The use of confidence intervals to describe the precision of trough/peak ratios for diltiazem CD in the treatment of hypertension.
S. Meeves, and G. Park. Journal of clinical pharmacology, 34 (3):
231-5(March 1994)2561.
Abstract
Once-daily diltiazem hydrochloride, CARDIZEM CD (diltiazem CD) 300 mg, was evaluated for safety, efficacy, and the relationship between peak and trough antihypertensive effects in a multicenter, placebo-controlled, parallel design trial. After a 4- to 6-week placebo baseline period, 111 patients with essential hypertension were randomized to receive placebo or diltiazem CD for a 4-week treatment period. Diltiazem CD 300 mg lowered supine diastolic and systolic blood pressure at trough significantly more than placebo (-7.5 mm Hg vs. -1.3 mm Hg, P = 0.0001 and -6.4 mm Hg vs. 0.5 mm Hg, P = 0.0051, respectively). Supine blood pressure was also measured hourly from 6 to 10 hours after the dose to assess peak effect and trough/peak ratios. Using the largest residual drug effect of -8.3 mm Hg at 6 hours as peak and the 24-hour residual drug effect of -5.9 mm Hg as trough, the trough/peak ratio was estimated to be 71%, with a lower one-sided 95% confidence limit of 50%. The precision of the trough/peak ratio is estimated by the lower confidence limit of 50%, which establishes the trough/peak ratio as statistically > or = 50%. No statistically significant differences in supine DBP were noted between the peak effect hours, indicating a plateau of the peak antihypertensive effect from 6 to 10 hours postdose. Diltiazem CD therapy was well tolerated, with no serious treatment-related adverse events reported during the trial and no patients discontinuing the trial due to a treatment-related adverse event.(ABSTRACT TRUNCATED AT 250 WORDS)
%0 Journal Article
%1 Meeves1994
%A Meeves, S G
%A Park, G D
%D 1994
%J Journal of clinical pharmacology
%K Adult BloodPressure BloodPressure:drugeffects ConfidenceIntervals Diltiazem Diltiazem:administration&dosage Diltiazem:pharmacology Diltiazem:therapeuticuse Double-BlindMethod DrugAdministrationSchedule Female HeartRate HeartRate:drugeffects Humans Hypertension Hypertension:drugtherapy Male MiddleAged
%N 3
%P 231-5
%T The use of confidence intervals to describe the precision of trough/peak ratios for diltiazem CD in the treatment of hypertension.
%U http://www.ncbi.nlm.nih.gov/pubmed/8021331
%V 34
%X Once-daily diltiazem hydrochloride, CARDIZEM CD (diltiazem CD) 300 mg, was evaluated for safety, efficacy, and the relationship between peak and trough antihypertensive effects in a multicenter, placebo-controlled, parallel design trial. After a 4- to 6-week placebo baseline period, 111 patients with essential hypertension were randomized to receive placebo or diltiazem CD for a 4-week treatment period. Diltiazem CD 300 mg lowered supine diastolic and systolic blood pressure at trough significantly more than placebo (-7.5 mm Hg vs. -1.3 mm Hg, P = 0.0001 and -6.4 mm Hg vs. 0.5 mm Hg, P = 0.0051, respectively). Supine blood pressure was also measured hourly from 6 to 10 hours after the dose to assess peak effect and trough/peak ratios. Using the largest residual drug effect of -8.3 mm Hg at 6 hours as peak and the 24-hour residual drug effect of -5.9 mm Hg as trough, the trough/peak ratio was estimated to be 71%, with a lower one-sided 95% confidence limit of 50%. The precision of the trough/peak ratio is estimated by the lower confidence limit of 50%, which establishes the trough/peak ratio as statistically > or = 50%. No statistically significant differences in supine DBP were noted between the peak effect hours, indicating a plateau of the peak antihypertensive effect from 6 to 10 hours postdose. Diltiazem CD therapy was well tolerated, with no serious treatment-related adverse events reported during the trial and no patients discontinuing the trial due to a treatment-related adverse event.(ABSTRACT TRUNCATED AT 250 WORDS)
@article{Meeves1994,
abstract = {Once-daily diltiazem hydrochloride, CARDIZEM CD (diltiazem CD) 300 mg, was evaluated for safety, efficacy, and the relationship between peak and trough antihypertensive effects in a multicenter, placebo-controlled, parallel design trial. After a 4- to 6-week placebo baseline period, 111 patients with essential hypertension were randomized to receive placebo or diltiazem CD for a 4-week treatment period. Diltiazem CD 300 mg lowered supine diastolic and systolic blood pressure at trough significantly more than placebo (-7.5 mm Hg vs. -1.3 mm Hg, P = 0.0001 and -6.4 mm Hg vs. 0.5 mm Hg, P = 0.0051, respectively). Supine blood pressure was also measured hourly from 6 to 10 hours after the dose to assess peak effect and trough/peak ratios. Using the largest residual drug effect of -8.3 mm Hg at 6 hours as peak and the 24-hour residual drug effect of -5.9 mm Hg as trough, the trough/peak ratio was estimated to be 71%, with a lower one-sided 95% confidence limit of 50%. The precision of the trough/peak ratio is estimated by the lower confidence limit of 50%, which establishes the trough/peak ratio as statistically > or = 50%. No statistically significant differences in supine DBP were noted between the peak effect hours, indicating a plateau of the peak antihypertensive effect from 6 to 10 hours postdose. Diltiazem CD therapy was well tolerated, with no serious treatment-related adverse events reported during the trial and no patients discontinuing the trial due to a treatment-related adverse event.(ABSTRACT TRUNCATED AT 250 WORDS)},
added-at = {2023-02-03T11:44:35.000+0100},
author = {Meeves, S G and Park, G D},
biburl = {https://www.bibsonomy.org/bibtex/2299c2d92655f2c4089fa783cea05ec64/jepcastel},
interhash = {af81ee8ae26f3432574c92de91209738},
intrahash = {299c2d92655f2c4089fa783cea05ec64},
issn = {0091-2700},
journal = {Journal of clinical pharmacology},
keywords = {Adult BloodPressure BloodPressure:drugeffects ConfidenceIntervals Diltiazem Diltiazem:administration&dosage Diltiazem:pharmacology Diltiazem:therapeuticuse Double-BlindMethod DrugAdministrationSchedule Female HeartRate HeartRate:drugeffects Humans Hypertension Hypertension:drugtherapy Male MiddleAged},
month = {3},
note = 2561,
number = 3,
pages = {231-5},
pmid = {8021331},
timestamp = {2023-02-03T11:44:35.000+0100},
title = {The use of confidence intervals to describe the precision of trough/peak ratios for diltiazem CD in the treatment of hypertension.},
url = {http://www.ncbi.nlm.nih.gov/pubmed/8021331},
volume = 34,
year = 1994
}