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Signal detection of rosuvastatin compared to other statins: data-mining study using national health insurance claims database.
Pharmacoepidemiol Drug Saf. 2010 Mar; 19(3):238-46.PD

Abstract

PURPOSE

To detect adverse drug reaction (ADR) signals of rosuvastatin compared to other statins with a novel data-mining approach based on relative risk (RR) using the national health insurance claims database, and to evaluate the usefulness of this method as a tool for signal detection.

METHODS

We used the Health Insurance Review & Assessment Service (HIRA) claims database (Seoul, Korea). Serious adverse events (SAE) were defined as any diagnostic code at the time of hospitalization within 12 weeks from a statin prescription date, regardless of causality. Among statin users, RRs were calculated to compare the proportion of rosuvastatin-specific SAE pairs for rosuvastatin users with the corresponding proportion of drug-SAE pairs for users of other statins. Any SAE for which the lower limit of the RR's 95% confidence interval was greater than 1 was defined as a signal. All detected signals were reviewed to determine whether the signals corresponded with published adverse events (AEs) exclusive to rosuvastatin.

RESULTS

Among 96 236 elderly outpatients who received rosuvastatin, or other statins, from January 2005 to September 2005, 40 304 drug-SAE pairs and 376 SAEs were observed. Twenty-five (6.6%) SAEs were detected as signals by the RR-based data-mining approach. Among the 13 references AEs published to be exclusive to rosuvastatin, 8 (61.5%) were found to correspond with the detected signals with a positive predictive value (PPV) of 32%.

CONCLUSIONS

The RR-based data-mining approach successfully detected signals for rosuvastatin using a national health insurance claims database. This approach could be useful for safety surveillance of marketed products.

Authors+Show Affiliations

Department of Preventive Medicine, Seoul National University College of Medicine, Seoul 110-799, Korea.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20049851

Citation

Choi, Nam-Kyong, et al. "Signal Detection of Rosuvastatin Compared to Other Statins: Data-mining Study Using National Health Insurance Claims Database." Pharmacoepidemiology and Drug Safety, vol. 19, no. 3, 2010, pp. 238-46.
Choi NK, Chang Y, Choi YK, et al. Signal detection of rosuvastatin compared to other statins: data-mining study using national health insurance claims database. Pharmacoepidemiol Drug Saf. 2010;19(3):238-46.
Choi, N. K., Chang, Y., Choi, Y. K., Hahn, S., & Park, B. J. (2010). Signal detection of rosuvastatin compared to other statins: data-mining study using national health insurance claims database. Pharmacoepidemiology and Drug Safety, 19(3), 238-46. https://doi.org/10.1002/pds.1902
Choi NK, et al. Signal Detection of Rosuvastatin Compared to Other Statins: Data-mining Study Using National Health Insurance Claims Database. Pharmacoepidemiol Drug Saf. 2010;19(3):238-46. PubMed PMID: 20049851.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Signal detection of rosuvastatin compared to other statins: data-mining study using national health insurance claims database. AU - Choi,Nam-Kyong, AU - Chang,Yoosoo, AU - Choi,Yu Kyong, AU - Hahn,Seokyung, AU - Park,Byung-Joo, PY - 2010/1/6/entrez PY - 2010/1/6/pubmed PY - 2010/5/19/medline SP - 238 EP - 46 JF - Pharmacoepidemiology and drug safety JO - Pharmacoepidemiol Drug Saf VL - 19 IS - 3 N2 - PURPOSE: To detect adverse drug reaction (ADR) signals of rosuvastatin compared to other statins with a novel data-mining approach based on relative risk (RR) using the national health insurance claims database, and to evaluate the usefulness of this method as a tool for signal detection. METHODS: We used the Health Insurance Review & Assessment Service (HIRA) claims database (Seoul, Korea). Serious adverse events (SAE) were defined as any diagnostic code at the time of hospitalization within 12 weeks from a statin prescription date, regardless of causality. Among statin users, RRs were calculated to compare the proportion of rosuvastatin-specific SAE pairs for rosuvastatin users with the corresponding proportion of drug-SAE pairs for users of other statins. Any SAE for which the lower limit of the RR's 95% confidence interval was greater than 1 was defined as a signal. All detected signals were reviewed to determine whether the signals corresponded with published adverse events (AEs) exclusive to rosuvastatin. RESULTS: Among 96 236 elderly outpatients who received rosuvastatin, or other statins, from January 2005 to September 2005, 40 304 drug-SAE pairs and 376 SAEs were observed. Twenty-five (6.6%) SAEs were detected as signals by the RR-based data-mining approach. Among the 13 references AEs published to be exclusive to rosuvastatin, 8 (61.5%) were found to correspond with the detected signals with a positive predictive value (PPV) of 32%. CONCLUSIONS: The RR-based data-mining approach successfully detected signals for rosuvastatin using a national health insurance claims database. This approach could be useful for safety surveillance of marketed products. SN - 1099-1557 UR - https://www.unboundmedicine.com/medline/citation/20049851/Signal_detection_of_rosuvastatin_compared_to_other_statins:_data_mining_study_using_national_health_insurance_claims_database_ L2 - https://doi.org/10.1002/pds.1902 DB - PRIME DP - Unbound Medicine ER -