title: Time Course of Incident Adverse Experiences Associated with Doxazosin, Finasteride and Combination Therapy in Men with Benign Prostatic Hyperplasia: The MTOPS Trial.
abstract: We examined first (incident) reports of selected adverse experiences associated with medical therapy in men with lower urinary tract symptoms secondary to benign prostatic hyperplasia.
  
  
  
  We studied the 6 most common adverse experiences, including nonsexual function related experiences (dizziness, orthostatic hypotension and weakness) and sexual function related experiences (impotence, decreased libido and abnormal ejaculation) reported in the MTOPS (Medical Therapy of Prostatic Symptoms) Study. A total of 3,047 men were randomized to placebo, doxazosin, finasteride or combination therapy and followed for a mean duration of 4.5 years. We compared the incidence rates of adverse experiences at year 1 to the rates thereafter.
  
  
  
  For each assigned treatment group, the incidence rates were significantly higher for all 6 adverse experiences examined at year 1 compared with the rates thereafter. Men assigned to combination therapy experienced the highest rates at year 1 with rates 3.4-fold to 10.6-fold higher than rates after year 1. The incidence rates for orthostatic hypotension and dizziness were significantly higher in the doxazosin and combination therapy groups compared with the placebo group at year 1. The incidence rates of the 3 examined sexual function related adverse experiences were significantly higher in the finasteride and combination therapy groups than in the placebo group at year 1.
  
  
  
  Rates of the first report of sexual function related and other adverse experiences associated with doxazosin, finasteride and combination therapy were greatest during year 1 of treatment. These patterns should be considered by patients and physicians when treatment for lower urinary tract function is initiated with these drugs.
authors.affiliation: Department of Urology, Icahn School of Medicine at Mount Sinai, Mount Sinai Health System, New York, New York. Electronic address: steven.kaplan@mountsinai.org.
authors.forename: Steven A
authors.initials: SA
authors.lastname: Kaplan
authors.affiliation: University of Arkansas for Medical Sciences, Little Rock, Arkansas.
authors.forename: Jeannette Y
authors.initials: JY
authors.lastname: Lee
authors.affiliation: Merck & Co., Inc., Kenilworth, New Jersey.
authors.forename: Alan G
authors.initials: AG
authors.lastname: Meehan
authors.affiliation: National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland.
authors.forename: John W
authors.initials: JW
authors.lastname: Kusek
mesh_terms: D058891:5-alpha Reductase Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D058668:Adrenergic alpha-1 Receptor Antagonists / Q000009:adverse effects* / Q000627:therapeutic use; D017292:Doxazosin / Q000009:adverse effects* / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D018120:Finasteride / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D011467:Prostate / Q000503:physiopathology; D011470:Prostatic Hyperplasia / Q000188:drug therapy*; D013997:Time Factors
chemical_list: D058891:5-alpha Reductase Inhibitors; D058668:Adrenergic alpha-1 Receptor Antagonists; D018120:Finasteride; D017292:Doxazosin
keywords: doxazosin; drug-related side effects and adverse reactions; finasteride; prostatic hyperplasia; sexual dysfunction, physiological