Analysis of cardiovascular events or diabetes mellitus during androgen deprivation therapy in Korean prostate cancer patients. Issue 2 (12th March 2012)

• Record Type: Journal Article
• Authors: Kim, J.
• Is Part Of: European journal of hospital pharmacy. Volume 19:Issue 2(2012)
• Page Start: 170
• Page End: 171
• Publication Date: 2012-03-12
• Subjects: Pharmacy -- Periodicals; Hospital pharmacies -- Periodicals; 615.1
• DOI: 10.1136/ejhpharm-2012-000074.225
• Languages: English
• ISSNs: 2047-9956

Abstract

Abstract : Background: ADT (Androgen Deprivation Therapy) is widely used as prostate cancer treatment which suppresses serum testosterone and inhibits the cancer cell growth. Since people with prostate cancer have relatively high 5-year survival rate, chronic diseases such as cardiovascular disease (CVD) and diabetes mellitus (DM) may impact their quality of life and overall survival more than those of patients with other cancer types. Recently, possible adverse effects of ADT have been issued which may be associated with an increased risk of CVD and DM. Purpose: The possible association between ADT and CVD or DM has not been fully studied in Korean men with prostate cancer, and the purpose of the current retrospective observation study is to investigate this association. Materials and methods: The study included 546 patients treated with ADT and 262 patients treated with radical retropubic prostatectomy (RRP) at the National Cancer Center in Korea from January 2001 through December 2008. Study subjects were those who have node-negative localised and advanced localised prostate cancer. After excluding patients with a history of radiation therapy, node-positivity, evidence of metastasis and pre-existing CVD and DM, 96 patients treated with ADT and 90 patients with RRP were remained for the analysis. The data on these patients, followed-up until December 2010, were retrospectively reviewed from electronic medical records (EMR). To test the difference in the incidences of CVD or DM between RPP and ADT groups, exact logistic regression analysis was performed due to the small number of incidences. Baseline variables including age, body mass index, family history of CDV or DM, history of smoking and T-stage were examined to check the imbalance between two groups. Variables that were significantly imbalanced between groups were considered in the multivariable logistic regression, and variable selection method based on exclusion criteria of p-value at 0.1 was performed to obtain the final model. All reported p-values are two-sided and the criterion for significance was p-value less than 0.05. All statistical analyses were performed using R statistical software, version 2.12. Results: Newly developed CVD or DM were found in 7 out of 96 patients in the ADT group, and 1 out of 90 patients in the RRP group. The incidence of CVD or DM was higher in ADT group than RRP group, but it failed to reach statistical significant at 0.05 with the observed p-value=0.066. Subgroup analysis based on different treatment drugs (LHRH agonists + antiandrogen (AA), or each alone) revealed that the incidence of CVD or DM was higher in the combination of LHRH agonists and AA group (odds ratio=2.05; 95% CI 1.01-4.12; p=0.043). However, it was not significant in LHRH agonists alone, and AA alone groups. Conclusions: In conclusion, our study found that there is a tendency of increased CVD or DM in Korean men with prostate cancer treated with ADT compared to RRP, however, it failed to reach statistical significance. Considering the limitations of the retrospective observation study, including possible selection bias, further well-designed prospective studies are needed to thoroughly assess the impact of ADT on CVD or DM in patients with prostate cancer, and as recommended by Food and Drug Administration (FDA) and Korea Food and Drug Administration (KFDA), careful monitoring of prostate cancer patients treated with ADT who have pre-existing CVD or DM is required.