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 Antipsychotic treatment is associated with metabolic side effects that include various degrees of weight gain, dyslipidemia, and susceptibility to type 2 diabetes (1). In addition, patients with chronic psychotic disorders have increased CHD mortality (2,3) and adverse CHD risk profiles (4,5). Although it is difficult to separate the contributions of illness, lifestyle, and medication factors to these risks, there is now a pressing clinical need to monitor patients treated with antipsychotic medications for metabolic disturbance. Treatment of medical conditions such as diabetes and dyslipidemia is beyond the scope of psychiatric practice. However, because metabolic effects can be related to antipsychotic prescription, because metabolic disturbance is common in those with serious mental illness, and because these patients often have limited access to general medical care (6), psychiatric care systems are now challenged to develop methods of surveillance and to facilitate appropriate medical care for patients. Psychiatrists are similarly challenged to update their medical knowledge and to incorporate monitoring protocols into their practice (7). In this paper, we establish goals for effective metabolic monitoring of antipsychotic-treated patients, provide background information for clinicians on screening procedures and tests, and review the various published international antipsychotic monitoring guidelines to identify areas of overall consensus and clarify points of dissention. We also identify barriers to monitoring implementation and make recommendations for clinical practice. Goals of Screening and MonitoringMetabolic monitoring can be seen as having 2 overall goals:
Rates of type 2 diabetes and other CHD risks are remarkably increased in patients with schizophrenia and other forms of serious mental illness (8). Although screening is certainly indicated when a new antipsychotic medication is started, clinicians should also screen patients stably maintained on existing medications. The results of these tests can inform antipsychotic choice and allow for ongoing monitoring of the development of various metabolic derangements. Monitoring is also essential in high-risk situations, for example, when a patient with established diabetes needs to be treated with clozapine. Monitoring can also be used to gauge the outcome of such interventions as antipsychotic switching or lifestyle modification programs on body weight, diabetes progression, and other metabolic endpoints. Screening for Diabetes, Dyslipidemia, and HypertensionThese easily diagnosed and treatable conditions have a significant impact on both health and life expectancy. Diagnosis and timely intervention make a tremendous difference to long-term outcomes. Practice guidelines in the general population establish parameters for screening and treatment. Patients on antipsychotic medications should be screened with the same procedures and treated to the same targets as are individuals in the general population. In fact, because of increased morbidity in this population, one could argue that screening should be conducted earlier and more frequently. However, in actual practice, patients with mental illness receive less intensive medical care. For example, a recent study of Veterans Health Administration patients with diabetes found that failure to meet diabetes performance measures was more common in those with mental health conditions, including those with psychotic disorders (9). In the NIMH-sponsored CATIE schizophrenia trial, rates of metabolic disorder assessed at baseline were markedly elevated, with diabetes at 12.5%, hyperlipidemia at 53%, and hypertension at 37%. However, among individuals with established pathology, 45%, 89%, and 62%, respectively, were not receiving treatment (10). Clearly, it is urgent to address the disparity in health screening and treatment for individuals with schizophrenia and other forms of serious mental illness. Diabetes (11–14) Diagnosis and Screening. Guidelines in the general population suggest screening asymptomatic individuals for diabetes from age 45 years (United States) and age 40 years (Canada) and that screening should be repeated every 3 years. Those at high risk should be screened earlier and more frequently. In Canada, the most recent diabetes treatment guidelines recognize schizophrenia is as an independent risk factor for type 2 diabetes (11). We hope that this recognition will raise awareness of the need for early diagnosis and treatment in this population. The usual diagnostic test for diabetes is the FPG (≥ 7.0 mmol/L, or 126 mg/dL). The 2-hour plasma glucose level taken after a 75-gm glucose drink (≥ 11.1 mmol/L, or 200 mg/dL), that is, the postload plasma glucose in the OGTT, is also diagnostic, as is the random glucose level (≥ 11.1 mmol/L, or 200 mg/dL) when there are clear symptoms of diabetes (see Table 1). Any abnormal result should be confirmed by a repeat test on a different day. The fasting glucose level is the favoured screening test for diabetes because of its diagnostic specificity and its ease of use, but the OGTT is considered the gold standard test and has greater diagnostic sensitivity (15).
IFG 6.1 to 6.9 mmol/L (110 to 125 mg/dL) in Canada and IFG 5.6 to 6.9 mmol/L (100 to 125 mg/dL) in the United States and IGT of 7.8 to 11.0 mmol/L (140 to 199 mg/dL) are considered prediabetic conditions and warrant increased vigilance. Studies have shown that lifestyle (diet and exercise) and medication (for example, metformin) interventions can delay or prevent progression from IGT to frank diabetes (16). Since elevated postload glucose precedes elevated fasting glucose, often by several years (17), the FPG test is less sensitive than the OGTT in the early diagnosis of diabetes and IGT in both the general population (15) and in patients on antipsychotic treatment (17,18). An explanation for this is that reduced sensitivity to insulin occurs in muscle before it occurs in the liver, which influences glucose disposal earlier than fasting hepatic glucose production (19). There is some discordance between US diabetes screening guidelines and other guidelines concerning the emphasis placed on the OGTT. Canadian diabetes guidelines, for example, suggest that individuals with IFG, especially those with multiple diabetes risk factors, should be further screened with an OGTT, whereas the US guidelines do not emphasize routine clinical use of the OGTT. This difference in emphasis is helpful for understanding discrepancies in the ensuing antipsychotic monitoring guidelines. The percentage of HbA1c and random glucose measurements are not considered diagnostic for diabetes but have the advantage of not requiring patients to fast. There is debate over the utility of these tests because they lack both sensitivity and specificity. At best, they should be considered screening tests where fasting samples are difficult or impossible to obtain. Mild elevations in these tests (for example FPG ≥ 5.6 mmol/L, or 100mg/dL) should be followed by a fasting diagnostic test (14). Prescreening prior to diagnostic testing may have some utility, for example, in the opportunistic screening of clozapine-treated patients who are already having regular blood draws, an approach that one of the authors is piloting at the Centre for Addiction and Mental Health in Toronto, Ontario. Although the sensitivity of urine glucose as a screening test is low (21% to 64%), its specificity is very high (> 98%) (20). Urine screening should be limited to low-resource settings where other procedures are not available (14). Routine use of finger-stick glucose testing has not been recommended for screening but is useful in emergency settings to rapidly rule out frank hyperglycemia. Dyslipidemia (21,22) Screening. In the general population, lipid screening with a fasting lipid profile (total Chol, LDL, HDL, and triglyceride) is recommended for all adults aged 20 years and older, repeated every 5 years in asymptomatic individuals (21). In Canada, screening is recommended for men older than age 40 years and for women older than age 50 years, but earlier screening is recommended for those with diabetes and other risk factors (22). Adequate fasting (about 10 to 12 hrs) is necessary to obtain valid LDL and triglyceride levels. LDL, because of its well-established association with atherosclerosis, is considered the primary focus for intervention. Target LDL levels are determined by the CHD risk category, which is in turn determined by a Framingham risk assessment based on age, sex, Chol, HDL, systolic blood pressure, and smoking status (23). Those with diabetes or established CHD are considered high risk and are treated to the most stringent LDL targets (21,22). Patients on antipsychotic treatment frequently have a metabolic dyslipidemia with elevations of triglyceride and reduced HDL (4), along with associated features of the metabolic syndrome (see below). Treatment of metabolic dyslipidemia is a secondary goal for intervention following achievement of LDL targets (21,22). Hypertension (24) Diagnosis and Screening. Hypertension is a major contributing factor in the development of CHD. In clinical trials, antihypertensive therapy has been associated with a 20% to 25% reduction in myocardial infarction, a 50% reduction in heart failure, and a 35% to 40% reduction in stroke incidence (25). The accurate measurement of blood pressure is important. Individuals should be seated quietly for at least 5 minutes, with the arm supported at heart level. At least 2 measures should be taken and the average recorded. Blood pressure is classified as follows:
Identification of Additional Risk Factors (11,23,26)Nonmodifiable Risk Factors These include:
Modifiable Risk Factors These include:
Multifactored Risk Assessments The metabolic syndrome connotes increased risk for diabetes, hypertension, and CHD (based on waist circumference; fasting glucose and HDL; triglycerides; and blood pressure). The Framingham risk assessment (see section on dyslipidemia) determines the 10-year risk of a coronary event. Early Identification of Those at Greatest Risk for Developing Type 2 Diabetes As mentioned, those with IFG or the metabolic syndrome are at increased risk. Elevations of 2-hour postload plasma glucose and fasting insulin are early markers of the development of diabetes, but these tests are used less often in routine practice. Use of the OGTT is discussed above. Insulin measurements are not well standardized, and reference ranges for fasting insulin tend to vary between laboratories; they also depend on the assay technique. An isolated fasting insulin level provides limited information unless a reference range has been clearly established with a well-characterized control population and with the same assay technique. Serial fasting insulin levels may be more valuable in tracking the development of insulin resistance. Tracking and Linking of the Disturbance to Antipsychotic TreatmentTo monitor for antipsychotic-associated metabolic disturbances, patients should be assessed before antipsychotic treatment is initiated. The results of such an assessment can also influence antipsychotic choice, particularly when patients have existing metabolic pathology or elevated risk factors. The frequency of subsequent assessments is a matter of some debate, as is reflected in the various antipsychotic monitoring guidelines that follow. Emergent diabetes and diabetic ketoacidosis have been reported in close temporal relation to antipsychotic prescription and, in many cases, have been reversible when the antipsychotic is stopped or switched (27). One surveillance approach is to monitor glucose levels frequently, particularly in the first few months of treatment. However, clear emergent diabetes after initiation of an antipsychotic may be rare (28), and frequent (monthly or weekly) monitoring can be impractical and costly. An alternative approach is to educate patients, caregivers, and families about the symptoms of emergent diabetes and diabetic ketoacidosis (see Table 1). Suggestive symptoms should be an urgent trigger for glucose testing. Weight gain and lipid disturbance (often in the form of increased triglycerides) can occur within a few weeks of initiating antipsychotic treatment (1), and frequent monitoring of body weight during the first few months of treatment, with repeat evaluation of glucose and lipids after this time, may flag emerging metabolic concerns and allow for reevaluation of the risks and benefits of a specific antipsychotic treatment. What actions should be taken in the event of elevated body weight, glucose, and lipids, and at what threshold values, is a matter of debate, again reflected in the ensuing guidelines. Existing Monitoring GuidelinesThis section reviews the major efforts to provide recommendations for monitoring patients treated with antipsychotics in regard to the development of metabolic abnormalities. In addition to describing the specific recommendations of each of the groups (see Tables 2 and 3), we highlight the common suggestions. There have been 6 principal attempts. All the recommendations were published in 2004 or 2005. We briefly describe the participants in each group: Mount Sinai A group of psychiatric and other medical experts concerned about the physical health and health care of individuals with schizophrenia convened in October 2002 and made recommendations for physical health monitoring. The proceedings of the Mount Sinai Conference were published in the American Journal of Psychiatry (29). Australia A consensus group was convened in Australia “from the disciplines of psychiatry, endocrinology, epidemiology, general practice, mental health nursing, and pharmacy, along with representatives of community and non-government organizations” (30, p 544). Its findings were published in the Medical Journal of Australia (30). The Mental Health Council of Australia published a companion guide for consumers and caregivers (31). American Diabetes Association–American Psychiatric Association The American Diabetes Association, the American Psychiatric Association, the American Association of Clinical Endocrinologists, and the North American Association for the Study of Obesity convened a consensus development conference in November 2003. The results were copublished in Diabetes Care, The Journal of Clinical Psychiatry, and Obesity Research (32). Belgium “A panel of psychiatrists, diabetologists, and pharmacists convened a workshop from major hospitals in Belgium.” (33, p 131) The consensus recommendations were published in the International Journal of Psychiatry in Clinical Practice (33). United Kingdom A group comprising pharmacologists, endocrinologists, psychiatrists, a pharmacist from the United Kingdom, and one from the United States convened in October 2003. Their recommendations were published in the British Journal of Psychiatry (34). Canada A group of diabetes specialists representing the Canadian Diabetes Association developed a position paper, “Antipsychotic Medications and Associated Risks of Weight Gain and Diabetes,” published in the Canadian Journal of Diabetes (35). There was no single format for the presentation of the different groups’ recommendations. To compare recommendations across the various groups, we identified the following main issues. Patients Who Should Be Monitored (Table 2)
Each group had specific, although somewhat discordant, recommendations about which patients and medications should be monitored. Two suggested that all patients on all antipsychotics be monitored, whereas 4 recommended that only patients with schizophrenia be monitored. Similarly, 3 suggested limiting monitoring to second-generation antipsychotics, and 3 recommended monitoring any antipsychotic. Recommendations for the Initial Workup (Table 2) Hyperglycemia. All the groups recommended the FPG as a baseline test, although random glucose determination was sometimes thought to be acceptable. The utility of determining HbA1c was more controversial, with the Mount Sinai group deeming it an acceptable substitute if the FPG were not feasible, the UK group recommending it, and the Belgian group recommending against it. The Belgian group specifically suggested the use of OGTTs in this population. Australian and Canadian guidelines suggest the OGTT as a follow-up to IFG findings, particularly when there are multiple diabetes risk factors. Other Parameters of Interest. Although the UK group was relatively silent about this issue, there was generally a great degree of agreement about other areas worth monitoring initially. The other 5 groups unanimously recommended measuring fasting lipids, weight, waist circumference, and BMI, as well as obtaining a family and personal medical history. Some of the groups also explicitly recommended measuring blood pressure and hip circumference; noting ethnicity; and inquiring about tobacco use, other habits (for example diet and activity level), and signs and symptoms of diabetes. Recommendations for Ongoing Monitoring (Table 3)
Recommendations in this area can be reduced to 4 areas: monitoring for the development of abnormal glucose regulation, weight gain, increased blood pressure, and dyslipidemia. All groups agreed on the utility of measuring FPG as a monitoring tool, but recommendations for frequency ranged from yearly to monthly for 6 months. Again, the UK group recommended measuring HbA1c (at 4 months), whereas the Mount Sinai and Canadian groups explicitly recommended looking for signs and symptoms of diabetes. Four of the groups had specific recommendations about weighing patients, monitoring lipid levels, and monitoring blood pressure. As before, there were differences in the recommended frequencies of these procedures. Indications for Monitoring Change (Table 3) Each group had recommendations about responding to increased patient risk to develop metabolic abnormalities. In response to increasing FPG levels, almost all agreed that consulting with an internist, general practitioner, or diabetologist. Several also recommended changing the patient’s antipsychotic medication, although the UK group stated that such a change would usually be unnecessary. The Belgian group recommended what might be considered an aggressive response for mental health professionals: an OGTT, monthly FPG, and possible addition of metformin. A subsequent publication provides some empirical support for this approach (36). The Canadian group suggested that diabetes-prevention strategies (such as diet and activity interventions or metformin prescription) be considered for those with IGT. In a patient with increasing weight, recommendations ranged from intensifying monitoring to FPG taken monthly, dietary changes, nutritional and activity counselling, and possibly changing antipsychotic medication. When lipids increase, most groups supported increased monitoring, and the Belgian group recommended dietary change and possibly changing antipsychotic medication if diet failed to rectify the lipid profile. In patients with family histories of diabetes mellitus, recommendations ranged from more frequent monitoring to taking monthly FPG. For patients with a medical history of cardiac disease, sedentary lifestyle, or other risk factors, 2 groups suggested more frequent monitoring. To summarize these recommendations, there are many areas of general agreement, although some specifics vary. There was agreement about the importance of baseline monitoring before starting antipsychotic treatment and that patients should be followed more closely for the first 3 to 4 months of treatment, with subsequent ongoing reevaluation. There was also agreement about the utility of the following tests and measures: FPG, fasting lipid profile, weight and height (for BMI), waist circumference, and blood pressure. Areas of disagreement included which patients should be monitored, the frequency of testing for the various metabolic parameters, and the usefulness of glucose tolerance testing. Cost and Cost-EffectivenessRemarkably, there are currently no reports of applying the various international guidelines in real-world settings. Similarly, there are no studies of the cost-effectiveness of employing these recommendations. Such studies are critically important in determining the most effective monitoring scheme. Screening for type 2 diabetes, particularly in high-risk groups, has been estimated to be cost-effective and to lead to reduced diabetes complications, improved quality of life, and extended life expectancy (37). The costs of laboratory tests vary from one jurisdiction to another. The Mount Sinai conference publication (29) emphasized that it should be possible to implement monitoring recommendations in any public psychiatric setting and included the costs of relevant tests (US dollars): glucose level, $5.00; HbA1c, $13.00; total cholesterol, $6.00; triglyceride level, $8.00; HDL-Chol, $11.00. In the Canadian single-payer health system, greater cost containment may be possible. Use of a monitoring protocol also allows for budgeting for a predictable number of yearly laboratory tests per person. Additional equipment costs (such as scales, tape measures, and blood pressure devices) are modest. Possibly, the major challenge and cost is associated with organizing and coordinating clinical services to expedite monitoring practice. Barriers to Monitoring ImplementationSpecific challenges vary between mental health jurisdictions and from one country and health system to another. However several common themes can be identified. Responsibility The issue of responsibility for monitoring for metabolic abnormalities is much debated. Who should do it? Should not monitoring be done by family physicians or internists? Is it realistic to expect psychiatrists to participate? We suggest that along with the prescription of antipsychotics comes the responsibility for monitoring for metabolic abnormalities potentially induced by them. It is not necessary for psychiatrists to actually perform the tests indicated for monitoring; as leaders of the psychiatric treatment team, however, they are responsible for ensuring that the task is clearly delegated if they are not going to personally perform the appropriate tests. The delegation of the various tasks required for adequate monitoring should be explicitly addressed by the treatment team and may well vary from one clinical situation to another. Competing Demands in Mental Health Care and the Demedicalization of Psychiatry There are many competing demands on limited resources in the treatment of those with severe mental illness. As a result, actual medical care of patients has frequently been deemphasized, and at times, it has been thought that dollars spent on medical care in community mental health centres have not been optimally allocated. This concern about resource allocation has led to the evolution of systems that do not systematically address the medical needs of psychiatric patients. There is now little medical knowledge or emphasis on medical needs in many mental health settings, and there is a perception that no extra time and staff exist to address the monitoring issues raised in this paper. In addition, many of the psychiatric leaders in these systems may be uncomfortable exerting leadership in areas where they may feel that they are no longer sufficiently knowledgeable. However, this can change. Although it may well require the application of resources, mental health centres can provide the kind of medical services called for in this article and thereby greatly improve the care of the whole patient. Liability Issues Clinicians often describe a dilemma in regard to the medicolegal issues raised by the discussion of medical monitoring. Some are concerned about what types of added liability are implied when tests are performed that would document the existence of significant medical illnesses such as diabetes, dyslipidemia, or hypertension. They worry that their interpretation or response to these tests will be inadequate. This is a legitimate concern, and it can be addressed through education and planning. We suggest that the alternative—not adequately monitoring—is unacceptable. Our patients deserve the same standard of care that the general population expects, and if we are the only providers for this care, we must do so. Recommendations for PracticePsychiatrists are encouraged to adopt a structure for metabolic monitoring that includes a monitoring protocol, an organized way of recording results, and collaborations with primary care physicians, diabetes specialists, nutritionists and activity– recreation therapists. When such collaborative relationships are not in place, clinicians should advocate for their development. Accepting the need for and implementing metabolic monitoring requires more than a “top-down” approach focused on educating physicians. An excellent example of a combined “top-down” and “bottom-up” approach is illustrated in the development and dissemination of the Australian guidelines. In addition to professionals, the consensus group included representatives of community and nongovernmental organizations. The guidelines were then disseminated together with an extensive companion document for consumers and caregivers (31). This document describes in lay terms, and puts in perspective, such issues as physical illness in people with mental illness, psychotic disorders and diabetes, monitoring for diabetes, and the risks and benefits of antipsychotic treatment. Similar educational material should be developed in other jurisdictions, with careful attention paid to potential conflicts of interest. The ADA–APA guidelines are true consensus guidelines with broad medical representation and a practical monitoring structure useful to clinicians. These guidelines include a simple table of scheduled measures for routine use (Table 4) that has become perhaps the most often-cited schedule of the various published guidelines. This schedule fulfills most of the monitoring goals established in this paper. However, more emphasis should be placed on the screening of all patients with schizophrenia and other forms of serious mental illness for metabolic disturbance—particularly diabetes, dyslipidemia, and hypertension—even prior to a new antipsychotic prescription. Fasting lipids should be evaluated annually rather than every 5 years, given the high rate of untreated dyslipidemia in this population (10). Monitoring by both caregivers and patients for the signs and symptoms of emergent diabetes or diabetic ketoacidosis, particularly during the first few months of antipsychotic treatment, should be stressed. In addition, the possibility of primary and secondary prevention should be kept in mind. Strategies that allow for early diagnosis and detection of those at greatest risk for the development of diabetes, such as testing for glucose tolerance and (or) fasting insulin, should be considered when resources permit and tests are appropriately anchored. Finally, the greatest challenges to implementing monitoring may be organizational. Developing systems for structuring, recording, and interpreting monitoring data and defining responsibility for these tasks would further facilitate patient care. Computer-based systems may be particularly helpful in this regard. Funding and SupportAn honorarium is available for each In Review series. References1. Newcomer JW. Second-generation (atypical) antipsychotics and metabolic effects: a comprehensive literature review. CNS Drugs 2005;19(Suppl 1):1–93. 2. Osby U, Correia N, Brandt L, Ekbom A, Sparen P. Mortality and causes of death in schizophrenia in Stockholm County, Sweden. Schizophr Res 2000;45:21–8. 3. Brown S. Excess mortality of schizophrenia. a meta-analysis. Br J Psychiatry 1997;171:502–8. 4. Cohn T, Prud’homme D, Streiner D, Kameh H, Remington G. Characterizing coronary heart disease risk in chronic schizophrenia: high prevalence of the metabolic syndrome. 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Effects of ace inhibitors, calcium antagonists, and other blood-pressure-lowering drugs: results of prospectively designed overviews of randomised trials. Blood pressure lowering treatment trialists’ collaboration. Lancet 2000;356:1955–64. 26. Health Canada. Atypical antipsychotics: impaired glucose metabolism. Canadian Adverse Drug Reaction Newsletter 2001;11. Available: www.hc-sc.gc.ca/ dhp-mps/medeff/bulletin/carn-bcei_v11n4_e.html. Accessed 2006 May 16. 27. Jin H, Meyer JM, Jeste DV. Atypical antipsychotics and glucose dysregulation: a systematic review. Schizophr Res 2004;71:195–212. 28. Holt RI, Peveler RC. Association between antipsychotic drugs and diabetes. Diabetes Obes Metab 2006;8(2):125–35. 29. Marder SR, Essock SM, Miller AL, Buchanan RW, Casey DE, Davis JM, and others. Physical health monitoring of patients with schizophrenia. Am J Psychiatry 2004;161:1334–49. 30. Lambert TJ, Chapman LH. Diabetes, psychotic disorders and antipsychotic therapy: a consensus statement. 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Canadian Diabetes Association. Position paper: antipsychotic medications and associated risks of weight gain and diabetes. Canadian Journal of Diabetes 2005;29:111–2. 36. De Hert M, Van Eyck D, Hanssens L, Peuskens H, Thys E, Wampers M, and others. Oral glucose tolerance tests in treated patients with schizophrenia. Data to support an adaptation of the proposed guidelines for monitoring of patients on second generation antipsychotics? Eur Psychiatry 2005.(Epub, ahead of print). Available: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=16139484. Accessed: 2006 May 17. 37. Centers for Disease Control and Prevention. The cost-effectiveness of screening for type 2 diabetes. CDC Diabetes Cost-Effectiveness Study Group, Centers for Disease Control and Prevention. JAMA 1998;280:1757–63. Author(s)Manuscript received and accepted March 2006. 1. Staff Psychiatrist, Centre for Addiction and Mental Health, Toronto, Ontario; Lecturer, Department of Psychiatry, University of Toronto, Toronto, Ontario. 2. Chief of Psychiatry, VA Connecticut Healthcare System, West Haven, Connecticut; Professor of Psychiatry, Yale School of Medicine, West Haven, Connecticut. Address for correspondence: Dr Tony Cohn, Centre for Addiction and Mental Health, 1001 Queen Street West, Toronto, ON, M6J 1H4 e-mail: Tony_Cohn@camh.net
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