PMID- 16550731
OWN - NLM
STAT- MEDLINE
DCOM- 20060707
LR  - 20190608
IS  - 0946-1965 (Print)
IS  - 0946-1965 (Linking)
VI  - 44
IP  - 3
DP  - 2006 Mar
TI  - Comparison of doxazosin GITS and standard doxazosin in the treatment of high 
      blood pressure.
PG  - 99-106
AB  - OBJECTIVE: To examine (1) the relative therapeutic equivalence of 4 mg doxazosin 
      gastrointestinal therapeutic system (DOX GITS) and 4 mg doxazosin standard 
      (DOX-S4) and (2) the efficacy and safety of 4 mg DOX GITS versus 2 mg doxazosin 
      standard (DOX-S2). PATIENTS: Male or female patients aged 18-80 diagnosed with 
      mild-to-moderate essential hypertension (sitting diastolic blood pressure (DBP) 
      95-110 mmHg and systolic blood pressure (SBP) < 180 mmHg) were randomized into 
      the study. METHODS: This double-blind, parallel, 9-week trial compared DOX-GITS 
      with doxazosin standard (DOX-S) in 310 hypertensive patients. Following a 2-week 
      placebo run-in phase, patients were randomized to receive DOX-GITS at 4 mg/d or 
      DOX-S at 2 or 4 mg/d. DOX GITS dosage remained unchanged at 4 mg throughout the 
      study. Titration in the DOX-S groups was initiated at Week 0 with 1 mg DOX-S and 
      increased to 2 mg DOX-S at Week 1. Dosage in the DOX-S4 group was increased to 4 
      mg DOX-S at Week 3. Therapeutic equivalence was measured by the change from 
      baseline in sitting diastolic BP (DBP). Efficacy was assessed using the change 
      from baseline for all blood pressure measures. Safety analysis included 
      evaluation of laboratory tests at clinic visits and adverse events (AEs). 
      RESULTS: Therapeutic equivalences between DOX GITS and DOX-S4 and DOX-S2 were 
      established at all study visits except for a significant difference in favor of 
      DOX GITS at Week 1 (p = 0.019) when the dose of DOX-S was 1 mg. All groups had a 
      significant decrease in BP at all study visits compared with baseline. The 
      proportion of patients who reached goal sitting DBP (< 90 mmHg) was similar among 
      the three treatment groups, except at Week 1, when more patients in the DOX GITS 
      group had obtained the goal compared with those in the DOX-S2 group (40.6% vs. 
      22.3%; p = 0.005). The proportion of patients who reached sitting SBP (< 140 
      mmHg) goal was similar among groups. AE profiles among the groups were similar. 
      CONCLUSION: DOX GITS was as effective as DOX-S in patients with mild-to-moderate 
      hypertension. The improved pharmacokinetic profile of the GITS formulation 
      compared with the standard formulation allows a therapeutic dose to be delivered 
      earlier and without dose titration. Both formulations of doxazosin were well 
      tolerated.
FAU - Os, I
AU  - Os I
AD  - Department of Nephrology, Ulleval University Hospital, Oslo, Norway. 
      ingrid.os@medisin.uio.no
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - Germany
TA  - Int J Clin Pharmacol Ther
JT  - International journal of clinical pharmacology and therapeutics
JID - 9423309
RN  - 0 (Anticholesteremic Agents)
RN  - 0 (Drug Carriers)
RN  - NW1291F1W8 (Doxazosin)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anticholesteremic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Blood Pressure/drug effects
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Doxazosin/administration & dosage/adverse effects/*therapeutic use
MH  - Drug Carriers
MH  - Female
MH  - Humans
MH  - Hypertension/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Technology, Pharmaceutical/methods
MH  - Therapeutic Equivalency
EDAT- 2006/03/23 09:00
MHDA- 2006/07/11 09:00
CRDT- 2006/03/23 09:00
PHST- 2006/03/23 09:00 [pubmed]
PHST- 2006/07/11 09:00 [medline]
PHST- 2006/03/23 09:00 [entrez]
AID - 10.5414/cpp44099 [doi]
PST - ppublish
SO  - Int J Clin Pharmacol Ther. 2006 Mar;44(3):99-106. doi: 10.5414/cpp44099.