EXPLORATIVE ANALYSIS ABOUT THE APPROPRIATENESS OF A GPS LONGITUDINAL DATABASE ON EVALUATING ATYPICAL ANTIPSYCHOTICS IN TERMS OF DRUGS ADVERSE EVENTS

Author(s)

Heiman F1, Pegoraro V1, Katz P1, Didoni G2, Calandriello M21CSD Medical Research S.r.l., Milan, Italy, 2HE OR Unit - Bristol-Myers Squibb S.r.l., Rome, Italy

OBJECTIVES: The main objective of this study was to understand the appropriateness of a GPs Longitudinal Database on exploring potential causal associations among therapies and adverse events. We’ve focused on subjects treated with three of the most widespread atypical antipsychotics drugs known as affecting patients’ lipidic profile and cardiovascular and diabetes risk. METHODS: Data were obtained from CSD LPD, an Italian General Practitioner’s longitudinal database. Patients with a first prescriptions of Aripiprazole, Olanzapine or Quetiapine during the period January 2005 to December 2009 have been selected. For each patient, the first prescription has been considered as the Index Date. The final study sample was composed of patients that during the following three months had at least another prescription of the same atypical antipsychotic. Patients have been followed-up for a maximum of 12 months starting from three months after the Index Date. RESULTS: Treatment groups were composed of 367 patients for Aripiprazole, 1825 patients for Olanzapine and 3088 patients for Quetiapine. The proportion of patients with an out of range value of Total Cholesterol and LDL was significantly lower in Aripiprazole group. The same trend has been observed for the proportion of patients with at least one recorded diagnosis of cardiovascular events and diabetes. The association between treatment and cardiovascular diagnosis presence was still significant even when performing a multivariate logistic model adjusted for age, gender and presence of a cardiovascular diagnosis during the year before the Index Date (Odds Ratio Olanzapine VS. Aripiprazole: 1.76 [1.08 – 2.85]; Odds Ratio Quetiapine versus Aripiprazole: 1.67 [1.03 – 2.70]). CONCLUSIONS: CSD LPD  database resulted to be appropriate in exploring potential causal associations among treatments and potential adverse events both in terms of recorded diagnosis and in terms of recorded laboratory exams values even if, in this case, the sample size was reduced. 

Conference/Value in Health Info

2011-11, ISPOR Europe 2011, Madrid, Spain

Value in Health, Vol. 14, No. 7 (November 2011)

Code

PCV1

Topic

Epidemiology & Public Health

Topic Subcategory

Safety & Pharmacoepidemiology

Disease

Cardiovascular Disorders, Diabetes/Endocrine/Metabolic Disorders, Mental Health, Respiratory-Related Disorders

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