVE: To report a fatal case of toxic epidermal necrolysis in a man who was treated with oral ofloxacin for epididymitis. CASE SUMMARY: A 75-year-old white man received 23.6 grams of ofloxacin over a 51-day period for epididymitis. He experienced a severe skin reaction diagnosed as toxic epidermal necrolysis. The man died from complications related to toxic epidermal necrolysis. DISCUSSION: Toxic epidermal necrolysis is an infrequent, yet often fatal, severe, systemic, cutaneous disease most often the result of an adverse drug reaction. Fluoroquinolones have rarely been implicated in cases of toxic epidermal necrolysis. A MEDLINE search from 1966 to December 2000 revealed no reports of toxic epidermal necrolysis, erythema multiforme, or Stevens—Johnson syndrome due to ofloxacin therapy. However, a large case-control study included three cases of either Stevens—Johnson syndrome or toxic epidermal necrolysis associated with ofloxacin use, but no details of the cases were given. This report rules out other causes of toxic epidermal necrolysis and implicates ofloxacin in what appears to be an atypical presentation of drug-induced toxic epidermal necrolysis. CONCLUSIONS: There is very little published information regarding ofloxacin-induced toxic epidermal necrolysis. There are a few case reports of other fluoroquinolones that have been associated with toxic epidermal necrolysis. It is hoped that this case report creates awareness that ofloxacin-induced toxic epidermal necrolysis is possible.
Aggravation of Glaucoma with Fluvoxamine
Authors: Jiménez-Jiménez Félix Javier , Ortí-Pareja Miguel , Zurdo José Martín 
Published: June 2003

OBJECTIVE: To report a case of aggravation of glaucoma associated with the use of fluvoxamine. CASE SUMMARY: A 66-year-old white woman diagnosed with narrow-angle glaucoma showed an increase in intraocular pressure and experienced orbital pain and blurred vision after the initiation of fluvoxamine for tension-type headache. These symptoms disappeared and intraocular pressure normalized after withdrawal of this drug. DISCUSSION: Aggravation of narrow-angle glaucoma is a well-known adverse effect of tricyclic antidepressants. Because this adverse effect had been rarely reported to date with selective serotonin-reuptake inhibitors (paroxetine and fluoxetine), we used fluvoxamine in our patient. The disappearance of ocular symptoms and the normalization of intraocular pressure two days after stopping fluvoxamine suggest a possible relationship between fluvoxamine and aggravation of glaucoma. CONCLUSIONS: Fluvoxamine should be considered as a drug that can induce or aggravate narrow-angle glaucoma.
Possible Interaction between Warfarin and Lycium Barbarum L.
Authors: Lam Annie Y , Elmer Gary W , Mohutsky Michael A 
Published: June 2003

OBJECTIVE: To describe a patient who was stabilized on warfarin and developed an elevated international normalized ratio (INR) after drinking a concentrated Chinese herbal tea. Additionally, to determine the effect of the tea on CYP2C9, the isoenzyme responsible for the metabolism of S-warfarin. CASE SUMMARY: An elevated INR of 4.1 was observed in a 61-year-old Chinese woman, previously stabilized on anticoagulation therapy (INR 2–3). With no changes in her other medications or lifestyle, a review of her dietary habits revealed four days of drinking a concentrated Chinese herbal tea made from Lycium barbarum L. fruits (3–4 glasses daily) prior to her clinic visit. Warfarin was withheld for one day and then resumed at a lower weekly dose. She discontinued the tea, while maintaining consistency with medications and dietary habits. A follow-up INR seven days later was 2.4, and seven subsequent INR values were in the 2.0–2.5 range. DISCUSSION: L. barbarum L. (family Solanaceae) is a commonly used Chinese herb considered to have a tonic effect on various organs. Any impact of an herbal product on the metabolism of S-warfarin, the enantiomer responsible for most of the anticoagulant activity, could alter the INR values. An herbal—drug interaction was suspected in this case. In vitro evaluation showed inhibition of S-warfarin metabolism by CYP2C9 by the tea of L. barbarum L.; however, the inhibition observed was weak, with a dissociation constant (Ki) value of 3.4 mg/mL, suggesting that the observed interaction may be caused by factors other than the CYP450 system. CONCLUSIONS: There is a potential herbal—drug interaction between warfarin and L. barbarum L., based on an increased INR value noted with concurrent use. Thus, combination of L. barbarum L. and warfarin should be avoided. Vigilance is needed with other herbal combinations taken with drugs of narrow therapeutic indices.