5-ARI treatment linked to decline in sexual function

August 21, 2014

Sexual function in men with lower urinary tract symptoms/BPH generally declines over time whether or not they are treated with medication. However, the magnitude of worsening differs depending on the treatment received, according to findings from the Medical Therapy of Prostatic Symptoms study.

Orlando, FL-Sexual function in men with lower urinary tract symptoms/BPH generally declines over time whether or not they are treated with medication. However, the magnitude of worsening differs depending on the treatment received, according to findings from the Medical Therapy of Prostatic Symptoms (MTOPS) study.

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MTOPS randomized 3,047 men to treatment with placebo, finasteride (Proscar), doxazosin (Cardura), or a combination of the two drugs. Patients were followed for 4 years. Data on sexual function were collected at baseline and yearly thereafter using the Brief Male Sexual Function Inventory (BMSFI). About 91% of the study population was eligible for analysis of sexual function based on having at least one follow-up BMSFI.

The results, presented at the AUA annual meeting in Orlando, FL and subsequently published in the Journal of Urology (2014; 191:1828–34), showed a decreasing trend (worsening) overall in all five domains of the BMSFI in all four treatment groups. However, compared to the placebo-treated controls, doxazosin had a minimal impact whereas there were statistically significant differences in four of the five BMSFI domains indicating greater worsening among men receiving finasteride alone or as combination therapy, reported first author R. Charles Welliver, Jr., MD, andrology fellow at Southern Illinois University School of Medicine, Springfield, IL.

“While LUTS/BPH is frequently managed with drug therapy for long intervals of time, the sexual side effects of these medications have not been rigorously studied. Most information on this topic is from studies of 3 to 6 months duration and often using broad binomial endpoints that were included in the research as an afterthought and may be subject to recall bias,” Dr. Welliver said.

 

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Counseling on 5-ARI effects warranted

“MTOPS looked at sexual function as a rigorously studied secondary outcome. Based on the results obtained, patient counseling on the risk of declining sexual function associated with long-term use of a 5-alpha-reductase inhibitor is certainly warranted. In addition, we believe that chronic use of the 5-ARIs in the overall continuum of BPH treatment options should be further considered,” added Dr. Welliver, who worked on the study with Kevin T. McVary, MD, and co-authors.

The BMSFI is a validated sexual health questionnaire that is self-administered and features a range of answers for each of its 11 items. Its five domains are sexual drive, erectile function, ejaculatory function, sexual problem assessment, and sexual satisfaction.

“The International Index of Erectile Function was not introduced until 1997, and so when MTOPS began in 1995, the BMSFI was considered the state-of-the-art instrument for measuring sexual function,” Dr. Welliver said.

The MTOPS population had an average age of 63 years and was primarily composed of non-Hispanic Caucasians (83%) with a greater than secondary education level (71%). At baseline, they had an average symptom index of 17, mean prostate volume of 36 mL, and mean PSA of 2.4 ng/mL.

“The study population was fairly representative of men seen in clinical practice. The four treatment groups were well matched in their baseline demographics, disease characteristics, and BMSFI scores,” Dr. Welliver said.

Analyses of changes from baseline scores showed a general trend toward decreasing sexual drive in all groups and without any separation between them at any follow-up interval. However, for comparisons to the controls in the other four domains, there was significantly greater worsening in erectile function and general sexual problem assessment in the combination group and in ejaculatory function in both the combination group and finasteride-treated men. Data for overall sexual satisfaction showed an improvement between years 2 and 3 in the doxazosin group and a further increase at 4 years.

The data were also analyzed using a threshold score to identify men with “poor function” within each BMSFI domain. In all treatment groups for all domains, the proportion of men categorized as having poor function increased between year 1 and year 4. In comparisons to the placebo-treated controls for each of the domains, only the finasteride and combination groups showed significantly higher rates of men categorized as having poor function.

Dr. McVary is a consultant/adviser to Allergan, Lilly USA, NxThera, Watson, NeoTract, and GlaxoSmithKline.UT

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