PMID- 16751161
OWN - NLM
STAT- MEDLINE
DCOM- 20060705
LR  - 20191110
IS  - 0741-238X (Print)
IS  - 0741-238X (Linking)
VI  - 23
IP  - 2
DP  - 2006 Mar-Apr
TI  - Antihypertensive safety and efficacy and physician and patient satisfaction: 
      results from a phase 4 practice-based clinical experience trial with diltiazem 
      LA.
PG  - 284-94
AB  - This study was undertaken to assess the safety and efficacy of a new long-acting 
      formulation of diltiazem (DLA) (Cardizem LA; Biovail Pharmaceuticals, Inc., 
      Bridgewater, NJ) in a large heterogeneous group of hypertensive patients, and to 
      evaluate physician and patient treatment satisfaction. In this open-label, 30-day 
      study, physicians enrolled patients with hypertension who were to be evaluated 
      and treated at an initial visit and at 2 follow-up visits. Data recorded for each 
      patient included demographic information, DLA dosing strength, blood pressure 
      (BP) readings, and adverse events (AEs). A total of 15,155 physicians completed 
      the baseline questionnaire, and 9679 (64%) completed the final clinical 
      evaluation questionnaire. In all, 139,965 patients with hypertension were 
      enrolled. Initial and follow-up BP data were recorded for 50,856 (36%) of these 
      patients. On average, systolic BP (SBP) decreased from the initial visit by 10.9 
      mm Hg at the first follow-up (P<.0001) and by 15.5 mm Hg at the second follow-up 
      (mean SBP, 135.7) (P<.0001). On average, diastolic BP (DBP) decreased by 6.7 mm 
      Hg (P<.0001) and by 9.2 mm Hg (mean DBP, 79.4) (P<.0001), respectively. The most 
      commonly reported AEs included edema, headache, dizziness, nausea, and rash; two 
      thirds of these events were attributed to DLA. None of the AEs attributed to DLA 
      was reported in more than 1% of patients. Both physicians and patients expressed 
      a high degree of satisfaction with DLA. Results from this large-scale, open-label 
      study show that DLA was safe and produced clinically meaningful reductions in SBP 
      and DBP; in addition, a moderate to high degree of physician and patient 
      satisfaction was reported in a large and heterogeneous cohort of patients with 
      hypertension.
FAU - Glasser, Stephan P
AU  - Glasser SP
AD  - Division of Preventative Medicine, University of Alabama at Birmingham, 
      Birmingham, Alabama 35205-4785, USA.
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Adv Ther
JT  - Advances in therapy
JID - 8611864
RN  - 0 (Antihypertensive Agents)
RN  - EE92BBP03H (Diltiazem)
MH  - Adult
MH  - Aged
MH  - Antihypertensive Agents/administration & dosage/adverse effects/*therapeutic use
MH  - *Attitude of Health Personnel
MH  - Blood Pressure
MH  - Cohort Studies
MH  - Diltiazem/administration & dosage/adverse effects/*therapeutic use
MH  - Drug Utilization Review
MH  - Female
MH  - Humans
MH  - Hypertension/*drug therapy/pathology
MH  - Male
MH  - Middle Aged
MH  - Patient Satisfaction/*statistics & numerical data
MH  - Practice Patterns, Physicians'
MH  - Safety
MH  - Severity of Illness Index
MH  - Surveys and Questionnaires
MH  - Treatment Outcome
MH  - United States
EDAT- 2006/06/06 09:00
MHDA- 2006/07/06 09:00
CRDT- 2006/06/06 09:00
PHST- 2006/06/06 09:00 [pubmed]
PHST- 2006/07/06 09:00 [medline]
PHST- 2006/06/06 09:00 [entrez]
AID - 469 [pii]
AID - 10.1007/BF02850134 [doi]
PST - ppublish
SO  - Adv Ther. 2006 Mar-Apr;23(2):284-94. doi: 10.1007/BF02850134.