Our library of drug research abstracts drawn from the medical literature is updated on a regular schedule, and you can be assured that new tiazac research articles will be listed here shortly after becoming available to us.
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Medical research on tiazac
Am J Cardiovasc Drugs. 2006; 6(6): 393-400
Fitchett DH, Casanova A, Jaffer S, Tan M, Kornilova O, Goodman SG, Langer A,
BACKGROUND: Achievement of target BP is a challenge in patients attending family practice. The long duration between administration of the last bedtime dose of antihypertensive medication and the physiologic early morning surge in BP makes it difficult to achieve satisfactory BP control. OBJECTIVE: To determine whether a new graded-release preparation of diltiazem (diltiazem XC), taken once daily at bedtime, will show an acceptable adverse-effect profile as well as improved BP control. STUDY DESIGN/SETTING: This is an open label, observational study in an ambulatory care setting. PATIENTS: 954 patients with mild to moderate hypertension and BP not at target levels were attended by 85 physicians. Group 1 patients were receiving a diltiazem preparation and group 2 patients were not receiving any diltiazem preparation at baseline. INTERVENTION: Group 1 patients were given diltiazem XC at the same dose as the prestudy diltiazem. Treatment with diltiazem XC 180 mg was initiated in group 2 patients. Diltiazem XC was taken once daily at bedtime in both groups. MAIN OUTCOME MEASURE: The predetermined main outcome measure was the development of adverse events with diltiazem XC when changing or adding the study medication. The secondary outcome measure was the proportion of patients who achieved target BP levels. RESULTS: Moderate or severe adverse events occurred in 8.7% of patients. Although 21.8% of patients reported either new or worsening adverse events after starting diltiazem XC, the large majority of adverse events were mild in severity. The most frequent moderate or severe adverse events were headache (2.0%) and constipation (1.7%). More patients in group 2 reported adverse events compared with patients in group 1.Target BP levels were achieved in 47.8% (95% CI 44.3, 51.3) of patients completing the 8- to 12-week treatment. No difference was found in the proportion of patients at target BP levels in groups 1 and 2. CONCLUSION: Diltiazem XC, when used in an ambulatory care setting for patients who have not achieved BP targets, shows an acceptable adverse-effect profile and results in an important improvement of BP control.
Diltiazem-induced photodistributed hyperpigmentation.
Dermatol Online J. 2003 Dec; 9(5): 10
Boyer M, Katta R, Markus R
Diltiazem is a calcium-channel antagonist commonly prescribed in the treatment of cardiovascular disease. Although an extensive spectrum of cutaneous reactions to diltiazem has been described, only two published reports of hyperpigmentation induced by diltiazem are known. We report the cases of a 71-year-old black male and a 49-year-old Hispanic male, who both presented with characteristic hyperpigmentation on sun-exposed areas after taking an extended-release form of diltiazem hydrochloride (Tiazac).
Am J Ther. 1998 May; 5(3): 173-9
Dimmitt DC, Bhargava VO, Arumugham T, Eller M, Weir SJ
The purpose of this study was to determine the relative bioavailability of Cardizem CD compared to Tiazac after single and multiple doses. Twenty-three healthy males were enrolled in this open-label, two-way, complete crossover investigation. During each of the two treatment periods, a single 240-mg dose of diltiazem HCl was given in the morning on study day 1, then once daily on days 3 through 9. Serial plasma samples were obtained and pharmacokinetic parameters were calculated from the single-dose and steady-state concentration-time profiles. After single doses, mean diltiazem maximum plasma concentration (Cmax ) was 46% higher with the Tiazac formulation compared with Cardizem CD, and the mean area under the plasma concentration-time profile (AUC) was 19% higher with Tiazac. At steady-state, similar Cmax and AUC for the 24-hour dosing interval were found for Cardizem CD and Tiazac. However, Tiazac produced a 21% lower diltiazem minimum plasma concentration, a 28% lower trough concentration (the concentration in the plasma sample obtained just before the daily dose was given), and a 1.5-times higher fluctuation in maximum to minimum diltiazem plasma concentration compared with Cardizem CD. The pharmacokinetic profiles of the two pharmacologically active diltiazem metabolites, desacetyldiltiazem and N-desmethyldiltiazem, followed that of parent drug after single and multiple doses of Cardizem CD and Tiazac. From these results, it is concluded that the pharmacokinetic profiles of Tiazac and Cardizem CD are significantly different.
Clin Ther. 1997 Nov-Dec; 19(6): 1379-93
Neutel JM, Smith DH, Frishman WH
Although the effectiveness of diltiazem for the treatment of patients with hypertension has been well demonstrated in numerous placebo-controlled and comparative clinical trials, most physicians have had some concern about its efficacy and have used it predominantly in patients with mild hypertension. Few large-scale studies have evaluated the efficacy and safety of higher dosages of diltiazem for the treatment of patients with hypertension, and few have evaluated the use of diltiazem in patients with more severe hypertension. Tiazac (Forest Pharmaceuticals, Inc., St. Louis, Missouri), a new, extended-release formulation of diltiazem, provides 24-hour blood pressure control with a single daily dose of up to 360 mg. The Study of Titration and Response to Tiazac (START) is an ongoing practice-based, open-label, multicenter study designed to evaluate the efficacy and safety profiles of Tiazac at greater-than-traditional doses in hypertensive patients and to assess the ability of Tiazac to decrease the rate-pressure product, a surrogate marker for cardiac workload. Patients were eligible for study entry whether their hypertension was newly diagnosed or previously treated with a different formulation of diltiazem or any other antihypertensive agent. Normotensive (sitting diastolic blood pressure [SDBP] < 90 mm Hg) subjects and those with mild (SDBP 90 to 99 mm Hg), moderate (SDBP 100 to 109 mm Hg), severe (SDBP 110 to 119 mm Hg), and very severe (SDBP > or = 120 mm Hg) hypertension were assessed at baseline (visit 1), visit 2 (10 to 14 days after visit 1), and visit 3 (25 to 28 days after visit 1). A total of 3082 patients were enrolled, and data from 2802 assessable patients (i.e., those who completed visits 1, 2, and 3) were analyzed. No subjects were lost to follow-up as a result of adverse effects. All subjects received a starting dose of Tiazac 180 mg or 240 mg once daily, and doses were titrated upward to 360 mg once daily as clinically indicated. Blood pressure reduction matched the severity of hypertension in all patients. Subjects who were switched from another diltiazem formulation demonstrated further decreases in SDBP. Antihypertensive monotherapy with Tiazac was well tolerated. This interim START report demonstrates that a daily dose of up to 360 mg of diltiazem is optimal in terms of both control of hypertension and patient compliance. It also provides the practice-based physician with useful clinical information on dose titration and response to a new formulation of an approved drug and supports the efficacy and safety profiles of diltiazem documented in previous well-controlled clinical trials.
Int J Clin Pharmacol Ther. 1997 Sep; 35(9): 369-73
Eradiri O, Midha KK
Diltiazem has proven to be an effective antihypertensive and antianginal agent, due to its potent calcium channel blocking activity. The present study was conducted to compare the bioavailability of a new extended release diltiazem HCl capsule formulation (Tiazac) with 2 other currently marketed products (Cardizem CD and Dilacor XR). Fourteen healthy male subjects participated in this randomized, 3-period, multiple daily dose (240 mg for 7 days), crossover bioavailability study. ANOVA and multiple comparison tests showed the parent drug AUC0-tau to be significantly higher after daily dosing with Tiazac than with the other 2 marketed products, but the diltiazem Cmin values were not significantly different between the 3 formulations. Between 5 and 12 hours after drug administration, mean plasma diltiazem levels for Tiazac capsules were found to be significantly higher than those of the 2 other products tested. Comparison of plasma concentrations of metabolites for the 3 capsule formulations by ANOVA and multiple comparison tests showed similar trends as in the case of parent drug concentrations. These findings may be clinically important as higher and more consistent plasma concentrations of diltiazem, and its active metabolite during daytime are needed to counteract higher blood pressures in hypertensive patients due to circadian variations. The new extended release product of diltiazem HCl was found to exhibit significantly differing pharmacokinetics of the parent compound compared to either of the other 2 products tested.