Antipsychotic Medications and the Risk of Diabetes and Cardiovascular Disease

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1 Antipsychotic Medications and the Risk of Diabetes and Cardiovascular Disease Professional Tool #1: Screening and Monitoring in a High-Risk Population: Questions and Answers

2 Overview of Cardiometabolic Risk in the Psychiatric Population Major psychiatric disorders, such as schizophrenia, bipolar disorder, and major depressive disorder, are associated with increased morbidity and mortality from a range of medical causes, including cardiovascular disease and diabetes mellitus. Recent data from multiple states during have demonstrated that patients with major psychiatric disorders die 25 to 30 years earlier than unaffected individuals, primarily as the result of premature cardiovascular disease. 1 Major mental illness is associated with elevated prevalence of key modifiable risk factors for cardiovascular disease and diabetes, including overweight/obesity, dyslipidemia, hyperglycemia, hypertension, and smoking. 2 The American Diabetes Association (ADA) is strongly committed to increasing awareness of the associations between key risk factors, diabetes, and cardiovascular disease (coronary heart disease and cerebrovascular disease), among professionals and the public alike. An example is the recent Cardiometabolic Risk Initiative, detailed on the ADA website (diabetes.org/cmr), which lists obesity, hypertension, high LDL cholesterol, low HDL cholesterol, smoking, and physical inactivity as Cardiometabolic Risk Factors. In addition to the direct threats to health presented by each of these factors, the risks of type 2 diabetes and of cardiovascular disease are strongly associated with the number of risk factors present in an individual. Patients with major psychiatric disorders may be confronted with multiple contributors to increased prevalence of these risk factors, including poor nutrition, physical inactivity, poverty, substance abuse, and adverse effects associated with certain psychotropic medications. 3,4

3 Overview of Risks Associated with Second-Generation Antipsychotics The availability of second-generation antipsychotic drugs (SGAs; also known as atypical antipsychotics ) has facilitated effective treatment of psychotic disorders while reducing the risk of extrapyramidal side effects. In addition to their indicated use in schizophrenia and other psychotic disorders, SGAs are also often used in the management of depression with psychotic features, other psychiatric disorders, behavioral disturbances of dementia, and increasingly, in the treatment of psychiatric disorders in children and adolescents. 5 Recent evidence has identified an association between the use of specific SGAs and elevated risk for dyslipidemia, weight gain, obesity, prediabetes, and type 2 diabetes. A similar association has been identified for the earlier first-generation antipsychotics (FGAs). 3 Although previous case-control and epidemiological studies suggested elevated risk for obesity, impaired fasting glucose, and diabetes among patients with psychiatric disorders, evidence from clinical trials and other randomized controlled studies have also demonstrated additional risk associated with the use of these medications. 3,6,7,8 A 2004 American Diabetes Association (ADA) Consensus Development Conference concluded that certain SGAs are associated with the potential for rapid weight gain, deterioration in lipoprotein profile and increased risk of type 2 diabetes. Although the mechanisms underlying these effects remain incompletely understood, these potential side effects are of significant concern because of the association between these adverse cardiometabolic events and risk for diabetes and premature cardiovascular mortality. 1,4,8 Patients with major mental illness can benefit from the services of multidisciplinary team of health care professionals, including a primary care provider and a psychiatrist. However, a substantial number of patients lack access to key resources, including

4 primary care physicians (PCPs). Therefore, psychiatrists are often in the position of being the sole physician caring for their patients, who may require regular monitoring attention for both their psychiatric disorder and comorbid medical conditions. The increased cardiometabolic risks associated with psychiatric disorders and the medications used to treat them highlight the need for all members of the health care team to be aware of these risks, especially the psychiatrist who in many cases is the physician with the highest frequency of patient contact. 9 In addition, the psychiatrist may be well positioned to lead a team of qualified professionals, who may include the primary care physician or appropriate specialist, case manager, psychiatric nurse, dietitian, certified diabetes educator, ophthalmologist, podiatrist, and others. The team leader should coordinate a treatment plan individualized to the patient s specific needs and resources, and should facilitate a high degree of intercommunication among team members. For example, the psychiatrist is in an excellent position to advise other team members regarding the management of psychiatric symptoms that may interfere with the patient s capacity for self-care education and treatment. It is essential for the psychiatrist or other team leaders to provide or refer the patient for routine screening of cardiometabolic risk factors. Regardless of the site or setting of such screening, the psychiatrist needs to be aware of the results of screening and ongoing monitoring, so that the patient s risk profile and any adverse events are considered in the development and ongoing modification to the individualized treatment plan. Psychiatrists should know when to consider a change in treatment regimens incorporating antipsychotic medications, and when to provide referral(s) to a qualified PCP or specialist for diagnosis and treatment.

5 The ADA Consensus Development Conference developed a set of recommendations for screening and monitoring of patients receiving SGAs; this toolkit addresses these recommendations in a question-and-answer format. 8 Questions/Answers Q: Should all patients receiving antipsychotic medications be screened and monitored for obesity, dyslipidemia and type 2 diabetes risk? A: Yes although the risk of weight gain and type 2 diabetes appears to differ between agents (see below), any patient being initiated on antipsychotic therapy should first be screened for overweight and obesity, dyslipidemia and hyperglycemia, hypertension, and personal or family history of cardiometabolic disease or risk. While being treated with antipsychotic medications the patient should be monitored for treatment-emergent changes in weight, waist circumference, plasma lipid and glucose levels, and acute symptoms of diabetes (e.g., polyuria, polydipsia). Q: Are all antipsychotics associated with increased risk of obesity and type 2 diabetes? A: The Consensus Development Conference report in 2004 concluded that clozapine and olanzapine were associated with the greatest risk for weight gain; risperidone and quetiapine were associated with lower but intermediate risk, and aripiprazole and ziprasidone with the lowest risk. Clozapine and olanzapine were also

6 associated with increased risk for diabetes and dyslipidemia. Discrepant results in the published literature prevented the development of firm conclusions regarding the risk of diabetes and dyslipidemia associated with risperidone and quetiapine, and there was no clear evidence for increased risk (or no clear effect on risk) associated with aripiprazole and ziprasidone. However, any treatment condition associated with substantial increases in body weight could lead to an increase in risk for diabetes. Q: How should patients be assessed prior to initiating antipsychotic treatment? A: Baseline assessment of any patient being considered for antipsychotic treatment should include a complete individual and family history, a physical exam, measurement of weight and height, and calculation of body mass index (BMI), waist circumference (measured perpendicular to the top of the iliac crest; a spring-loaded biometric tape measure may be especially useful), blood pressure, fasting plasma glucose (FPG)*, and fasting lipid profile (A1c has recently been recommended as a screening or diagnostic tool 10 ). All values should be recorded for comparison against follow-up evaluations. The results of baseline assessment, especially when prediabetes, diabetes, dyslipidemia, or other cardiometabolic risks are uncovered, may influence the selection of antipsychotic agents; agents with a lower propensity for weight gain and lower risk for dyslipidemia and type 2 diabetes may be preferred in this situation. *Fasting (no food, gum or drink except tap water) should be for a minimum of 8 hrs.

7 Q: What if pretreatment screening reveals type 2 diabetes, or other cardiometabolic risk factors? A: Conditions should be treated according to current ADA standards of care. The 2010 Standards of Care executive summary pdf is included in this set of toolkits and can also be found at: Q: What follow-up assessments are most important? A: After initiating a new antipsychotic treatment or switching treatments, it is especially important to monitor body weight closely. The ADA recommends reassessment 4 weeks, 8 weeks, and 12 weeks after starting a new antipsychotic, and quarterly thereafter. The detailed monitoring schedules for body weight and other metabolic parameters from the ADA Consensus Development Conference are summarized in the adapted table below: 8 Assessment(s) Baseline Quarterly Annually weeks weeks weeks Personal/family history; physical X X exam Weight (BMI)/ Height X X X X X X Waist Circumference X X Blood Pressure X X X Fasting Plasma Glucose/ A1C X X X Fasting Lipid Profile X X X

8 Q: What clinical findings should prompt the treating physician to consider as a switch to an alternative antipsychotic medication and/or a referral to a qualified primary care provider or specialist? A: An increase in body weight from baseline of 5% or greater at any time during antipsychotic treatment should prompt the treating physician to consider a switch to another antipsychotic medication, if possible; guidelines for such a switch are provided in the ADA Consensus statement. 8 In general, cross-titration is recommended by the consensus panel as the safest approach, with a caution about abrupt discontinuation of any antipsychotic drug. The patient should be monitored closely during the switch process for worsening psychiatric symptoms. If the patient develops dyslipidemia or worsening glycemia at any time while receiving an antipsychotic medication, the treating physician should consider a switch to an antipsychotic associated with a lower risk of weight gain, dyslipidemia and diabetes. In addition, for those patients who develop diabetes or experience a worsening of pre-existing diabetes, the patient should be referred to a qualified clinician with extensive experience in managing patients with diabetes. Patients presenting with prediabetes or diabetes, as well as their identified caregivers, should also be referred to a recognized ADA Diabetes Self-Management Education Program capable of considering the individual needs of persons with major mental illness. The ADA patient and

9 professional toolkit materials are available to all health care professionals working with this special patient population, and should be employed as needed. Q; What information should be provided to patients and their families? A: Prior to initiating antipsychotic treatment, patients and family members should be counseled on the potential for weight gain and increased risk of dyslipidemia and type 2 diabetes associated with such treatment. In particular, the prescribing clinician should ensure that the acute signs and symptoms of type 2 diabetes (including polyuria, polydipsia, unexplained weight loss, and blurred vision), and those of hyperosmolar non-ketotic syndrome and diabetic ketoacidosis, as well as the need for regular follow-up monitoring, are adequately stressed.

10 References 1. Colton CW, Manderscheid RW. Congruencies in increased mortality rates, years of potential life lost, and causes of death among public health clients in eight states. Prev Chron Dis 2006;3 (April):1-14. Available at: Accessed August 21, McEvoy JP, Meyer JM, Goff DC, et al. Prevalence of the metabolic syndrome in patients with schizophrenia: baseline results from the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia trial and comparison with national estimates from NHANES III. Schizophr Res 2005; 80: Newcomer JW. Second-generation (atypical) antipsychotics and metabolic effects: a comprehensive literature review. CNS Drugs 2005; 19 Suppl 1: Newcomer JW and Hennekens C. Severe Mental Illness and Risk of Cardiovascular Disease. JAMA; 298: Olfson M, Blanco C, Liu L, et al. National trends in the outpatient treatment of children and adolescents with antipsychotic drugs. Arch Gen Psychiatry 2006; 63: Ryan MC, Collins P, Thakore JH. Impaired fasting glucose tolerance in firstepisode, drug-naive patients with schizophrenia. Am J Psychiatry 2003; 160: Dixon L, Weiden P, Delahanty J, et al. Prevalence and correlates of diabetes in national schizophrenia samples. Schizophr Bull 2000; 26: Consensus development conference on antipsychotic drugs and obesity and diabetes. Diabetes Care 2004; 27: Improving the quality of health care for mental and substance-abuse conditions: Quality chasm series. Board on Healthcare Services, Institute of Medicine, Washington, DC: The National Academies Press.

11 10. International Expert Committee Report on the Role of the A1C Assay in the Diagnosis of Diabetes. Diabetes Care 2009; 32:

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