Antihypertensive safety and efficacy and physician and patient satisfaction: results from a phase 4 practice-based clinical experience trial with diltiazem LA.

Academic Article

Abstract

  • 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.
  • Published In

    Keywords

  • Adult, Aged, Antihypertensive Agents, Attitude of Health Personnel, Blood Pressure, Cohort Studies, Diltiazem, Drug Utilization Review, Female, Humans, Hypertension, Male, Middle Aged, Patient Satisfaction, Practice Patterns, Physicians', Safety, Severity of Illness Index, Surveys and Questionnaires, Treatment Outcome, United States
  • Author List

  • Glasser SP
  • Start Page

  • 284
  • End Page

  • 294
  • Volume

  • 23
  • Issue

  • 2