New-Onset Type-2 Diabetes and Atypical Antipsychotic Medications - Research Paper Example

?Running Head: ARTICLE CRITIQUE: NEW-ONSET Article Critique: New-Onset Type-2 Diabetes Associated with Atypical Antipsychotic Medications Michael T. Lambert, Laurel A. Copeland, Nancy Sampson, and Sonia A. Duffy Progress in Neuro-Psychopharmacology & Biological Psychiatry 30 (2006) 919–923 Students Name Course Name Instructor Date Article Critique New-Onset Type-2 Diabetes Associated with Atypical Antipsychotic Medications Michael T. Lambert, Laurel A. Copeland, Nancy Sampson, and Sonia A. Duffy Progress in Neuro-Psychopharmacology & Biological Psychiatry 30 (2006) 919–923 Statement of the Problem: The authors state that the issue regarding atypical antipsychotics and metabolic disease has been previously clarified, it has only been in a general way. The authors feel that the distinction between these atypical medications and the comorbidity with weight gain and diabetes is an important distinction. Furthermore, this certainly has ramifications for nursing in regards to the diet and importance of monitoring signs of diabetes and increased weight gain in this cohort. The population under study and the quantitative analysis of the data is appropriate and meaningful for this study. Literature Review: The references cited, while not extensive, are suitable for the size of the study. Twenty-two references are used directly. Of these, seven are directly related to the effects the study is analyzing. The others relate to the specific mediations under study as well as the general information regarding diabetes and adiposity. Twenty are current and date from 2002 forward, only two are older, (1) the American Diabetes Association’s “Report of the expert committee on the diagnosis and classification of diabetes mellitus.” dates from 1997 but is only used as a general reference and (2) Gray and Fujioka (1991) “Use of relative weight and body mass index for the determination of adiposity,” also for general guidelines. The review successfully analyzes all the variables in the study. It also cites studies which appear to have already reviewed the topic and presented a direct correlation between these drugs and diabetes/weight gain. In Cohen’s (2004) review of the existing literature he cites that: …22 cases of new-onset diabetes that resolved and 6 that did not when the antipsychotic was stopped. In a survey of diabetes associated with clozapine, glycemic control improved after clozapine was stopped in 78% of individuals who developed diabetes; 62% of these patients no longer required hypoglycemic drugs. Of 12 patients who were restarted on clozapine, 9 developed hyperglycemia again. (Cohen, 2004, 3) While other references used generalized this effect there is other literature that directly supports it. For instance, in a study they did not reference, Koller and Doraiswamy (2002) showed in their research that 78% of the group had improved glycemic balance once they stopped taking or decreased the dosage of olanzapine and that if olanzapine was restarted eight out of ten patients had a recurrence of hyperglycemia. So it is clear that there were previous studies which connected the same inferences the authors are stating. There is also some research that counter-indicates their results as to weight gain to some extent: …patients taking antipsychotic drugs can develop diabetes without significant weight gain or can lose weight. Furthermore, their diabetes usually improves rapidly when the antipsychotic drug is withdrawn, without significant reduction in body weight, and often recurs rapidly if the drug is started again. (Wirshing, 2001, 8) They do cite another study from Wirshing, Boyd and Meng (2002) which does concur with their weight gain hypothesis. Furthermore, as far back as 1999, the diabetic inducing effects off clozapine and olanzapine were already known: Several cases of new-onset diabetes attributed to clozapine and olanzapine were associated with acute pancreatitis. It is possible, therefore, that antipsychotic-induced diabetes results from chemical damage to the pancreas. However, diabetes associated with atypical antipsychotics is associated with hyperinsulinemia rather than failure of insulin release. Goldstien et. Al., 1999, 440) Overall this study does not appear to present any new information, and appears to merely reaffirm previous studies and research. This study does focus more on weight gain as a consequence, but as mentioned this may be counter indicated in other studies which show no correlation. They main purpose, however, is to reinforce the idea that patients on these atypical antipsychotics do need to be more closely monitored by medical caregivers for signs of the onset of the comorbid conditions of diabetes and obesity. Conceptual/Theoretical Framework: The framework of the study is rather straightforward. It was an electronic chart review researching the onset of diabetes in subjects who also receive the atypical antipsychotic medications described. There was no theoretical framework other than collection and data analysis which proved effective for this study. Hypotheses or Research Question: These are clearly defined and assessed throughout as well as in the research literature. They hypothesize a direct connection between the use of atypical antipsychotics and the occurrence of new onset diabetes and weight gain. Research Design: This current research study was conducted under the guidance of the Institutional Review Board (IRB). The design of the study was an electronic chart review regarding the incidence of the new development of diabetes mellitus patients whose metal illness was being ameliorated with olanzapine, risperidone or quetiapine over a one-year period compared to a control group of patients on haloperidol. Population and Sample: Charts for study were culled from a list of pharmacy patients who had recently begun taking these atypical medications and had continued to take them for at least a full year (four outpatient refills being the requirement for a year). Data Collection and Measurement: Baseline measurements of the patients were taken primarily for weight, but also height to correctly ascertain adiposity and a confirmed psychiatric diagnosis. Reasons for exclusions from the study included taking any other study’s medication or death occurring during the period being studied. Data collection, as previously mentioned, were chart reviews and collection of laboratory analysis regarding blood levels consistent with the onset of diabetes as well as increases in weight over the period. Procedures: The study protocol which had been determined by a statistical power analysis that indicated that from one hundred subjects per cell would yield >80% power, which would give credibility to detect significant change in the outcome variables of new-onset diabetes and weight change. In order to meet this protocol subjects were collected as follows: 1034 olanzapine, 889 quetiapine, 987 risperidone, and 730 haloperidol. Measurements for diabetes were determined by the guideline of the American Diabetic Association (1997) criteria of a fasting plasma glucose of 126 mg/dl or higher, as well as a new diagnosis of diabetes in any medical records, or start of any new anti-diabetic medication during the follow-up period. Changes in weight during the course of the study were measure and compared to baseline as well as during the follow-up period. Data Analysis: The researchers conducted a statistical analysis on the independent variables and covariants. This required the use of a Multivariate model and adapted to the particular study. These multivariate models included data about gender, race, and psychiatric and medical comorbid diagnoses. They also utilized a panel of five academic psychiatrists who analyzed the comorbid conditions and rated likelihood of weight loss associated with each of the diagnoses found in the study sample. The results from the panel were used to create dichotomous indicators. They also screened out certain patients who had a preexisting diagnosis of obesity by omitting those with a BMI of 30 or greater from the study. Three age categories were created: young (age 21–35), middle (age 36–50), and older (age 50–88). They also restricted patients who had a prior diagnosis of diabetes as well. Finally a logistic regression model was used that would determine the relationship between the use of these atypical antipsychotic medications and the development of new onset diabetes and weight gain. Findings: While their study began by going over old ground, their key finding was that the use of olanzapine clearly showed a higher risk for onset of new diabetes, while the other atypical drugs, quetiapine and risperidone, showed no such effect. The patients in all groups using olanzapine developed new onset diabetes at a significantly higher incidence (10 to 130 per 1000) as indicated by the U.S. Department of Health and Human Services (2002) which is 6.3 per 1000. This study also showed that olanzapine patients had a higher rate of diabetes development that in previously reported studies of patients with schizophrenia (Leslie and Rosenheck, 2004). Weight gain was found not to be strongly associated with the risk of new-onset diabetes with relationship to this particular study. These finding were well presented in both in the text and discussion as well as the following tables: (Lambert, et. Al, 2006, 921) Interpretation of the Findings and Recommendations: The authors of the study recommend that patients who are prescribed olanzapine should receive much more careful monitoring, testing and observation for diabetes. The current nursing and general medical practice is to rely on weight assessment alone and this will be inadequate in light of this new information. Furthermore, if patients also present with additional risk factors such as obesity, or are from older age groups they will need significantly increase observation. Presentation: The report is well written and succinctly demonstrates the finding in an easily accessible manner for both the nursing community as well as for most medical professionals. The reports brevity may be its only flaw in that more extensive analysis of additional information may have been helpful in determining the viability of the data presented. Summary Assessment: The report contributes to an accelerated awareness regarding the higher incidence on new onset diabetes in patients using olanzapine. The findings overall appear to be valid and the cohort used was statistically sufficient to make the findings plausible. The authors do not address the generalizability of the findings other than to say that, “Surveillance bias may exist in the subject selection process as patients on certain atypical agents may have been more closely monitored for adverse effects” (Lambert, 2006, 922) Furthermore, the authors do not mention that there are alternatives to discontinuing olanzapine that have been used to counter the development of diabetes and increased weight gain in patients using this and other atypical antipsychotics as indicated by Baptista, et.al (2006) in their study, Metformin for Prevention of Weight Gain and Insulin Resistance with Olanzapine: A Double-Blind Placebo-Controlled Trial, “In patients with type 2 diabetes, metformin improves insulin resistance and lipid profile and either has a neutral effect or decreases body weight” (196). This study may have been released after theirs so they may not have been completely aware of an alternative medication. References American Diabetes Association. (1997). Report of the expert committee on the diagnosis and classification of diabetes mellitus. Diabetes Care, 20, 1183–97. Baptista, T., Martinez, J., Lacruz, A., Rangel, N. (2006). Metformin for Prevention of Weight Gain and Insulin Resistance with Olanzapine: A Double-Blind Placebo-Controlled Trial. Canadian Journal of Psychiatry, 51(3), 192-99. Koller E.A. and , Doraiswamy, P.M. (2002). Olanzapine-associated diabetes mellitus. Pharmacotherapy 22 841–852. Gray, D.S., Fujioka, K. (1991) Use of relative weight and body mass index for the determination of adiposity. Journal of Clinical Epidemiology,44(6), 545–50. Goldstein, L.E., Sporn, J., Brown, S., Kim. H., Finkelstein, J., Gaffey, G.K., Sachs. G, Stern, T.A. (1999) New-onset diabetes mellitus and diabetic ketoacidosis associated with olanzapine treatment. Psychosomatics, 40, 438–443. Lambert, M. T., Copeland, L. A., Sampson, N., Duffy S. A. (2006) New-onset type-2 diabetes associated with atypical antipsychotic medications Progress in Neuro-Psychopharmacology & Biological Psychiatry, 30, 919–923 Leslie, D.L,, Rosenheck, R.A., (2004) Incidence of newly diagnosed diabetes attributable to atypical antipsychotic medications. American Journal of Psychiatry, 161, (9):1709–11. U.S. Department of Health and Human Services. (2002). National Diabetes Fact Sheet: general information and national estimates on diabetes in the United States, 2002. Atlanta, U.S.A.: U.S. Department of Health and Human Services, Center for Disease Control. Wirshing, D.A., (2001). Adverse effects of atypical antipsychotics. Journal of Clinical Psychiatry, 62, 7–10. Wirshing, D.A., Boyd, J.A., Meng, L.R., (2002) The effects of novel antipsychotics on glucose and lipid levels. Journal of Clinical Psychiatry, 63, 856–65. Read More