[Show abstract][Hide abstract] ABSTRACT: To detect the signals of celecoxib compared with other analgesics and anti-inflammatory drugs (AAIDs) by proportional claims ratio (PCR), claims odds ratio (COR), information component (IC), and relative risk (RR) using the Korean claims database. In addition, the concordance of the identified signals by the data-mining indices (DMIs) and the validity of the DMIs were evaluated.
The Korean Health Insurance Review and Assessment Service claims database was used. The study population consisted of elderly ambulatory care patients with osteoarthritis who were prescribed AAIDs in Seoul from 1 January 2005 to 30 September 2005. A short-term serious adverse event (SAE) was defined as a hospital admission within 12 weeks from each AAID prescription. Among the screened SAEs, signals were identified by the DMIs. The sensitivity, specificity, and predictability were estimated with reference to known adverse events associated with celecoxib.
A total of 135,232 elderly patients with osteoarthritis were prescribed AAIDs. There were 309,717 drug-SAE pairs and 481 different SAEs. The PCR, COR, IC, and RR detected were as follows: 56 (11.6%), 57 (11.9%), 129 (26.8%), and 123 (25.6%) signals for celecoxib, respectively. The RR detected signals had a relatively high sensitivity (23.4%) compared with the other indices (PCR 9.9%, COR 10.8%, and IC 18.9%). The specificity of RR (73.8%) was higher than that of IC (70.8%). The positive and negative predictive values of the RR were 21.1% and 76.3%, respectively.
This study suggested that the RR was the most accurate of the DMIs for detecting signals in the claims database.
Pharmacoepidemiology and Drug Safety 12/2011; 20(12):1278-86. DOI:10.1002/pds.2237 · 2.94 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To evaluate the possibility of an association between polyethylene glycol (PEG) and acute renal failure (ARF) in elderly patients using a health insurance claims database.
We conducted a population-based case-crossover study using information obtained from Korean Health Insurance Review and Assessment Service (HIRA) claims from January 1, 2005 to December 31, 2005 (Seoul, Korea). The study population consisted of elderly patients who received PEG prior to experiencing their first ARF-related hospitalization from April 1, 2005 to December 31, 2005. For each patient, one case and two control periods were matched. PEG use in a 2- or 4-wk window period prior to hospitalization for ARF was compared with PEG use in two earlier 2- or 4-wk control window periods. Conditional logistic regression analysis was used to estimate odds ratios (ORs) and 95% CI, adjusting for concomitant uses of diuretics, angiotensin converting enzyme inhibitors, non-steroidal anti-inflammatory drugs, antibiotics, anti-cancer drugs, and contrast media.
Within the HIRA database which contained 1,093,262 elderly patients, 1156 hospitalized ARF cases were identified. Among these cases, PEG was prescribed to 17 (1.5%) patients before hospitalization. The adjusted ORs when applying the 2- and 4-wk window periods were 0.4 (95% CI: 0.03-5.24) and 2.1 (95% CI: 0.16-27.78), respectively.
No increased risk of ARF was found in elderly PEG users. However, based on the limited number of study subjects, further analysis should be performed to confirm these results.
World Journal of Gastroenterology 02/2011; 17(5):651-6. DOI:10.3748/wjg.v17.i5.651 · 2.37 Impact Factor