bluuebunny/crossref_metadata_2025 huggingface dataset:
Efficacy and Cost Analysis of Ibutilide
Authors: Dunn Alisha B , White C Michael , Reddy Prabashni , Chow Moses SS , Kluger Jeffrey
Published: June 2003

OBJECTIVE:

To determine the efficacy and safety of ibutilide in atrial fibrillation (AF) and atrial flutter (AFl) in a clinical setting and to compare the cost of first-line ibutilide with that of projected first-line electrical cardioversion (EC) from a hospital and third-party payer perspective.

METHODS:

Medical records of all patients (n = 60) who received ibutilide from August 1996 to March 1998 were reviewed. Efficacy was defined as successful conversion to sinus rhythm within 60 minutes of the end of the infusion, and the maintenance of sinus rhythm until hospital discharge. Safety was evaluated by determining the incidence of torsade de pointes. Charges for EC and drug administration were obtained from the hospital database and converted to costs using cost/charge ratios. Hospital costs included drug, drug administration, cardiac intensive care laboratory fee, and the cost of managing torsade de pointes. The third-party payer calculation included all of the above plus the cardiologist and anesthesiologist fees.

RESULTS:

Fifty percent of patients with AF or AFl were successfully converted with ibutilide; 67% of these remained in sinus rhythm at hospital discharge. Three patients experienced nonsustained torsade de pointes; all resolved with pharmacologic management. From a hospital perspective, the cost of first-line ibutilide was greater than the cost of first-line EC ($280 vs. $138 per patient). However, from a third-party payer perspective, the use of ibutilide saved approximately $324 per patient ($718 vs. $1042).

CONCLUSIONS:

The efficacy and safety of ibutilide in the clinical setting are consistent with data reported in clinical trials. In contrast to a previous decision analysis, ibutilide was not associated with cost savings from a hospital perspective, but was from a payer perspective.
Treatment of Chronic Hepatitis C Virus Infection
Authors: Malnick Stephen DH , Beergabel Marc , Lurie Yoav
Published: June 2003

OBJECTIVE:

To review the literature on the treatment of chronic hepatitis C virus (HCV) infection. DATA SOURCES: MEDLINE search (1986–December 1999) using key words such as HCV, hepatitis, non-A and non-B hepatitis, as well as terms regarding treatment during that time period. DATA SYNTHESIS: HCV infection was initially treated with interferon monotherapy, but only a minority of patients responded to long-term therapy. A higher rate of response in both interferon-naïve patients and interferon-relapsers has been achieved by using the combination of interferon and ribavarin. Other treatment regimens including high-dose interferon protocols, ursodeoxycholic acid, amantadine, and nonsteroidal antiinflammatory drugs have been less promising. Many alternative therapies are being investigated.

CONCLUSIONS:

HCV infection is a major public health problem. It is now possible to achieve a cure in nearly 50% of the patients with this infection. Many additional therapies are being evaluated in order to achieve a higher cure rate.
Compatibility and Stability of Linezolid Injection Admixed with Three Quinolone Antibiotics
Authors: Zhang Yanping , Xu Quanyun A , Trissel Lawrence A , Williams Kimberly Y
Published: June 2003

OBJECTIVE:

To evaluate the physical compatibility and chemical stability of linezolid 200 mg/100 mL admixed with ciprofloxacin 400 mg, ofloxacin 400 mg, and levofloxacin 500 mg for seven days at 4 and 23 °C.

METHODS:

The test samples were prepared by adding the required amount of the quinolone antibiotic to bags of linezolid injection. Evaluations for physical and chemical stability were performed initially and after one, three, five, and seven days of storage at temperatures of 4 and 23 °C. Physical stability was assessed using visual observation in normal light and using a high-intensity monodirectional light beam. In addition, turbidity and particle content were measured electronically. Chemical stability of the drugs was evaluated by using stability-indicating HPLC analytical techniques.

RESULTS:

The linezolid admixtures with levofloxacin and ofloxacin were clear and pale yellow when viewed in normal fluorescent room light, and slightly hazy with a green cast when viewed using a Tyndall beam. Measured turbidity and particulate content were low and exhibited little change. HPLC analysis found no loss of the drugs in any sample stored at either temperature throughout the study. The linezolid admixtures with ciprofloxacin stored at room temperature (23 °C) were clear and nearly colorless in normal room light and when viewed using a Tyndall beam. They exhibited little or no change in measured turbidity or particulate content during the study period. HPLC analysis found no loss of either drug in seven days. However, the refrigerated samples were only compatible for 24 hours and developed a gross white precipitate thereafter.

CONCLUSIONS:

Admixtures of linezolid 200 mg/100 mL with levofloxacin 500 mg and with ofloxacin 400 mg were physically compatible and chemically stable for at least seven days stored at 4 and 23 °C. Admixtures of linezolid with ciprofloxacin 400 mg were compatible and stable for seven days at 23 °C, but ciprofloxacin precipitation occurred after 24 hours stored under refrigeration. Linezolid/ciprofloxacin admixtures should not be stored under refrigeration.
Metronidazole-Associated Pancreatitis
Authors: Sura Michael E , Heinrich Kathleen A , Suseno Mira
Published: June 2003

OBJECTIVE:

To report a case of acute reversible pancreatitis associated with metronidazole-treated aspiration pneumonia. CASE SUMMARY: A 61-year-old white woman requiring coronary artery bypass surgery developed acute pancreatitis following treatment with metronidazole for suspected postsurgical aspiration pneumonia. The patient developed moderate to severe bilateral upper quadrant abdominal pain; laboratory studies revealed elevated amylase and lipase concentrations four days following the initiation of metronidazole therapy. After discontinuation of metronidazole, the patient's abdominal pain subsequently improved, and both amylase and lipase concentrations immediately declined and were within normal limits within one week. DISCUSSION: An acute attack of pancreatitis is characterized by moderate to severe abdominal pain that may radiate to the back, accompanied by increased concentrations of pancreatic enzymes and few morphologic changes in the pancreas. Metronidazole is reported as having a probable association with acute pancreatitis, although the mechanism of drug-induced pancreatitis is not known. One speculative mechanism of metronidazole-induced pancreatitis is that, under aerobic conditions, metronidazole may undergo redox cycling and yield hydrogen peroxide, superoxide, and other free radicals. Such redoxactive compounds are toxic to pancreatic β -cells, and oxygen-centered free radicals have been implicated in the induction of pancreatitis. Other suggested mechanisms include immune-mediated inflammatory response, pancreatic duct constriction, and metabolic effects.

CONCLUSIONS:

Very few cases of metronidazole-associated pancreatitis have been reported, and the long-term sequelae are unknown. However, if metronidazole or any other drug is suspected as the causative agent in pancreatitis, it should be discontinued and rechallenge should be avoided.
Influence of β -Blockers on Mortality in Chronic Heart Failure
Authors: Hart Susan M
Published: June 2003

OBJECTIVE:

To briefly discuss the pathophysiology of heart failure and the rationale for the use of β -blockers in the treatment of chronic heart failure. Key morbidity reduction trials are briefly mentioned, and recent mortality reduction trials are reviewed. General recommendations regarding the use of β -blockers in heart failure are also included to guide clinical practice.

STUDY SELECTION/DATA EXTRACTION:

Randomized, placebo-controlled clinical trials and meta-analyses evaluating mortality reduction with β -blockers in the treatment of heart failure were identified using a MEDLINE search from January 1993 to March 2000. Abstracts and presented results from recent scientific meetings were also considered.

DATA SYNTHESIS:

β -Blockers have been shown to decrease hospitalization for worsening heart failure, decrease the need for heart transplant, improve New York Heart Association (NYHA) functional class, and increase left-ventricular ejection fraction. A mortality benefit has recently been demonstrated for patients with chronic heart failure. Carvedilol, bisoprolol, and controlled-release/ extended-release metoprolol decreased the risk of dying by 65%, 34%, and 34%, respectively, in patients with primarily NYHA functional class II or III and systolic dysfunction. The benefit of these agents in patients with class IV heart failure or determining whether one agent has an advantage over another is being investigated in ongoing clinical trials.

CONCLUSIONS:

Several β -blockers have demonstrated mortality reduction in the treatment of patients with NYHA functional class II or III heart failure and systolic dysfunction. β -Blockers should be considered in these patients when they are clinically stable and taking the current standard therapy of a diuretic plus an angiotensin-converting enzyme inhibitor or other vasodilator agent.
Disulfiram—Ethanol Induced Delirium
Authors: Park Charles W , Riggio Silvana
Published: June 2003

OBJECTIVE:

To report a case of delirium, without major autonomic symptoms, as the primary manifestation of concomitant use of alcohol while taking disulfiram.

CASE SUMMARY:

A 50-year-old white woman with a history of bipolar disorder, type I, and alcohol dependence being treated with disulfiram was admitted to an inpatient psychiatric unit with a three- to four-day history of a change in mental status, including deficits in orientation, concentration, and visual hallucinations. Significant finding on review of systems included the spurious report of a 9.1kg weight loss. Tachycardia and nonfocal neurologic signs on physical examination were also noted. Extensive metabolic, infectious, and neurologic work-up revealed no abnormalities that alone could explain the patients acute confusional state. It was subsequently discovered that the patient had imbibed alcohol on at least two separate occasions while taking disulfiram prior to her change in mental status and that a similar, although shorter, experience had occurred previously.

DISCUSSION:

This is the first case, to the authors knowledge, that describes an acute confusional state as the primary manifestation of a patient taking alcohol while being prescribed disulfiram as aversive therapy for alcohol abuse. Possible pathophysiologic mechanisms for delirium as a complication of alcohol ingestion while taking disulfiram include disturbances in various neuroendocrine axes, neurotransmitter systems, and metabolic derangements. Other reports of possible neuropsychiatric complications of disulfiram therapy are also reviewed.

CONCLUSIONS:

The differential diagnosis for the presentation of delirium in a patient known to be undergoing aversive therapy for alcohol dependence with disulfiram should include nonadherence to alcohol abstinence.
Head Lice Resistance: Itching That Just Won't Stop
Authors: Bartels Cathy L , Peterson Kristi E , Taylor Karyn L
Published: June 2003

OBJECTIVE:

To evaluate the reports of resistance and cross-resistance to pediculicides in the head louse ( Pediculus capitis), as well as the mechanisms involved.

DATA SOURCES:

Literature identified through a MEDLINE search (1966–April 2000) and through other secondary literature databases and/or bibliographies of pertinent articles.

DATA SYNTHESIS:

Head lice infestation is a common, worldwide problem. The widespread use of insecticide treatments together with inadequate treatment methods has led to a concern regarding the potential development of resistant head lice. This literature review examines the reports of resistance of the head louse as well as the purported mechanisms involved.

CONCLUSIONS:

Current research suggests that head lice resistance exists, but little is known regarding the actual incidence of this resistance or whether this incidence is increasing. More research is needed to assess the status of this problem. Proposed mechanisms for head lice resistance include knock-down resistance, glutathione S-transferase—based resistance, and mono-oxygenase-based resistance.
A Randomized, Crossover Comparison of Warfarin Products in the Treatment of Chronic Atrial Fibrillation
Authors: Weibert Robert T , Yeager Bryan F , Wittkowsky Ann K , Bussey Henry I , Wilson David B , Godwin John E , Adler David S , Black Elizabeth A , McGee Daniel L , Vlasses Peter H
Published: June 2003

OBJECTIVE:

To compare the dosing requirements and international normalized ratios (INRs) associated with two bioequivalent crystalline warfarin sodium products in patients with chronic atrial fibrillation.

METHODS:

A multicenter, single-blind (prescriber), randomized, crossover evaluation of Apothecon warfarin and DuPont warfarin (Coumadin) was conducted in consenting adults with chronic or paroxysmal atrial fibrillation who had been receiving DuPont warfarin chronically for the prevention of thromboembolism. Patients were randomly assigned to initially either continue DuPont warfarin or receive Apothecon warfarin for four weeks, with weekly evaluation of dosage and INR changes, safety, and efficacy. Subsequently, patients crossed over and received the other product for four weeks.

RESULTS:

There were 113 patients randomized to receive study treatment. Neither the propensity for a dosage change or an INR change nor the magnitude of a dosage change or INR change appeared related to a particular warfarin product (NS for each variable after each study period). After four weeks of treatment, the same number of patients (n = 7) experienced a ≥20% change in warfarin dosage from the respective baseline with each product. The number of patients with INRs outside the desired protocol range after four weeks of treatment was similar for both groups (<1.8, n = 9 for both products, or >3.2, n = 9 for DuPont, n = 10 for Apothecon). No major hemorrhagic or thromboembolic events occurred.

CONCLUSIONS:

The results of this study show that Apothecon warfarin and DuPont warfarin provide equivalent anticoagulation in patients with chronic or paroxysmal atrial fibrillation.
Intramuscular Ceftriaxone in the Treatment of Childhood Meningitis Due to Haemophilus InfluenzaeType F
Authors: Ratka Anna , Erramouspe John
Published: June 2003

OBJECTIVE:

To describe a case of meningitis caused by Haemophilus influenzaetype f (Hif) in a child.

CASE SUMMARY:

A 2.5-year-old white girl (18 kg) was hospitalized because of acute ataxia. The cerebrospinal fluid culture grew H. influenzae, which was later identified as type f. Therapy was limited by the inability to gain intravenous access. Treatment was initiated with dexamethasone 8 mg (0.44 mg/kg) intramuscularly, one dose on the day prior to initiation of ceftriaxone therapy, and intramuscular ceftriaxone 2 g (111 mg/kg/dose) once a day. After the first day, dexamethasone was administered at 3 mg (0.17 mg/kg/d) orally four × per day for four days. Within two days, the patient became afebrile and improved significantly. The remaining treatments were given during daily hospital visits on an outpatient basis. No complications occurred during the follow-up visits.

DISCUSSION:

The clinical presentation and therapeutic management of Hif meningitis is similar to that of H. influenzaetype b (Hib) meningitis. Factors that may predispose a child to infections caused by Hif include upper respiratory tract infections, day care attendance, Down syndrome, and immunodeficiency. Hif meningitis usually is treated with a third-generation cephalosporin (frequently ceftriaxone). Although most often administered intravenously, intramuscular ceftriaxone can provide a satisfactory clinical outcome in a child with adequate peripheral perfusion but limited intravenous access. The majority of reported cases of Hif meningitis resolve with appropriate antibiotic therapy; however, long-term neurologic sequelae occasionally occur.

CONCLUSIONS:

Hif occasionally causes pediatric meningitis. In a patient with good perfusion and difficult intravenous access, daily intramuscular administration of ceftriaxone can be an effective treatment option. In this case, Hif meningitis occurred abruptly and resolved within 48 hours of initiation of ceftriaxone and dexamethasone without long-term sequelae. The risks of giving dexamethasone appear to be minimal, although efficacy for preventing Hif complications remains to be proven.
Warfarin Resistance Due to Sulfasalazine
Authors: Teefy Anna M , Martin Janet E , Kovacs Michael J
Published: June 2003

OBJECTIVE:

To report a case of warfarin resistance associated with the use of sulfasalazine.

CASE SUMMARY:

A 37-year-old white woman on oral anticoagulant therapy with warfarin was being evaluated for complaints of joint pains. Her past medical history consisted of recurrent deep-vein thrombosis, asthma, and ulcerative colitis. Warfarin concentrations had consistently remained within the therapeutic range with dosages of approximately 30 mg per week. In an attempt to treat arthritis, her gastroenterologist replaced 5-aminosalicylic acid (5-ASA) with sulfasalazine 1000 mg four × daily. Subsequent to the medication changes, the international normalized ratio (INR) decreased and remained at subtherapeutic concentrations despite increases in the warfarin dosage. During this period, the patient developed a deep-vein thrombosis in the right popliteal vein. The INR did not return to an acceptable level until six weeks after sulfasalazine was started. The new warfarin dosage was 75 mg per week, a 250% dosage increase. When sulfasalazine was discontinued and 5-ASA reinstituted, the warfarin dosage requirements to achieve therapeutic INRs returned to weekly dosages of approximately 45 mg.

DISCUSSION:

Sulfonamides have been well documented to enhance the anticoagulant effect of warfarin. This patient developed a new deep-vein thrombosis due to failure in maintaining therapeutic INR levels after the recent introduction of sulfasalazine. We suspect that she developed warfarin resistance secondary to concomitant use of sulfasalazine. This patient demonstrated warfarin resistance as opposed to enhanced anticoagulant effect with sulfasalazine.

CONCLUSIONS:

Clinicians managing warfarin therapy should exercise caution when sulfasalazine is added to a patient's medical regimen. This case suggests a possible warfarin—sulfasalazine interaction that resulted in warfarin resistance.
Symptomatic Crystalluria Associated with Indinavir
Authors: Famularo Giuseppe , Toro Stefania Di , Moretti Sonia , De Simone Claudio
Published: June 2003

OBJECTIVE:

To report a case of severe and recurrent crystalluria resulting from the use of indinavir and to review the literature describing this adverse effect.

CASE SUMMARY:

A 26-year-old HIV-positive white woman had recurrent episodes of left-sided flank pain accompanied by dilation of the left renal collecting system while undergoing treatment with a triple-drug regimen including indinavir 1200 mg every 12 hours (full dosage). Typical indinavir crystalluria was observed, with no evidence of stones. Acute episodes were treated with intravenous fluids, diclofenac, and ciprofloxacin. Crystalluria and clinical symptoms eventually resolved with withdrawal of indinavir and substitution with a different protease inhibitor. Renal function remained normal.

DISCUSSION:

A wide spectrum of disorders of the urinary tract can occur in subjects taking indinavir, with potentially severe complications caused by crystalluria and stones. Indinavir is excreted in the urine; the low solubility of those crystals is the critical factor accounting for the risk of stone formation. An elevated pH with a reduced excretion of citric acid contributes to the low urinary solubility of indinavir. Pharmacokinetic interactions with other drugs, leading to elevated plasma concentrations of indinavir, and dehydration could also increase the risk of stone formation. The impact on renal function can be unfavorable over the long-term period. Cornerstones of treatment and prevention are increased fluid intake and possibly urinary acidification. Emergency drainage may be required for patients with severe obstruction. Reducing the dosage of indinavir has been proposed, but this carries the risk of viral mutations with development of resistance.

CONCLUSIONS:

Treatment with indinavir can result in crystalluria with potentially severe obstruction. All patients taking indinavir, not only those with documented crystalluria or renal effects from the drug, should greatly increase their fluid intake and have renal function checked at baseline and then monitored regularly. Urinalysis also should be performed regularly for appropriate monitoring and prevention.
Clinical and Economic Impact of Adverse Drug Reactions in Hospitalized Patients
Authors: Suh Dong-Churl , Woodall Betsy S , Shin Soung-Kook , Santis Evelyn R Hermes-De
Published: June 2003

OBJECTIVE:

To identify the classes of drugs that most commonly cause adverse drug reactions (ADRs) and the characteristics of these ADRs and to determine the economic impact of ADRs on patients' length of stay and hospitalization costs.

METHODS:

Data on ADRs from patients admitted to a hospital in New Jersey were collected, studied, and analyzed over a five-month period. To determine the economic impact of ADRs, patients who experienced ADRs during hospitalization were matched to controls. Each ADR was rated with regard to its severity, the patients' outcomes were determined, and specific classes of medications were identified as particularly causative of ADRs.

RESULTS:

A total of 196 patients experienced ADRs; 131 of these individuals were matched with 1338 patients who did not experience an ADR, based on their diagnosis-related group code. The leading causal drugs according to therapeutic class were antiinfective (17%), cardiovascular (17%), antineoplastic (15%), and analgesics/antiinflammatory agents (15%). The organ systems most often affected were gastrointestinal (24%), dermatologic (19%), and immune systems (15%). The mean length of stay per patient differed significantly between the ADR case group and matched control group (10.6 vs. 6.8 d; p = 0.003), as did the total hospitalization cost ($22 775 vs. $17 292; p = 0.025).

CONCLUSIONS:

Length of hospital stay and total hospitalization costs were significantly higher for patients experiencing ADRs than those who did not experience ADRs. ADR reporting systems in hospitals need to be changed and strengthened to decrease the incidence of avoidable reactions.
Intravenous Theophylline — An Alternative to Temporary Pacing in the Management of Bradycardia Secondary to AV Nodal Block
Authors: Cawley Michael J , Al-Jazairi Abdulrazaq S , Stone Elizabeth A
Published: June 2003

OBJECTIVE:

To report a case of bradycardia secondary to atrioventricular nodal block (AVNB) successfully treated with intravenous theophylline. Intravenous theophylline was used as an alternative to temporary pacing in a patient with sepsis secondary to thermal injury.

CASE SUMMARY:

A 79-year-old white woman with significant cardiac history was admitted with 14.5% total body surface area burns after a house fire. Cardiac events included intermittent episodes of sinus bradycardia complicated by the development of second-degree AVNB and periods of sinus arrest. Intravenous theophylline initiation maintained normal sinus rhythm without further episodes of sinus bradycardia or heart block, thus preventing the need for cardiac pacemaker placement.

DISCUSSION:

This is the first case published in the English-language literature describing the use of intravenous theophylline as an alternative therapy to temporary pacing in a patient with sepsis secondary to thermal injury. Bradyarrhythmic events in sepsis patients have been associated with catecholamine production increasing adenosine formation. High concentrations of adenosine in the areas of the sinoatrial or atrioventricular nodal regions may induce sinus bradycardia or AVNB. Theophylline, an adenosine antagonist, has been identified as a treatment option for such bradyarrhythmic events.

CONCLUSIONS:

Theophylline, a methylxanthine derivative, may represent an alternative to other pharmacologic therapies and temporary pacing in the treatment of bradycardia secondary to AVNB. These agents may represent a pharmacologic alternative in patients in whom other pharmacologic strategies or cardiac pacemaker insertion may be contraindicated.
Possible Serotonin Syndrome Associated with Clomipramine after Withdrawal of Clozapine
Authors: Zerjav-Lacombe Sylvia , Dewan Vijay
Published: June 2003

OBJECTIVE:

To report on the possible development of serotonin syndrome in a patient receiving clomipramine after clozapine was withdrawn from the treatment regimen.

CASE REPORT:

A 44-year-old white man with a 23-year history of undifferentiated schizophrenia and obsessive—compulsive behavior had been treated with clozapine and clomipramine for several years. He tolerated both agents together well, with the exception of experiencing chronic constipation. Clomipramine was tapered and reduced to 50 mg over a period of 10 days. A worsening of ritualistic behavior was noted, and the clomipramine dosage was increased to 150 mg/d over 14 days. Simultaneously with the clomipramine dosage increase, clozapine was tapered and stopped over a period of 19 days. The day after clozapine was stopped, while he was still receiving clomipramine 150 mg/d, he began behaving oddly, started sweating profusely, shivering, and became tremulous, agitated, and confused. He was diagnosed with possible serotonin syndrome; his symptoms resolved after clomipramine was stopped but before clozapine was restarted eight days later.

DISCUSSION:

There are similarities in symptoms between serotonin syndrome and clozapine withdrawal. This article discusses the reasons why this case may represent serotonin syndrome rather than clozapine withdrawal and the possible pharmacologic mechanisms involved.

CONCLUSIONS:

Clinicians should be aware that removing a serotonin-2a (5-HT2a) antagonist from a treatment regimen including an agent that increases serotonin in the synaptic cleft may worsen clozapine withdrawal or potentially result in serious adverse drug reactions, such as serotonin syndrome.
Drowsiness and Poor Feeding in a Breast-Fed Infant: Association with Nefazodone and its Metabolites
Authors: Yapp Patrick , Ilett Kenneth F , Kristensen Judith H , Hackett L Peter , Paech Michael J , Rampono Jonathon
Published: June 2003

OBJECTIVE:

To investigate whether adverse effects in a premature neonate could be attributed to nefazodone exposure via breast milk.

CASE SUMMARY:

The breast-fed white infant (female, 2.1 kg, 36 weeks corrected gestational age) of a 35-year-old woman (60 kg) taking nefazodone 300 mg/d was admitted to the hospital because she was drowsy, lethargic, unable to maintain normal body temperature, and was feeding poorly. A diagnosis of exposure to nefazodone via breast milk was considered only after other more likely diagnoses had been excluded. After breast feeding was discontinued, the infant's symptoms resolved slowly over a period of 72 hours. The maternal plasma and milk concentration—time profiles for nefazodone and its metabolites, triazoledione, HO-nefazodone, and m-chlorphenylpiperazine, were quantified by HPLC. The calculated infant dose for nefazodone and its active metabolites (as nefazodone equivalents) via the milk was only 0.45% of the weight-adjusted maternal nefazodone daily dose.

DISCUSSION:

Our data suggest a putative association between maternal nefazodone ingestion and adverse effects in a premature breast-fed neonate. The measured amount of drug exposure would normally be considered safe in a full-term infant. However, there was a temporal relationship between resolution of adverse effects in the infant and cessation of breastfeeding.

CONCLUSIONS:

This case highlights the importance of individualizing the risk—benefit analysis for exposure to antidepressants in breast milk, especially when dealing with premature neonates.
Ping Wei San, a Chinese Medicine for Gastrointestinal Disorders
Authors: Riedlinger June E , Tan Phyllis W , Lu Weidong
Published: June 2003

OBJECTIVE:

To describe the dilemma that American pharmacists face when their patient uses a traditional Chinese herbal formula. Ping wei san (PWS), an agent used to treat gastrointestinal disorders, is used to illustrate the problems encountered and to identify resources on Chinese herbal medicines available to pharmacists.

DATA SYNTHESIS:

In the US, Chinese herbal medicine is making its way into mainstream Western medicine. Patients may discover PWS in their search for a substitute for cisapride, which was partially withdrawn from the US market in July 2000. The pharmacist may be called on to assist in the management of patients who wish to use PWS for treatment of common gastrointestinal disorders like gastritis, esophageal reflux, gastric or duodenal ulcers, and acute or chronic enteritis. As with most other Chinese herbal formulas, English-language literature about PWS is limited and is often difficult to interpret. Pharmacists who are unfamiliar with the basic principles and terminology used in traditional Chinese medical practices will need to identify sources of information about this complementary alternative practice to be able to provide pharmaceutical care for patients taking a Chinese herbal formula like PWS.

CONCLUSIONS:

To develop a pharmaceutical care plan for patients using a Chinese herbal medicine therapy such as PWS, the pharmacist will need to become familiar with traditional Chinese medical practices and terminology describing indications, therapeutic effects, and risks. Fortunately, resources are available to pharmacists who need assistance in interpreting information on Chinese herbal therapies so that they can appropriately manage patients using them.
Celecoxib as Adjunctive Therapy for Treatment of Colorectal Cancer
Authors: North Ginnie Lee T
Published: June 2003

OBJECTIVE:

To describe the role of celecoxib as adjunctive therapy in the treatment of familial adenomatous polyposis (FAP), an inherited autosomal dominant predisposition syndrome for colorectal cancer.

DATA SOURCES:

Literature was evaluated through MEDLINE search (1995–March 2000) and through secondary sources, using the search terms celecoxib, cyclooxygenase-2 inhibitors, and familial adenomatous polyps.

DATA SYNTHESIS:

Observational studies have found a decreased rate of colorectal cancer in people who regularly took aspirin or other nonsteroidal antiinflammatory drugs (NSAIDs). The Food and Drug Administration granted accelerated approval in December 1999 for the NSAID celecoxib, a selective cyclooxygenase-2 (COX-2) inhibitor, for adjunctive therapy in patients with FAP, based on a six-month, randomized, controlled clinical trial.

CONCLUSIONS:

Aspirin and other NSAIDs reduce the incidence of colorectal cancer in the general population. Limited clinical studies in patients with FAP using nonaspirin NSAIDs have shown a reduction in polyp burden. A current clinical trial using celecoxib has also shown a reduction in polyp burden in patients with FAP. The long-term clinical impact of using a selective COX-2 inhibitor is not known, since celecoxib has not been studied beyond six months in patients with FAP. By reducing the polyp burden in FAP patients, celecoxib may be useful as adjunctive chemotherapy, in addition to routine endoscopic surveillance and surgery.
Effects of Heparin on Hypertonic Potassium Chloride—Induced Bronchoconstriction
Authors: Tutluoğlu Bülent , Gürbüz Nesrin , Atiş Sibel , Abanozlu Seher , Ibiş Raziye , Kanik Arzu
Published: June 2003

BACKGROUND:

Changes in bronchial osmolarity is a well-known factor for bronchoconstriction. Recently, nonisotonic aerosols have begun to be used for the assessment of bronchial hyperreactivity. Hypertonic KCl can cause bronchoconstriction even in non-symptomatic asthmatic patients.

OBJECTIVE:

To evaluate the protective role of heparin on hypertonic KCl-induced bronchospasm in asthma.

METHODS:

Thirty-eight asthmatic patients were included in this double-blind, placebo-controlled study. On day 1 of the study, after performing the respiratory function test (RFT), patients had inhaled KCl 10% and RFTs were done after 20 minutes. On day 2 of the study, after the basal RFT, 18 patients inhaled NaCl 0.9% 0.2 mL/kg solution. After the completion of this procedure, patients waited for 20 minutes and inhaled KCl 10% 10 mL, and RFTs were repeated 20 minutes later. The second group consisted of 20 patients who inhaled heparin 1000 units/kg after the RFTs were performed. Twenty minutes later, they inhaled KCl 10% and waited for 20 minutes. Finally, RFTs were done and compared with those from the other group.

RESULTS:

In the control group, forced expiratory volume in one second (FEV1) decreased 17.4% on day 1 and 16.4% on day 2. In the heparin-treated group, FEV1 decreased 18.6% on day 1, but almost no change occurred after this group was treated with heparin before inhalation of hypertonic KCl on day 2.

CONCLUSIONS:

Heparin was found to be highly protective against hypertonic KCl—induced bronchospasm in bronchial asthma.
Women in Pharmacy: Twenty-Five Years of Growth
Authors: Henderson Metta Lou
Published: June 2003

In the last 25 years, the number of women pharmacists has increased. Some of the predictions concerning the impact of these women on the profession of pharmacy have proven to be true. The issues presented in the predictions, a decline in manpower, a decrease in pharmacists' salaries, and a lack of leadership, are discussed. Pharmacy education and the increased number of women faculty members illustrate the changes that have occurred. These changes will have a positive impact on the pharmacy profession.
Implanon: A Critical Review
Authors: Le Jennifer , Tsourounis Candy
Published: June 2003

OBJECTIVE:

To evaluate clinical information on Implanon as a long-term method of contraception and, specifically, to review the efficacy and adverse effect profile of Implanon.

DATA SOURCES:

A MEDLINE search (from 1966 through June 1999) was performed to retrieve primary and review articles. The search was limited to data on human subjects. Some references were identified through secondary sources.

STUDY SELECTION AND DATA EXTRACTION:

Pharmacokinetic and pharmacodynamic studies, and clinical trials assessing the efficacy and safety of desogestrel implants were reviewed. Relevancy and consistency of information was assessed for each trial.

DATA SYNTHESIS:

Implanon is the newest contraceptive implant system that has completed worldwide Phase III clinical trials. It is a single rod that contains a core of 68 mg of 3-keto-desogestrel with a membrane of ethylene vinyl acetate. Inhibition of ovulation occurs within one day of implantation, and effective contraception lasts for three years. Fertility returns within one month after implant removal. Insertion and removal by trained medical professionals is simple, and only minor complications have been documented. Adverse effects are mild and primarily consist of abnormal bleeding, weight gain, acne, breast pain, and headache.

CONCLUSIONS:

The data on Implanon indicate that it provides effective long-term contraception with limited adverse effects. It appears to be a good addition to the currently available contraceptives.
Nelfinavir Desensitization
Authors: Abraham Prasad E , Sorensen Suellyn J , Baker William H , Cushing Herbert E
Published: June 2003

OBJECTIVE:

To report the first case of nelfinavir desensitization in an HIV patient who was intolerant to protease inhibitors.

CASE SUMMARY:

A 43-year-old HIV-positive white man was treated with several protease inhibitors. The patient developed rashes in response to all protease inhibitors. His viral load was controlled only in the presence of a protease inhibitor. The patient tolerated nelfinavir longer than the other agents; therefore, the decision was made to attempt to desensitize him to nelfinavir. A six-hour inpatient protocol was used, and he tolerated the procedure without event. His disease is now well managed without recurrence of the rash.

DISCUSSION:

The use of protease inhibitors has had a major impact on the morbidity and mortality of HIV-infected patients. Despite their benefits, this class of drugs is not without adverse effects. Allergic reactions in the form of rashes may develop, which can severely limit treatment options in HIV patients. We report the first case of rapid desensitization of nelfinavir in a patient who developed rashes to several protease inhibitors.

CONCLUSIONS:

Intolerance to protease inhibitors due to rash is a well-documented phenomenon. In HIV patients, this can limit treatment options severely. This case demonstrates how desensitization to nelfinavir can be performed successfully.
Lithium Intoxication Due to Carbamazepine-Induced Renal Failure
Authors: Mayan Haim , Golubev Nina , Dinour Dganit , Farfel Zvi
Published: June 2003

OBJECTIVE:

To report the case of a patient with manic—depressive disorder who developed lithium intoxication following carbamazepine-induced acute renal failure.

CASE SUMMARY:

A 33-year-old white man with bipolar manic—depressive disorder was treated with lithium for the last 18 months. Three weeks prior to admission, carbamazepine 600 mg was added to the drug regimen due to a recurrence of the psychiatric disorder. He was admitted with signs of lithium intoxication. Acute renal failure due to carbamazepine-induced interstitial nephritis was diagnosed.

DISCUSSION:

The combination of carbamazepine and lithium is known to cause neurotoxicity. We describe a different interaction in which the toxic lithium concentrations were the result of carbamazepine-induced acute renal failure.

CONCLUSIONS:

When considering adding carbamazepine to lithium, careful follow-up of the patients is warranted to prevent this indirect drug interaction.
Is the Sildenafil Product Information Adequate to Facilitate Informed Therapeutic Decisions?
Authors: Cohen Jay S
Published: June 2003

BACKGROUND:

Optimal therapeutics and the prevention of adverse drug effects begin with complete information. When new drugs are released, the manufacturer's product information is the main and often only readily available source of drug information and, therefore, greatly influences treatment strategies. Thus, it is vital that the information in the package insert is not only complete, but also as relevant as possible for the great diversity of patients that physicians encounter.

OBJECTIVE:

To review the product information for sildenafil for comprehensiveness and accuracy, with respect to whether the information is sufficient to facilitate optimal therapeutics and to prevent avoidable adverse events in the wide diversity of patients with erectile dysfunction seen in clinical practice.

DATA SOURCES:

Sildenafil package inserts, unpublished information provided by the manufacturer, Food and Drug Administration reports, and articles retrieved through MEDLINE through March 2000.

DATA SYNTHESIS:

Deficiencies or inaccuracies persist in the sildenafil product information regarding sildenafil's effects on blood pressure; potential drug interactions with cimetidine, protease inhibitors, some antihypertensive drugs, alcohol, and drugs that may competitively inhibit cytochrome P450 pathways; and recommended sildenafil doses for older patients.

CONCLUSIONS:

For physicians to practice optimal therapeutics, adequate, clinically relevant drug information is required. Several brief changes and additions in the sildenafil product information would assist physicians in making therapeutic decisions regarding the use of sildenafil in a very diverse patient population and in avoiding preventable adverse events.
Fluconazole Dose Recommendation in Urinary Tract Infection
Authors: Boedeker Kimi S , Kilzer Wanda J
Published: June 2003

OBJECTIVE:

To identify the most appropriate dose of fluconazole for the treatment of symptomatic fungal urinary tract infection (UTI).

DATA SOURCES:

Primary literature identified through MEDLINE (1990–June 2000). Key search terms included fluconazole and urinary tract infection.

DATA SYNTHESIS:

Fluconazole is approved for the treatment of candidal UTIs, but dosage recommendations are not consistent. An evaluation of clinical studies of fluconazole for the treatment of candidal UTI was performed.

CONCLUSIONS:

Questions remain about the optimal dosing of fluconazole, including the most appropriate dose in non-albicans species of candida as well as the optimal duration of therapy. Until further studies are performed, a fluconazole 200-mg loading dose followed by 100 mg/d for at least four days appears to be the most appropriate dose for the treatment of symptomatic candidal UTI in patients without systemic fungal infection or severe renal failure.
Mood Disorders Associated with Interferon Treatment: Theoretical and Practical Considerations
Authors: Malek-Ahmadi Parviz
Published: June 2003

OBJECTIVE:

To review the theoretical and clinical aspects of mood disorders associated with interferon treatment and discuss their management.

DATA SOURCES:

Pertinent and selected laboratory/clinical studies, review articles, letters, abstracts, and book chapters on behavioral and mood-related adverse effects of interferons published in English-language journals in the past two decades were identified by MEDLINE (June 1980–June 2000) and manual searches.

DATA SELECTION AND DATA EXTRACTION:

All of the publications identified were reviewed, and the relevant data were included. Studies not using criteria for psychiatric diagnosis or instruments for psychiatric monitoring were excluded.

DATA SYNTHESIS:

Clinical observations and limited research data suggest that interferon treatment may be associated with mood disorders. Mood-related symptoms induced by interferons emerge in a few days or weeks and tend to be dose dependent. Their severity may necessitate discontinuation of interferon therapy and/or the use of antidepressant or antimanic agents. The mechanisms responsible for inducing or exacerbating mood disorders in interferon-treated patients have not been elucidated. There is limited evidence implicating alterations in the serotonin system.

CONCLUSIONS:

While interferon therapy may trigger or induce mood-related symptoms, preexisting or stable concurrent mood disorders in remission do not necessarily constitute a contraindication to treatment with interferons. Mood disorders associated with interferon treatment can present clinical challenges. However, they may promote our understanding of mood disorders in the context of the current biologic theories of depression and mania.
Olanzapine-Induced Hyperglycemic Nonketonic Coma
Authors: Roefaro John , Mukherjee S Mimi
Published: June 2003

OBJECTIVE:

To report a case of olanzapine-induced hyperglycemia leading to a hyperosmolar, hyperglycemic, nonketonic coma.

CASE SUMMARY:

A 51-year-old, 85.5-kg (ideal body weight 79.9 kg), white man presented to a Veterans Affairs hospital with a serum glucose concentration of 1596 mg/dL. Soon thereafter, he went into a hyperosmolar, hyperglycemic, nonketonic coma. Olanzapine therapy had been instituted less than six months prior to this event; approximately two months before this event, his blood glucose was 108 mg/dL. Eight days after stopping olanzapine, the glucose concentration returned to normal, and the patient no longer required insulin nor any other glucose-lowering agents.

DISCUSSION:

The insulin resistance caused by olanzapine is normally attributed to the weight gain associated with the drug. In this patient, it appears that olanzapine caused hyperglycemia by a mechanism other than weight gain.

CONCLUSIONS:

This case report and others from the literature suggest that olanzapine therapy may induce hyperglycemia in some patients.
Lack of Methemoglobinemia with Flutamide
Authors: Schulz Martin , Schmoldt Achim , Donn Folkert , Becker Hermann
Published: June 2003

OBJECTIVE:

To determine whether the nonsteroidal antiandrogenic drug flutamide is a clinically relevant inducer of methemoglobinemia in patients with prostatic cancer.

METHODS:

Fifty consecutive outpatients with prostatic cancer stage D2 entered the study (age 71.1 ± 7.3 y). Five patients were lost to follow-up; the remaining 45 patients received the recommended oral dose of flutamide 250 mg three × daily. Total hemoglobin (Hb) and methemoglobin (Met-Hb) concentrations were measured on varying days using an ultraviolet/visible-spectrophotometric method with an intra- and interday variability <8%. In 12 patients, Met-Hb was analyzed before initiating flutamide therapy and after therapy was begun.

RESULTS:

On average, 2.6 venous blood samples per patient were analyzed with a mean Met-Hb concentration of 1.9% of total Hb. Mean concentrations of ⩾ 3% were detected in only six patients (13%). The data from 12 patients evaluated before and after initiating flutamide therapy were without significantly different changes. During the study period, no clinical signs of methemoglobinemia were reported or observed.

CONCLUSIONS:

This study found no clinically relevant increase of Met-Hb concentrations in elderly patients with prostatic cancer during chronic treatment with flutamide. However, clinicians should be aware of the very rare possibility of flutamide-induced methemoglobinemia.
Successful Use of Donepezil for the Treatment of Dementia with Lewy Bodies
Authors: Rojas-Fernandez Carlos H
Published: June 2003

OBJECTIVE:

To report a case of the successful use of donepezil for treatment of cognitive and noncognitive symptoms in a patient with dementia with Lewy bodies.

CASE SUMMARY:

An 86-year-old white woman with dementia was experiencing early-onset significant fluctuation of her cognitive status, functional impairment, visual hallucinations, aggression, and parkinsonism. She was initially diagnosed with Alzheimer disease and Parkinson's disease and prescribed donepezil 5 mg/d and benztropine 1 mg twice daily. On reexamination of the case by a neurologist, the diagnoses were revised to dementia with Lewy bodies. The benztropine was discontinued, and donepezil was increased to 10 mg/d. The patient's cognitive and functional status significantly improved, as did her visual hallucinations.

DISCUSSION:

This case supports previous reports of the marked responsiveness of patients with dementia with Lewy bodies to acetylcholinesterase inhibitors. This may be explained by the marked cholinergic deficit observed in patients with dementia with Lewy bodies and the evidence linking cognitive as well as noncognitive symptoms to this deficit.

CONCLUSIONS:

The present case suggests that patients with dementia with Lewy bodies respond well to acetylcholinesterase inhibitors. Controlled trials are necessary to further define the role of these drugs for this disease.
Megestrol-Induced Cushing Syndrome
Authors: Caparrós Gracia Cruz , Zambrana Jose L , Delgado-Fernández Marcial , Díez Felipe
Published: June 2003

OBJECTIVE:

To report a case of Cushing syndrome associated with megestrol acetate therapy in a patient with renal insufficiency.

A 17-year-old boy with renal insufficiency due to unilateral renal agenesis developed Cushing syndrome and worsening of his renal function after megestrol acetate therapy. The diagnosis was based on clinical and analytical evaluation.

DISCUSSION:

Megestrol acetate is indicated for the treatment of cachexia associated with AIDS and malignancy. Due to its glucocorticoid activity, megestrol use has resulted in the occurrence of Cushing syndrome in both patient groups. We report the case of a young patient with renal insufficiency due to unilateral renal agenesis who developed Cushing syndrome two months after administration of high-dose (900-mg/d) megestrol acetate for an eating disorder.

CONCLUSIONS:

The risk of megestrol-induced Cushing syndrome, especially with high doses of the medication, should be considered as a possible adverse effect in patients with renal insufficiency.