PMID- 17617290
OWN - NLM
STAT- MEDLINE
DCOM- 20070807
LR  - 20131121
IS  - 0149-2918 (Print)
IS  - 0149-2918 (Linking)
VI  - 29
IP  - 4
DP  - 2007 Apr
TI  - Effects of branded versus generic terazosin hydrochloride in adults with benign 
      prostatic hyperplasia: a randomized, open-label, crossover study in Taiwan.
PG  - 670-82
AB  - BACKGROUND: Terazosin is an alpha1-selective adrenoceptor blocking agent that has 
      been reported in many clinical trials to be an effective choice for the treatment 
      of benign prostatic hyperplasia (BPH). To improve cost-effectiveness, the 
      development of an effective and well-tolerated generic formulation is needed. 
      OBJECTIVE: The aim of this study was to compare the efficacy and tolerability of 
      branded versus generic terazosin hydrochloride in adult patients with symptomatic 
      BPH in Taiwan. METHODS: This randomized, open-label, 2-sequence, 2-period 
      crossover study was conducted at the Urological Clinic, National Cheng Kung 
      University Medical Center, Taman, Taiwan. Men newly diagnosed with symptomatic 
      BPH who had not previously received treatment for BPH were recruited between 
      August 2002 and April 2006. Patients were randomly assigned to 1 of 2 treatment 
      sequences. Group A received generic terazosin during period 1 (6 weeks) and 
      branded terazosin in period 2 (6 weeks); group B received the branded drug during 
      period 1 and the generic during period 2. The 2 study periods were separated by a 
      1-week washout period. All treatments were given by mouth once daily (bedtime) at 
      an initial dosage of 2 mg/d for the first 2 weeks. At the week-2 study visit in 
      each treatment period, the dosage could be increased to 4 mg/d or decreased to 1 
      mg/d based on each patient's response and experience of adverse effects (AEs), 
      based on the opinion of the investigator. Efficacy variables included the total 
      score on the International Prostate Symptom Scale (IPSS), a 7-item instrument 
      used to assess objective lower urinary tract symptoms, including quality of life. 
      IPSS was measured at baseline and weeks 2 and 6 of each treatment period, and 
      maximal and mean uroflow rates, measured at baseline and week 6. Tolerability was 
      assessed at each time point using physical examination, including vital signs; 
      laboratory analysis; and spontaneous reporting. RESULTS: Fifty-three patients 
      were randomized; 43 were included in the efficacy analysis (mean [SD] age, group 
      A, 64.5 [7.7] years and group B, 62.9 [8.2] years; mean [SD] weight, group A, 
      66.4 [7.2] kg and group B, 67.1 [8.9] kg; all patients were Taiwanese). At 2 and 
      6 weeks, no significant between-product differences were found in mean (SD) 
      decreases from baseline in IPSS total score (generic, 2.46 [0.84] and 2.46 
      [1.00], respectively; branded, 1.56 [0.60] and 2.87 [0.71]). At week 6, the 
      between-product difference in mean increase from baseline in maximal uroflow rate 
      was nonsignificant (generic, 2.36 [0.90] mL/s; branded, 2.03 [0.62] mL/s). A 
      total of 86 treatment-emergent AEs were reported (45 with the generic drug; 41 
      with the branded drug), all of which were considered by the investigator as 
      nonserious except for 1 case of acute epididymitis, which occurred with the 
      generic drug. The most common AEs reported with the generic and branded 
      formulations were dizziness (7/48 [14.6%] and 10/50 [20.0%], respectively) and 
      peripheral edema (1/48 [2.1%] and 3/50 [6.0%]). No significant differences in the 
      prevalences of AEs were found between the 2 treatments. CONCLUSION: In this group 
      of Taiwanese patients with symptomatic BPH, the efficacy and tolerability of 
      generic terazosin were similar to those of branded terazosin.
FAU - Tsai, Yuh-Shyan
AU  - Tsai YS
AD  - Department of Urology, College of Medicine, National Cheng Kung University, 
      Tainan, Taiwan.
FAU - Lan, Shih-Kai
AU  - Lan SK
FAU - Ou, Jiann-Hui
AU  - Ou JH
FAU - Tzai, Tzong-Shin
AU  - Tzai TS
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Adrenergic alpha-1 Receptor Antagonists)
RN  - 0 (Drugs, Generic)
RN  - 8L5014XET7 (Terazosin)
RN  - XM03YJ541D (Prazosin)
SB  - IM
MH  - *Adrenergic alpha-1 Receptor Antagonists
MH  - Aged
MH  - Cross-Over Studies
MH  - Dizziness/chemically induced
MH  - Drugs, Generic/adverse effects/pharmacokinetics/*therapeutic use
MH  - Edema/chemically induced
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Prazosin/adverse effects/*analogs & derivatives/pharmacokinetics/therapeutic use
MH  - Prostatic Hyperplasia/*drug therapy
MH  - Taiwan
MH  - Therapeutic Equivalency
EDAT- 2007/07/10 09:00
MHDA- 2007/08/08 09:00
CRDT- 2007/07/10 09:00
PHST- 2007/02/14 00:00 [accepted]
PHST- 2007/07/10 09:00 [pubmed]
PHST- 2007/08/08 09:00 [medline]
PHST- 2007/07/10 09:00 [entrez]
AID - S0149-2918(07)00113-0 [pii]
AID - 10.1016/j.clinthera.2007.04.013 [doi]
PST - ppublish
SO  - Clin Ther. 2007 Apr;29(4):670-82. doi: 10.1016/j.clinthera.2007.04.013.