Possible link between Tamsulosin (Flormax) and dementia

From www.practiceupdate.com.

This study is not a randomized trial prospective trial, hence the results may be misleading.

Roughly, tamsulosin was found to confer about a 17% higher probability of developing dementia than no medication and v.s. other drugs for treating BPH.  However, the incidence rate over 19.8 months in the sample was 3.13% for tamsulosin and 2.59% for no medication.  The difference is only 0.54%.  Thus, it might be said, humorously, that the study shows that tamulosin association with dementia is significantly insignificant.

To put this in perspective, From age 65 to age 85, the risk of dementia with tamsulosin is about 31.7%, assuming a constant risk rate of 3.13% per 20 months and is about 27.0% for no medication - perhaps not enough difference to worry about.

Statistically significant hazard ratios are not the whole story to life.
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PURPOSE

Clinicians use tamsulosin, an α1-adrenoceptor antagonist, to manage symptomatic benign prostatic hyperplasia (BPH). Because α1-adrenoceptors are also present in the brain, the potential exists for adverse effects on cognitive functions. We explored the association between tamsulosin use and dementia risk.

METHODS

We used Medicare data (2006-2012) to conduct a cohort study among patients aged ≥65 years and diagnosed with BPH. Men taking tamsulosin (n = 253 136) were matched at a 1:1 ratio using propensity-scores to each of 6 comparison cohorts: patients who used no BPH-medication (n = 180 926), and patients who used the following alternative-BPH-medications: doxazosin (n = 28 581), terazosin (n = 23 858), alfuzosin (n = 17 934), dutasteride (n = 34 027), and finasteride (n = 38 767). Assessment began following the first fill of BPH-medication to identify incident dementia by ICD-9 diagnosis codes. We estimated hazard ratios (HR) and 95% confidence intervals (CI) for dementia using Cox proportional hazard regression for each of the 6 propensity-score-matched cohort-pairs.

RESULTS

The median follow-up period for all cohorts was 19.8 months. After propensity-score matching, the tamsulosin cohort had an incidence of dementia of 31.3/1000 person-years compared with only 25.9/1000 person-years in the no-BPH-medication cohort. The risk of dementia was significantly higher in the tamsulosin cohort, when compared with the no-BPH-medication cohort (HR [95% CI]: 1.17 [1.14, 1.21]) and each of the alternative-BPH-medication cohorts: doxazosin (1.20 [1.12, 1.28]), terazosin (1.11 [1.04, 1.19]), alfuzosin (1.12 [1.03, 1.22]), dutasteride (1.26 [1.19, 1.34]), and finasteride (1.13 [1.07, 1.19]). The significance of these findings persisted in sensitivity analyses.

CONCLUSION

Tamsulosin may increase the risk of dementia in older men with BPH.