bluuebunny/crossref_metadata_2025 huggingface dataset:
Possible Hypothyroidism Associated with Quetiapine
Authors: Feret Brett M , Caley Charles F
Published: June 2003

OBJECTIVE:

To report a case of hypothyroidism occurring after the addition of quetiapine to an existing drug regimen.

CASE SUMMARY:

A 46-year-old African-American woman diagnosed with schizoaffective disorder, bipolar type, and a four-year history of successfully treated hyperthyroidism, was suboptimally responsive to olanzapine treatment. Transition from olanzapine to quetiapine was initiated and, approximately two months after adding quetiapine to a standing pharmacotherapeutic regimen, the patient developed an elevated thyroid-stimulating hormone (TSH) concentration of 8.45 μU/L. A diagnosis of hypothyroidism was subsequently made, treatment with levothyroxine was initiated, and the patient's thyroid function became stable.

DISCUSSION:

Drug-induced hypothyroidism is known to occur with several medications. Quetiapine is an atypical antipsychotic with the potential to decrease thyroid hormone concentrations in some patients; this effect may be dose related. Despite this known adverse effect, the manufacturer of quetiapine reports that elevated TSH concentrations and subsequent treatment with thyroid hormone supplementation have occurred only rarely. We report the development of hypothyroidism in a patient who had previously received successful radioactive iodine treatment for hyperthyroidism in 1994, but who had no detected thyroid abnormalities until treatment with quetiapine was started four years later.

CONCLUSIONS:

Patients with compromised thyroid function who receive treatment with quetiapine may develop hypothyroidism. Appropriate care for these patients may include an increased awareness of possible hypothyroidism and consideration of thyroid function monitoring.
Performance of Three Blood Glucose Meters
Authors: Rheney Catherine C , Kirk Julienne K
Published: June 2003

OBJECTIVE:

To evaluate the performance of three blood glucose meters.

METHODS:

The One Touch II (LifeScan, Milpitas, CA), Glucometer Elite (Bayer, Elkhart, IN), and Accu-Chek Advantage (Boehringer Mannheim, Indianapolis, IN) were compared with a reference laboratory method (Technicon Chem System, Tarrytown, NY). Blood glucose meters used in this study were validated by a clinically oriented approach known as the error grid analysis (EGA), for which the performance of the meters was compared to a laboratory standard, and by the criteria of the American Diabetes Association (ADA). Limits of agreement were evaluated using differences from the reference laboratory method and 95% CIs. Capillary blood was obtained from study participants in fasting state with the morning blood draw and tested on the three meters simultaneously.

RESULTS:

A total of 120 blood glucose meter readings were analyzed; values ranged from 62 to 396 mg/dL. For all three meters, at least 75% of the capillary blood glucose values fell into zone A (acceptable) of the EGA. The number of values falling into zone B (unacceptable) were 10, 8, and 6 for the Accu-Chek Advantage, the One Touch II, and the Glucometer Elite, respectively. Only 15–25% of the meter glucose readings met the ADA criteria of being within 5% of the laboratory standard. The mean difference from the reference values was least with the Glucometer Elite.

CONCLUSIONS:

The majority of blood glucose determinations obtained on the meters used in this study were within the acceptable limits using the EGA. The Glucometer Elite meter had the fewest values in the unacceptable range and had the least mean difference from reference laboratory values.
Anthropometric and Pharmacotherapeutic Variables on Acute Emesis Induced by Cisplatin-Containing Chemotherapy
Authors: Arlandis José Luis Catalán , Torres N Víctor Jiménez
Published: June 2003

OBJECTIVE:

To characterize the effects of anthropometric and pharmacotherapeutic variables on acute emesis induced by cisplatin-containing regimens with dosages ·50 mg·m−2.

METHODS:

A prospective, cross-sectional, noncontrolled study was performed to analyze acute vomiting during the first 24 hours in patients treated in a Spanish hospital. The patients received an intravenous combination of drugs (2 doses of metoclopramide 3 mg/kg, dexamethasone 20 mg) as first-choice antiemetic therapy. Intravenous ondansetron 8 mg and dexamethasone 20 mg served as an alternative regimen in patients <30 years old with a history of extrapyramidal manifestations or emesis in previous cycles. Therapeutic failure was used as a dependent variable, defined as three or more vomiting episodes documented by the patients. Other variables were the chemotherapeutic regimen; antiemetic regimen; patient gender, age, weight, and height; and cycle number. The reference logistic model and two reduced-models derived from the latter were designed. The logistic models were subsequently validated by means of receiving operating characteristic curves.

RESULTS:

A total of 319 cycles involving 106 patients were studied. The metoclopramide regimen was administered in 66% of the cycles. The therapeutic failure rate was 21% for the metoclopramide regimen and 32% for the ondansetron treatment. The logistic model developed identified the type of chemotherapeutic regimen provided as the most significant prognostic variable (p < 0.0001). Patient weight (odds ratio 1.64) and height (odds ratio 1.28) were identified as prognostic factors related with therapeutic failure.

CONCLUSIONS:

The type of chemotherapeutic regimen administered and the anthropometric characteristics of the patients exert a clear conditioning effect on risks associated with therapeutic failure against acute emesis following high-dose cisplatin therapy. Such anthropometric parameters have not been previously identified as prognostic factors.
Outpatient Carboplatin Desensitization in a Pediatric Patient with Bilateral Optic Glioma
Authors: Sims-McCallum Rosalyn P
Published: June 2003

OBJECTIVE:

To report a case of successful outpatient carboplatin desensitization in a pediatric patient with bilateral optic glioma.

CASE SUMMARY:

A 10-year-old white girl with bilateral optic glioma developed a hypersensitivity reaction to carboplatin after nine courses. She had received 18 courses six years earlier without incident. A desensitization regimen was administered, and she has tolerated all subsequent courses of carboplatin therapy.

DISCUSSION:

Carboplatin is an important chemotherapeutic agent in the treatment of a variety of pediatric brain tumors. It is usually given in an outpatient setting. Hypersensitivity to this agent appears to develop after frequent exposure such as with the once-weekly regimens often used to treat brain tumors in pediatric patients.

CONCLUSIONS:

Carboplatin desensitization can be successfully performed on an outpatient basis with close observation and cardiorespiratory monitoring. This regimen could prove useful for other patients who develop hypersensitivity reactions to carboplatin and allow therapy to continue.
Epididymo-Orchitis following Intravesical Bacillus Calmette–Guérin Therapy
Authors: Menke Jennifer J , Heins Jodi R
Published: June 2003

OBJECTIVE:

To describe a case of epididymo-orchitis that developed four years after treatment with intravesical bacillus Calmette–Guérin (BCG) and to review the incidence of this adverse effect.

DATA SOURCES:

Information about the patient was obtained from the medical chart. A MEDLINE search of English-language literature (from January 1976 to April 1999) was conducted.

STUDY SELECTION:

All case reports of BCG-related epididymo-orchitis were evaluated. Review articles describing complications of BCG therapy for bladder cancer and the prevention and treatment of these complications were reviewed.

DATA EXTRACTION:

Studies were evaluated for reports of BCG-related epididymo-orchitis and its treatment.

DATA SYNTHESIS:

Our case report is compared with others reported in the literature. The incidence of BCG-associated epididymo-orchitis is rare.

CONCLUSIONS:

Epididymo-orchitis should be considered as a late complication of BCG therapy for bladder cancer. Proper patient selection may help decrease the risk of complications from BCG therapy.
Pharmacists' Understanding of Patient Education on Metered-Dose Inhaler Technique
Authors: Erickson Steven R , Landino Heather M , Zarowitz Barbara J , Kirking Duane M
Published: June 2003

OBJECTIVE:

To assess pharmacists' attitudes, beliefs, and knowledge about assessing and educating patients regarding metered-dose inhaler (MDI) technique; to determine frequency of MDI assessment and teaching behavior; and to assess the effect of an asthma pharmaceutical care educational program on the same variables six months later.

DESIGN:

Questionnaire completed before and six months after the educational intervention.

SETTING:

Pharmacies based in clinics owned by a healthcare system located in communities of a large metropolitan area.

MAIN OUTCOMES MEASURES:

Pharmacists' self-reported frequency of assessment and education; attitudes and beliefs about assessing and educating patients using MDIs; and knowledge of MDI technique.

RESULTS:

The survey response rate was 53.7% (n = 39) for baseline and 43% (n = 32) for follow-up. Most pharmacists (85.4% at baseline, 87.5% at follow-up; p = 0.79) indicated that they educate patients receiving new MDI prescriptions. In addition, 47.4% at baseline and 68.8% at follow-up indicated they educate patients using inhalers for three months (p = 0.07). Only 21.1% at baseline and 18.8% at follow-up (p = 0.81) indicated that they follow up with long-term users. The mean ± SD MDI technique knowledge score (steps correct out of 9 possible) at baseline was 7.2 ± 1.1 and 7.5 ± 1.3 at follow-up (p = 0.29). Significant changes in level of agreement with some beliefs/attitudes were observed, including the importance of frequently assessing/educating patients, confidence and comfort when assessing/educating patients, and that assessing/educating patients is not the role of only the physician. Respondents continued to acknowledge that MDI education and assessment are important to improving and maintaining control of disease. However, the respondents thought that barriers exist that inhibit this activity, such as not enough time for education and assessment.

CONCLUSIONS:

Pharmacists reported they frequently educate patients and assess MDI technique for new prescriptions but not very often for patients recently started, as well as for long-term users. Six months after an educational program, attitudes and beliefs toward this activity were either not changed or, in some, improved. Pharmacists perceive that there is not enough time to assess and educate patients who use MDIs.
Hyperventilation Associated with Quetiapine
Authors: Shelton Penny S , Barnett Faith L , Krick Stacie E
Published: June 2003

OBJECTIVE:

To describe a case of hyperventilation associated with the administration of quetiapine.

CASE SUMMARY:

A 69-year-old African-American woman admitted to a psychiatric hospital for treatment of major depression with psychotic features was treated and successfully discharged with quetiapine, along with metronidazole and miconazole to treat bacterial/monilial vaginitis. Three days after discharge, the patient presented to a community hospital with shortness of breath and hyperventilation. The patient was admitted and treated for tachypnea and acute respiratory alkalosis. During this hospitalization, the patient was noted to have increased respiratory rate following the administration of quetiapine.

DISCUSSION:

Hyperventilation was reported during the clinical trials of quetiapine; however, this is the first published report to date. Serotonin is involved both centrally and peripherally in the regulation of respiration. A contributing factor in this case may have been the concomitant administration of metronidazole, which inhibits the cytochrome P450 enzyme (CYP3A4) also responsible for the metabolism of quetiapine.

CONCLUSIONS:

The development of hyperventilation and respiratory alkalosis was associated with the administration of quetiapine.
The Role of Carnitine Supplementation during Valproic Acid Therapy
Authors: Raskind Jackie Y , El-Chaar Gladys M
Published: June 2003

OBJECTIVE:

To review the pathophysiology and significance of valproic acid–induced carnitine deficiency; to present and evaluate the literature pertaining to carnitine supplementation in pediatric patients receiving valproic acid; and to present the consensus guidelines for carnitine supplementation during valproic acid therapy.

DATA SOURCES:

A MEDLINE search (1966–December 1998) restricted to English-language literature, using MeSH headings of carnitine and valproic acid, was conducted to identify clinically relevant articles. Selected articles and references focusing on the pediatric population were included for review.

DATA EXTRACTION:

Study design, patient population, methods, and clinical outcomes were evaluated.

DATA SYNTHESIS:

Valproic acid, a widely used antiepileptic agent in the pediatric population, is limited by a 1/800 incidence of fatal hepatotoxicity in children under the age of two years. Carnitine is an essential amino acid necessary in β-oxidation of fatty acids and energy production in cellular mitochondria. It has been hypothesized that valproic acid may induce a carnitine deficiency in children and cause nonspecific symptoms of deficiency, hepatotoxicity, and hyperammonemia. Relevant published case reports and trials studying this relationship are evaluated, and a consensus statement by the Pediatric Neurology Advisory Committee is reviewed.

CONCLUSIONS:

Despite the lack of prospective, randomized clinical trials documenting efficacy of carnitine supplementation in preventing valproic acid–induced hepatotoxicity, the few limited studies available have shown carnitine supplementation to result in subjective and objective improvements along with increases in carnitine serum concentrations in patients receiving valproic acid. The Pediatric Neurology Advisory Committee in 1996 provided more concrete indications on the role of carnitine in valproic acid therapy, such as valproic acid overdose and valproic acid–induced hepatotoxicity. Carnitine was strongly recommended for children at risk of developing a carnitine deficiency. Although carnitine has been well tolerated, future studies are needed to evaluate the efficacy of prophylactic carnitine supplementation for the prevention of hepatotoxicity.
Frequency of Cutaneous Reactions on Rechallenge with Nevirapine and Delavirdine
Authors: Gangar Mona , Arias Gabriela , O'Brien John G , Kemper Carol A
Published: June 2003

OBJECTIVE:

To determine the frequency of cutaneous reactions in a group of HIV-infected adults attending a public hospital HIV clinic who received nevirapine, delavirdine, or both, as well as the consequences of rechallenge with the same or alternative agent.

DESIGN:

The medical records of patients who had received either or both agents between March 1997 and July 1998 were reviewed, including 69 patients who initially received nevirapine and 20 who initially received delavirdine. Gender, ethnicity, HIV status, and plasma HIV RNA concentrations were analyzed as risk factors for the development of rash.

RESULTS:

The overall incidence of rash attributed to the initial use of one of these drugs was 37.1%. While rash due to delavirdine occurred more often, the rash due to nevirapine was more severe and resulted in hospitalization more frequently. There was a trend toward a higher frequency of rash in Latinos and possibly in women, but HIV status, CD4+ cell counts, and plasma HIV RNA were not risk factors for the development of rash. Drug therapy was temporarily or permanently discontinued because of rash in 19 of 69 (28%) and in five of 20 (25%) patients initially receiving nevirapine or delavirdine, respectively. Rash recurred in six of eight (75%) patients rechallenged with the same agent, and in seven of 10 (70%) who were crossed over to the alternative agent because of rash. Fever, in the absence of any apparent cause, was a significant predictor for the development of rash in patients receiving nevirapine.

CONCLUSIONS:

There is probably little value in attempting to retreat patients with cutaneous reactions, even with the alternative agent, except in patients with limited treatment options.
Incidence of Intravenous Site Reactions in Neurotrauma Patients Receiving Valproate or Phenytoin
Authors: Anderson Gail D , Lin Yixin , Temkin Nancy R , Fischer James H , Winn H Richard
Published: June 2003

OBJECTIVE:

To determine the incidence of intravenous site reactions to phenytoin and valproate in a large population of patients with neurotrauma.

DESIGN:

Retrospective chart review of two double-blind, randomized clinical trials evaluating the use of antiepileptic drugs to prevent posttraumatic seizures in patients with neurotrauma: phenytoin versus placebo (n = 390), and valproate versus phenytoin with placebo (n = 385). Information collected from the charts included the number, type, and location of intravenous lines and intravenous site events.

SETTING:

Tertiary care trauma and university teaching hospital.

MAIN RESULTS:

Intravenous site reactions occurred in 18% and 25% of patients receiving valproate or phenytoin, respectively, with the majority of events (70%) occurring in the first intravenous site. Patients received the neurosurgery study drug (NSSD) by either central or peripheral lines; all intravenous site reactions occurred in peripheral administration sites. When patients who received the drug by central line during the course of therapy were excluded, the estimated incidence of site reactions was 21% and 30% for valproate and phenytoin, respectively (p = 0.056). The time to the first event was shorter with phenytoin compared with valproate (2.0 ± 1.3 vs. 3.0 ± 1.9 d; p = 0.009). Fewer adverse events were noted with phenytoin in the phenytoin-without-valproate study than in the phenytoin-with-valproate study, with 4.3% and 8.2% of intravenous site events recorded in patients receiving placebo or phenytoin, respectively. There was no significant difference in the number of intravenous lines per patient used during NSSD drug infusion for phenytoin versus placebo or phenytoin versus valproate.

CONCLUSIONS:

Both intravenous phenytoin and valproate resulted in intravenous site reactions, with the loading doses responsible for the majority of the events.
Selective Prescribing of Spasmolytics
Authors: Movig Kris LL , Egberts Antoine CG , Lenderink Albert W , Leufkens Hubert GM
Published: June 2003

BACKGROUND:

Daily clinical practice often differs largely from the clinical trial setting, so extrapolation of outcomes from trial data, such as safety, effectiveness, and economic outcomes, can be deceptive. Prescribers may intend to treat a selected group of patients with new drugs; this practice could result in significant bias in assessing outcomes of these agents during their use in daily clinical practice.

OBJECTIVE:

To evaluate what type of patient received tolterodine compared with the spasmolytic drugs previously marketed (oxybutynin, flavoxate, emepronium).

DESIGN:

An observational, follow-up study.

SETTING:

Eighteen collaborating community pharmacies.

PATIENTS:

Aged ≥18 years, noninstitutionalized; initial therapy with tolterodine, oxybutynin, flavoxate, or emepronium.

RESULTS:

Tolterodine was often used as a second-line and even as a third-line treatment, and was prescribed to a “polluted” population in terms of concomitant psychotropic medication. Tolterodine users were 7.5 times more likely to have received another spasmolytic drug (RR 7.5, 95% CI 4.8 to 11.9). In addition, these patients more frequently used antiparkinsonian drugs (RR 4.1, 95% CI 1.6 to 10.4) as well as antipsychotic drugs (RR 2.9, 95% CI 1.4 to 6.2). There was a small difference in concomitant use of antidepressants and benzodiazepines between patients receiving tolterodine versus those taking other spasmolytic drugs.

CONCLUSIONS:

Tolterodine is prescribed for a population differing from that receiving previously marketed spasmolytic drugs. Selective prescribing should be recognized when evaluating new drugs in daily clinical practice. Policy makers, such as pharmacy and therapeutics committees, should consider this aspect in their formulary decisions since selective prescribing can lead to unjustified conclusions about a drug's therapeutic effects (e.g., efficacy, safety, cost-effectiveness).
Stability of Dapsone in Two Oral Liquid Dosage Forms
Authors: Nahata Milap C , Morosco Richard S , Trowbridge James M
Published: June 2003

OBJECTIVE:

Dapsone use in pediatric patients is increasing; however, the currently available tablet dosage form cannot be used in young children. The objective of our study was to determine the stability of dapsone in two oral suspensions stored at two temperatures.

METHODS:

Commercially available dapsone tablets (25 mg) were used to prepare the suspensions: the first in simple syrup and water with citric acid, the second in 1:1 Ora Sweet:Ora Plus to yield a concentration of 2.0 mg/mL. The dosage forms were stored in 10 amber plastic prescription bottles. Five were stored at 25 °C and five at 4 °C. Three samples were taken from each of five bottles at 0, 7, 14, 28, 42, 56, 70, and 91 days (n = 15). Dapsone concentrations in each sample were measured in duplicate by a validated and stability-indicating HPLC method; the pH of each sample was also determined. The drug was considered stable if the mean concentration ≥90% of the original concentration.

RESULTS:

The mean concentrations of dapsone were >95% of the initial concentrations for 91 days at both 4 °C and 25 °C in each suspension. There was a slight darkening of the samples stored at 25 °C.

CONCLUSIONS:

Dapsone was stable in two suspensions prepared from commercially available tablets for at least three months at 4 °C and 25 °C.
The Effect of Helicobacter Pylori Eradication on NSAID-Induced Gastrointestinal Toxicity
Authors: Kanji Salmaan , Dumo Peter
Published: June 2003

OBJECTIVE:

To review the data to determine whether Helicobacter pylorieradication alters nonsteroidal antiinflammatory drug (NSAID)–induced gastrointestinal toxicity.

DATA SOURCE:

Literature accessed through MEDLINE from 1966 to May 2000 and abstracts of recently presented data at scientific meetings.

DATA SYNTHESIS:

NSAID use and H. pyloriinfection are independent risk factors for the development of gastrointestinal ulcers. An evaluation of the relationship between these two risk factors and the impact of H. pylorieradication on NSAID-induced gastrointestinal toxicity was conducted.

CONCLUSIONS:

H. pyloricolonization and NSAID use are independent risk factors for the development of gastrointestinal ulcers. The data regarding the interaction between these two risk factors in the development of gastrointestinal ulcers are conflicting. Eradication of H. pyloridoes not appear to decrease the risk of NSAID-induced gastrointestinal toxicity in the majority of patients. As there is little evidence to support a clear benefit of eradicating H. pyloriin patients requiring NSAID therapy, routine screening for and eradication of H. pyloriin these patients is not recommended.
Cyclosporine-Induced Anaphylaxis
Authors: Kuiper Rob AJ , Malingré Mirte M , Beijnen Jos H , Schellens Jan HM
Published: June 2003

OBJECTIVE:

To describe a case of an anaphylactic reaction after first ingestion of oral cyclosporine capsules (Neoral).

CASE SUMMARY:

A 73-year-old white woman was admitted for the treatment of metastatic breast carcinoma with an experimental oral paclitaxel solution in combination with cyclosporine capsules. After ingestion of the cyclosporine capsules, the patient collapsed within one hour. She initially experienced severe hypotension and bradycardia. After a few minutes, she developed severe tachycardia, dyspnea, and decreased consciousness. Administration of epinephrine, dexamethasone, clemastine, oxygen, and gelofusine (succinylated gelatin 4% in NaCl 0.9%) infusion resulted in complete recovery after several hours. The planned oral paclitaxel administration was canceled. Intravenous paclitaxel was given the next day, preceded by standard premedication with dexamethasone, clemastine, and cimetidine, without complications.

DISCUSSION:

To our knowledge, this is the first report in the literature of an anaphylactic reaction after oral ingestion of cyclosporine capsules. Earlier reports of anaphylaxis concerned intravenous cyclosporine or oral solutions of cyclosporine (both Sandimmune). These anaphylactic reactions were considered to be due to the pharmaceutical vehicle Cremophor EL or related substances, which are well-known causes of anaphylaxis. The capsules used in this case contain the Cremophor EL–related polyoxyl 40 hydrogenated castor oil as a base; our patient's anaphylactic shock may have been due to this substance.

CONCLUSIONS:

In addition to earlier reports about anaphylactic reactions after administration of an intravenous or oral solution of cyclosporine, this case shows that anaphylactic shock can occur after ingestion of cyclosporine capsules.
Potentiation of Warfarin Anticoagulation Associated with Topical Methyl Salicylate
Authors: Joss Jacqueline D , LeBlond Richard F
Published: June 2003

OBJECTIVE:

To report a case of international normalized ratio (INR) elevation resulting from the administration of topical methyl salicylate in a patient whose INR was previously stable while she received warfarin anticoagulation.

CASE SUMMARY:

A 22-year-old white woman presented with an INR of 12.2 after applying a topical pain-relieving gel to her knees daily for eight days. The potentiation of the warfarin anticoagulation was attributed to the low-dose methyl salicylate contained in the product.

DISCUSSION:

Methyl salicylate is systemically absorbed through the skin in measurable amounts, and may increase warfarin action by affecting vitamin K metabolism or by displacing warfarin from protein-binding sites. While several investigators have reported this interaction with use of high-dose methyl salicylate, this case indicates that a significant interaction can occur with the use of lower topical doses of methyl salicylate as well.

CONCLUSIONS:

Healthcare providers and patients taking warfarin must be aware of the potential hazard of using topical methyl salicylate in combination with warfarin.
Mania with Bupropion: A Dose-Related Phenomenon?
Authors: Goren Jessica L , Levin Gary M
Published: June 2003

OBJECTIVE:

To report a case in which bipolar depression was resistant to usual therapies, requiring dosages of bupropion >450 mg/d and to review the literature on mania associated with bupropion and propose a potential theory of a dose-related threshold associated with bupropion and mania.

CASE SUMMARY:

A 44-year-old white man with a 25-year history of bipolar affective disorder presented with depression resistant to usual therapies. Bupropion therapy was initiated and the dosage was titrated to 600 mg/d. After exceeding the maximum recommended daily dose (450 mg/d), he experienced a manic episode attrib uted to high-dose bupropion.

DISCUSSION:

Due to increased risk of seizures, current prescribing guidelines state that the total daily dose of bupropion is not to exceed 450 mg/d. Since bupropion is the agent least likely to cause a manic switch in bipolar disorder, this agent seemed a logical choice to treat the patient's depression. Due to a lack of response, the bupropion dosage was titrated to a maximum of 600 mg/d. Since the patient did not switch into mania until the dosage exceeded 450 mg/d, we speculate that this adverse reaction is a dose-related phenomenon. Scientific literature supports this theory.

CONCLUSIONS:

A switch into mania is a potential risk associated with antidepressant drug use in bipolar affective disorder. Bupropion is believed to be associated with a decreased risk compared with other antidepressant therapies. However, our case report as well as others support the theory that this decreased risk may be due to dosages not exceeding the recommended daily dose (450 mg/d). Doses of bupropion >450 mg/d should be used with caution in depressed patients with bipolar affective disorder.
Understanding Quality-Adjusted Life Years and Their Application to Pharmacoeconomic Research
Authors: Raisch Dennis W
Published: June 2003

OBJECTIVE:

To provide a basic overview of quality-adjusted life years (QALYs) and their application in cost-effectiveness analysis (CEA), compare and contrast QALYs with other health-related quality-of-life (HRQOL) assessments, describe current controversies regarding QALYs, and provide comparisons between QALY instruments.

METHODS:

The literature regarding HRQOL and QALYs was reviewed and key issues are summarized.

RESULTS:

QALYs provide relative preferences of patients for different health states. They range from 0, representing death, to 1.0, representing optimal health. QALYs are distinguished from other HRQOL assessments in that they provide a summary measurement that incorporates quantity of life in addition to HRQOL. When QALYs are used as the outcome measure in CEA, a cost per QALY is calculated. The Panel on Cost Effectiveness in Health and Medicine has recommended that QALYs be used as outcome measures in CEA; when QALYs are used in CEA, comparisons between treatments for different illnesses as well as within an illness are possible. The three most commonly used preference measurement techniques in determining QALYs are visual analog scales, time trade-off, and standard gamble. Controversies regarding QALYs include which preference measurement technique is most appropriate, whether QALY assessments should be obtained from patients or the community, and how to address states, such as coma, that individuals sometimes assess as worse than death. QALY instruments can be compared regarding preference measurement technique, HRQOL domains assessed, ease of administration, validity, reliability, and sensitivity.

CONCLUSIONS:

When used appropriately, QALYs provide valuable outcome measures for pharmacoeconomic research.
Treatment of Listeriosis
Authors: Temple Mary E , Nahata Milap C
Published: June 2003

OBJECTIVE:

To review the most currently accepted treatment options for the treatment of listeriosis.

DATA SOURCES:

Clinical literature was accessed through MEDLINE (1966–October 1999). Key search terms included Li steria monocytogenes, food-borne illness, penicillins, fluoroquinolones, cephalosporins, and vancomycin.

DATA SYNTHESIS:

Listeriosis is mainly a food-borne illness caused by L. monocytogenes;people most prone to the disease are pregnant women, newborns, elderly, and those with HIV or other diseases compromising immunity. Listeria infections are associated with a high mortality rate, and thus effective antibiotic treatment is essential. Although a variety of antibiotics have activity against the organism, ampicillin alone or in combination with gentamicin remains the treatment of choice. Some patients may require alternative therapies due to allergies or certain disease states. Second-line agents for these cases include trimethoprim/ sulfamethoxazole, erythromycin, vancomycin, and the fluoroquinolones. Cephalosporins are not active against Listeria.

CONCLUSIONS:

Ampicillin is currently the drug of choice for treating L. monocytogenes infections. Many antibiotics have been shown to be effective and are used as second-line agents. However, further study is required for some of the most recently introduced antibiotics, such as the fluoroquinolones, to determine their place in the treatment of Listeriainfections.
Fludrocortisone for the Treatment of Heparin-Induced Hyperkalemia
Authors: Sherman Deb S , Kass Carrie L , Fish Douglas N
Published: June 2003

OBJECTIVE:

To report the use of fludrocortisone for heparin-induced hyperkalemia and to briefly review the available literature relating to heparin-induced hyperkalemia.

CASE SUMMARY:

A 34-year-old African-American man was admitted to the hospital for pneumococcal pneumonia and sepsis. His hospital course was complicated by the development of acute respiratory distress syndrome, severe sepsis, acute renal failure, placement of a tracheostomy, and recurrent nasopharyngeal bleeding. The patient also developed a subclavian vein thrombosis with extension to the cephalic and basilic veins secondary to placement of a pulmonary artery catheter; anticoagulation with heparin was required. On day 9 of heparin therapy, the patient developed symptomatic hyperkalemia refractory to conventional therapies. Oral fludrocortisone 0.1 mg/d was initiated with resolution of the hyperkalemia within 24 hours despite the continued administration of heparin.

DATA SOURCES:

A MEDLINE (1966–October 1999) search was performed to identify case reports and clinical trials discussing heparin-induced hyperkalemia or the use of fludrocortisone for hyperkalemia.

DISCUSSION:

Heparin has the potential to induce hyperkalemia by several mechanisms, including decreased aldosterone synthesis, reduction in number and affinity of aldosterone II receptors, and atrophy of the renal zona glomerulosa. Fludrocortisone promotes potassium excretion by its direct actions on the renal distal tubules. In this patient, fludrocortisone resulted in a significant and rapid decrease in serum potassium even with continued heparin administration and acute renal failure.

CONCLUSIONS:

This case suggests that fludrocortisone is a reasonable alternative therapy for patients with hyperkalemia secondary to heparin therapy when the continued administration of heparin is necessary.
Detrimental Effects of High-Dose Dexamethasone in Severe, Refractory, HIV-Related Thrombocytopenia
Authors: Marroni Massimo , Gresele Paolo
Published: June 2003

OBJECTIVE:

To report a case of HIV-related thrombocytopenia in which high-dose dexamethasone was ineffective and immunologically detrimental. CASE SUMMARY: A 39-year-old white man with persistent, severe, HIV-1—related thrombocytopenia was admitted for epistaxis, bleeding gums, petechiae, and bruising. Previous unsuccessful attempts to reverse the thrombocytopenia included zidovudine, prednisone, vincristine, interferon alfa, and intravenous immune globulins. Based on previous anecdotal reports of the effectiveness of high-dose dexamethasone in refractory, HIV-related thrombocytopenia, we instituted treatment with intravenous dexamethasone 40 mg/d for four sequential days every 28 days. After three cycles of therapy, the platelet count remained <15 × 109/L; however, the CD4+ lymphocyte count decreased progressively from 1447 × 106/L at baseline to 560 × 106/L three months after the third cycle. Due to persistent, severe thrombocytopenia and bleeding, the patient underwent splenectomy, resulting in normalization of the platelet count. DISCUSSION: High-dose dexamethasone has been proposed as treatment for patients with immune thrombocytopenia as an alternative to chronic oral corticosteroids and claimed to be associated with better effectiveness and fewer adverse effects. The results of this treatment in our patient show that this regimen may not only be ineffective, but may also be immunologically detrimental in HIV-infected patients. Although the deterioration of the immunologic status of our patient cannot be fully attributed to high-dose dexamethasone based on the Naranjo scale, the previous long-lasting stability of CD4+ cells and the temporal relationship of a decrease in the CD4+ cell count coinciding with administration of high-dose dexamethasone suggest a causative role of the treatment.

CONCLUSIONS:

A possible cause—effect relationship between the treatment and the decrease in the CD4+ cell count suggests that the use of high-dose dexamethasone may not be justified in patients with severe, HIV-related thrombocytopenia.
Impact of Pharmacists Providing a Prescription Review and Monitoring Service in Ambulatory Care or Community Practice
Authors: Tully Mary P , Seston Elizabeth M
Published: June 2003

OBJECTIVE:

To systematically review the impact, on patient outcomes and costs to the healthcare system, of pharmacists reviewing and monitoring prescribing in ambulatory care or community practice.

DATA SOURCES:

We conducted a systematic search of published literature, up to and including 1998, on outcomes of prescription monitoring and review by pharmacists. Thirteen electronic databases were reviewed, along with a hand search of 11 journals known to publish pharmacy practice research. Fifty-five articles describing 50 comparative studies were identified.

DATA EXTRACTION:

Data were extracted including study design, clinical site, and results. A qualitative synthesis of the findings was conducted and methodological quality was appraised.

DATA SYNTHESIS:

Pharmacist-run services may be accompanied by improvements in clinical outcomes. Inconsistent definitions used in the research evaluated meant that an overall interpretation of a change in the incidence of compliance and adverse drug reactions was impossible. Other outcomes such as knowledge and satisfaction showed equivocal results overall. There was little or no change in quality of life where this was assessed. Savings in drug acquisition costs may have accrued, but it was impossible to calculate the magnitude. Pharmacist involvement produced a positive impact on cost—benefit and cost-effectiveness.

CONCLUSIONS:

The heterogeneity of the studies found and the variety in quality of much of the research design prevent the rigorous assessment of the direction and magnitude of any changes reviewed. Further studies are required, which must be rigorously designed, with blind and independent assessment of clearly defined outcomes. In particular, there is a need to investigate the effect of such services on the incidence of adverse drug reactions and quality of life and to conduct robust cost—benefit analyses.
Costs Related to Inappropriate Use of Albumin in Spain
Authors: Remohí María J Tarín , Arcos Antonia Sánchez , Ramos Bernardo Santos , Paloma Javier Bautista , Aznar María Dolores Guerrero
Published: June 2003

BACKGROUND:

Albumin has been used in various treatments for >50 years, but, recently, its use in clinical practice has become very controversial.

OBJECTIVE:

To assess the use of albumin in clinical practice in the public hospital setting in Andalucía, Spain, focusing on the economic repercussions of the inappropriate use of albumin.

METHODS:

Multicentered observational study in 22 public hospitals in which all patients receiving albumin (from start to conclusion of treatment) were assessed during a five-month period on three predetermined, nonconsecutive days. The clinical indications for albumin were evaluated on the basis of Guidelines, a consensus document created by a multidisciplinary team for dissemination by the Governmental Health Authority to all hospitals within its purview. The data were abstracted from the patient case report forms by the pharmacist selected to compile the data in each of the participating hospitals.

RESULTS:

A total of 242 forms reporting the use of 62 282 g of albumin were evaluated. The most frequent prescribing motives were nutritional intervention (23%), paracentesis in cirrhotic patients (19%), and radical surgery (11%). Only 59 prescriptions (24%), corresponding to 14 539 g of albumin (23%), were considered appropriate. The total cost of albumin therapy for the 242 cases was $183 796 (US$); $42 905 (23%) of this figure was the cost of appropriate use of albumin and $140 891 (77%) was the amount related to inappropriate use.

CONCLUSIONS:

Evaluated against model guidelines, the use of most of the albumin, deemed clinically necessary by the prescribers, was considered unnecessary or inappropriate. Hence, institutions need to define and implement guidelines that focus on responsible use of such agents in an increasingly cost-conscious healthcare environment.
Minocycline-Induced Pericardial Effusion
Authors: Christe Caroline , Ricou François , Stoller Ruedi , Vogt Nicole
Published: June 2003

OBJECTIVE:

To describe a reversible hypersensitivity reaction characterized by pericardial effusion and acute mixed liver injury in a woman treated with minocycline.

CASE SUMMARY:

A 39-year-old white woman developed dyspnea and chest pain with pericardial effusion on echocardiography approximately 20 days after starting minocycline treatment. Additional manifestations consisted of eosinophilia and liver injury. No lung, skin, or joint involvement was noted; antinuclear antibody testing was negative.

DISCUSSION:

Minocycline has been associated with rare but severe hypersensitivity reactions and autoimmune disorders, generally involving the lungs, skin, or joints. We observed a patient with an unusual minocycline-induced reaction with pericardial effusion and acute mixed liver injury. The number of spontaneously reported cases in national and international databases indicates that minocycline-induced pericardial effusion is very rare as a main clinical manifestation.

CONCLUSIONS:

Clinicians should be aware of the possibility of pericardial effusion without lung, skin, or joint involvement as an adverse effect of minocycline.
Mild Cognitive Impairment: Emerging Therapeutics
Authors: Sramek John J , Veroff Amy E , Cutler Neal R
Published: June 2003

OBJECTIVE:

To present a general overview of the etiology, definition, and prevalence of mild cognitive impairment (MCI), as well as outline possible treatment strategies. DATA SOURCES: A MEDLINE search was conducted for relevant references generated from 1990 to 2000 concerning MCI, mild to moderate Alzheimer disease (AD), and therapeutic strategies. Several books were also used in the compilation of data for this review, as well as the authors' experience in designing and conducting MCI trials. DATA EXTRACTION: All of the references listed were assessed, and all relevant information was included in this review. DATA SYNTHESIS: Forgetful individuals most likely to develop AD have a condition known as MCI previous to their development of dementia. This condition is hallmarked by memory impairment that is abnormal for the individual's age and educational level. While not all individuals with MCI develop AD, it is apparent that the condition can serve as a potential marker for early onset of AD.

CONCLUSIONS:

As many clinicians can attest, occasional forgetfulness is a common aspect of the aging process. Eventually, however, a large portion of forgetful individuals, especially those with MCI, will be diagnosed with AD or some other form of dementia. Indeed, many researchers have suggested that MCI should be regarded as incipient AD and that these individuals would benefit from drug therapy. Thus, MCI screening may be beneficial in terms of both early AD intervention and perhaps even AD prevention.
Fulminant Peripheral Neuropathy with Severe Quadriparesis Associated with Vincristine Therapy
Authors: Moudgil Shyam S , Riggs Jack E
Published: June 2003

OBJECTIVE:

To report a case of fulminant neuropathy with severe quadriparesis associated with vincristine chemotherapy. CASE SUMMARY: A 48-year-old white man with acute lymphoblastic leukemia was started on an induction chemotherapeutic regimen that included intravenous vincristine. He received a total of 6 mg of vincristine over two weeks during induction chemotherapy. Over the next two weeks, he developed a fulminant peripheral neuropathy with severe quadriparesis. DISCUSSION: Although commonly associated with peripheral neuropathy, vincristine neurotoxicity only rarely involves instances of fulminant peripheral neuropathy with severe quadriparesis. Guillain-Barré syndrome is also associated with leukemia and may present as a fulminant peripheral neuropathy with severe quadriparesis.

CONCLUSIONS:

Fulminant neuropathy with severe quadriparesis occurring in patients with leukemia being treated with vincristine (and who do not have coexistent Charcot-Marie-Tooth disease) is more likely due to Guillain-Barré syndrome than to vincristine neurotoxicity.
Insulin Aspart: A New Rapid-Acting Insulin Analog
Authors: Setter Stephen M , Corbett Cynthia F , Campbell R Keith , White John R
Published: June 2003

OBJECTIVE:

To examine the pharmacology, therapeutics, pharmacokinetics, dosing guidelines, adverse effects, and drug interactions of insulin aspart, and summarize the clinical trials of efficacy and safety in patients with type 1 or type 2 diabetes mellitus.

DATA SOURCES:

A MEDLINE database search (1985–May 2000) was performed to identify all applicable published articles and abstracts; in some cases, Novo Nordisk unpublished information was also obtained. Review articles on insulin analogs were also identified, as well as review chapters in medical textbooks.

STUDY SELECTION:

The majority of the studies identified were in abstract form. These studies reported information on the pharmacokinetics of insulin aspart in healthy volunteers and in those with diabetes, as well as the therapeutic utility, safety, and clinical efficacy in patients with diabetes. A limited number of randomized studies were reported as articles in the medical literature.

DATA EXTRACTION:

All published clinical studies were reviewed.

DATA SYNTHESIS:

Insulin aspart, the second Food and Drug Administration—approved rapid-acting insulin analog, is produced by recombinant technology that replaces the proline at position 28 on the B chain of insulin with negatively charged aspartic acid. Insulin aspart exists as hexamers that rapidly dissociate into monomers and dimers on subcutaneous injection. When administered immediately prior to a meal, insulin aspart is at least as effective as regular human insulin in control of postprandial blood glucose concentrations. Insulin aspart achieves higher peak insulin concentrations in less time and with a shorter duration of action than regular human insulin.

CONCLUSIONS:

Insulin aspart is a convenient premeal insulin for use by patients requiring mealtime insulin. Furthermore, due to favorable pharmacokinetics, insulin aspart controls postprandial blood glucose concentrations at least as well as regular human insulin and contributes to improved quality of life.
Hormone Replacement Therapy in a Postmenopausal Woman with Epilepsy
Authors: Peebles Carolyn T , McAuley James W , Moore J Layne , Malone Helen J , Reeves Andrew L
Published: June 2003

OBJECTIVE:

To prospectively evaluate the effects of hormone replacement therapy (HRT) on seizure activity in a postmenopausal woman with epilepsy.

BACKGROUND:

Postmenopausal women are at an increased risk for cardiovascular disease and osteoporosis secondary to a lack of estrogen's protective effects. As a result, women without known contraindications often take HRT to counteract this risk. Postmenopausal women with epilepsy are at a greater risk for osteoporosis because of the negative effects that certain antiepileptic drugs have on bone density. Clinical studies and experience have shown that hormonal variances across a woman's lifetime play a significant role in seizure activity, but the effects of HRT in postmenopausal women with epilepsy are unknown.

CASE SUMMARY:

We report the case of a 51-year-old postmenopausal white woman with epilepsy who presented with frequent vasomotor flushing. To determine individual effects of HRT on seizure activity, therapy was initiated in two three-month phases, with monthly evaluation. A weekly transdermal patch of estradiol 0.1 mg/d was initiated for the first three months. During the second three months, the regimen was expanded to include oral medroxyprogesterone acetate 2.5 mg once daily. Antiepileptic medications and their dosages remained constant. HRT was associated with a decreased incidence of seizures, cessation of vasomotor flushing, improved sleep, and a positive impact on the lipid profile.

CONCLUSIONS:

This case report describing the prospective addition of HRT in a postmenopausal woman with epilepsy suggests that HRT can be initiated in certain women to achieve therapeutic benefits without adversely affecting seizure activity.