bluuebunny/crossref_metadata_2025 huggingface dataset:
Isotretinoin-Induced Inflammatory Bowel Disease in an Adolescent
Authors: Reniers Denise E , Howard John M
Published: June 2003

OBJECTIVE:

To report a case of inflammatory bowel disease (IBD) associated with use of isotretinoin.

CASE SUMMARY:

A 17-year-old boy presented with new-onset rectal bleeding after completion of a five-month course of isotretinoin. A diagnosis of ulcerative colitis was made. His condition worsened despite therapy with 5-aminosalicylic acid, steroid retention enema, iron supplement, and prednisone. Five months after the onset of rectal bleeding, he had lost 11.4 kg and developed bilateral pitting edema of the hips and profound anemia. A subtotal colectomy and ileostomy was performed.

DISCUSSION:

Rectal bleeding has been reported to occur during or up to several years after treatment with isotretinoin. The mechanism by which isotretinoin may induce IBD is unknown. Proposed mechanisms include inhibition of epithelial cell growth resulting in ulceration and inflammation of the gut mucosa, inhibition of glycoprotein synthesis affecting the integrity of the mucosal wall, and stimulation of killer T cells, leading to epithelial cell injury and a resultant inflammatory response.

CONCLUSIONS:

This case of probable isotretinoin-induced IBD suggests that patients with suspected IBD should be asked about current or past use of isotretinoin to improve documentation of this serious adverse event.
Olanzapine-Induced Rhabdomyolysis
Authors: Rosebraugh Curtis J , Flockhart David A , Yasuda Sally Usdin , Woosley Raymond L
Published: June 2003

OBJECTIVE:

To report a possible case of olanzapine-induced rhabdomyolysis with concomitant lithium-induced pseudo-infarction electrocardiogram changes.

CASE SUMMARY:

A 13-year-old white boy was admitted to the hospital with profound weakness and electrocardiogram (ECG) changes suggestive of myocardial damage after starting olanzapine and lithium. An adverse medication effect was not considered at the time of the patient's admission. The time course of onset of weakness was coincident with administration of olanzapine. ECG abnormalities are a known manifestation of lithium therapy.

DISCUSSION:

This is a case description of olanzapine-induced rhabdomyolysis. Although other antipsychotic agents have been reported to cause rhabdomyolysis, an adverse drug reaction was not initially part of this patient's differential diagnosis. The patient had begun reporting myalgias six days after starting olanzapine. Fourteen days later, these symptoms forced him to bed rest; lithium was added for behavior misinterpreted as disobedience and oppositional disorder. Only when medications were considered as cause of the weakness and ECG changes, was the true nature of the patient's illness discovered.

CONCLUSIONS:

Olanzapine, like other neuroleptic agents, can cause rhabdomyolysis. Lithium can cause multiple ECG changes that can be misinterpreted as myocardial damage. Medication effects and adverse effects must always be considered in any disease complex.
Mirtazapine for Treatment of Depression and Comorbidities in Alzheimer Disease
Authors: Raji Mukaila A , Brady Shannon R
Published: June 2003

BACKGROUND:

Depression in patients with Alzheimer disease is a treatable cause of functional decline, caregiver burden, and mortality. It is often associated with severe weight loss, insomnia, and anxiety. These symptoms independently and collaboratively further worsen the prognosis of these vulnerable patients. An antidepressant medication with good adverse effect profile and salutary effects on these comorbid symptoms may be of significant therapeutic value in these patients.

OBJECTIVE:

To describe the role of mirtazapine in the treatment of depressed Alzheimer patients with comorbid weight loss, insomnia, and anxiety.

CASE SUMMARY:

Three patients with dementia and depression complicated by weight loss, insomnia, and anxiety were treated with mirtazapine at an outpatient memory loss clinic of a university hospital.

DISCUSSION:

Despite the persistence of memory loss, the patients experienced a prompt and sustained response to mirtazapine. There was a complete remission of poor appetite, weight loss, sleep disturbances, and anxiety. Other depression symptoms, including sad mood, anhedonia, and energy level, were also substantially improved.

CONCLUSIONS:

The clinical response of our patients underscores the usefulness of mirtazapine in the treatment of the comorbid symptoms of weight loss, insomnia, and anxiety. The effectiveness of mirtazapine in depressed Alzheimer patients may be a reflection of its enhancement of brain serotonergic and noradrenergic neurotransmission. The usefulness of mirtazapine in depressed Alzheimer patients merits further study in a large randomized, controlled, clinically comparative trial.
Pharmacists' Attitudes toward Diabetes and Their Involvement in Diabetes Education
Authors: Younis Wisam S , Campbell Suzanne , Slack Marion K
Published: June 2003

OBJECTIVE:

To determine the relationship between pharmacists' attitudes toward diabetes and their involvement in diabetes patient education in the community setting.

METHODS:

Registered pharmacists in Arizona were mailed surveys regarding their attitudes toward diabetes and their involvement in diabetes patient education. Attitudes were measured using the Diabetes Attitude Scale (DAS); the types of educational skills evaluated were based on those recommended by the American Diabetes Association's Standards of Medical Care.

RESULTS:

Pharmacists' attitudes were significantly positive toward the need for special training for diabetes care, the importance of tight glycemic control, the team approach to care, and the preference for diabetes education in an outpatient setting (p < 0.001). The majority of the time, pharmacists provided basic patient education (52%) rather than intermediate or advanced patient education (26% and 27%, respectively). There was a negative correlation between the attitude that diabetes is a difficult disease to treat and pharmacists' involvement in diabetes patient education (p < 0.05). This indicates that, although pharmacists believe that diabetes is a treatable disease, they infrequently provide diabetes patient education.

CONCLUSIONS:

Overall, pharmacists had positive attitudes toward diabetes. These attitudes did not correlate with the degree of their involvement in diabetes patient education. More diabetes patient education through community pharmacists is needed.
A Cost-Benefit Analysis of RSV Prophylaxis in High-Risk Infants
Authors: Schrand Linda M , Elliott Jane M , Ross Mary B , Bell Edward F , Mutnick Alan H
Published: June 2003

OBJECTIVE:

To determine the cost and benefit of using RSV-IG and palivizumab as prophylactic therapy against respiratory syncytial virus (RSV)–associated illness in high-risk infants.

METHODS:

A nonrandomized, retrospective, cohort control study was conducted comparing the outcomes of patients who received either RSV-IG or palivizumab therapy against RSV during the 1998–1999 RSV season with patients identified from the 1994–1995 RSV season who would have been eligible to receive prophylaxis had either agent been available at that time. Medical record reviews were conducted to gather data regarding the costs associated with both the administration of the prophylactic drugs and the treatment of RSV-associated hospitalizations in both groups. Decision analysis was used to determine the average cost per patient for both groups. A cost—benefit analysis was then conducted to determine the return on investment, if any, for the use of these drugs. A sensitivity analysis was also conducted to determine the robustness of the data.

RESULTS:

Patients who received RSV-IG or palivizumab had a hospitalization rate of 1.6% compared with 25% for the group who did not receive prophylactic drugs. The average costs for the RSV prophylaxis group were less per patient: $3733 compared with $4258 in the group who did not receive prophylaxis. The benefit is a 23.4% lower chance of hospitalization for each infant or, in dollar figures, $3985 ($17 031 × 0.234). The benefit—cost ratio is 1.15:1 ($3985:3461). The benefits, therefore, exceed the costs associated with the prophylaxis program. The prophylaxis program saved healthcare dollars by preventing RSV-related hospital-izations.

CONCLUSIONS:

Results demonstrate that when used according to our institution's criteria, RSV prophylaxis is of benefit to our institution.
Compliance from Self-Reported versus Pharmacy Claims Data with Metered-Dose Inhalers
Authors: Erickson Steven R , Coombs John H , Kirking Duane M , Azimi Anita R
Published: June 2003

OBJECTIVE:

To determine how well self-reported compliance with metered-dose inhalers (MDIs) agrees with compliance determined from pharmacy claims data. Additional analyses were conducted to establish psychometric properties of the questionnaire.

METHODS:

A cross-sectional survey was performed of all adult enrollees with asthma of a managed care organization. The overall return rate was 63.4% (696/1098). Patients with persistent asthma and at least one prescription claim for a controller MDI during the four months preceding the survey were included. Pharmacy claims data were used to calculate a compliance ratio. Self-reported compliance was based on a four-item questionnaire. The primary end points were the percent-agreement and the overall correlation between the two measures. The questionnaire's internal reliability and construct validity were assessed using Cronbach's α and Pearson's correlations, respectively. Mean item response scores for compliant patients were compared with scores of noncompliant patients using the Student's t-test.

RESULTS:

One hundred questionnaire respondents met the study criteria. The mean ± SD compliance ratio was 0.52 ± 0.27, the mean ± SD self-reported compliance score was 4.07 ± 1.0. The overall percent agreement and correlation between self-reported compliance score and the compliance ratio were 75.5% and r = 0.348 (p = 0.01), respectively. The percent agreement was highest (85%) when noncompliant patients (by compliance ratio <0.8) reported being noncompliant (questionnaire score <5). Cronbach's α was 0.86.

CONCLUSIONS:

This study demonstrated a moderate correlation between self-reported asthma compliance and the compliance ratio determined using claims data. The questionnaire may be useful as a screening tool to detect noncompliant behavior in populations or individual patients with asthma.
Antiplatelet Agents for Secondary Prevention of Ischemic Stroke
Authors: Majid Arshad , Delanty Norman , Kantor Jonathan
Published: June 2003

OBJECTIVE:

To review and summarize the efficacy, mechanisms of action, and cost of the options available when choosing antiplatelet agents for secondary stroke prevention.

DATA SOURCES:

This article is based on a review of the literature found with MEDLINE, CINAHL, and Cochrane Reviews (1980–June 2000) and abstracts from relevant international scientific meetings. We searched for the terms aspirin, ticlopidine, dipyridamole, antiplatelet, and clopidogrel.

STUDY SELECTION:

English-language articles, both reviews and original studies, were evaluated, and all information considered relevant was included in this review. In addition, guidelines from the American Heart Association are included.

DATA SYNTHESIS:

Aspirin is a relatively inexpensive and effective agent for secondary stroke prevention, and lower doses of aspirin appear as effective as higher doses. Ticlopidine has been used alone or in combination with aspirin, but serious adverse effects have limited its use. Clopidogrel has emerged as a safe and effective alternative to ticlopidine and lacks some of the serious adverse effects associated with ticlopidine, but is not superior to aspirin in secondary stroke prevention. Unlike previous studies, one recent trial showed that dipyridamole in combination with aspirin is superior to aspirin alone.

CONCLUSIONS:

Antiplatelet therapy is a key component of secondary prevention strategies in ischemic stroke. While aspirin has been the cornerstone in the management of stroke, other classes of antiplatelet drugs present new opportunities to optimize antiplatelet therapy.
Upper Gastroduodenal Ulceration in Arthritis Patients Treated with Celecoxib
Authors: Ashcroft Darren M , Chapman Stephen R , Clark Wendy K , Millson David S
Published: June 2003

OBJECTIVE:

To evaluate the comparative incidence of endoscopic gastroduodenal ulcers in patients with rheumatoid arthritis or osteoarthritis treated with celecoxib.

DESIGN:

Quantitative systematic review of randomized controlled trials.

SUBJECTS:

Patients (n = 4632) with rheumatoid arthritis or osteoarthritis reported in five trials.

MAIN OUTCOME MEASURES:

Rate ratios, rate differences, and the number needed to harm were calculated for the incidence of endoscopically documented gastroduodenal ulcers.

RESULTS:

Pooled rate ratios (RRs) relative to placebo for endoscopic ulcers at 12 weeks were 1.96 (95% CI 0.85 to 4.55) for celecoxib 100 mg twice daily and 2.35 (95% CI 1.02 to 5.38) for celecoxib 200 mg twice daily. There was no significant difference in gastroduodenal ulcers at 12 weeks between celecoxib 200 mg twice daily and celecoxib 100 mg twice daily; the corresponding pooled RR was 1.21 (95% CI 0.62 to 2.38). In contrast, celecoxib 200 mg twice daily was associated with a significantly lower rate of gastroduodenal ulcers than was naproxen 500 mg twice daily at 12 weeks (RR 0.24; 95% CI 0.17 to 0.33). On average, for every seven patients treated with naproxen, one more had an endoscopic ulcer than if they were treated with celecoxib. Celecoxib 200 mg twice daily also had a significantly lower risk of endoscopic ulcers than did either modified-release diclofenac 75 mg twice daily at 24 weeks (RR 0.24; 95% CI 0.11 to 0.52) or ibuprofen 800 mg three × daily at 12 weeks (RR 0.30; 95% CI 0.20 to 0.46).

CONCLUSIONS:

Endoscopic studies have shown that celecoxib, at a wide range of doses, is associated with a lower incidence of gastroduodenal ulcers than are diclofenac, ibuprofen, or naproxen. The incidence rates of gastroduodenal ulcers associated with celecoxib were similar, although not equivalent, to placebo. Head-to-head comparisons suggest that, at the wide range of doses studied (100–800 mg/d), there are no dose-related increases in endoscopic gastroduodenal ulcers with celecoxib. The results of longer term comparative trials of celecoxib based on clinical outcomes are needed to determine celecoxib's ultimate risk—benefit profile.
Delirium Associated with Zolpidem
Authors: Brodeur Michael R , Stirling Alexandra L
Published: June 2003

OBJECTIVE:

To report a case of an elderly woman sustaining an episode of delirium after one dose of zolpidem.

CASE SUMMARY:

An 86-year-old white woman was admitted to the hospital for headaches and diplopia. On hospital day 3, the patient received zolpidem 5 mg and, approximately two hours later, became restless, disoriented, and physically agitated. She was treated with haloperidol and was restrained for her safety. The patient's symptoms resolved by day 5, and she had no recollection of the incident. No rechallenge was attempted.

DISCUSSION:

Pharmacokinetic factors may play an important role in zolpidem-induced adverse drug reactions. Elderly women can achieve up to a 63% higher serum concentration than men. The patient in our report had factors such as age, gender, and hypoalbuminemia, which may have increased the maximum concentration and the AUC of zolpidem and possibly increased her risk of an adverse reaction.

CONCLUSIONS:

This case, along with previous reports, warrants the cautious use of zolpidem. Clinicians should be aware that a majority of these reactions occur in women. It appears that the reactions are concentration dependent; therefore, dosage reductions should be made in elderly patients and those with hepatic insufficiency.
Recurrent Ingrown Toenails Secondary to Indinavir/Ritonavir Combination Therapy
Authors: James Christopher W , McNelis Kelly C , Cohen David M , Szabo Susan , Bincsik Arlene K
Published: June 2003

OBJECTIVE:

To report five cases of ingrown toenails (IGTN) associated with indinavir/ritonavir (IDV/RTV) combination therapy.

CASE SUMMARY:

The median onset of IGTN from initiation of IDV/RTV therapy was 18.4 weeks. Four patients previously received IDV, with one of these experiencing prior IGTN. All patients required surgical management of IGTN. All patients received virologic benefit from ongoing antiretroviral therapy, and the majority of patients elected to maintain IDV/RTV combination therapy. Two patients experienced recurrent IGTN while receiving ongoing IDV/RTV combination therapy.

DISCUSSION:

IGTN and paronychia have previously been reported with IDV and lamivudine. IGTN in patients with HIV infection is more likely to present acutely, involve more digits, and require surgical management. IDV increases retinoic acid signaling and, based on elevated IDV concentrations from concomitant RTV therapy, the risk of IGTN may be increased in patients receiving IDV/RTV combination therapy.

CONCLUSIONS:

With the increasing popularity of IDV/RTV combination therapy, clinicians should be aware of the potential increase in frequency of dose-related toxicities including IGTN. Evaluation of hands and feet on physical examination should be recommended for all patients being treated with lamivudine and IDV, especially when used in combination with RTV.
Intravenous Valproate in Status Epilepticus
Authors: Hodges Brian M , Mazur Joseph E
Published: June 2003

OBJECTIVE:

To evaluate the role of intravenous valproate sodium (IV VPA) in the treatment of status epilepticus (SE).

DATA SOURCES:

A literature search of the English language was performed (MEDLINE 1966–July 2000). Search terms included valproate, valproic acid, and status epilepticus. Bibliographies of articles chosen were reviewed to identify other possible sources.

DATA SYNTHESIS:

A review of the medical literature was conducted to evaluate the safety and efficacy of IV VPA in the treatment of SE.

CONCLUSIONS:

Experience with IV VPA in the treatment of SE is too limited to recommend its use as a first-line agent. IV VPA may represent a third- or fourth-line option in cases of SE when other agents are ineffective or contraindicated.
Intermittent Dosing of Alendronate
Authors: Tsun Ellen C , Heck Amy M
Published: June 2003

OBJECTIVE:

To review data describing use of intermittent dosing of alendronate.

DATA SOURCES:

A comprehensive literature search was conducted using MEDLINE (1966–May 2001) and EMBASE (1974–May 2001) databases to identify all information regarding intermittent dosing of alendronate.

DATA SYNTHESIS:

A small number of clinical studies have evaluated the use of intermittent alendronate dosing in an attempt to improve patient compliance and adverse events.

CONCLUSIONS:

Evidence from more controlled clinical trials and postmarketing data are needed to demonstrate the therapeutic efficacy and tolerability of intermittent alendronate dosing. The definitive role of intermittent dosing in patients with postmenopausal osteoporosis remains to be determined.
Use of Infliximab in Pediatric Patients with Inflammatory Bowel Disease
Authors: Serrano Maria-Stella , Schmidt-Sommerfeld Eberhard , Kilbaugh Todd J , Brown Raynorda F , Udall John N , Mannick Elizabeth E
Published: June 2003

BACKGROUND:

The concentration of tumor necrosis factor, a proinflammatory cytokine, is increased in the gastrointestinal mucosa of patients with active Crohn's disease (CD) and ulcerative colitis (UC). Neutralization of tumor necrosis factor decreases the mucosal inflammatory response of adults with CD. Little information is available on the use of monoclonal antibody to tumor necrosis factor (infliximab) in children and adolescents with CD or UC.

OBJECTIVE:

To evaluate the clinical response and side effects of patients to infliximab.

METHODS:

A retrospective review of data regarding 18 pediatric and adolescent patients with active CD (n = 15) and UC (n = 3) poorly controlled with conventional therapy. All patients received one to six intravenous infusions of infliximab 5 mg/kg, while receiving their usual medications.

RESULTS:

All patients experienced clinical improvement, including decrease in the frequency of stooling and resolution of extraintestinal symptoms such as arthropathy, malaise, and skin manifestations after treatment with infliximab. All but one patient had a documented decrease in the erythrocyte sedimentation rate. Prednisone dosage was tapered in all but two patients, and discontinued in seven patients. Intravenous infusion of infliximab was well tolerated. One patient developed a rash several days after the infusion. A patient who received six infliximab infusions developed recurrent Staphylococcus aureus infections, as well as septic arthritis and chronic osteomyelitis during the follow-up period, raising the issue of the long-term safety of infliximab.

CONCLUSIONS:

Treatment of our patients with refractory CD and UC with infliximab was associated with remarkable clinical improvement. Although the drug may have an important role in their management, further assessment of long-term safety and efficacy is needed.
Mifepristone
Authors: DeHart Renee M , Morehead M Shawn
Published: June 2003

OBJECTIVE:

To review the efficacy and safety of mifepristone (with misoprostol) for the termination of early pregnancy.

DATA SOURCES:

A MEDLINE search (1966–October 2000) was conducted, and additional references listed in articles were included; unpublished data obtained from the manufacturer were used to identify data from the scientific literature. Studies evaluating mifepristone were considered for inclusion.

STUDY SELECTION:

Human clinical studies in the English language were reviewed and evaluated. Clinical trials selected for detailed review were limited to those including the regimens of mifepristone and misoprostol, recently approved by the Food and Drug Administration for early pregnancy termination.

DATA SYNTHESIS:

Mifepristone is an antiprogestin available for pregnancy termination in combination with a prostaglandin such as misoprostol. Mifepristone offers efficacy similar to, if not better than, other drugs used for pregnancy termination, but appears less efficacious overall than surgical termination of pregnancy. Mifepristone in combination with misoprostol commonly causes adverse effects such as abdominal pain and, less commonly, can cause serious adverse effects such as incomplete abortion; endometritis; and bleeding warranting transfusion, hospitalization, or surgery. Mifepristone is metabolized by the cytochrome P450 system. Thus, the potential for drug interactions with this agent exists, although this has not been well studied. Data are included from clinical trials evaluating the safety, tolerability, efficacy, and pharmacoeconomics of mifepristone combined with misoprostol for early pregnancy termination. Data comparing the use of these agents with surgical abortion and other drugs used for pregnancy termination are included where available.

CONCLUSIONS:

Mifepristone in combination with misoprostol for the termination of early pregnancy (amenorrhea of ⩽49 d) is effective in 92–95% of women. Incomplete abortion requiring surgical abortion after the fact occurs in 3–5% of women, and pregnancy continues 1–2% of the time. Mifepristone with misoprostol treatment is not without significant risks, including hemorrhage, infection, and potential for long-term emotional consequences.
Prescribing Patterns and Therapeutic Implications for Diabetic Hypertension in Bahrain
Authors: Al Khaja Khalid AJ , Sequeira Reginald P , Mathur Vijay S
Published: June 2003

OBJECTIVE:

To determine drug prescription patterns and the extent of conformity with World Health Organization/International Society of Hypertension (WHO/ISH) guidelines in diabetic hypertension.

DESIGN:

Retrospective prescription-based survey.

SETTING:

Seven primary-care health centers, comprising approximately one-third of primary-care health centers in Bahrain.

PATIENTS:

Patients with type 2 diabetes and hypertension.

MAIN OUTCOME MEASURE:

The prescribing pattern of antihypertensive and antidiabetic drugs.

RESULTS:

Among a study sample of 1463 patients with type 2 diabetes and hypertension, antidiabetic agents were prescribed as monotherapy in the following descending order: glyburide, gliclazide, insulin, and metformin. As combinations, sulfonylureas plus metformin was most popular, followed by metformin plus insulin, and sulfonylureas plus insulin. Sulfonylurea and metformin with insulin was rarely used. There was no significant difference in prescribing of glyburide and metformin between the elderly and young middle-aged diabetic patients; many patients older than 65 years were treated with a β-blocker along with a long-acting sulfonylurea. Both as monotherapy and in overall use, β-blockers, angiotensin-converting enzyme (ACE) inhibitors, and calcium-channel blockers were most often prescribed. Among 35.5% patients treated with antihypertensive combinations, various two- and three-drug combinations of β-blockers, ACE inhibitors, calcium-channel blockers, and diuretics were often used. The proportion of patients taking atenolol 100 mg/d was higher with combination regimens. Hydrochlorothiazide 25 mg or equivalent thiazide diuretics were extensively used.

CONCLUSIONS:

The prescribing pattern of antihypertensives in diabetic hypertension differs in many instances from WHO/ISH guidelines, especially regarding the choice of antihypertensive drugs and their combinations. The appropriateness of antidiabetic drug choice is questionable in relation to the antihypertensive used.
Appropriateness of Nitrate Use in a General Medicine Population
Authors: Shilo Lotan , Hadari Ruth , Kovatz Susy , Qasim Mahmud , Shenkman Louis
Published: June 2003

BACKGROUND:

Nitrates are one of the most commonly prescribed drug groups for cardiac disease, especially for angina pectoris and congestive heart failure. The chronic efficacy of nitrates is limited by the development of tolerance, which can be attenuated by use of sustained-release preparations or administration of regular-release preparations asymmetrically.

OBJECTIVE:

To determine whether patients receiving isosorbide 5-mononitrate (ISMN) use the drug in a pharmacologically appropriate manner and whether they had been instructed in the prophylactic use of sublingual nitrates prior to effort.

METHODS:

We administered a questionnaire regarding details of nitrate use to 229 patients with ischemic heart disease using oral ISMN, prescribed prior to their current admission. The study was conducted in a 600-bed university-affiliated hospital.

RESULTS:

We found that only 15% of patients receiving regular-release ISMN were taking the drug asymmetrically. In contrast, 82.6% of the patients receiving sustained-release ISMN were using the drug properly. Only 38.1% of the patients treated with regular-release ISMN were treated with the dose recommended in the literature. Furthermore, of the 190 patients who reported experiencing effort angina, only 17.9% had been instructed in the prophylactic use of nitrates prior to effort.

CONCLUSIONS:

The majority of patients (85%) using regular-release ISMN were taking the medication in an inappropriate fashion, while most patients taking sustained-release preparations were using them properly. More than half the patients treated with regular-release ISMN were treated with doses exceeding the recommended dose. In addition, most patients experiencing effort angina had not been instructed regarding the prophylactic use of nitrates. These findings suggest that both physicians and pharmacists must be reminded of the continuing need to properly counsel patients regarding appropriate drug use.

TRASFONDO:

Los nitratos representan uno de los grupos de medicamentos que más se prescriben para enfermedad cardíaca, especialmente angina de pecho e insuficiencia cardíaca congestiva. La eficacia crónica de los nitratos está limitada por el desarrollo de tolerancia, la cual puede ser atenuada mediante el uso de preparaciones de liberación sostenida o la administración asimétrica de preparaciones de liberación regular.
Potential Adverse Drug Events in an Indigent and Homeless Geriatric Population
Authors: Spiker Erin C , Emptage Ruth E , Giannamore Martin R , Pedersen Craig A
Published: June 2003

OBJECTIVE:

To identify potential adverse drug events (ADEs) in a geriatric ambulatory population using the modified Beers criteria.

METHODS:

This is a cross-sectional study of an indigent and homeless geriatric population served by a network of six primary healthcare clinics with clinical pharmacy services. Medical records of patients ≥65 years old visiting the clinics between December 1999 and April 2000 were retrospectively reviewed by a clinical pharmacist. Medications meeting the modified Beers criteria were evaluated for the most common drug classes involved, severity potential, and dose or disease state restrictions. Following the identification of medications meeting Beers criteria, the pharmacist left a written recommendation regarding use of alternative drugs or doses in the medical record. Physician acceptance of pharmacy recommendations was also evaluated.

RESULTS:

Medical records of 146 patients (71.9% women, average age 72.6 ± 6.7 y) were reviewed. Overall, 52 patients (35.6%) had 70 medications with the potential for causing an ADE based on the modified Beers criteria. The most commonly identified medication classes were narcotic analgesics (20.0%), antihypertensives (20.0%), and antihistamines (14.3%). Fifteen of these medications (21.4%) had a high severity potential. Identified medications met the following modified Beers criteria: 41.4% were inappropriate in a specific disease state, 38.6% were inappropriate for the elderly, 10.0% exceeded maximum dosage guidelines, and 10.0% were inappropriate for both the elderly and the patient's disease state. Approximately 60% of pharmacy recommendations were accepted by physicians.

CONCLUSIONS:

The modified Beers criteria are a useful tool for reviewing medical records to identify potential ADEs in an ambulatory geriatric population.
Managing the Pharmaceutical Industry—Health System Interface
Authors: Zarowitz Barbara J , Muma Bruce , Coggan Peter , Davis Glenn , Barkley Gregory L
Published: June 2003

BACKGROUND:

Direct-to-consumer advertising, media, and Internet marketing to physicians and patients, as well as enticing marketing strategies, are used by the pharmaceutical industry to ensure market share growth of new drugs. Our health system adopted a strict vendor policy governing detailing and sampling activities of pharmaceutical representatives, but realized that further analysis of vendor influence in our system was needed.

OBJECTIVE:

An assessment of tangible benefits, ethical concerns, and financial liabilities and gains was conducted to reassess the need for further vendor restriction.

CONCLUSIONS:

Based on our findings, several recommendations have been made. Medical practices and health systems are encouraged to establish and enforce explicit vendor policies, measure their effectiveness, partner proactively with representatives to deliver a drug-detailing message consistent with system initiatives, monitor and regulate continuing medical education funding, and implement strategies to ensure appropriate drug use.
Serotonin Syndrome Induced by Fluvoxamine and Mirtazapine
Authors: Demers Jason C , Malone Margaret
Published: June 2003

OBJECTIVE:

To document a case of serotonin syndrome associated with the combined use of fluvoxamine and mirtazapine, and to discuss the pharmacodynamic and pharmacokinetic interactions that were the likely causes of this potentially serious adverse drug reaction (ADR).

CASE SUMMARY:

A 26-year-old white woman with a 12-year history of anorexia nervosa was being treated with fluvoxamine. After mirtazapine was added to her therapy, she developed tremors, restlessness, twitching, flushing, diaphoresis, and nausea, symptoms that are consistent with serotonin syndrome.

DISCUSSION:

The possible causes of this ADR are discussed, including the effects of fluvoxamine and mirtazapine alone, the possible pharmacodynamic and pharmacokinetic interactions of these two drugs, and the patient's underlying anorexia nervosa.

CONCLUSIONS:

An increasing number of drugs that affect serotonin are available and are indicated for various disorders. Since there is a significant likelihood of these agents being prescribed concomitantly, clinicians must be aware of possible interactions that could lead to serotonin syndrome.
Sudden Cardiac Death with Clozapine and Sertraline Combination
Authors: Hoehns James D , Fouts Michelle M , Kelly Michael W , Tu Katie B
Published: June 2003

OBJECTIVE:

To report a case of sudden cardiac death in a patient receiving combination therapy with clozapine and sertraline.

CASE SUMMARY:

A 26-year-old white man was discovered dead at his residence. His medical history included chronic paranoid schizophrenia, obsessive—compulsive disorder, major depressive disorder, obstructive sleep apnea, and akathisia. He had no prior history of cardiovascular disease. His medication regimen included clozapine 100 mg twice daily (started 4 y prior to his death), risperidone 3 mg twice daily, sertraline 200 mg once daily, atenolol 50 mg twice daily, and lorazepam 0.5 mg four × daily. Autopsy and toxicology studies revealed cardiomegaly suggestive of idiopathic cardiomyopathy, single-vessel coronary artery disease, sertraline and clozapine blood concentrations in the expected range, undetectable lorazepam and risperidone blood concentrations, obesity, and moderate fatty changes to the liver. The most likely cause of death was sudden cardiac death due to acute cardiac arrhythmia.

DISCUSSION:

Clozapine is structurally similar to the tricyclic antidepressants, which have type 1A antiarrhythmic properties. Case reports have described electrocardiographic abnormalities, cardiomyopathy, and fatal myocarditis associated with its use. Unexplained death in patients on clozapine therapy has also been reported. Sertraline appears to have less cardiac effect; however, one report has observed clinically significant QT prolongation during sertraline therapy.

CONCLUSIONS:

Clozapine-induced cardiomyopathy and cardiac arrhythmia from clozapine and/or sertraline use may have contributed to this man's death.
Clinical Use of Fluoroquinolones in Children
Authors: Alghasham Abdullah A , Nahata Milap C
Published: June 2003

OBJECTIVE:

To review the pharmacokinetics, efficacy, and safety of fluoroquinolones in children.

DATA SOURCES:

A MEDLINE search (January 1966–March 1998) was conducted for relevant literature.

STUDY SELECTION AND DATA EXTRACTION:

Data from compassionate use and published studies were reviewed for the assessment of pharmacokinetics, efficacy, and safety of fluoroquinolones in children.

DATA SYNTHESIS:

Fluoroquinolones have a broad spectrum coverage of gram-positive and gram-negative bacteria, including Pseudomonas aeruginosa and intracellular organisms. Fluoroquinolones are well absorbed from the gastrointestinal tract, have excellent tissue penetration, low protein binding, and long elimination half-lives. These antibiotics are effective in treating various infections and are well tolerated in adults. However, the use of fluoroquinolones in children has been restricted due to potential cartilage damage that occurred in research with immature animals. Fluoroquinolones have been used in children on a compassionate basis. Ciprofloxacin is the most frequently used fluoroquinolone in children, most often in the treatment of pulmonary infection in cystic fibrosis as well as salmonellosis and shigellosis. Other uses include chronic suppurative otitis media, meningitis, septicemia, and urinary tract infection. Safety data of fluoroquinolones in children appear to be similar to those in adults. Fluoroquinolones are associated with tendinitis and reversible arthralgia in adults and children. However, direct association between fluoroquinolones and arthropathy remains uncertain.

CONCLUSIONS:

Fluoroquinolones have been found to be effective in treating certain infections in children. Additional research is needed to define the optimal dosage regimens in pediatric patients. Although fluoroquinolones appear to be well tolerated, further investigations are needed to determine the risk of arthropathy in children. However, their use in children should not be withheld when the benefits outweigh the risks.
Transdermal Nitroglycerin for the Prevention of Intravenous Infusion Failure Due to Phlebitis and Extravasation
Authors: Tjon James A , Ansani Nicole T
Published: June 2003

OBJECTIVE:

To evaluate the clinical use of transdermal nitroglycerin for the prevention of intravenous infusion failures due to phlebitis or extravasation. DATA SOURCES: Clinical literature was accessed through a MEDLINE search (1966–May 2000). Key search terms included nitroglycerin, transdermal, phlebitis, extravasation, intravenous, and infusion. DATA SYNTHESIS: Common and serious consequences of intravenous therapy include the occurrence of postinfusion phlebitis and failure to maintain intravenous therapy due to intravenous fluid extravasation. Transdermal application of nitroglycerin has been evaluated as a treatment and preventive method for intravenous infusion failures related to phlebitis or extravasation. An evaluation of studies focusing on transdermal nitroglycerin in the prevention of infusion failures due to phlebitis or extravasation was conducted.

CONCLUSIONS:

Use of transdermal nitroglycerin as a prophylactic measure for intravenous infusion failures is a therapeutic option for patients requiring long-term intravenous therapy (i.e., >50 h).
Tamsulosin for the Treatment of Benign Prostatic Hypertrophy
Authors: Lee Mary
Published: June 2003

OBJECTIVE:

To review the information necessary to assess the efficacy and safety of tamsulosin compared with other adrenergic antagonists for treatment of symptomatic benign prostatic hyperplasia.

DATA SOURCES:

A search was conducted of Cumulated Index Medicus, January 1993–August 1999, which was restricted to human trials and English-language journals.

STUDYSELECTION AND DATAEXTRACTION:

Efficacy studies were included if the design was randomized and included a control group. Drug safety was assessed using data from any patient series or controlled study.

DATA SYNTHESIS:

Tamsulosin, a uroselective α1A-adrenergic receptor antagonist, relaxes smooth muscle in the prostate and bladder neck, thereby enhancing bladder emptying. In randomized, controlled clinical trials using standardized instruments, tamsulosin improves obstructive voiding symptoms by at least 25% in 65–80% of patients with symptomatic benign prostatic hyperplasia. Tamsulosin also improves peak urinary flow rate by 1.4–3.6 mL/sec in various studies and reduces post-void residual urine volume. The usual dosage of tamsulosin was 0.4 or 0.8 mg orally once a day in the studies performed in the US and Europe; daily doses of 0.1–0.4 mg were used in studies performed in Japan. The beneficial effects of tamsulosin on voiding symptoms, peak urinary flow rate, and bladder emptying appear to be dose-related, up to a ceiling dose of 0.4 mg. The most common adverse effects are headache, asthenia, dizziness, and rhinitis-like complaints. Retrograde or delayed ejaculation occurs in 4.5–14.0% of patients and has required discontinuation of treatment in a minority of these patients. At the usual dose of 0.4–0.8 mg/d, tamsulosin does not appear to significantly reduce blood pressure, increase heart rate, or cause first-dose syncope; therefore, dosage titration is not necessary when initiating treatment. Use of nifedipine, enalapril, atenolol, furosemide, or digoxin does not require dosage modification when tamsulosin is initiated concomitantly; hypotension has not been reported with combined use of tamsulosin and these commonly used agents.

CONCLUSIONS:

Tamsulosin is an improvement over other a-adrenergic antagonists for the management of symptoms of benign prostatic hyperplasia. It is a more convenient alternative that does not require initial dosage titration, has a fast onset of action, and has a low potential to cause hypotension when used alone or in combination with commonly used antihypertensive agents. It is more costly than some of the other second-generation α-adrenergic antagonists.
Use of Epidural Corticosteroids in Low Back Pain
Authors: Tonkovich-Quaranta Lynn A , Winkler Susan R
Published: June 2003

OBJECTIVE:

To review the literature regarding the safety and efficacy of epidural corticosteroid injections in the treatment of low back pain (LBP) of various etiologies. DATA SOURCES: A MEDLINE search (1966–February 1999) of English-language literature pertaining to the use of epidural corticosteroids in LBP was performed. Additional literature was obtained from reference lists of pertinent articles identified through the search. STUDY SELECTION AND DATA EXTRACTION: All articles were considered for the review. The clinical trials included are those that enrolled a larger patient population and were primarily controlled clinical trials. The authors selected pertinent information for further discussion. DATA SYNTHESIS: Nerve root compression and inflammation are thought to be factors contributing to LBP. Corticosteroids act to decrease inflammation and may be of benefit in relieving LBP, especially if administered directly to the affected area via the epidural route. However, data on the efficacy of various corticosteroid agents administered via this route are limited. In addition, there have been reports of significant adverse reactions, thought to be due primarily to the preservative components in the corticosteroid preparations. Therefore, the role of these agents in the therapy of LBP remains to be determined.

CONCLUSIONS:

Based on the studies reviewed, epidural corticosteroids may be an effective treatment for LBP. Their use is warranted in patients who have failed conservative therapy. Although they contain preservatives, it appears that these agents are relatively safe and do not cause significant neurotoxicities.
The Use of Calcium Salts in the Prevention and Management of Verapamil-Induced Hypotension
Authors: Moser Lynette R , Smythe Maureen A , Tisdale James E
Published: June 2003

OBJECTIVE:

To review the available literature on the use of intravenous calcium salts for the prevention of hypotension associated with intravenous verapamil.

METHODS:

A MEDLINE search (1966–June 1999) identified pertinent articles; references from these articles were identified to serve as additional resources.

DISCUSSION:

Verapamil is effective in inhibiting atrioventricular nodal conduction, thereby controlling ventricular rate in patients with atrial fibrillation/flutter and terminating paroxysmal supraventricular tachycardia. However, hypotension may be caused by the negative inotropic and vasodilating effects of verapamil. In vitro and animal data suggest that calcium pretreatment may minimize the effects of verapamil on cardiac output and blood pressure. Case reports suggest that intravenous calcium may be useful for both prevention and reversal of the hemodynamic effects of verapamil. A number of small clinical trials have been performed, suggesting that calcium administered prior to intravenous verapamil results in a decreased incidence of hypotension. The most common adverse effect of intravenous calcium is flushing.

CONCLUSIONS:

Calcium pretreatment prior to intravenous calcium-channel blocker administration should be considered in patients in whom further reductions in blood pressure may precipitate hypoperfusion or worsen underlying cardiovascular status. A dose of calcium gluconate 1 g (ionized calcium 90 mg) administered over three minutes is recommended for preventing or lessening the hypotensive effect of verapamil without affecting the antiarrhythmic effects of verapamil.
Tacrolimus: An Alternative for Graft-Versus-Host Disease Prevention
Authors: Lee Traci J , Kennedy LeAnne D
Published: June 2003

OBJECTIVE:

To evaluate the efficacy of tacrolimus for prevention of graft-versus-host disease (GVHD) in patients receiving allogeneic bone marrow transplants.

DATA SOURCES:

Published literature was identified through MEDLINE (January 1990–December 1998) using the key words tacrolimus, FK506, graft-versus-host disease, and bone marrow transplant.

DATA SYNTHESIS:

GVHD associated with allogeneic bone marrow transplant is a serious life-threatening complication. An evaluation of studies using tacrolimus for prevention of GVHD was conducted.

CONCLUSIONS:

Tacrolimus is effective for the prevention of GVHD in allogeneic bone marrow transplant. Further studies need to be conducted to optimize the dosage schedule and to determine therapeutic ranges, efficacy, and safety.
Fluorouracil-Induced Neurotoxicity
Authors: Pirzada Noor A , Ali Imran I , Dafer Rima M
Published: June 2003

OBJECTIVE:

To report a case of acute neurologic adverse effects related to fluorouracil administration and to review the neurotoxicity of this agent.

CASE SUMMARY:

A 73-year-old white man with a history of esophageal carcinoma was treated with fluorouracil 1500 mg iv daily for four days. After completing treatment, he presented with sudden onset of confusion, cognitive disturbances, a cerebellar syndrome, and repeated seizures. A magnetic resonance image of the brain showed no structural abnormalities, and cerebrospinal fluid examination was normal; none of the other laboratory tests provided an explanation for his symptoms. The patient was treated with anticonvulsants, and the cognitive changes resolved in 72 hours. The cerebellar signs, however, did not resolve completely and persisted when the patient was examined two weeks after discharge.

DISCUSSION:

Fluorouracil can cause both acute and delayed neurotoxicity. Acute neurotoxicity manifests as encephalopathy or as cerebellar syndrome; seizures, as seen in our patient, have rarely been reported. Acute neurotoxicity due to fluorouracil is dose related and generally self-limiting. Various mechanisms for such toxicity have been postulated, and treatment with thiamine has been recommended. Delayed neurotoxicity has been reported when fluorouracil was given in combination with levamisole; this form of subacute multifocal leukoencephalopathy is immune mediated and responds to treatment with corticosteroids.

CONCLUSIONS:

Clinicians should be aware of the adverse neurologic effects of fluorouracil and should include them in the differential diagnosis when patients receiving the drug present with neurologic problems.