Comparison of Diltiazem Standard Formulation and Diltiazem Controlled Release in Patients with Stable Angina Pectoris
H.W. VliegenErnst E. van der WallJ. A. KragtenN. J. HolwerdaW. M. SchenkelW. M. Muijs van de MoerJ. B. L. ten KatePaul MulderA. V. G. Bruschke
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In a randomized, double-blind, cross-over, multicenter study with a placebo run-in phase, the efficacy and safety of two oral formulations of diltiazem, standard three or four times daily (t.i.d. or q.i.d.) and controlled release twice daily (b.i.d.), were compared in 49 patients with stable angina pectoris. ST-segment depression at maximum exercise 12 h after tablet intake was less frequently observed with diltiazem controlled release than with standard diltiazem (34 of 49, 69% vs. 43 of 49, 88%, p = 0.007). In patients with ST-segment depression after both treatments (n = 33), the average time to 1-mm ST-segment depression was 55.4 ± 19.9 s longer with diltiazem controlled release than with standard diltiazem [476 ± 195 vs. 422 ± 163 s, p = 0.009; 95% confidence interval (CI) 14.8–96 s]. Reduction in mean number of anginal attacks and nitroglycerin (NTG) intake was not significantly different between treatment with standard diltiazem and diltiazem controlled release. The incidence of side effects was low and not different between the two treatments. Both formulations are equally effective in reducing the number of anginal attacks and are well tolerated. Diltiazem controlled release is more effective than standard diltiazem in preventing myocardial ischemia 12 h after tablet intake. Thus, diltiazem controlled release allows twice-daily intake frequency and may therefore be preferable to standard diltiazem in treatment of stable angina pectoris.Objective To evaluate the curative effect and tolerability of intravenous nitrates combined with diltiazem on angina pectoris.Methods 100 patients with coronary heart disease were chose.Diltiazem was added to the routine therapy of nitrates and anticoagulants.The episodes,duration of angina attack,changes of electrocardiogram were observed before and after treatment in a month.Results The effective rate of intravenous nitrates in treating angina pectoris was 85%,and the effective rate of intravenous nitrates combined with diltiazem was 90%.Conclusion Diltiazem has certain effect in treating angina pectoris,it can achieve even better effect when combined with nitrates.
Tolerability
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Objective To investigate the effect of diltiazem in the therapy of variant angina.Methods 50 cases patients with variant angina were randomly divided into diltiazem group and control group,each of 25 cases.On the basis of conventional therapy,control group were treated with lsosorbide mononitrate,diltiazem group were treated with diltiazem.After treatment,compared the clinical effect,pectoris frequency and duration of angina in two groups.Results The total effective rate of two groups all was 100.0%(P0.05).After treatment,pectoris frequency of angina reduced,duration shortened(P0.05).Conclusion Diltiazem in the treatment of variant angina is effective and safe.
Stable angina
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A 60-year-old man presented to an emergency department 2 h after the ingestion of 8 g of diltiazem (about 40 slow-release capsules, 200 mg/each) in a suicide attempt. The subject was treated with a gastric lavage and activated charcoal; then, a temporary transvenous pacing was also inserted. Despite emergency pharmacological treatment, the subject died about 20 h after ingestion. Postmortem diltiazem and desacetyl-diltiazem concentrations, measured by gas chromatography-mass spectrometry, were as follows: 31.1 mg/mL diltiazem and 9.7 mg/mL desacetyl-diltiazem in blood; 33.1 mg/g diltiazem and 13.7 mg/g desacetyl-diltiazem in brain; 179.5 mg/g diltiazem and 47.5 mg/g desacetyl-diltiazem in lung; 41.8 mg/g diltiazem and 10.1 mg/g desacetyl-diltiazem in heart; 182.1 mg/g diltiazem and 47.3 mg/g desacetyl-diltiazem in liver; 49.2 mg/g diltiazem and 22.6 mg/g desacetyl-diltiazem in kidney; and 294.9 mg/mL diltiazem and 29.4 mg/mL desacetyl-diltiazem in bile. It is interesting to note that although several cases of acute diltiazem poisoning have been reported in literature, only a few were lethal. Diltiazem concentrations found in our case are notably higher than those reported in other studies, including those in which diltiazem ingestion resulted in the death of the patient. Notably, in many of these latter cases, the doses of diltiazem ingested were higher than those taken by our patient.
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This study included 168 patients with angina pectoris, who were divided into two groups, the diltiazem SR (No. 88) group and diltiazem HCL (No. 80) group. The two groups were comparable in age and duration of coronary heart disease. The results were as follows: (1) The total clinical effect of diltiazem SR (94.3%) was slightly greater than that of diltiazem HCL (82.5%), the effect in ECG improvement was 53.3% and 53.4% respectively. (2) The rate of adverse effect was 12.5% in diltiazem SR group and 14.4% in diltiazem HCL group. It is concluded that the two different types of diltiazem have similar effect in the treatment of angina pectoris. However, it is more convenient to take diltiazem SR than diltiazem HCL as the former needs only twice a day.
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Diltiazem, a drug from the group of calcium channel blockers, has been gradually marginalized over last ten years as a choice of treatment for hypertension. Amlodopine has replaced both diltiazenm and older calcium channel blockers, thus becoming one of the most frequently prescribed antihypertensive drugs in our country. Author conducted a small clinical study to verify empirical effectiveness of diltiazem in treatment of hypertension, isolated or associated with cardiac ischemia. Results demonstrate that diltiazem is an effective antihypertensive drug, which has been suppressed from daily clinical practice without compelling reasons.
Clinical Practice
Drug treatment
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Platelet aggregation with collagen, ADP and sodium arachidonate was significantly inhibited by 0.48 and 0.24 mg/ml of diltiazem but no significant effect occurred with 0.024 mg/ml of diltiazem. It is suggested that the antiplatelet property of diltiazem may be utilized in clinical setting and diltiazem may be tried synergistically with other antiplatelet drugs.
Calcium channel blocker
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OBJECTIVE To investigate the clinical therapeutic effect and safety of diltiazem to treat unstable angina(UA) of old people by continuous intravenous injection.METHODS 26 aged UA patients who did not get well with the glyceryl trinitrate therapy accepted the continuous intravenous injection of diltiazem with a dosage of 30mg.The initial dosage was 1μg/(kg·min)~(-1),if the effect was not obvious,the dosage would be increased to 3μg/(kg·min)~(-1) ~5μg/(kg·min)~(-1).When the symptom was relieved,the effective dosage was maintained to 48h,then 30mg(tif) of diltiazem tablets was given.The angina symptom,ECG and the hemodynamics changes were observed during the process. RESULTS The advent frequency of angina during the 72 hours before therapy was(5.26±2.57),while the symptom relieved after the diltiazem injection for an average of(9.2±6.8) minutes.Among them 7 patient's angina did not get controlled until the dosage was adjusted to 5μg/(kg·min)~(-1).Compared with the 72 hours before therapy,the angina frequency descended after the injection for 48 hours and the duration of angina got decreased.3 patients got normal ST and T waves after injection and 6 patients recovered obviously.Their blood pressures and heart rates decreased after therapy(P0.05) and no adverse-effects such as AMI and death occurred.CONCLUSION It is an effective therapy of continuous diltiazem intravenous injection to the aged UA patients whose symptoms can not be relieved after given of glyceryl trinitrate.
Unstable angina
Therapeutic effect
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The antiarrhythmic action of diltiazem in the model of barium arrhythmia was studied in rats non-dependent and dependent on ethanol. The results of our studies showed that single intragastric administration of ethanol jointly with diltiazem did not significantly attenuate the antiarrhythmic effect of diltiazem. Ethanol administered repeatedly and jointly with diltiazem influenced the antiarrhythmic action of diltiazem in different ways, depending on the used dose of diltiazem. After repeated joint administration of ethanol and diltiazem in a lower dose, attenuation of the antiarrhythmic effect of diltiazem was not observed. Repeated joint administration of ethanol and diltiazem in a higher dose attenuated the antiarrhythmic effect of diltiazem. Those experiments also showed that single administration of diltiazem did not significantly influence the ethanol level in the blood; however, when administered repeatedly, diltiazem reduced the concentration of ethanol in blood.
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Abstract Diltiazem, a calcium‐channel blocker, is an effective antianginal agent, particularly in treating the vasospastic type of angina pectoris. This drug has recently been released for use in the United States. Noncardiac untoward effects of diltiazem are few. We describe a case of mania with psychotic features that occurred while a patient was on diltiazem.
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