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Cardiovascular Safety Profile (cardiovascular + safety_profile)
Selected AbstractsCardiovascular Tolerability and Safety of Triptans: A Review of Clinical DataHEADACHE, Issue 2004David W. Dodick MD Triptans are not widely used in clinical practice despite their well-established efficacy, endorsement by the US Headache Consortium, and the demonstrable need to employ effective intervention to reduce migraine-associated disability. Although the relatively restricted use of triptans may be attributed to several factors, research suggests that prescribers' concerns about cardiovascular safety prominently figure in limiting their use. This article reviews clinical data,including results of clinical trials, postmarketing studies and surveillance, and pharmacodynamic studies,relevant to assessing the cardiovascular safety profile of the triptans. These data demonstrate that triptans are generally well tolerated. Chest symptoms occurring during use of triptans are usually nonserious and usually not attributed to ischemia. Incidence of triptan-associated serious cardiovascular adverse events in both clinical trials and clinical practice appears to be extremely low. When they do occur, serious cardiovascular events have most often been reported in patients at significant cardiovascular risk or in those with overt cardiovascular disease. Adverse cardiovascular events also have occurred, however, in patients without evidence of cardiovascular disease. Several lines of evidence suggest that nonischemic mechanisms are responsible for sumatriptan-associated chest symptoms, although the mechanism of chest symptoms has not been determined to date. Importantly, most of the clinical trials and clinical practice data on triptans are derived from patients without known cardiovascular disease. Therefore, the conclusions of this review cannot be extended to patients with cardiovascular disease. The cardiovascular safety profile of triptans favors their use in the absence of contraindications. [source] Cardiovascular effects of high dose venlafaxine XL in patients with major depressive disorderHUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 3 2007Patrick Mbaya Abstract Objective To assess cardiovascular safety profile of high dose Venlafaxine XL in patients with major depression. Method Effects of high dose venlafaxine (mean 346.15,mg;) on the cardiovascular system in 37 patients with major depressive disorder were evaluated: BP, ECG (PR, QT, QRSD and QTc intervals) and heart rate. Results 12.5% of patients developed hypertension after starting treatment with venlafaxine. There was an association between heart rate and the dose of venlafaxine although not statistically significant. There was no association between dose of venlafaxine and PR, QT, QRSD and QTc intervals. One patient on 300,mg who was hypertensive and on other medications that may prolong QTc, had mildly prolonged QTc. However this was not clinically significant. Conclusion This study of subjects on high dose venlafaxine (mean 346.15,mg; range 225,525,mg) did not demonstrate any clinical or statistically significant effects on electrocardiogram (ECG) parameters including PR, QT, QRSD and QTc interval. Copyright © 2007 John Wiley & Sons, Ltd. [source] Once-daily desloratadine improves the signs and symptoms of chronic idiopathic urticaria: a randomized, double-blind, placebo-controlled studyINTERNATIONAL JOURNAL OF DERMATOLOGY, Issue 1 2001Johannes Ring MD Background Chronic idiopathic urticaria (CIU) is the most common type of chronic urticaria, and pruritus is the most prominent symptom. Antihistamines are the first-line treatment for CIU. Sedation and anticholinergic adverse effects are often experienced with the first-generation antihistamines and there is a risk of cardiovascular adverse effects and drug interactions with some second-generation agents. Hence, new treatment options are needed. Desloratadine is a new, potent, nonsedating antihistamine that has an excellent cardiovascular safety profile. Methods This was a multicenter, randomized, double-blind, placebo-controlled study designed to determine the efficacy and safety of desloratadine in the treatment of moderate-to-severe CIU. A total of 190 patients, aged 12,79 years, with at least a 6-week history of CIU and who were currently experiencing a flare of at least moderate severity, were randomly assigned to therapy with desloratadine 5 mg or placebo once daily for 6 weeks. Twice daily, patients rated the severity of CIU symptoms (pruritus, number of hives, and size of largest hive), as well as the impact of CIU symptoms on sleep and daily activity. Patients and investigators jointly evaluated therapeutic response and overall condition. Safety evaluations included the incidence of treatment-emergent adverse events, discontinuations due to adverse events, and changes from baseline in vital signs, laboratory parameters, and ECG intervals. Results Desloratadine was superior to placebo in controlling pruritus and total symptoms after the first dose and maintained this superiority to the end of the study. Measures of sleep, daily activity, therapeutic response, and global CIU status were also significantly better with desloratadine after the first dose; these clinical benefits were also maintained throughout the 6-week study. No significant adverse events occured. Conclusions Desloratadine 5 mg daily is a safe and effective treatment for CIU with significant benefits within 24 h and maintained through the treatment period. [source] A retrospective evaluation of congestive heart failure and myocardial ischemia events in 14,237 patients with type 2 diabetes mellitus enrolled in 42 short-term, double-blind, randomized clinical studies with rosiglitazonePHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 8 2008Alexander Cobitz MD Abstract Purpose Retrospectively investigate potential associations between rosiglitazone and congestive heart failure (CHF) and, separately, events of myocardial ischemia. Methods Data from 14,237 individuals in 42 short-term, double-blind, randomized studies of rosiglitazone versus placebo or active diabetes medications were analyzed across seven treatment comparisons using an exact logistic regression model, adjusted for number of major cardiovascular risk factors and duration of exposure. Results CHF incidence ranged 0,1.27% (SAEs) and 0.12,2.42% (all AEs) with rosiglitazone versus 0.07,0.75% (SAEs) and 0.25,1.36% (all AEs) with control. Higher odds ratios (95%CI) were observed for CHF SAEs with sulfonylurea- and insulin-containing combinations: rosiglitazone monotherapy versus placebo, 0.25 (<0.01,4.75); rosiglitazone monotherapy versus sulfonylurea/metformin monotherapy, 0.23 (<0.01,2.14); sulfonylurea,+,rosiglitazone versus sulfonylurea monotherapy, 0.95 (0.01,75.20); metformin,+,rosiglitazone versus metformin monotherapy, 0.60 (0.00,8.28); metformin,+,rosiglitazone versus metformin,+,sulfonylurea, 1.04 (0.39,2.86); sulfonylurea,+,metformin,+,rosiglitazone versus sulfonylurea,+,metformin, 3.15 (0.35,150.52); insulin,+,rosiglitazone versus insulin monotherapy, 1.63 (0.52,6.01). Myocardial ischemia incidence ranged 0.75,1.40% (SAEs) and 1.49,2.77% (all AEs) with rosiglitazone versus 0.21,2.04% (SAEs) and 0.56,2.38% (all AEs) with control. Each comparison had an OR >1, with wide confidence intervals generally including unity. With data pooling, more events of myocardial ischemia were observed with rosiglitazone (2.00%) versus control (1.53%) (HR 1.30, 95%CI 1.004,1.69). Conclusions CHF incidence may be greater when rosiglitazone is combined with sulfonylureas or insulin. When data were pooled, more events of myocardial ischemia were observed with rosiglitazone versus control. Final results from RECORD will allow a more rigorous evaluation of the cardiovascular safety profile. Copyright © 2008 John Wiley & Sons, Ltd. [source] | ||||||||||