%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 }