PMID- 12517683
OWN - NLM
STAT- MEDLINE
DCOM- 20030716
LR  - 20190513
IS  - 0895-7061 (Print)
IS  - 0895-7061 (Linking)
VI  - 16
IP  - 1
DP  - 2003 Jan
TI  - Efficacy and safety of a once daily graded-release diltiazem formulation in 
      essential hypertension.
PG  - 51-8
AB  - BACKGROUND: The efficacy and safety of a chronotherapeutic, graded-release 
      diltiazem HCl extended-release (GRD) 120-, 240-, 360- and 540-mg dose 
      administered once-daily at bedtime (10 PM) were evaluated in a 7-week randomized, 
      double-blind comparison to placebo and to GRD 360 mg administered once-daily at 8 
      AM in 478 patients with moderate-to-severe essential hypertension. METHODS: We 
      assessed the change from baseline to end point in trough diastolic blood pressure 
      (DBP) at 6 PM to 10 PM and in mean DBP from 6 AM to 12 noon between GRD 360 mg PM 
      and GRD 360 mg AM, measured by ambulatory BP monitoring (ABPM). RESULTS: Bedtime 
      doses of GRD showed dose-related mean reductions in trough DBP that were 
      significant for GRD doses of 240 mg and higher. Bedtime GRD 360 mg was associated 
      with a significantly greater reduction in mean DBP between 6 AM and 12 noon 
      compared to morning GRD 360 mg with a least squares mean for treatment difference 
      of -3.3 mm Hg (P =.0004). Similar dose-related and significant reductions in 
      systolic BP (SBP) and heart rate (HR) were obtained. Incidence of adverse events 
      (AEs) for all GRD groups (44.5%) was less than that obtained for the placebo 
      group (49.3%). The 540-mg group showed an incidence of AEs (43.5%) similar to 
      that observed for the 240-mg group (42.6%). CONCLUSIONS: The GRD dose-dependently 
      significantly reduces BP and HR over the 24-h interval after once-daily bedtime 
      dosing. Further greater reductions were obtained between 6 AM and 12 noon, when 
      circadian BP is highest, compared to morning administration of the same dose. The 
      540-mg GRD was safe, well tolerated, and offers further therapeutic option for 
      patients with severe hypertension who required additional BP control.
FAU - Glasser, Stephen P
AU  - Glasser SP
AD  - Division of Epidemiology, School of Public Health, University of Minnesota, 
      Minneapolis, Minnesota 55454-1015, USA. glasser@epi.umn.edu
FAU - Neutel, Joel M
AU  - Neutel JM
FAU - Gana, Theophilus J
AU  - Gana TJ
FAU - Albert, Kenneth S
AU  - Albert KS
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - Am J Hypertens
JT  - American journal of hypertension
JID - 8803676
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Delayed-Action Preparations)
RN  - EE92BBP03H (Diltiazem)
SB  - IM
MH  - Adult
MH  - Antihypertensive Agents/*administration & dosage/adverse effects
MH  - Blood Pressure/drug effects
MH  - Delayed-Action Preparations
MH  - Diltiazem/*administration & dosage/adverse effects
MH  - Female
MH  - Heart Rate/drug effects
MH  - Humans
MH  - Hypertension/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Treatment Outcome
EDAT- 2003/01/09 04:00
MHDA- 2003/07/17 05:00
CRDT- 2003/01/09 04:00
PHST- 2003/01/09 04:00 [pubmed]
PHST- 2003/07/17 05:00 [medline]
PHST- 2003/01/09 04:00 [entrez]
AID - S0895706102031539 [pii]
AID - 10.1016/s0895-7061(02)03153-9 [doi]
PST - ppublish
SO  - Am J Hypertens. 2003 Jan;16(1):51-8. doi: 10.1016/s0895-7061(02)03153-9.