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A real-world data analysis of dose effect of second-generation antipsychotic therapy on hemoglobin A1C level.
Prog Neuropsychopharmacol Biol Psychiatry. 2011 Jul 01; 35(5):1326-32.PN

Abstract

Previous studies have demonstrated an association between certain second-generation antipsychotics (SGAs) and diabetes mellitus. The study assessed the impact of SGA dose on hemoglobin A1C (HbA(1c) >6.0) levels in a real-world setting. Patients aged ≥ 18 years during 2002-2006 in Ingenix LabRx claims database were included. The database collects medical and prescription claims and a subset of laboratory results for an employed, commercially insured population distributed throughout the United States. Patients with previously diagnosed diabetes, identified by the ICD-9-CM code of 250.x or use of antidiabetic agents, were excluded. The main exposure measure was the cumulative dose over a 30 day period before the HbA(1c) test, calculated as [sum of (number of pills per day×strength)]/100. A logistic regression was used to examine the relation with HbA(1c) >6.0 by tertile of the cumulative dose and average daily dose, adjusted for the covariates. The study included 391 patients on olanzapine, 467 on quetiapine, and 262 on risperidone. Patients treated with aripiprazole or ziprasidone (n=212) were included as a secondary reference because of their minimal metabolic risk. Compared to lower (Tertiles 1 and 2) cumulative doses of risperidone, patients with a high cumulative dose of risperidone (Tertile 3) had a significantly higher odds ratio (OR) for HbA(1c) >6.0 (adjusted OR=2.45; 95% confidence interval=1.13-5.32; P=0.023). A similar increase in OR was seen in patients with high cumulative dose of olanzapine (2.41; 1.19-4.89; P=0.015). Analyses of average daily dose revealed that quetiapine ≥ 400 mg/day and risperidone ≥ 2 mg/day had an OR of 2.29 (1.04-5.06; P=0.041) and 2.28 (1.08-4.83; P=0.032), respectively, compared to aripiprazole/ziprasidone. Both olanzapine groups (≥ 10 and <10mg/day) were associated with a significantly increased OR. All results remained similar after further adjustment for the predicated probability of having an HbA(1c) test and additional medication covariates. In this claims data study, use of olanzapine was associated with elevated HbA(1c) and risperidone and quetiapine appeared to have dose-related association with elevated HbA(1c). One of the limitations of a claims data analysis is the lack of information on potential confounders such as ethnicity and weight.

Authors+Show Affiliations

Bristol-Myers Squibb, Wallingford, CT 06492, USA. zhenchao.guo@bms.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

21515328

Citation

Guo, Zhenchao, et al. "A Real-world Data Analysis of Dose Effect of Second-generation Antipsychotic Therapy On Hemoglobin A1C Level." Progress in Neuro-psychopharmacology & Biological Psychiatry, vol. 35, no. 5, 2011, pp. 1326-32.
Guo Z, L'italien GJ, Jing Y, et al. A real-world data analysis of dose effect of second-generation antipsychotic therapy on hemoglobin A1C level. Prog Neuropsychopharmacol Biol Psychiatry. 2011;35(5):1326-32.
Guo, Z., L'italien, G. J., Jing, Y., Baker, R. A., Forbes, R. A., Hebden, T., & Kim, E. (2011). A real-world data analysis of dose effect of second-generation antipsychotic therapy on hemoglobin A1C level. Progress in Neuro-psychopharmacology & Biological Psychiatry, 35(5), 1326-32. https://doi.org/10.1016/j.pnpbp.2011.03.020
Guo Z, et al. A Real-world Data Analysis of Dose Effect of Second-generation Antipsychotic Therapy On Hemoglobin A1C Level. Prog Neuropsychopharmacol Biol Psychiatry. 2011 Jul 1;35(5):1326-32. PubMed PMID: 21515328.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A real-world data analysis of dose effect of second-generation antipsychotic therapy on hemoglobin A1C level. AU - Guo,Zhenchao, AU - L'italien,Gilbert J, AU - Jing,Yonghua, AU - Baker,Ross A, AU - Forbes,Robert A, AU - Hebden,Tony, AU - Kim,Edward, Y1 - 2011/04/15/ PY - 2011/02/17/received PY - 2011/03/25/revised PY - 2011/03/31/accepted PY - 2011/4/26/entrez PY - 2011/4/26/pubmed PY - 2012/1/20/medline SP - 1326 EP - 32 JF - Progress in neuro-psychopharmacology & biological psychiatry JO - Prog Neuropsychopharmacol Biol Psychiatry VL - 35 IS - 5 N2 - Previous studies have demonstrated an association between certain second-generation antipsychotics (SGAs) and diabetes mellitus. The study assessed the impact of SGA dose on hemoglobin A1C (HbA(1c) >6.0) levels in a real-world setting. Patients aged ≥ 18 years during 2002-2006 in Ingenix LabRx claims database were included. The database collects medical and prescription claims and a subset of laboratory results for an employed, commercially insured population distributed throughout the United States. Patients with previously diagnosed diabetes, identified by the ICD-9-CM code of 250.x or use of antidiabetic agents, were excluded. The main exposure measure was the cumulative dose over a 30 day period before the HbA(1c) test, calculated as [sum of (number of pills per day×strength)]/100. A logistic regression was used to examine the relation with HbA(1c) >6.0 by tertile of the cumulative dose and average daily dose, adjusted for the covariates. The study included 391 patients on olanzapine, 467 on quetiapine, and 262 on risperidone. Patients treated with aripiprazole or ziprasidone (n=212) were included as a secondary reference because of their minimal metabolic risk. Compared to lower (Tertiles 1 and 2) cumulative doses of risperidone, patients with a high cumulative dose of risperidone (Tertile 3) had a significantly higher odds ratio (OR) for HbA(1c) >6.0 (adjusted OR=2.45; 95% confidence interval=1.13-5.32; P=0.023). A similar increase in OR was seen in patients with high cumulative dose of olanzapine (2.41; 1.19-4.89; P=0.015). Analyses of average daily dose revealed that quetiapine ≥ 400 mg/day and risperidone ≥ 2 mg/day had an OR of 2.29 (1.04-5.06; P=0.041) and 2.28 (1.08-4.83; P=0.032), respectively, compared to aripiprazole/ziprasidone. Both olanzapine groups (≥ 10 and <10mg/day) were associated with a significantly increased OR. All results remained similar after further adjustment for the predicated probability of having an HbA(1c) test and additional medication covariates. In this claims data study, use of olanzapine was associated with elevated HbA(1c) and risperidone and quetiapine appeared to have dose-related association with elevated HbA(1c). One of the limitations of a claims data analysis is the lack of information on potential confounders such as ethnicity and weight. SN - 1878-4216 UR - https://www.unboundmedicine.com/medline/citation/21515328/A_real_world_data_analysis_of_dose_effect_of_second_generation_antipsychotic_therapy_on_hemoglobin_A1C_level_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0278-5846(11)00113-8 DB - PRIME DP - Unbound Medicine ER -