bluuebunny/crossref_metadata_2025 huggingface dataset:
Neurotoxic Syndrome Associated with Risperidone and Fluvoxamine
Authors: Reeves Roy R , Mack James E , Beddingfield John J
Published: June 2003

OBJECTIVE:

To report a case of a neurotoxic syndrome in a patient undergoing concomitant treatment with risperidone and fluvoxamine.

CASE REPORT:

A 24-year-old African American woman hospitalized for psychosis was unresponsive to risperidone. Because of obsessive symptoms, low doses of fluvoxamine were added to her treatment regimen. Within 2 days, she developed confusion, diaphoresis, diarrhea, hyperreflexia, and myoclonus, which then progressed to rigidity, fever, and unresponsiveness, requiring endotracheal intubation. Symptoms resolved over 10 days with discontinuation of medication, hydration, and bromocriptine 5 mg 3 × daily. Ultimately, she was treated with olanzapine and fluvoxamine without adverse effects.

DISCUSSION:

This represents the first reported case of a neurotoxic syndrome secondary to treatment with risperidone and fluvoxamine. Differential diagnosis between neuroleptic malignant syndrome (NMS) and serotonin syndrome (SS) could not be accurately determined because of the overlap of signs and symptoms of both syndromes. NMS and SS may represent different aspects of a more generalized neurotoxic syndrome. This could be an important consideration in formulating treatment for neurotoxic syndromes.

CONCLUSIONS:

Clinicians should be aware of potentially serious adverse reactions that may occur during concomitant treatment with antipsychotics and selective serotonin-reuptake inhibitors.
Use of Cisapride with Contraindicated Drugs in the Netherlands
Authors: De Bruin Marie L , Panneman Martien JM , Leufkens Hubert GM , Hoes Arno W , Herings Ron MC
Published: June 2003

OBJECTIVE:

To investigate the prevalence of concomitant use and coprescribing of cisapride with potentially interacting drugs to evaluate the impact of these warnings from 1994 to 1998.

DESIGN:

Retrospective follow-up study of patients using cisapride.

SETTING:

Data for this study were obtained from the pharmacy database of the Dutch PHARMO record linkage system ( n = 834 000).

RESULTS:

From 1994 to 1998, the prevalence rate of the observed versus expected use of any potentially interacting drug decreased significantly over time (p < 0.01). However, the number of days-at-risk and number of coprescriptions of potentially interacting drugs among cisapride users increased on average by 13% and 9% per year, respectively. This increase was almost exclusively explained by a large increase in concomitant prescribing of clarithromycin, the most commonly used potentially interacting drug. Decreases in prevalence rates were observed for all individual potentially interacting drugs, except for concomitant use of fluconazole and miconazole.

CONCLUSIONS:

Over the last few years, healthcare professionals have refrained from dispensing potentially interacting drugs to patients who use cisapride, probably as a result of drug warnings implemented during this period. The limited absolute effects result from an increase of coprescription and concomitant use of clarithromycin and fluconazole among cisapride users. Because therapeutically equivalent alternatives were available for both drugs, such combinations were avoidable. Communicating information on these drug—drug interactions to prescribers and pharmacists and inclusion of cardiovascular morbidity as a relative contraindication for prescribing cisapride with these drugs may substantially decrease the risk of potentially adverse events to cisapride.
Stereoselective Pharmacokinetics and Pharmacodynamics of Anti-Asthma Agents
Authors: Vakily Majid , Mehvar Reza , Brocks Dion
Published: June 2003

OBJECTIVE:

To review the previously published studies on pharmacokinetics and pharmacodynamics of chiral drugs used in the treatment of asthma.

DATA SOURCES:

Primary and review articles were identified with a MEDLINE search (1980–May 2001) and through secondary sources.

STUDY SELECTION AND DATA EXTRACTION:

All English-language studies and reviews obtained from the MEDLINE search pertaining to stereoselective pharmacokinetics and pharmacodynamics of chiral anti-asthma drugs were assessed.

DATA SYNTHESIS:

Several anti-asthma drugs (e.g., β2-adrenergic agonists, leukotriene modifiers) are chiral and marketed as racemates, which consist of equal proportions of 2 enantiomers. Significant stereoselectivity has also been reported in pharmacodynamics and pharmacokinetics of the β2-agonists. The enantiomers of β2-agonists in the R configuration are primarily responsible for the bronchodilating effects of the racemate. The plasma concentrations of the enantiomers of anti-asthma drugs may differ as a reflection of stereoselectivity in clearance, volume of distribution, and route of administration.

CONCLUSIONS:

Stereoselectivity in the pharmacokinetics of anti-asthma drugs may complicate the relationship between dose and/or plasma concentration of racemic drug versus effect relationship. An appreciation of the stereoselective pharmacokinetics and pharmacodynamics of chiral anti-asthma drugs may optimize the use of these agents in asthmatic patients.
A Decade of Antimicrobial Susceptibilities at the University of Kentucky Hospital
Authors: Rapp Robert P , Ribes Julie A , Overman Sue B , Darkow Theodore E , Evans Martin E
Published: June 2003

OBJECTIVE:

To determine the antimicrobial susceptibility rates for key antimicrobial agents and selective bacterial pathogens in the decade of the 1990s.

METHODS:

Data from 1990 to 2000 from the University of Kentucky Clinical Microbiology Laboratory were analyzed by linear regression analysis to identify agents and pathogens that show a decline in susceptibility. For selected pathogens and antimicrobial agents, predictions were made for further declines in susceptibility for 2005 and 2010.

RESULTS:

Significant declines in susceptibility to selected antimicrobial agents were found for Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Staphylococcus aureus, Staphylococcus epidermidis, and Streptococcus pneumoniae. Further declines were predicted for 2005 and 2010.

CONCLUSIONS:

Examination of susceptibility rates over time in a university hospital medical center provides useful data for future planning. In our institution, antimicrobial susceptibility rates have significantly declined during the 1990s for certain antimicrobial agents and bacterial pathogens. We are attempting to change our antimicrobial use patterns through formulary manipulation and clinician education, which may retard or prevent such declines in the future.
Therapeutic Drug Monitoring of Lamotrigine
Authors: Chong Elaine , Dupuis L Lee
Published: June 2003

OBJECTIVE:

To evaluate the usefulness of routine monitoring of serum lamotrigine concentration.

DATA SOURCE:

Literature was accessed through MEDLINE (1990–January 2001). Key search terms included lamotrigine, pharmacokinetics, and epilepsy.

DATA SYNTHESIS:

A decision-making algorithm was used to evaluate the clinical evidence to support or refute the routine use of serum lamotrigine concentrations to adjust doses. The value of serum lamotrigine concentration monitoring remains controversial, primarily because clear relationships between concentration and pharmacologic response (either efficacy or toxicity) have not been demonstrated.

CONCLUSIONS:

Serum concentration monitoring of lamotrigine is not recommended as a tool for routine dose adjustment.
Accuracy of the AvoSure PT Pro System Compared with a Hospital Laboratory Standard
Authors: Rigelsky Janene M , Choe Hae Mi , Curtis Dawn M , Brosnan Marcia J , Mitrovich Sonya , Streetman Daniel S
Published: June 2003

OBJECTIVE:

To compare international normalized ratio (INR) values obtained using the AvoSure PT Pro point-of-care (POC) system with those obtained using a standard laboratory method.

METHODS:

Forty-one INR values obtained from the POC system were compared with those obtained from a standard laboratory method. The POC method was evaluated for both laboratory and clinical agreement. To evaluate laboratory agreement, various analyses were used, including mean-squared prediction error (MSE) and mean prediction error (ME), Bland—Altman analysis, correlation, and paired t-test comparing group INR means. For clinical accuracy, discrepant pairs were identified and evaluated to determine whether dosage adjustments would have been needed based on values obtained.

RESULTS:

The POC system demonstrated modest precision (MSE = 0.147, 95% CI 0.065 to 0.228) and relatively little bias (ME = 0.090, 95% CI–0.025 to 0.205). Bland—Altman analysis also suggested good agreement at average INRs from 2.0 to 3.0. At average INR values >3.0, the POC system consistently overestimated INR. Values obtained with the POC system were significantly correlated with those obtained from the hospital laboratory (r = 0.77; p < 0.001). Similarly, mean ± SD POC INR did not differ significantly from the laboratory-determined INR (2.45 ± 0.59 vs. 2.37 ± 0.48, respectively; p = 0.176). Regarding clinical accuracy, the values clinically agreed in 85.4% of the cases.

CONCLUSIONS:

The AvoSure PT Pro POC system appears to be useful for INR values within the 2.0–3.0 range, but values outside of this range should probably be confirmed with a standard laboratory method.
Discontinuing or Switching Selective Serotonin-Reuptake Inhibitors
Authors: Bull Scott A , Hunkeler Enid M , Lee Janelle Y , Rowland Clayton R , Williamson Todd E , Schwab Joseph R , Hurt Stephen W
Published: June 2003

OBJECTIVE:

To describe reasons for discontinuing or switching selective serotonin-reuptake inhibitors (SSRIs) at 3 and 6 months after starting treatment, and to identify information provided to patients that may help prevent premature discontinuation of medication.

METHODS:

Telephone surveys were conducted at 3 and 6 months after patients (n = 672) were started on an SSRI for a new or recurrent case of depression.

RESULTS:

Significantly more patients discontinued or switched their SSRI because of an adverse effect within the first 3 months of starting (43%) compared with the second 3 months (27%; p = 0.023). The adverse effect most frequently reported as the reason for early discontinuation or switching was drowsiness/fatigue (10.2%), followed by anxiety, headache, and nausea — All at just over 5%. The odds ratio for discontinuation was 61% less in patients who recalled being told to take the medication for at least 6 months compared with those who did not (OR 0.39; p < 0.001). Patients who recalled being informed of potential adverse effects increased their reported incidence of mild to moderate adverse effects by 55% (OR 1.55; p < 0.05) without affecting rates of premature discontinuation (OR 1.06; p = 0.77).

CONCLUSIONS:

Adverse effects are the most frequent reason for discontinuing or switching SSRIs within the first 3 months of treatment. Patients are more likely to continue taking their antidepressant if they fully understand how long to take the medication. Informing patients of potential adverse effects does not appear to prevent premature discontinuation, but may increase the patient's awareness and reporting of mild to moderate adverse effects.
Adjuvant Ketamine Analgesia for the Management of Cancer Pain
Authors: McQueen Angela L , Baroletti Steven A
Published: June 2003

OBJECTIVE:

To review the clinical literature evaluating the utilization of intravenous ketamine for the management of cancer-related pain, to summarize the data that suggest ketamine is an appropriate adjuvant method of providing analgesia and to report a case of successful pain management using ketamine in a patient with recurrent testicular cancer at our institution.

DATA SOURCES:

Primary literature was identified through a MEDLINE search (1966–March 2002), and additional information was obtained through secondary and tertiary sources.

DATA SYNTHESIS:

The available data suggest that supplementation of morphine with ketamine improves analgesia in patients with cancer, and also provides insight to the controversy regarding the efficacy and adverse effects of various ketamine doses. At subanesthetic doses, ketamine may be beneficial at reducing opioid requirements and related adverse effects.

CASE SUMMARY:

A 34-year-old white man with recurrent testicular cancer was admitted with radiating neuropathic pain of the legs and lower back. The patient was suspected to also be experiencing opioid adverse effects; therefore, alternative analgesic options were warranted. Ketamine was successful in reducing patient-reported pain and was also well tolerated.

CONCLUSIONS:

Ketamine is an adjuvant analgesic for the treatment of cancer-related pain when other agents either fail or are intolerable. Accordingly, there are several factors that may prevent adequate pain control with opioid use; therefore, alternative analgesic options should be considered. Promise exists for ketamine as a contemporary analgesic in the appropriate patient.
Effect of Stress on International Normalized Ratio during Warfarin Therapy
Authors: Hawk Toni L , Havrda Dawn E
Published: June 2003

OBJECTIVE:

To discuss the effect of stress on the international normalized ratio (INR) when patients are taking warfarin.

CASE SUMMARY:

Two patients at a pharmacist-managed anticoagulation clinic who were stable with anticoagulation developed elevated INR values after a stressful event occurred. All other factors known to elevate the INR were unchanged; furthermore, the INR values returned to the prior level of control after resolution of the stressful events.

DISCUSSION:

Management of anticoagulation with warfarin requires the knowledge of factors that may alter an INR. Many of these factors, such as dietary changes, illnesses, drug interactions, patient compliance, and physical activity, have been described. In spite of this understanding, many patients continue to experience variability in their INR values, suggesting there are other factors that can alter the INR that have not been fully described. The cases presented here demonstrate that stressful events, physical or psychological, can elevate the INR. The mechanism for this occurrence is unknown, but may be related to decreased metabolism of warfarin during stress.

CONCLUSIONS:

When an unexplained INR value exists, a stressor should be evaluated as a potential cause.
Promethazine Treatment of Steroid-Induced Psychosis in a Child
Authors: Ingram Dena G , Hagemann Tracy M
Published: June 2003

OBJECTIVE:

To report a case of steroid-induced psychosis in a child that resolved with the treatment of promethazine, a phenothiazine derivative.

CASE SUMMARY:

A 2-year-old white boy with a history of relapsed acute lymphoblastic leukemia underwent a bone marrow transplant and developed graft-versus-host disease, which was treated with methylprednisolone. Within 24 hours of initiation of the methylprednisolone, the patient developed symptoms associated with steroid-induced psychosis including mania, head-banging, and excessive crying. Because the corticosteroid could not be discontinued, promethazine, a phenothiazine derivative, was used to treat the psychotic symptoms. Symptoms resolved with use of promethazine.

DISCUSSION:

A number of published reports describe the appearance of psychological symptoms with corticosteroid use. While the mechanism is unclear, the reaction is usually reversible with dose reduction or discontinuation of the corticosteroid. In cases where this cannot be done, typical treatment involves an antipsychotic medication. Most antipsychotic medications, such as the phenothiazine class, have not been evaluated in very young childen. Promethazine is a phenothiazine derivative that has been used in children for a number of nonpsychiatric indications.

CONCLUSIONS:

Promethazine may be effective in treating steroid-induced psychosis in pediatric patients.
Immunization Recommendations for Adults with Cancer
Authors: Arrowood Jodi R , Hayney Mary S
Published: June 2003

OBJECTIVE:

To review the published literature on immunizing nonbone marrow transplant adult cancer patients, summarize the findings, and make recommendations for the use of vaccines in this population.

DATA SOURCE:

A search of MEDLINE and CancerLit was conducted (1966–June 2001) to find English-language clinical studies and review articles pertaining to immunization, vaccines, and cancer in humans. Recommendations of the Advisory Committee on Immunization Practices were used extensively. References of each identified article were subsequently reviewed for additional relevant articles.

STUDY SELECTION AND DATA EXTRACTION:

Representative epidemiologic reports, clinical trials, and recommendations of expert panels are summarized in this report. Relevant information was selected to describe the epidemiology of vaccine-preventable diseases, efficacy of the vaccines, and recommendations specific to adults with cancer.

DATA SYNTHESIS:

In general, adults with cancer are at least at the same risk of infection with vaccine-preventable diseases as are healthy populations. Because of their compromised immune function, many patients who have undergone cancer treatment are specifically at increased risk of morbidity and mortality associated with measles and varicella infections. Asplenic patients with lymphoma are at increased risk of fulminant bacterial infections. Influenza infection is associated with significant morbidity in cancer patients. Although the protection conferred by immunization is lower in immunosuppressed patients with cancer, immunization with inactivated vaccines is indicated. Live vaccines should not be used except in very rare instances.

CONCLUSIONS:

Immunization of adults with cancer is a critical component of their care. Although additional research is necessary, following established recommendations may protect individuals with malignancies from significant morbidity and mortality associated with vaccine-preventable diseases.
Blood Pressure Elevation in a Patient Treated with Salsalate
Authors: Phillips Beth Bryles , Joss Jacqueline D , Mulhausen Paul L
Published: June 2003

OBJECTIVE:

To report a case of increased blood pressure associated with the use of salsalate in an elderly patient with no prior history of hypertension.

CASE SUMMARY:

A 78-year-old white man with no prior history of hypertension initiated salsalate therapy for low-back pain. Over the 15 months prior to the initiation of salsalate, his blood pressure averaged 127 ± 7 mm Hg systolic and 84 ± 6 mm Hg diastolic (mean ± SD). After initiation of salsalate, he experienced significant elevations in blood pressure, which led to a preliminary diagnosis of hypertension. Blood pressure after initiation of salsalate averaged 150 ± 13 mm Hg systolic and 95 ± 5 mm Hg diastolic. No changes in medications or medication doses (with the exception of warfarin) occurred in the 18 months prior to or during salsalate therapy. His weight remained stable. A detailed review of his medical records and history revealed no other causes for these elevations in blood pressure. Salsalate therapy was discontinued and his blood pressure returned to normotensive levels (119 ± 2 mm Hg systolic and 81 ± 2 mm Hg diastolic).

DISCUSSION:

Nonsteroidal antiinflammatory drug (NSAID)–induced elevations in blood pressure have been well documented in patients receiving antihypertensive medications. Due to its relative weak inhibition of cyclooxygenase and lack of published literature in hypertensive patients, salsalate is considered to have little or no effect on blood pressure. Our report documents a possible case of salsalate-induced hypertension in a previously normotensive elderly man. Observational studies suggest that NSAID use may increase the risk of developing hypertension in older patients.

CONCLUSIONS:

Clinicians should be aware of the possible effects of NSAIDs on blood pressure. Blood pressure monitoring following the initiation of salsalate may be warranted, particularly in older patients.
Pharmacokinetic Analysis of Theophylline to Assess Noncompliance in Therapy
Authors: Konishi Hiroki , Nakatsuka Takayuki , Yoshida Michiaki , Tamaki Shinji , Minouchi Tokuzo , Yamaji Akira , Kinoshita Masahiko
Published: June 2003

OBJECTIVE:

To report a case showing patient noncompliance, supported by outcomes of pharmacokinetic analysis of theophylline as a surrogate drug.

CASE SUMMARY:

A 45-year-old woman with severe hypertension was treated with a variety of oral antihypertensive drugs, but there was no improvement in her elevated blood pressure. Since we suspected that her intestinal drug absorption capacity was impaired, a theophylline absorption test was performed. When oral theophylline was given to the patient in tablet form, the apparent bioavailability was only 20%, which agreed with our hypothesis. However, the bioavailability of theophylline given in liquid form was almost 100%, and theophylline in tablet form was confirmed to be fully bioavailable when the test was performed under supervision by medical staff.

DISCUSSION:

The almost complete bioavailability of oral theophylline indicated that there was no impairment in intestinal absorption capacity. The low bioavailability of theophylline observed after tablet administration in the first trial was apparently a result of noncompliance, because the staff did not supervise administration to ensure that tablets were swallowed. Thus, the low response to antihypertensive therapy was attributed to patient noncompliance in taking the drugs, despite her insistence to the contrary.

CONCLUSIONS:

The use of theophylline was a novel approach to evaluating the absorbability of orally administered drugs in a patient suspected of poor compliance with therapy. A great difference in theophylline bioavailability between the supervised and unsupervised trials was strongly indicative of patient noncompliance. The possibility of impaired absorption was virtually ruled out.
New and Emerging Therapies for Sepsis
Authors: Healy Daniel P
Published: June 2003

OBJECTIVE:

To review the recent advances related to the pathophysiology of sepsis and the rationale for recombinant human-activated protein C (drotrecogin alfa) and other antisepsis agents currently in Phase III trials.

DATA SOURCES:

A MEDLINE (1990–December 2001) search was performed to identify pertinent literature on the pathophysiology of sepsis and treatment strategies. The search was supplemented with AdisInsight (Adis International) using the search terms sepsis, severe sepsis, or septic shock combined with agents in Phase II or higher clinical development. Abstracts presented at infectious diseases and critical care meetings were also reviewed.

STUDY SELECTION AND DATA EXTRACTION:

Clinical efficacy studies were selected for drotrecogin alfa and other Phase III investigational agents.

DATA SYNTHESIS:

Our current understanding of the pathophysiology of sepsis underscores the contribution of increased coagulation and diminished fibrinolytic activity working in conjunction with an excessive and dysregulated inflammatory response. The loss of homeostatic balance among these systems results in a systemic inflammatory response with generalized coagulopathy, microvascular thrombosis, and, ultimately, acute organ failure and death. As a result of these advances, several compounds are now in various phases of development. A recombinant human form of endogenous activated protein C (drotrecogin alfa) was recently approved by the Food and Drug Administration for severe sepsis in adults who have a high risk of death. It possesses anticoagulant, profibrinolytic, and antiinflammatory properties. Other compounds currently in Phase III trials include tissue-factor pathway inhibitor, tumor-necrosis factor antibody fragment, platelet-activating factor acetylhydrolase, antithrombin III, and pyridoxylated hemoglobin polyoxyethylene.

CONCLUSIONS:

With the recent approval of drotrecogin alfa, there is renewed optimism that we can effectively reduce sepsis-associated mortality.
FDA Adverse Event Reports on Statin-Associated Rhabdomyolysis
Authors: Omar Mohamed A , Wilson James P
Published: June 2003

OBJECTIVE:

To determine the number of cases of statin-associated rhabdomyolysis reported to the Food and Drug Administration for 6 statins and to profile the cases.

METHODS:

A retrospective analysis of all domestic and foreign reports of statin-associated rhabdomyolysis between November 1997 and March 2000 was conducted. Outcome measures included the total number of reports (initial plus follow-up), the number of unique cases, age, gender, percentages of report codes and role codes, and frequencies of concomitant interacting drugs that may have precipitated rhabdomyolysis, outcomes codes, and report source codes.

RESULTS:

There were 871 reports of statin-associated rhabdomyolysis in the 29-month time frame examined, representing 601 cases. The following number of cases were associated with each of the individual statins: simvastatin, 215 (35.8%); cerivastatin, 192 (31.9%); atorvastatin, 73 (12.2%); pravastatin, 71 (11.8%); lovastatin, 40 (6.7%); and fluvastatin, 10 (1.7%). Drugs that may have interacted with the statins were present in the following number of cases: mibefradil (n = 99), fibrates (n = 80), cyclosporine (n = 51), macrolide antibiotics (n = 42), warfarin (n = 33), digoxin (n = 26), and azole antifungals (n = 12). The reports of 62.1% of cases were classified as expedited. Statins were designated as the primary suspect in 72.0% of the cases. Death was listed as the outcome in 38 cases. The majority of reports (n = 556) were from health professionals.

CONCLUSIONS:

Compared with the other statins, simvastatin and cerivastatin were implicated in a relatively higher number of reports. Because of the various limitations of a spontaneous reporting-system database, caution is urged when interpreting the relative number of cases reported.
Pharmacy-Based Bone Mass Measurement to Assess Osteoporosis Risk
Authors: Elliott Mary E , Meek Patrick D , Kanous Nathan L , Schill Gary R , Weinswig Patricia A , Bohlman John P , Zimpel Casey L , Jensen Brian C , Walters Dan R , Sutter Sue L , Peterson Andy N , Peterson Rhonda M , Binkley Neil C
Published: June 2003

OBJECTIVE:

To evaluate elderly women's knowledge of their skeletal status, assess adequacy of calcium intake, determine the prevalence of low bone density, and determine whether peripheral bone density testing led to medical interventions in a group of rural, elderly Wisconsin women recruited in community pharmacies.

DESIGN:

Recruiting notices were posted in each pharmacy, and eligible women were enrolled in the order in which they volunteered. Each completed a fracture-risk questionnaire. Calcaneal bone density was measured within the following 6 weeks, using peripheral dual-energy X-ray absorptiometry. Mail surveys were used to assess interventions subsequent to the womens' study participation.

SETTING:

The study was conducted at 5 community pharmacies in rural Wisconsin.

RESULTS:

Of 133 women, 20% had calcaneal osteoporosis, defined as a T score ≤2.5 (calcaneal bone density <2.5 SDs below the young reference database). Thirty percent of women met National Osteoporosis Foundation (NOF) treatment criteria based on heel bone density and NOF-designated risk factors. Of those meeting treatment criteria, 75% were unaware of their low bone mass. Half of the women received <1200 mg/d of calcium, the recommended dose for osteoporosis prevention. Those who were taking a calcium supplement were much more likely to receive the recommended amount. Women who had discussed bone density test results with their physicians were more likely to receive central dual energy X-ray absorptiometry (DXA) measurements and/or start antiresorptive therapy than women who did not.

CONCLUSIONS:

Rural, elderly Wisconsin women are at substantial risk for osteoporosis, based on calcaneal bone density, but most are unaware of their risk. Compounding this risk is low calcium intake. Community screening of rural, elderly women by peripheral bone density measurement can lead to medical interventions in such individuals.
Glucose-Insulin-Potassium Solution for Acute Myocardial Infarction
Authors: Janiger Jeffrey L , Cheng Judy WM
Published: June 2003

OBJECTIVE:

To review the role of glucose-insulin-potassium (GIK) solution in the management of acute myocardial infarction (AMI).

DATA SOURCES:

MEDLINE (1966–October 2001) database, using the search terms glucose, insulin, potassium, and myocardial infarction.

STUDY SELECTION:

Relevant English-language human studies and meta-analyses.

DATA SYNTHESIS:

Most studies that have investigated the use of GIK in AMI have been from the prethrombolytic era. Although most data trended toward favoring GIK in improving mortality and morbidity of AMI, the Polish GIK study was terminated prematurely because of an increase in mortality in patients treated with GIK. Dosage, duration of treatment, and route of administration of GIK varied among studies.

CONCLUSIONS:

Until results from larger-scale studies become available, the routine use of GIK infusion in AMI patients is not recommended.
Insulin Glargine: A New Basal Insulin
Authors: Levien Terri L , Baker Danial E , White John R , Campbell R Keith
Published: June 2003

OBJECTIVE:

To review the pharmacology, pharmacokinetics, dosing guidelines, adverse effects, drug interactions, and clinical efficacy of insulin glargine.

DATA SOURCES:

Primary and review articles regarding insulin glargine were identified by MEDLINE search (1966–July 2001); abstracts were identified through Institute for Scientific Information Web of Science (1995–July 2001) and the American Diabetes Association. Additional information was obtained from the insulin glargine product information.

STUDY SELECTION AND DATA EXTRACTION:

All of the articles and meeting abstracts identified from the data sources were evaluated, and all information deemed relevant was included in this review. Priority was placed on data from the primary medical literature.

DATA SYNTHESIS:

Insulin glargine is a long-acting, recombinant human insulin analog that is given once daily as a basal source of insulin in patients with type 1 or type 2 diabetes mellitus. Modification of the basic insulin structure has produced a new insulin that is soluble at an acidic pH, but precipitates in the subcutaneous tissue and is slowly released from a depot. Insulin glargine has a slower onset of action than NPH insulin and a longer duration of action with no peak activity. Once-daily administration of insulin glargine has comparable efficacy to that of NPH insulin administered once or twice daily in basal-bolus regimens when used in combination with intermittent doses of regular insulin or insulin lispro in patients with type 1 and type 2 diabetes, and in conjunction with oral antidiabetic agents in patients with type 2 diabetes. Overall, insulin glargine has an incidence of hypoglycemia comparable to or less than that of NPH insulin, with a reduced incidence of nocturnal hypoglycemia compared with NPH insulin seen in some studies.

CONCLUSIONS:

Insulin glargine is a long-acting insulin analog capable of providing 24-hour basal insulin coverage when administered once daily at bedtime. Its activity profile, which lacks a pronounced peak, more closely resembles that of endogenous basal insulin than that of other intermediate- or long-acting insulins and appears more likely to be associated with a reduced incidence of hypoglycemia, particularly nocturnal hypoglycemia. Insulin glargine physiologically provides basal insulin but, for most patients, the addition of a rapid-acting insulin, like insulin lispro, before or with meals will need to be included in the treatment regimen to achieve optimal management of blood glucose concentrations.
Severe Serotonin Syndrome Induced by Mirtazapine Monotherapy
Authors: Hernández José L , Ramos Francisco J , Infante Jon , Rebollo Mariano , González-Macías Jesús
Published: June 2003

OBJECTIVE:

To document a case of serotonin syndrome (SS) associated with mirtazapine monotherapy, review the previously reported cases of SS associated with this tetracyclic antidepressant, and discuss the possible pathogenic mechanisms leading to this serious adverse drug reaction.

CASE SUMMARY:

A 75-year-old man developed agitation, confusion, incoordination, and gait disturbance because of progressive rigidity. Mirtazapine had been started 8 days earlier to control major depression. Physical examination revealed diaphoresis, low-grade fever, hypertension, tachycardia, bilateral cogwheel rigidity, hyperreflexia, tremor, and myoclonus, symptoms and signs that are consistent with severe SS.

DISCUSSION:

A review of the cases of SS with implication of mirtazapine as the cause was performed. The possible pathogenic mechanisms leading to this adverse reaction in this patient are also discussed, and pathophysiologic hypotheses are formulated.

CONCLUSIONS:

Although mirtazapine offers clinicians a combination of strong efficacy and good safety, we suggest bearing SS in mind when prescribing this drug, especially in frail, elderly patients with underlying chronic conditions. In these patients, it might be more adequate to start mirtazapine therapy at a lower dose (<15 mg/d).
Lansoprazole-Induced Thrombocytopenia
Authors: Zlabek Jonathan A , Anderson Christopher G
Published: June 2003

OBJECTIVE:

To describe a case of thrombocytopenia associated with the administration of lansoprazole.

CASE SUMMARY:

An 85-year-old white man presented with an upper gastrointestinal hemorrhage from a gastric ulcer. His platelet count was normal on admission. He was started on oral lansoprazole 60 mg twice daily and, on hospital day 2, his platelet count decreased to 102 × 103/mm3; on hospital day 3, the platelet count was 36 × 103/mm3. Lansoprazole was discontinued, and the platelet count returned to normal. He has not had any further episodes of thrombocytopenia to date.

DISCUSSION:

After exclusion of other causes, the onset of thrombocytopenia after administration of lansoprazole, the resolution of the adverse reaction after discontinuation of the drug, and the fact that no other medicines were introduced during this time frame lead us to believe that this was most likely an idiosyncratic thrombocytopenic response to lansoprazole. To date, this is the first reported case of what appears to be isolated thrombocytopenia associated with lansoprazole.

CONCLUSIONS:

Clinicians should be aware of the possible association of thrombocytopenia with lansoprazole and discontinue the drug if thrombocytopenia becomes apparent.
Hepatitis B Vaccination Safety
Authors: Geier Mark R , Geier David A
Published: June 2003

BACKGROUND:

Recent studies have suggested that adult hepatitis B vaccination may be associated with adverse reactions.

OBJECTIVE:

To further examine the relative risk, percentage association, and statistical significance of arthritic, immunologic, and gastrointestinal adverse reactions reported after adult hepatitis B vaccination compared with control vaccines.

DESIGN:

The Vaccine Adverse Events Reporting System (VAERS) database was analyzed for the incidence of adverse reactions after adult hepatitis B immunization compared with the incidence of adverse reactions reported to VAERS about vaccine control groups.

SETTING:

The medical and scientific communities have generally accepted that hepatitis B vaccine, a highly purified, genetically engineered single-antigen vaccine, is a safe vaccine.

METHODS:

The VAERS database was analyzed from 1997 to 2000 for adverse reactions associated with adult hepatitis B vaccination and from 1991 to 2000 for adverse reactions reported about vaccine control groups.

RESULTS:

The results showed a statistically significant increase in the incidence of adverse reactions reported after adult hepatitis B vaccination when compared with the incidence of adverse reactions reported to VAERS about control vaccines.

CONCLUSIONS:

Patients and physicians need to be fully informed of the potential adverse reactions associated with hepatitis B vaccination so that together they can make an informed consent decision about the risk versus the benefit. Patients who may have had an associated adverse reaction to hepatitis B vaccine should be made aware that they may be eligible for compensation from the no-fault Vaccine Compensation Act, administered by the US Court of Claims.

TRASFONDO:

Estudios recientes sugieren que la vacunación para hepatitis B en adultos podría estar asociada con reacciones adversas.
Lipid-Lowering Drug Use and Cardiovascular Events after Myocardial Infarction
Authors: Klungel Olaf H , Heckbert Susan R , de Boer Anthonius , Leufkens Hubert GM , Sullivan Sean D , Fishman Paul A , Veenstra David L , Psaty Bruce M
Published: June 2003

BACKGROUND:

The benefits of lipid-lowering drug treatment for the secondary prevention of coronary heart disease have been well established by randomized, controlled trials. Nonetheless, the risk of events has not been compared directly for inhibitors of hydroxymethylglutaryl coenzyme A reductase (statins) and non-statin lipid-lowering drugs. Further, it remains uncertain whether patients in usual practice who are treated with lipid-lowering drugs after myocardial infarction (MI) gain a similar benefit with regard to the risk of cardiovascular events compared with patients in randomized, controlled trials.

OBJECTIVE:

To assess the association between lipid-lowering drug therapies in usual clinical practice and the risk of cardiovascular events in patients with a first MI who were discharged alive from the hospital.

METHODS:

An inception-cohort study was performed among 1956 enrollees of Group Health Cooperative who sustained an incident MI between July 1986 and December 1996 and survived for at least 6 months after hospitalization. Subjects with untreated low-density-lipoprotein cholesterol concentrations >130 mg/dL or untreated total cholesterol concentrations >200 mg/dL were included. The median duration of follow-up after the first MI was 3.3 years. Medical record review was used to collect information on cardiovascular risk factors. Computerized pharmacy records were used to assess antihyperlipidemic drug use during the first 6 months after hospitalization.

RESULTS:

Compared with 1263 subjects who did not receive lipid-lowering drug treatment, 373 subjects who received statins had a lower risk of recurrent coronary events (relative risk [RR] 0.59; 95% CI 0.39 to 0.89), stroke (RR 0.82; 95% CI 0.35 to 1.95), atherosclerotic cardiovascular mortality (RR 0.49; 95% CI 0.21 to 1.13), and any atherosclerotic cardiovascular event (RR 0.63; 95% CI 0.40 to 0.98). Among 320 subjects who used non-statin drug therapies, the RRs were 0.66 (95% CI 0.45 to 0.97) for recurrent coronary events, 0.95 (95% CI 0.46 to 1.95) for stroke, 0.68 (95% CI 0.35 to 1.32) for cardiovascular mortality, and 0.77 (95% CI 0.53 to 1.11) for any atherosclerotic cardiovascular event, compared with untreated hyperlipidemic patients.

CONCLUSIONS:

In this study of MI survivors, the use of lipid-lowering drug therapies after hospitalization was associated with a reduced risk of cardiovascular events. These results emphasize the importance of lipid-lowering drug treatment in patients with hyperlipidemia who survive a first MI.
The Economic Burden of Barrett's Esophagus in a Medicaid Population
Authors: Amonkar Mayur M , Kalsekar Iftekhar D , Boyer J Gregory
Published: June 2003

OBJECTIVE:

To estimate the overall healthcare expenditures of patients with Barrett's esophagus in the West Virginia Medicaid population.

METHODS:

West Virginia Medicaid—paid claims data for the period January 1, 1995, to December 31, 1999, were used for the study. The population included all individuals eligible for West Virginia Medicaid during the study period except for Medicare eligible– And Medicaid managed—care recipients. A prevalence-based approach was used to determine the cost of illness for Barrett's esophagus.

RESULTS:

The total cost of illness for Barrett's esophagus more than tripled, from $182 399 in 1995 to $623 864 in 1999, with approximately a 4 1/2-fold increase in medical and more than a threefold increase in pharmacy costs. The average cost of treating Barrett's esophagus was found to be approximately $1207 per patient in 1999. Overall, pharmacy costs accounted for >66% of the total costs. Controlling for age, gender, and number of comorbidities, patients with Barrett's esophagus incur 21.2% higher overall costs than patients with gastroesophageal reflux disease and 62.4% higher overall costs than the general Medicaid population.

CONCLUSIONS:

The increasing prevalence of and resource utilization for Barrett's esophagus provide a framework for further analysis and implementation of policies aimed at appropriate allocation of resources for the state's Medicaid program.
Evidence for the Cardioprotective Effects of Omega-3 Fatty Acids
Authors: Carroll Douglas N , Roth Mary T
Published: June 2003

OBJECTIVE:

To review available literature regarding the cardiovascular effects of marine-derived ω-3 fatty acids and evaluate the benefit of these fatty acids in the prevention of coronary heart disease.

DATA SOURCES:

Biomedical literature accessed through a MEDLINE search (1966–April 2002). Search terms included fish oil, omega-3 fatty acid, sudden death, hypertriglyceridemia, myocardial infarction, and mortality.

DATA SYNTHESIS:

Following an early 1970's observational investigation that ω-3 fatty acids may reduce the occurrence of myocardial infarction—related deaths in Greenland Eskimos, additional trials have been conducted that support this finding. Epidemiologic and clinical trial data suggest that ω-3 fatty acids may reduce the risk of cardiovascular-related death by 29–52%. In addition, the risk of sudden cardiac death was found to be reduced by 45–81%. Possible mechanisms for these beneficial effects include antiarrhythmic properties, improved endothelial function, antiinflammatory action, and reductions in serum triglyceride concentrations. ω-3 Fatty acids are fairly well tolerated; potential adverse effects include bloating and gastrointestinal distress, “fishy taste” in the mouth, hyperglycemia, increased risk of bleeding, and a slight increase in low-density-lipoprotein cholesterol.

CONCLUSIONS:

ω-3 Fatty acids may be beneficial and should be considered in patients with documented coronary heart disease. They may be particularly beneficial for patients with risk factors for sudden cardiac death.
Clinical Outcomes of Ambulatory Acute Exacerbations of Chronic Bronchitis with Older versus Newer Antimicrobials
Authors: Madaras-Kelly Karl J , Magdanz Stephanie B , Johnson Christopher K , Jue Sandra G
Published: June 2003

OBJECTIVE:

To determine whether the cure rate was similar between traditional and newer antibiotics in the treatment of acute exacerbations of chronic bronchitis (AECB), to determine whether antibiotic selection during the first AECB of the season influences the frequency of subsequent AECB, and to identify variables associated with poor short- and long-term treatment outcome.

METHODS:

A retrospective analysis of subjects seen for management of their first seasonal AECB was conducted. Subjects were stratified into traditional therapies (n = 95) or newer therapies (n = 101) by antibiotic prescription.

RESULTS:

There was no difference in initial cure rates between older versus newer antibiotics (93% vs. 95%; p = 0.48). There was no difference in the number of subjects that remained AECB-free for 6 months after initial treatment with older versus newer antibiotic regimens (34% vs. 28%; p = 0.37). Oxygen initiation or increased dose (OR 10.9; 95% CI 1.4 to 84.2; p = 0.02) was the only variable independently associated with lack of AECB resolution. Nonsmoking status trended toward an association with remaining AECB-free at 180 days (OR 0.39; 95% CI 0.15 to 1.01; p = 0.053).

CONCLUSIONS:

The use of older versus newer antibiotics did not independently predict short-term outcome or future AECB.
Assessment of an Online Consumer “Ask Your Pharmacist” Service
Authors: Assemi Mitra , Torres Nina M , Tsourounis Candy , Kroon Lisa A , McCart Gary M
Published: June 2003

OBJECTIVE:

To describe consumer demographics and the types of questions submitted to an online Ask Your Pharmacist (AYP) drug information service.

METHODS:

This is a retrospective review of a sample of consecutive queries submitted online to an AYP service between 1999 and 2000. All data were coded, transcribed, and evaluated in a Microsoft Excel spreadsheet. Data regarding gender, age, patient relationship to consumer, allergies, medical conditions, products, and question types were evaluated.

RESULTS:

One thousand eighty-seven queries involving drug information or health-related questions were evaluated: 65% of the queries were from consumers requesting information for themselves; 55.2% of queries originated from women; 61% of consumers were between 19 and 55 years of age. The 5 most listed medical conditions were depression-related, hypertension, allergies, pain, and infectious disease. More than 60% of the questions involved prescription or over-the-counter (OTC) medications; another 10% targeted herbal products or dietary supplements. Consumers were most interested in drug efficacy, safety, and drug interactions.

CONCLUSIONS:

An AYP online service is a relatively new, unique way for consumers to receive medication information. Consumers of all ages use AYP services for both acute and chronic conditions. Most consumers asked questions related to their own health or medications. Consumers were more likely to ask questions related to prescription and OTC medications than to botanical and dietary supplements. Consumers were primarily interested in drug efficacy and adverse effects.
Propofol Infusion Syndrome in Critically Ill Patients
Authors: Kang Tep M
Published: June 2003

OBJECTIVE:

To describe the clinical presentation of propofol infusion syndrome in critically ill adults.

DATA SOURCES:

Clinical literature was accessed through MEDLINE (1966 — March 2001). Key search terms included Diprivan, propofol, and propofol infusion syndrome. Case reports and small case series evaluating the use and toxicity of propofol in sedating critically ill adults were reviewed.

DATA SYNTHESIS:

The association between propofol infusion syndrome and death in children secondary to myocardial failure is well documented. However, few data are available regarding the syndrome in critically ill adults. Based on a review of those data, it appears that propofol infusion syndrome can occur in both children and adults. Common clinical features of propofol infusion syndrome may include hyperkalemia, hepatomegaly, lipemia, metabolic acidosis, myocardial failure, and rhabdomyolysis. Although the premise has not been proven, recent published cases appear to demonstrate an association between propofol infusion and death secondary to myocardial failure.

CONCLUSIONS:

Until further safety data become available, caution should be exercised when using high-dose (>5 mg/kg/h) and long-term (>48 h) propofol infusion in sedating critically ill adults.