Pharmacoepidemiology and drug safety · 2008
An assessment of the effect of thiazolidinedione exposure on the risk of myocardial infarction in type 2 diabetic patients.
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Koro Carol E, Fu Qinggong, Stender Monika
Аннотация
PURPOSE: To determine the likelihood of myocardial infarction (MI) in type 2 diabetic patients exposed to rosiglitazone and pioglitazone, separately, compared to other antidiabetic therapies.
METHODS: A case-control analysis nested within the cohort of type 2 diabetic subjects from the Integrated Healthcare Information Services (IHCIS) claims database. Incident cases of MI were matched to three controls each on age (+/-5 years), gender, and year of first diabetes diagnosis. Subjects were classified according to their antidiabetic drug exposure in the 3, < 6, 6-12, and > 12 months prior to the index date. The adjusted odds ratios of MI were calculated for subjects exposed to rosiglitazone and pioglitazone, separately, compared to other antidiabetic agents. Risk factors adjusted for are age, ACE inhibitors, beta-blockers, diuretics, nitrates, diagnosis of hyperlipidemia, and hypertension and coronary artery disease (CAD).
RESULTS: A total of 891 901 diabetic subjects (9870 cases and 29 610 control) identified from 1999 to 2006 were included in the analysis. The mean age was 63 years for the cases and controls. Compared to those treated with other antidiabetic therapies, the adjusted odds ratio of MI was 1.03 [95%CI: 0.93-1.12] for rosiglitazone and 0.92 [95%CI: 0.83-1.01] for pioglitazone in the 3 months prior to the index date.
CONCLUSIONS: The results suggest that the risk of MI in subjects exposed to rosiglitazone or pioglitazone for < or = 12 months is not different from those exposed to other antidiabetic agents but exposure for > 12 months is associated with 15 and 13% increased risk of MI, respectively.
METHODS: A case-control analysis nested within the cohort of type 2 diabetic subjects from the Integrated Healthcare Information Services (IHCIS) claims database. Incident cases of MI were matched to three controls each on age (+/-5 years), gender, and year of first diabetes diagnosis. Subjects were classified according to their antidiabetic drug exposure in the 3, < 6, 6-12, and > 12 months prior to the index date. The adjusted odds ratios of MI were calculated for subjects exposed to rosiglitazone and pioglitazone, separately, compared to other antidiabetic agents. Risk factors adjusted for are age, ACE inhibitors, beta-blockers, diuretics, nitrates, diagnosis of hyperlipidemia, and hypertension and coronary artery disease (CAD).
RESULTS: A total of 891 901 diabetic subjects (9870 cases and 29 610 control) identified from 1999 to 2006 were included in the analysis. The mean age was 63 years for the cases and controls. Compared to those treated with other antidiabetic therapies, the adjusted odds ratio of MI was 1.03 [95%CI: 0.93-1.12] for rosiglitazone and 0.92 [95%CI: 0.83-1.01] for pioglitazone in the 3 months prior to the index date.
CONCLUSIONS: The results suggest that the risk of MI in subjects exposed to rosiglitazone or pioglitazone for < or = 12 months is not different from those exposed to other antidiabetic agents but exposure for > 12 months is associated with 15 and 13% increased risk of MI, respectively.