-- Back to Table of ContentsStudy Objective. To measure the extent of cardiovascular morbidity associated with nonadherence to 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin) therapy.
Design. Retrospective cohort study.
Data Source. Linked administrative health databases in Saskatchewan, Canada.
Patients. A total of 1221 patients aged 30-70 years who received a new prescription for a statin drug between 1994 and 2001, within 1 year of their first cardiovascular event (i.e., myocardial infarction, unstable angina, ischemic stroke, percutaneous transluminal coronary angioplasty [PTCA], or coronary artery bypass graft [CABG]).
Measurements and Main Results. Adherence was measured by the fill frequency (number of prescriptions filled during the observation period divided by months of observation). Patients with a fill frequency of 80% or greater were classified as adherent (661 patients); those with a fill frequency of 60% or less were classified as nonadherent (395 patients). The remaining 165 patients who had adherence rates of 61-79% were excluded from the analysis. The primary end point included a composite of myocardial infarction, unstable angina, PTCA, CABG, and death. Among 1056 patients, adherence was not associated with a reduction of the primary end point. However, patients in the adherent group were half as likely to experience a subsequent myocardial infarction as the patients in the nonadherent group (hazard ratio [HR] 0.45, 95% confidence interval [CI] 0.20-0.99, p=0.047). In patients younger than 65 years (both adherent and not), the associated reduction in myocardial infarction was even more profound (HR 0.14, 95% CI 0.04-0.46, p=0.001) and was accompanied by a trend for a lower frequency of unstable angina (HR 0.37, 95% CI 0.13-1.03, p=0.06). In patients 65 years or older (301 patients), adherence was not associated with significant changes in cardiovascular end points.
Conclusion. A detectable excess of cardiovascular morbidity appears to be associated with nonadherence to statin therapy. Our analysis suggests that many occurrences of myocardial infarction could be prevented with improvements in adherence. Larger studies are necessary to determine the association between adherence and other cardiovascular end points.
Key Words: statins, HMG-CoA reductase inhibitors, adherence, compliance, morbidity, outcomes.
(Pharmacotherapy 2005;25(8):1035-1043)
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Study Objective. To assess the risk of acute pancreatitis in patients receiving various combinations of protease inhibitors, nucleoside reverse transcriptase inhibitors (NRTIs), and nonnucleoside reverse transcriptase inhibitors (NNRTIs) for treatment of human immunodeficiency virus (HIV) infection.
Design. Retrospective cohort study.
Data Source. Ohio Medicaid claims database, January 1997-December 2002.
Patients. Four thousand nine hundred seventy-two patients with HIV infection who had received at least one antiretroviral drug.
Measurements and Main Results. Three combination regimens were evaluated: didanosine plus other antiretroviral agents, protease inhibitors plus NRTIs or NNRTIs, and NRTI combinations (no didanosine) or NRTIs plus NNRTIs. We used Cox proportional hazard regression and Kaplan-Meier plots to examine the risk for acute pancreatitis. We identified 159 (3.2%) cases of acute pancreatitis during the study period. For patients who were newly treated for HIV, the incidence of acute pancreatitis was 1.95/100 person-years. Half of these cases developed within 500 days of the start of drug therapy. Hazard ratios (HRs) for acute pancreatitis were 39-54% higher for nonwhite patients than Caucasians and 240-290% higher for symptomatic versus nonsymptomatic patients. Hazard ratios also were significantly associated with increased age, liver injuries (HR 2.94, 6.73), and cardiovascular diseases (HR 1.68, 2.36), respectively, for both newly treated and previously diagnosed patients with HIV. The risk for patients receiving either protease inhibitors plus an NRTI or an NNRTI, or NRTI plus NNRTI combinations was not significantly different from the risk associated with didanosine combination therapy (p>0.10).
Conclusion. The risk of acute pancreatitis was significantly associated with age, race, symptomatic HIV infection, and liver and cardiovascular diseases. However, risk did not differ significantly among patients with different antiretroviral regimens. Our results can be used by the medical community to enhance patient safety and minimize costly adverse drug reactions among patients with HIV infection.
Key Words: pancreatitis, HIV, Medicaid, didanosine, protease inhibitor, nucleoside reverse transcriptase inhibitor.
(Pharmacotherapy 2005;25(8):1044-1054)
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Study Objective. To determine the frequency of monitoring of international normalized ratio (INR) within 14 days of coprescription of warfarin and antimicrobial therapy and to evaluate differences in INR monitoring among antimicrobials.
Design. Retrospective cohort study.
Setting. Group model health maintenance organization.
Subjects. Patients aged 65 years or older who were taking warfarin and an antimicrobial agent.
Measurements and Main Results. Patients who received dispensings of both warfarin and an antimicrobial agent were identified. We found 2959 coprescribing instances in 1816 patients. The INR values were obtained for 2267 (77%) coprescribing situations within 14 days. Monitoring occurred more frequently (p<0.001) when warfarin was coprescribed with fluoroquinolones (641 [85%] of 755 situations), metronidazole (59 [81%] of 73), tetracyclines (274 [80%] of 341), or macrolides (201 [83%] of 243) than when warfarin was coprescribed with sulfonamides (35 [66%] of 53), penicillins (604 [71%] of 856), or cephalosporins (419 [71%] of 591). Among monitored patients, a higher proportion of monitoring (p<0.001) occurred within 7 days for patients prescribed antifungals (87%), fluoroquinolones (88%), tetracyclines (82%), metronidazole (86%), sulfonamides (86%), or macrolides (85%) than for patients prescribed cephalosporins (68%) or penicillins (75%).
Conclusion. Most older patients coprescribed warfarin and an antimicrobial in our organization had INR monitoring within 7 days. This is consistent with appropriate practice to manage a risk of clinically important drug-drug interaction between an antimicrobial agent and warfarin. Prospective identification of patients requiring INR monitoring after coprescription of interacting drugs by using merged administrative pharmacy and laboratory data should be further evaluated as a tool to improve clinical outcomes.
Key Words: warfarin, international normalized ratio, INR, antibiotic, antimicrobial, elderly, managed care.
(Pharmacotherapy 2005;25(8):1055-1061)
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Study Objective. To determine the effect of access to ambulatory anticoagu-lation management services (AMS) on the rate of warfarin use in patients with atrial fibrillation.
Design. Retrospective medical record review.
Setting. Two ambulatory care clinics in the same managed care system: one with and one without access to pharmacist-managed AMS.
Patients. One hundred seventy-eight patients with atrial fibrillation diagnosed between June 2000 and June 2001.
Measurements and Main Results. Warfarin use was assessed overall and by contraindications and risk factors for stroke. Independent predictors of therapy were identified. The overall rate of warfarin use in atrial fibrillation was higher in the clinic with access to AMS than in the clinic without access (77.9% vs 61.7%, p=0.03). In patients with no known contraindications, warfarin use increased by 20.2% with access to AMS versus no access (80.2% vs 60.0%, p=0.023). Patients aged 65 years or older with one or more risk factors for stroke and no contraindications were more likely to receive warfarin in the clinic with access to AMS than in the clinic without access (85.1% vs 53.8%, p=0.001). Access to AMS was an independent predictor of warfarin use (odds ratio 2.19, 95% confidence interval [CI] 1.05-4.56). Female sex was an independent negative predictor of warfarin use (odds ratio 0.48, 95% CI 0.24-0.96).
Conclusion. In the managed care setting, use of warfarin for stroke prophylaxis in patients with atrial fibrillation was higher in the ambulatory care clinic with access to pharmacist-managed AMS than in the clinic without access.
Key Words: anticoagulation, atrial fibrillation, warfarin, stroke, prescription practices.
(Pharmacotherapy 2005;25(8):1062-1067)
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Study Objective. To evaluate antiretroviral pharmacokinetics in patients who are coinfected with human immunodeficiency virus (HIV) and hepatitis B and/or C virus. Specifically, we sought to determine whether coinfection results in higher than expected concentrations of protease inhibitors and nonnucleoside reverse transcriptase inhibitors (NNRTIs).
Design. Case series.
Setting. Human immunodeficiency virus clinic.
Patients. Twenty-six patients infected with HIV and hepatitis B and/or C virus.
Measurements and Main Results. Patients’ plasma trough concentrations (Cmeasured) of protease inhibitors and NNRTIs were compared with population average trough concentrations reported in the literature (Cpredicted). Trough concentrations were obtained irrespective of the patients’ liver function. A concentration ratio of Cmeasured:Cpredicted was determined for each patient. The mean concentration ratio of the 26 patients was 1.43 (95% confidence interval 1.08-1.78). For the six patients taking nelfinavir, the ratio of nelfinavir’s active metabolite (M8):parent drug was calculated. The median M8:nelfinavir ratio for these six patients was 69% lower than what has been reported in a general HIV population.
Conclusion. These preliminary findings suggest that trough concentrations of protease inhibitors and NNRTIs may be elevated in patients with HIV infection who are coinfected with hepatitis B and/or C, compared with a general population of patients with HIV infection. Until further investigation defines the relationship between coinfection, metabolic dysfunction, and increased antiretroviral exposure, therapeutic drug monitoring may be helpful to identify coinfected patients at risk for antiretroviral toxicity secondary to elevated plasma drug concentrations.
Key Words: hepatitis B, hepatitis C, coinfection, HIV, antiretroviral therapy, protease inhibitors, reverse transcriptase inhibitors.
(Pharmacotherapy 2005;25(8):1068-1072)
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Study Objective. To standardize treatment of alcohol withdrawal syndrome (AWS) in internal medicine patients using an adult AWS practice guideline with a symptom-triggered management approach.
Design. Prospective interventional (pilot group) and retrospective (control group).
Setting. University teaching hospital.
Patients. Thirty-two internal medicine patients identified as being at risk for AWS and treated according to the AWS practice guideline who were compared with 49 internal medicine patients managed with nonstandardized approaches.
Intervention. Patients in the pilot group were assessed using the AWS type indicator. They received lorazepam, clonidine, or haloperidol, based on AWS type indicator assessment and adult AWS practice guideline criteria.
Measurements and Main Results. Data collected and analyzed were drugs administered to control AWS symptoms, use of sitters and physical restraints, length of hospital stay, and discharge from hospital receiving tapered drug therapy. Pilot patients received 46.6% less benzodiazepine (p=0.001), 20% more clonidine (p=0.01), and 18.2% more haloperidol (p=0.002) than control patients. No drug therapy was required in 19% of pilot patients compared with 2% of controls (p=0.01). Significantly more control (71.4%) than pilot patients (18.8%) were discharged with tapered benzodiazepine therapy (p<0.01). No significant differences were found between groups for sitters, restraints, or hospital length of stay.
Conclusion. This pilot project suggests that internal medicine patients at risk for AWS can be managed with a standardized, symptom-triggered approach using decreased amounts of benzodiazepine in combination with adjunctive agents to treat adrenergic hyperactivity and delirium. Further data are necessary to determine the impact of the practice guideline on patient outcome measurements.
Key Words: alcohol withdrawal syndrome, benzodiazepines, clonidine, haloperidol, practice guideline.
(Pharmacotherapy 2005;25(8):1073-1083)
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Ziconotide is a novel peptide that blocks the entry of calcium into neuronal N-type voltage-sensitive calcium channels, preventing the conduction of nerve signals. N-type calcium channels are present in the superficial laminae of the dorsal horn of the spinal cord. In various animal models of pain, intrathecal administration of ziconotide blocked nerve transmission and nociception. The United States Food and Drug Administration recently approved ziconotide intrathecal infusion for the management of severe chronic pain in patients who require intrathecal therapy and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or intrathecal morphine. The drug has a narrow therapeutic window and a lag time for the onset and offset of analgesia and adverse events. In early clinical trials, frequent and severe psychiatric and central nervous system adverse effects were associated with rapid intrathecal infusion (0.4 µg/hr) and frequent up-titration (every 12 hrs). Therefore, patients with psychiatric symptoms are not candidates for this drug. Drug trials of external intrathecal catheters and microinfusion devices demonstrated a 3% risk of meningitis. A low initial infusion rate of 0.1 µg/hour and limiting infusion rate increases to 2-3 times/week are now recommended. Patients responsive to intrathecal ziconotide require an implanted infusion system to receive long-term therapy.
Key Words: ziconotide, analgesia, N-type calcium channels, chronic pain, implanted pumps. )
(Pharmacotherapy 2005;25(8):1084-1094)
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Use of oral N-acetylcysteine for preventing radiographic contrast material-induced nephropathy (RCIN) has become widespread, despite conflicting results from clinical trials and meta-analyses. The variability in study results may reflect differences in baseline risks in study patients, hydration regimens, choice of contrast agent, definition of RCIN, and the oral dosage formulation of N-acetylcysteine used. Injectable N-acetylcysteine recently has become available in the United States. Although oral N-acetylcysteine regimens are typically administered during a 48-hour period, more rapid intravenous administration could offer an important advantage for urgent procedures such as coronary angiography. However, the three published studies in which intravenous N-acetylcysteine protocols were used have produced divergent results, likely because of substantially different dosage regimens. With few intravenous studies available, clinicians may look to more broadly studied oral regimens to estimate equivalent intravenous dosages. In the oral studies, however, a wide range of formulations were used, and the bioavailability of each product was uncertain. In addition, the intravenous route circumvents first-pass metabolism, resulting in less glutathione production, perhaps compromising the antioxidant effects of N-acetylcysteine administration. Overall, little evidence exists that any studied N-acetylcysteine protocol improves clinical outcomes in terms of reducing length of hospital stay, need for dialysis, or mortality. Furthermore, N-acetylcysteine may directly affect serum creatinine level, which all clinical trials to date have used as a primary outcome measure. If oral or intravenous N-acetylcysteine is used with the intention of preventing RCIN, more-established preventive measures should not be overlooked, including adequate hydration with isotonic saline, avoidance of potentially nephrotoxic drugs, and use of iso-osmolar radiographic contrast media.
Key Words: N-acetylcysteine, radiographic contrast material-induced nephropathy, RCIN. )
(Pharmacotherapy 2005;25(8):1095-1103)
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The literature concerning the efficacy and safety of ketamine for conscious sedation during procedures in pediatric emergency departments was reviewed. Data were obtained from the Guidelines for Monitoring and Management of Pediatric Patients During and After Sedation for Diagnostic and Therapeutic Procedures developed by the American Academy of Pediatrics Committee on Drugs, and from a MEDLINE search (January 1966-July 2004). Search terms were conscious sedation, ketamine, and emergency department; articles relevant to pediatric age group were selected. Clinical end points were efficacy and adverse effects associated with ketamine. Ketamine was effective for conscious sedation in 89-100% of patients in various studies using intravenous, intramuscular, or oral routes of administration. The efficacy of ketamine was similar to or greater than that of other drugs, such as midazolam and the combination of meperidine, promethazine, and chlorpromazine. The main adverse effects of ketamine were emesis, recovery agitation, and emergence phenomena. Ketamine appears to be an effective and well-tolerated agent for conscious sedation in pediatric patients. Overall physician and parent satisfaction with the administration of this agent for conscious sedation was high.
Key Words: conscious sedation, ketamine, pediatric, emergency department. )
(Pharmacotherapy 2005;25(8):1104-1111)
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The American College of Chest Physicians Consensus Conference on Antithrombotic Therapy recommends that patients with initial idiopathic deep vein thrombosis (DVT) receive treatment for at least 6-12 months. However, controversy exists as to what treatment duration and intensity are optimal. Some investigators have suggested that it may be feasible to identify patients who are at low risk and those who are at high risk of recurrent venous thromboembolism. If patients can be stratified according to risk, then it might be safe and effective to withdraw oral anticoagulation therapy in those at low risk of recurrence and continue the therapy in those at high risk. Parameters that have been used to attempt to stratify patients with idiopathic DVT according to risk are D-dimer levels, resolution of thrombosis on ultrasound, and sex.
Key Words: deep vein thrombosis, venous thromboembolism, D-dimer, oral anticoagulation therapy. )
(Pharmacotherapy 2005;25(8):1112-1115)
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Health care-associated infections (HAIs) are a leading cause of in-hospital mortality and adverse events such as antimicrobial resistance. These infections place tremendous burdens on the health care system and create situations for misuse of antimicrobial drugs. Recognition of these factors has led professional societies, clinicians, and hospitals to develop programs to improve the management of HAIs and the use of antimicrobial drugs. The clinical literature is replete with examples of these programs, often referred to as antimicrobial stewardship. Traditionally, antimicrobial stewardship programs have relied on manual methods combined with clinical oversight and intervention. The advent of modern health care information technology offers the opportunity to expand the breadth and depth of these programs. Expert clinical decision support systems are the most promising of these information technology advances.
Key Words: clinical decision support, patient safety, antimicrobial stewardship, infectious diseases, antimicrobial resistance, informatics, computer-assisted therapy. )
(Pharmacotherapy 2005;25(8):1116-1125)
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The renin-angiotensin-aldosterone system plays a major role in the pathophysiology of heart failure. Aldosterone is one of the central mediators involved in the cardiac remodeling process. Its classic effect in heart failure is attributed to mineralocorticoid receptor-mediated salt and fluid retention leading to increased afterload. New evidence demonstrates nonclassic effects of increased collagen synthesis and myocardial fibrosis resulting in left ventricular hypertrophy. Antagonism of aldosterone receptors with spironolactone benefits patients with severe heart failure, and eplerenone benefits those after myocardial infarction who have left ventricular dysfunction. Future research is directed at aldosterone antagonism in patients with mild-to-moderate heart failure, coronary artery disease treated with percutaneous coronary intervention, and nephropathy complicated by diabetes mellitus.
Key Words: aldosterone, antagonism, heart failure, left ventricular dysfunction, renin-angiotensin-aldosterone system, RAAS. )
(Pharmacotherapy 2005;25(8):1126-1133)
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Fortunately, the occurrence of acute myeloid leukemia (AML) during pregnancy is rare. We report a case of successful fetal outcome with standard induction and consolidation treatment in the second and third trimesters, respectively. A 37-year-old woman in her second trimester (21 wks) of pregnancy was found to have acute myeloid leukemia. She elected to maintain the pregnancy and underwent induction with cytarabine and idarubicin. Her hospital course was complicated by Pseudomonas vesicularis and gram-positive bacilli (not Bacillus anthracis) septicemia, but she obtained complete remission. After discharge, a fetal echocardiogram at 26 weeks revealed a mildly dilated right ventricle with mild systolic dysfunction, and the left ventricle appeared smaller than normal with mild systolic dysfunction. The patient then received consolidation therapy with high-dose cytarabine. On day 14 of consolidation, filgrastim 16 µg/kg was added to improve stem cell mobilization. A total of 19.8 x 106 CD34+ cells/kg were collected with a single apheresis session. At 37 weeks, she delivered a viable female infant weighing 3 lbs 12 oz. Fetal abnormalities included acrocyanosis, shallow sacral dimple, short digits and limbs, and prominent frontal skull with mild macrognathia. A postnatal echocardiogram revealed a moderate-sized membranous ventricular septal defect. The ventricular septal defect proved significant and required surgical repair at 5 months. Approximately 4 weeks after delivery, the mother underwent autologous peripheral stem cell transplantation. Unfortunately, 100 days after transplantation, she had a relapse of AML. After a brief remission from a second induction, the patient died.
Key Words: second-trimester pregnancy, acute myeloid leukemia, AML, stem cell mobilization. )
(Pharmacotherapy 2005;25(8):1134-1140)
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Central serous chorioretinopathy (CSC) is a condition characterized by serous detachment of the neurosensory retina in the posterior pole. Corticosteroids administered by various routes is reported as a possible cause of CSC. We report the cases of two patients who developed CSC after receiving a corticosteroid injection in the epidural space for the treatment of back pain. In both patients, the accumulation of subretinal fluid spontaneously resolved within several weeks. Patients who develop CSC after epidural analgesia with corticosteroids should be alerted to the possible relationship between CSC and this treatment. Clinicians should advise all patients with CSC to avoid systemic corticosteroids administered by any route, unless they have a compelling medical indication. Pharmacists should advise patients to seek evaluation if visual changes occur during or after corticosteroid therapy.
Key Words: central serous chorioretinopathy, corticosteroid injection, epidural steroid analgesia. )
(Pharmacotherapy 2005;25(8):1141-1146)
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An 81-year-old woman with ischemic bowel underwent laparotomy with small-bowel resection and developed septic shock. She required broad-spectrum antibiotics, norepinephrine, and mechanical ventilation. The patient received drotrecogin alfa (activated) 24 µg/kg/hour for a total of 67.5 hours. Coagulation parameters were monitored during her therapy. Significant increases in activated partial thromboplastin time (aPTT) during infusion led to two temporary discontinuations of the drug. Coagulation parameters decreased when the drug was held and increased with each rechallenge. The patient survived the episode and was discharged on postoperative day 27. Medical records of 26 other patients who received drotrecogin alfa (activated) at our institution from November 2001-August 2003 were reviewed retrospectively for coagulation parameters and bleeding rate. Of the 26 patients, nine (35%) were treatment compliant (> 90% of the 96-hr course). Coagulopathy and bleeding resulted in early discontinuation in four (15%) and six (23%) patients, respectively. An increase in aPTT from baseline to during infusion of drotrecogin alfa (activated) was noted in 14 patients with complete data (p=0.56). A decrease in median platelet count from baseline to during infusion was noted in the six patients who bled during therapy (p=0.01). Two of these patients had platelet counts less than 30 x 103/mm3 during administration. Drotrecogin alfa (activated) should be considered an anticoagulant. In postmarketing reports, clinically significant bleeding occurred more frequently than was noted in a large, randomized, multicenter trial. Patients receiving drotrecogin alfa (activated) should be closely monitored for prolongation of coagulation parameters. Temporary discontinuation of the drug should be considered when international normalized ratio is greater than 3.0, platelet count is less than 15 x 103/mm3, and aPTT is greater than 100 seconds.
Key Words: drotrecogin alfa (activated), anticoagulation, sepsis, partial thromboplastin time. )
(Pharmacotherapy 2005;25(8):1147-1150)
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A 53-year-old man developed delayed-onset neutropenia 6 weeks after completing first-line therapy with rituximab, cyclophosphamide, mitoxantrone, vincristine, and prednisone for high-grade B-cell lymphoma. Bone marrow biopsy demonstrated hypercellular marrow with normal maturation. He also developed interstitial pneumonitis, an adverse event associated with rituximab use. Infiltrates of T cells were found in the patient’s lungs. For the next 6 months, the patient required subcutaneous granulocyte colony-stimulating factor 300 µg twice/week to maintain a granulocyte count above 1000 cells/mm3. He also received oral antibiotics for mouth sores and thrush. Based on the existing evidence, monitoring blood counts for as long as 8 weeks after rituximab therapy may be advisable, although the literature reports that neutropenia can develop up to 1 year after treatment. The development of a registry and uniform testing may help uncover the cause of this delayed-onset neutropenia.
Key Words: B-cell lymphoma, delayed-onset neutropenia, interstitial pneumonitis, rituximab. )
(Pharmacotherapy 2005;25(8):1151-1155)
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A 39-year-old man with schizophrenia developed severe catatonia, hyperthermia, muscle rigidity, tachycardia, leukocytosis, and elevated muscle enzyme levels while receiving zotepine therapy. Neuroleptic malignant syndrome (NMS) was diagnosed. After withdrawal of zotepine therapy, transfer to a neurologic intensive care unit, provision of supportive care, and administration of adjunctive bromocriptine therapy, the patient’s fever and catatonia subsided. Biochemical irregularities spontaneously returned to normal with no complications. Antipsychotic therapy was restarted with risperidone 12 days after the patient’s NMS resolved. After more than 1 year of follow-up, he experienced no adverse events. A recent decrease in mortality from NMS is related to increased awareness of this disorder, but not to treatment with specific agents. Clinicians need to recognize NMS early; although rare, it is a potentially fatal complication of antipsychotic treatment.
Key Words: zotepine, risperidone, catatonia, NMS. )
(Pharmacotherapy 2005;25(8):1156-1159)
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