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Query: UMLS:C0012833 (dizziness)
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The results of an open prospective study that evaluated the long-term clinical safety of nicorandil are presented. This study included 199 patients with severe chronic stable angina treated over a 1-year period. The most often reported adverse event was headache, which was responsible for most of the study withdrawals due to clinical intolerance (9.6%). When using a progressive titration scheme, this incidence was substantially reduced to 2.7%. As with other less frequent adverse events (dizziness, gastrointestinal disorders), headaches were reported as being mild to moderate in severity, were experienced during the first days of treatment, and, if treatment was maintained, usually resolved within a few days. The incidence of adverse events was not modified when nicorandil was given in combination with a beta-blocker, a calcium antagonist, or both agents. Cardiovascular safety was satisfactory and laboratory parameters were not altered. At the end of the study, 70% of patients were maintained on nicorandil. These results are in agreement with those reported from the nicorandil safety database, which gathered 1152 patients treated by nicorandil, including those of the present study. In comparative studies of nicorandil versus beta-blockers, calcium antagonists, or nitrates, the overall incidence of adverse events was no different between the two treatment groups, although the safety profile differed according to the drug category.(ABSTRACT TRUNCATED AT 250 WORDS)
Cardiovasc Drugs Ther 1995 Mar
PMID:Nicorandil safety in the long-term treatment of coronary heart disease. 764 28

The efficacy and safety of cilazapril in chronic heart failure have been extensively investigated in an international clinical program in patients with underlying chronic heart failure with ischemic heart disease or dilated cardiomyopathy. Cilazapril in single doses of 1.25-5 mg produced a significant dose-dependent reduction in pulmonary capillary wedge pressure and systemic vascular resistance and a significant increase in cardiac index. In placebo-controlled studies, 1-5 mg of cilazapril once daily for 12 weeks prolonged predose exercise test duration and improved New York Heart Association classification status and signs and symptoms of chronic heart failure, including paroxysmal nocturnal dyspnea. Up to 86% of patients receiving these dosages had improvement, with only 12% of patients requiring the higher dose, 5 mg. These data indicate that cilazapril is effective when administered once daily to patients with chronic heart failure receiving concomitant therapy with digitalis and/or a diuretic. The safety of cilazapril in patients with chronic heart failure has been evaluated in 1,163 patients administered from 0.5 to 15 mg once daily for treatment periods ranging from 1 day to 57 months. Cilazapril was administered to 500 patients for at least 6 months, 264 patients for at least 1 year, and 101 patients for at least 2 years. The most frequently occurring adverse events were dizziness, coughing, dyspnea, fatigue, angina pectoris, and headache. Cilazapril was equally well tolerated by young and elderly patients. Treatment was discontinued due to adverse events in 12.9% of patients, mainly as a result of coughing (1.7%) and dizziness (1%). Forty-four patients (3.8%) died during cilazapril therapy or during a period without treatment. Of these deaths, 93% were due to cardiac causes, especially rhythm disturbances.(ABSTRACT TRUNCATED AT 250 WORDS)
J Cardiovasc Pharmacol 1994
PMID:Heart failure therapy with cilazapril: an overview. 770 63

A great number of calcium antagonists are available for the treatment of cardiovascular diseases. Differences in pharmacodynamic and/or pharmacokinetic properties can be used to optimize therapy in patients and to minimize side effects. In contrast to all dihydropyridine (DHP) derivatives, drugs of the verapamil type slow atrioventricular conduction and are widely used for treatment of supraventricular tachycardia. The higher vasoselectivity of new DHP derivatives as compared with nifedipine should be regarded as an advantage for the treatment of patients with impaired left ventricular function. Besides vasodilation, additional effects such as antiatherosclerotic action, amelioration of rheological parameters, bronchial relaxation, or improvement of cerebral capacity in patients with cerebro-organic disorders have been documented for individual drugs. The long plasma half-life of some new calcium antagonists is advantageous with respect to patient compliance. Furthermore, a delayed increase in plasma concentration (high tmax values) is useful to minimize side effects such as reflex tachycardia, flush, headache, and dizziness.
J Cardiovasc Pharmacol 1994
PMID:Calcium antagonists in comparison: view of the pharmacologist. 789

In order to assess the effective dose, tolerability, and safety of isradipine as a monotherapeutic antihypertensive agent for Chinese patients in Taiwan, an open trial was carried out. This study consisted of a 2-week, placebo, run-in period and an 8-week active treatment period, starting with isradipine 1.25 mg twice daily (bid) for the first 4 weeks, followed by 2.5 mg bid if the blood pressure was not normalized (diastole < 90 mmHg). One hundred and one patients (M/F = 48:53) were valid for efficacy analysis. Their age ranged from 30 to 64 years (mean +/- SD, 52 +/- 8). The blood pressure before active treatment was 160 +/- 2/104 +/- 1 mmHg. At the end of treatment period I (week 4), 12-14 hours after the last dose, 38 (37.6%) patients were normalized and 47 (46.5%) subjects responded (diastolic blood pressure reduction > or = 10 mmHg). At week 8, 68 (67.3%) patients were normalized and 79 (78.2%) subjects responded. Isradipine reduced both systolic and diastolic blood pressures within 2 weeks of treatment. There were no significant differences in blood pressure reduction between both genders and among age groups. Safety analysis showed two subjects with severe flushing, dizziness, and palpitation who used the dose of 1.25 mg bid. They withdrew from the study. The adverse reactions of other patients were transient, mild, and tolerable. Most of the side effects were related to vasodilatation, but edema was not found. There was no change in body weight or heart rate, nor any atrioventricular conduction disturbances.(ABSTRACT TRUNCATED AT 250 WORDS)
Cardiovasc Drugs Ther 1993 Feb
PMID:Dose titration study of isradipine in Chinese patients with mild to moderate essential hypertension. 848 68

To evaluate the safety and pharmacologic activity of ITF 296 in humans, three groups of healthy male normotensive subjects were studied. The first two groups (six subjects each) received, in ascending order, three dose levels of ITF 296 by 30-min intravenous infusion (group I, 0.1, 0.5, 1.0 microgram/kg/min; group II, 2.0, 4.0, 6.0 micrograms/kg/min). The third group of eight subjects received, in ascending order, four dose levels of ITF 296 (10, 20, 40, 80 micrograms/kg) by 1-min i.v. injection. The study was double-blind, and placebo-controlled according to a within-patient, incomplete, unbalanced block design, such that each subject received the placebo once. Hemodynamics were assessed by means of Dynamap and BOMED. The following parameters were evaluated at different times before and after ITF 296 administration: systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), stroke volume index (SVI), cardiac index (CI), and systemic vascular resistance index (SVRI). Blood samples for kinetic assessment of ITF 296 were taken before and at different times after ITF 296 administration. The drug was well tolerated. Only a few mild (except for one, moderate) side effects (mainly headache and dizziness) were reported, usually at the higher dose levels. All safety clinical chemistry and hematologic parameters were unaffected. After i.v. infusion of ITF 296, blood pressure started to fall at the dose of 2 micrograms/kg/min, DBP being significantly reduced at doses above 1 microgram/kg/min. The effect lasted for up to 60 min after the end of the infusion. The increase in heart rate was only modest, although apparently dose-dependent. SVI was only slightly reduced, and the other hemodynamic parameters did not change. After bolus administration of ITF 296, SBP was significantly reduced starting at a dose of 20 micrograms/kg with higher doses producing a more marked effect (up to -15 mm Hg). DBP was significantly reduced only at the higher dose level of 80 micrograms/kg. The effect lasted for up to 60 min after bolus administration. HR was slightly increased after doses of 40 and 80 micrograms/kg. SVI was slightly reduced and a small transient decrease in CI was observed, whereas SVRI did not change. Satisfactory, linear kinetic correlation was found between total doses administered and AUCs measured. ITF 296 in healthy male normotensive volunteers was effective and well tolerated. The results of this study justify the planning of further studies in patients in order to test the anti-ischemic activity of the compound.
J Cardiovasc Pharmacol 1995
PMID:Safety and pharmacologic activity of a new nitrate ester, ITF 296, after intravenous administration in healthy volunteers. 883 30

Sinus node recovery time assessment is used to diagnose clinically significant sinus node dysfunction (SND) when Holter has failed to prove a relationship between sinus bradyarrhythmias and symptoms, but consensus has not been reached as to the value of including assessment after pharmacologic blockade of the autonomic nervous system. This issue was addressed in the present study performed on 52 patients with syncope or presyncope/dizziness (n = 48), sinus bradyarrhythmias (n = 45), or both (n = 41). Group 1 consisted of 13 patients with a proven relationship between symptoms and sinus bradyarrhythmias. Group 2 consisted of 39 patients with suspected SND. The protocol included three pacing periods at two pacing rates and was performed at baseline (n = 52), after single doses of atropine and propranolol (0.02 mg/kg and 0.1 mg/kg, respectively) (n = 41), and again after a second dose (n = 29). The sensitivity of prolonged recovery times was 77% in group 1. Among group 2 patients, 56% had prolonged recovery times at baseline (79% when including the results after the first dose of drugs). The second dose did not contribute diagnostic information, but it caused significant adverse reactions in 7 of 29 patients (P < 0.001). These 7 patients were all older than 60 years. Assessment of sinus node recovery time after pharmacologic blockade of the autonomic nervous system thus increases the sensitivity of the method in patients with suspected SND and normal baseline results. However, only 50% of the initially suggested doses of atropine and propranolol is sufficient and eliminates the risk for significant adverse reactions.
J Cardiovasc Electrophysiol 1996 Feb
PMID:Sinus node recovery time assessment revisited: role of pharmacologic blockade of the autonomic nervous system. 885 19

Levosimendan belongs to a new group of heart failure drugs, the calcium sensitizers. Because these compounds are not yet available for clinical use, the adverse drug events (ADEs) during levosimendan treatment cannot be predicted in detail. To evaluate the tolerability of levosimendan in human subjects, ADEs, safety laboratory values before and after treatment, and ambulatory ECG findings have been collected from several phase I and phase II clinical studies. By June 1994, approximately 200 subjects had received levosimendan. The most common ADE seen in healthy volunteers is headache, reported by some 40% of subjects in oral dosing but only 10% in i.v. dosing. The incidence of headache does not correlate well with the total daily dose of the drug. However, the controlled release formulations tested appear to cause vasodilatory symptoms more frequently than i.v. or rapid release oral formulations. The other typical vasodilatory ADEs seen in healthy volunteers are nausea, palpitation, and dizziness. Symptomatic hypotension is rarely encountered. It appears that heart failure patients tolerate the vasodilatory actions of the drug better than healthy volunteers. Only individual cases of headache, vertigo, and flushing have been reported, and injection site irritation has been the most commonly reported ADE (with an incidence <5%). However, because the longest administration of the i.v. infusion has been only 24 h, the duration of exposure to the drug is too short to allow any definitive conclusions to be drawn. All patients who have received levosimendan have been monitored with an ambulatory ECG. Even though some increase in heart rate is seen with high doses of the drug, there are thus far no signs of an increased incidence of ventricular tachyarrhythmias, nor have there been any noteworthy changes in the clinical laboratory safety tests. The experience with levosimendan is limited thus far and long-term data are lacking. It can be concluded, however, that at least in i.v. dosing the drug is devoid of ADEs with significant medical seriousness.
J Cardiovasc Pharmacol 1995
PMID:Safety of levosimendan and other calcium sensitizers. 890 34

Moexipril is a new, long-acting angiotensin-converting enzyme (ACE) inhibitor. In contrast to captopril, it is a prodrug of the pharmacologically active agent moexiprilat and will be administered once daily. The objective of this study was to compare the efficacy, safety, and tolerability of moexipril with that of captopril during a 12-week treatment of patients with mild to moderate hypertension. Patients with a sitting diastolic blood pressure (SDBP) of 95-114 mm Hg, inclusive, were randomized in a 2:1 ratio to receive moexipril, 7.5 mg, once daily or captopril, 25 mg, twice daily. After 6 weeks of treatment, the dose of moexipril and captopril was increased to 15 mg once daily and 50 mg twice daily, respectively, if the patient's SDBP remained > or = 90 mm Hg. Blood pressure was measured at biweekly visits. At study endpoint, adjusted mean reductions in SDBP were comparable between the moexipril and captopril groups (-9.8 vs. -8.7 mm Hg), and moexipril was more effective than captopril in reducing sitting systolic blood pressure. Adverse experiences (headache, dizziness, and upper respiratory infection) occurred at similar frequencies in the moexipril and in the captopril groups. The data indicate that moexipril at dosages of 7.5 and 15 mg once daily is as efficacious as twice daily captopril in reducing blood pressure in patients with mild to moderate hypertension.
J Cardiovasc Pharmacol 1996 Dec
PMID:Moexipril versus captopril in patients with mild to moderate hypertension. 896 Oct 74

In controlled trials, long-term treatment of patients with chronic heart failure with beta-blockers improves symptoms, slows progression of disease, and reduces morbidity and mortality rates. However, in some patients the introduction of therapy can be associated with a period of clinical instability, including risks of fluid retention, hypotension, and bradycardia. Appropriate patient selection and optimization of background therapy can minimize the risk during the introduction of therapy. With vigilance for early signs of clinical deterioration and appropriate adjustment of background medications, the care of most patients exhibiting clinical instability can be successfully managed so the patient is able to continue with the long-term therapy, a prerequisite to realizing beneficial effects. With the initiation of carvedilol, any evidence of fluid retention warrants a prompt increase in the diuretic dosage, and in more pronounced cases the carvedilol dose may need to be reduced or interrupted. In contrast, symptoms of hypotension (most commonly dizziness) generally resolve without intervention, although persistent problems may necessitate adjusting the timing of dose administration or perhaps temporarily reducing the dose of vasodilators or diuretics (the latter with care to avoid fluid retention). Bradycardia should be managed as standard practice would indicate. During long-term treatment, adjustments in beta-blocker dosage may be required in the event of an exacerbation of heart failure. Dosages should be adjusted as would be the case with other heart-failure medications, based on the severity of the clinical decompensation, but with care to minimize abrupt changes unless mandated by the patient's condition and to avoid precipitating ischemia or further deterioration. The occurrence of effects such as these does not necessarily indicate that a patient cannot respond favorably to long-term beta-blockade, but all require understanding, vigilance, and the availability of medical personnel, especially during the introduction of this therapy.
Prog Cardiovasc Dis
PMID:Use of carvedilol in chronic heart failure: challenges in therapeutic management. 971 23

Loss of ventricular output resulting from an unexpected software error in a dual chamber implantable cardioverter defibrillator (ICD) is reported. A 70-year-old man with a dual chamber ICD implanted for a history of cardiac arrest and infra-Hisian block presented with acute onset of dizziness. He was found to have loss of ventricular output due to an internal software problem. The problem was corrected by software reprogramming via the programmer. This malfunction exemplifies the potential ability to correct current-generation ICD software problems noninvasively, thus avoiding the need for replacement.
J Cardiovasc Electrophysiol 1999 Jun
PMID:Software error resulting in malfunction of an implantable cardioverter defibrillator. 1037 26


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