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A bibliographic review of the safety profile of 311C90 or zolmitriptan is performed in the present study showing the large number of clinical trials carried out in both healthy volunteers and patients with migraine. The molecule, a potent, selective agonist for the 5HT1B/1D receptors with central and peripheral activity does not appear to have significant influence on arterial pressure. ECG and Holter ECG studies did not show any alterations in healthy volunteers. In migraine patients, the ECG did not demonstrate ischemic alterations at any of the dosages of zolmitriptan used. In patients who had undertaken treatment for months, the hemogram and biochemical follow up did not show any changes. This new triptan was well tolerated in a wide spectrum of patients and healthy volunteers. Complaints of subjective side effects usually increase according to an increase in dosage. The most frequent adverse effects were nausea and dizziness. Other discomforts are: dryness of the mouth, sensation of heat, paresthesia, asthenia, drowsiness, and dizziness. The sensation of heaviness, tightness or pressure of the throat and chest have also been reported. The adverse effects reported with 5 mg of zolmitriptan are similar to those found with 100 mg of sumatriptan. The adverse side effects are usually mild, last a short time and remit without therapy. Zolmitriptan used together with the other most often used drugs in migraine patients did not show any important clinical interactions. However, it seems reasonable to limit the daily administration of zolmitriptan with monoaminoxidase inhibitors (MAOI-A) since a possible increase of the levels of zolmitriptan and its metabolites may be detected in the presence of one (moclobemide). At a dose of 2.5 mg, zolmitriptan appears to provide the best relationship between benefits and risk.
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PMID:[Safety profile of 311C90 (zolmitriptan)]. 985 92

Tiagabine exerts its antiepileptic drug (AED) activity by selectively inhibiting the uptake of gamma-aminobutyric acid (GABA) onto the transporter molecules, and thus, increasing extracellular concentrations of GABA in the brain. The absorption and elimination of tiagabine follow linear pharmacokinetics. Tiagabine is metabolized by hepatic cytochrome P450 enzymes and enzyme-inducing AEDs increase tiagabine clearance by 50-65%. Tiagabine has shown no clinically important interactions with other drugs, including oral contraceptives. In the perforant pathway stimulation model of status epilepticus, tiagabine reduced the seizure number and severity, and also prevented the loss of pyramidal cells in the hippocampus as well as alleviated impairment of the spatial memory impairment associated with hippocampal damage. Tiagabine has both antiepileptogenic and anticonvulsant effects in the kindling model of epilepsy. Based on the data from the short- and long-term add-on studies, tiagabine is effective adjunctive therapy for all partial seizure types in adolescents and adults. Conversion to tiagabine monotherapy has been also possible in substantial amount of patients with partial seizures in three trials. Tiagabine is generally well-tolerated. The most common adverse events in controlled studies involve the central nervous system; for example, dizziness, asthenia, nervousness, tremor, depressed mood and emotional lability. Special safety analyses with formal neuropsychological testing suggest that tiagabine does not adversely affect cognition or mood. Tiagabine represents an important new therapeutic option for patients with treatment-refractory partial seizures. The role of tiagabine in the management of partial epilepsy of patients with intellectual disability is especially emphasized since tiagabine has a low side-effect profile in the cognitive area.
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PMID:Tiagabine: a new therapeutic option for people with intellectual disability and partial epilepsy. 1003 Apr 35

Management of benign prostatic hyperplasia (BPH) is often complicated by concomitant hypertension, a life-threatening condition that must be managed optimally. Many of the alpha blockers used to treat BPH also decrease blood pressure, and terazosin and doxazosin have been shown to have significant cardiovascular side effects, such as asthenia/fatigue, postural hypotension, and dizziness when used to treat BPH patients. Furthermore, these drugs are not first-line therapies for hypertension, and the majority of hypertensive BPH patients will be receiving other antihypertensive agents. Therefore, it is possible that the introduction of these drugs will affect blood pressure control, at least temporarily, with possible adverse effects. In contrast, the selective alpha1A blocker tamsulosin does not appear to have significant cardiovascular side effects and produces minimal blood pressure reductions. Therefore, urologists can choose either to use alpha blockers to treat both hypertension and BPH or to treat BPH using alpha blockers that do not interact with antihypertensive therapy. This review focuses on the alpha blockers currently being used to treat BPH, their effects on the cardiovascular system, and their interaction with antihypertensive drugs.
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PMID:Alpha-adrenergic blocking drugs in the management of benign prostatic hyperplasia: interactions with antihypertensive therapy. 1009 96

Paroxysmal supraventricular tachycardia (SVT) may have numerous electro-physiologic mechanisms. The most common type of SVT is AV-nodal reentry tachycardia (60%) followed by the bypass tract-mediated SVT (preexcitation. 30%) and a smaller group (10%) comprising paroxysmal atrial flutter or fibrillation and atrial ectopic tachycardia. In persons with otherwise normal hearts symptoms are usually mild and include palpitations or an uneasy feeling in the chest. But some describe precordial pain. Weakness, dizziness, nausea, vomiting, and even syncope. Whenever possible a 12-lead-ECG during an episode of SVT should be obtained. If not possible the use of several Holter-ECG or of an event-recorder may be helpful. Conversion of a SVT can be accomplished by vagal maneuvers or intravenous adenosine (6-18 mg bolus injection). Further diagnostic procedures should prove or rule out a significant structural heart disease. Therapeutic options (expectative, pharmacological prophylaxis, invasive electrophysiologic testing and catheter-mediated modification or ablation) are chosen according to the objective threat (e.g. ventricular fibrillation due to 1:1 conducted atrial fibrillation in a preexcitation syndrome) and the subjective complaints. Definitive healing of the AV-nodal reentry tachycardia and the bypass tract-mediated SVT can be achieved by use of catheter-mediated modification or ablation in 95 to nearly 100%.
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PMID:[Modern therapy of paroxysmal supraventricular tachycardia]. 1009 47

Benign prostatic hyperplasia (BPH) is a common disorder in elderly men which carries a substantial economic burden. Urinary symptoms associated with moderate to severe disease can significantly interfere with daily activities and reduce quality of life. Obstruction of urine flow in men with BPH can result from nonmalignant enlargement of the prostate gland (static component of BPH) and from alpha 1 receptor-mediated increased smooth muscle tone of the bladder neck and prostate (dynamic component of BPH). Transurethral resection of the prostate (TURP) is generally very effective and has traditionally been the standard treatment for men with moderate to severe BPH. However, response to therapy with TURP is not universal and the procedure is associated with a number of potential complications. Moreover, many men prefer to avoid or are not suitable candidates for this invasive procedure. Thus, there is an increasing role for less invasive treatment, including drug therapy, in men with moderate to severe BPH. Terazosin is an alpha 1 receptor antagonist which has been shown in placebo-controlled trials to significantly improve American Urology Association (AUA) symptom and quality-of-life scores and symptom problem index ('bother' score), as well as increase peak urinary flow rate, in men with BPH. In a recent large randomised US trial, treatment for 1 year with terazosin titrated to 10 mg/day improved mean AUA symptom score and peak urinary flow rate to a significantly greater extent than finasteride 5 mg/day in men with moderate to severe BPH. The most frequently reported adverse events associated with terazosin include dizziness, asthenia, postural hypotension, somnolence, headache, peripheral oedema, nasal congestion/rhinitis and syncope. Approximately 5% of men with BPH discontinue terazosin because of adverse events. Results of an economic evaluation of terazosin, in which both clinical and economic data were collected prospectively in a randomised placebo-controlled study design, showed similar total direct treatment costs per 1000 patients associated with 1 year of therapy with terazosin ($US3.57 million) and placebo ($US3.78 million) in men with moderate to severe BPH (1992 dollars). The analysis, which was conducted from the perspective of a managed care organisation in the US, demonstrated that the lower medication costs in the placebo group relative to the terazosin group were offset by increased inpatient care costs. Thus, terazosin (titrated to response up to a maximum of 10 mg/day) was significantly more effective than placebo in improving disease-specific symptoms and quality of life, but at a similar overall cost to placebo. Another economic analysis, also conducted from a third-party payer perspective in the US, modelled direct treatment costs associated with terazosin, finasteride and TURP during the first 2 years after initiating therapy in men with moderate to severe BPH. Results of the study favoured terazosin; the private insurance cost per patient undergoing primary treatment with TURP was $US6411, compared with $US2860 with finasteride (45% of the cost of TURP) and $US2422 with terazosin (38% of the cost of TURP). Medicare costs were lower for all 3 treatment groups but the relative comparisons were similar; corresponding costs per patient were $US3874, $US2161 and $US1820 (1992 dollars). A companion break-even cost analysis used a hypothetical cohort of men with BPH starting treatment at age 67 years. Private insurance costs associated with terazosin remained lower then those associated with TURP for approximately 15 years (the corresponding break-even point was 10 years for finasteride vs TRUP). Medicare costs associated with terazosin would not exceed those of TURP for approximately 7 years (5.5 years for finasteride vs TURP). In conclusion, a limited number of detailed pharmacoeconomic analysis of terazosin have been conducted to date, although it has not been compared with other a1 receptor antagonists.
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PMID:Terazosin. A pharmacoeconomic evaluation of its use in benign prostatic hyperplasia. 1016 27

Reduced cholinergic transmission is a key neurotransmitter dysfunction in Alzheimer's Disease (AD). NXX-066, a physostigmine analog and acetylcholinesterase (AChE) inhibitor, has demonstrated activity in animal models of memory function, and was well tolerated in healthy subjects up to a single dose of 64 mg and multiple doses of 60 mg QD for seven days. Since AChE inhibitors are often tolerated differently in AD patients than in healthy volunteers, a randomized, placebo-controlled, double-blind, single-center, inpatient bridging study was conducted to determine the maximum tolerated dose (MTD) of NXX-066 in the target patient population. Seven consecutive panels of eight AD patients each (6 active, 2 placebo) received fixed oral doses of NXX-066 (20, 30, 40, 50, 60, 70, or 80 mg BID) for seven days. Initiation of each subsequent panel (dose group) was contingent upon the tolerability of lower dose levels. The MTD was determined to be 70 mg BID when four of six patients receiving 80 mg BID were prematurely discontinued from the study due to nausea and/or vomiting, accompanied in some patients by mild to moderate dizziness, headache, asthenia, and gastric symptoms. Wide variability in plasma levels of NXX-066 was observed in all dose panels. AChE inhibition in whole blood correlated with both maximum plasma concentration and dose; however, AChE inhibition was not predictive of adverse events. In this study, AD patients tolerated larger daily doses of NXX-066 on a BID regimen than healthy normal subjects had tolerated with QD dosing. Further studies are warranted to examine whether differing tolerability between patients and healthy subjects or the reduced dosing interval explains these findings.
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PMID:NXX-066 in patients with Alzheimer's disease: a bridging study. 1021 Feb 64

Zolmitriptan is a selective 5-HT1B/1D receptor agonist for acute oral migraine therapy. This randomized, placebo-controlled, parallel-group study investigated the efficacy and tolerability of oral zolmitriptan (5, 10, 15 and 20 mg) in the treatment of single acute migraine attacks. Of 1181 patients randomized, 840 were evaluable for the primary efficacy analysis. Headache response rates (a reduction in headache intensity from severe or moderate at baseline to mild or no pain at 2 hours post-treatment) were similar across the zolmitriptan dose groups (66%, 71%, 69% and 77% for 5 mg, 10 mg, 15 mg and 20 mg, respectively) and were significantly higher than that for placebo (19%; all groups P < 0.001). A headache response was reported at 1 hour by 40-50% of zolmitriptan recipients (16% placebo). At 2 hours post dose, 39-47% of zolmitriptan-treated patients were pain-free, compared with 1% of placebo recipients. Headache recurrence occurred in 21-29% (upper 95% CI 37.1) of zolmitriptan-treated patients and in 65% (95% CI 38.3, 85.8) of placebo recipients. Zolmitriptan was well tolerated at each dose. The most commonly reported adverse events were asthenia, dizziness, paraesthesia and feelings of heaviness. Most adverse events were of mild or moderate intensity and were transient. The frequency of adverse events was dose-related. Although, zolmitriptan 5 mg exhibited the most favourable efficacy and tolerability profile, the dose response data suggest that lower doses would also offer significant efficacy. Copyright 1998 Lippincott Williams & Wilkins
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PMID:Zolmitriptan, a 5-HT1B/1D receptor agonist for the acute oral treatment of migraine: a multicentre, dose-range finding study. 1021 Aug 88

The long-term effects of radiofrequency catheter ablation on quality of life in patients with typical atrial flutter are still unknown. This study included 100 consecutive patients with clinically documented typical atrial flutter. Subjective perception of quality of life was assessed by a semiquantitative questionnaire before, and 1 and 6 months after ablation. Ablation of typical atrial flutter was associated with a significant improvement in the general quality of life, frequency of significant symptoms, and symptoms during attacks. The frequency of hospital admission and emergency room visits, and number of antiarrhythmic drugs significantly decreased after ablation. Activity capacity significantly improved after ablation in patients with depressed left ventricular function. All improvements after ablation were maintained over 6-month follow-up. However, patients with atrial fibrillation compared with those without atrial fibrillation before ablation had less improvement in the general quality of life, frequency of significant symptoms, and symptoms during attacks (including palpitation, asthenia, effort, dyspnea, rest dyspnea, and dizziness). Furthermore, patients with atrial fibrillation before ablation needed more antiarrhythmic drugs, and had a higher frequency of hospital admission and emergent room visits at 6-month follow-up (all variables p <0.01). Multivariate analysis demonstrated that only the presence of atrial fibrillation before ablation could independently predict improvement in general quality of life (p = 0.03), frequency of significant symptoms (p = 0.03), symptoms during attacks (p = 0.04), and decrease in the consumption of health care resources including antiarrhythmic drugs (p = 0.01), hospital admission (p = 0.02), and emergency room visits (p = 0.02). Ablation of typical atrial flutter could significantly improve quality of life, but patients who had atrial flutter associated with atrial fibrillation before ablation had less improvement than those without atrial fibrillation.
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PMID:Effects of radiofrequency catheter ablation on quality of life in patients with atrial flutter. 1049 35

Approximately 25% of men over 40 or 50 suffer from lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH). The bothersomeness of the symptoms varies considerably from one individual to the other and can fluctuate with time. Symptoms tend to gradually worsen as time goes on through. Surprisingly, there appears to be no particular relationship between symptoms and the overall prostate size and weight. Symptoms of BPH are divided in obstructive (voiding) and irritative (storage) symptoms, of which the irritative are the most bothersome. Until recently, surgery (open or transurethral resection) was the only treatment option. Nowadays, a range of less invasive treatments and pharmacological therapies are available to relieve BPH symptoms. Finasteride, for instance, reduces the prostate size by blocking 5-alpha-reductase, the enzyme which plays a role in the growth of the prostate. It takes however a long time before a clinically significant effect is noticed: +/- 6 to 12 months. Then, there are alpha 1-blockers. These agents result in relaxation of prostatic and bladder neck smooth muscle. alpha 1-blockers act relatively fast. Most alpha 1-blockers used in the treatment of symptomatic BPH were originally developed to treat hypertension. The adverse events most commonly associated with alpha 1-blockers, such as dizziness, headache, asthenia, tachycardia/palpitation, postural hypotension and syncope are possibly related to the blood pressure lowering effect. This stimulated the search for more selective alpha-blockers which act predominantly on the prostate and have less effect on the blood levels (afluzosin: Xatral and tamsulosin: Omic). Presently, alpha-blockers have become the first-line drugs in the medical treatment of symptomatic BPH. Surgery (open or TURP) is limited to patients with recurrent infections, large residue (> 200 ml), recurrent hematuria, bladder stones. New alternative and minimally invasive treatment such as TUNA generate necrotic lesions within the prostate through needle introduced endoscopically. This leads also to marked improvement in patients symptomatology.
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PMID:[Benign hypertrophy of the prostate: which treatment, for whom?]. 1052 95

Rizatriptan (MAXALT(TM), Merck & Co., Inc.) is a selective 5-HT(1B/1D) receptor agonist with rapid oral absorption and early onset of action for the acute treatment of migraine. This randomized, double-masked, double-dummy, placebo-controlled study compared rizatriptan 10 mg to naratriptan (NARAMIG(TM), AMERGE(TM), both Glaxo Wellcome plc) 2.5 mg in 522 patients treating a single migraine attack. Rizatriptan was more effective than naratriptan. Rizatriptan provided earlier headache relief than naratriptan (hazard ratio 1.62, p < 0.001), acting as early as 30 min. More patients were pain free at 2 h on rizatriptan than on naratriptan (44.8 vs. 20.7%, p < 0.001). Rizatriptan also provided earlier relief of associated migraine symptoms within 2 h than naratriptan and more patients had normal function at 2 h (39.3 vs. 22.6%, p < 0. 001). Both active treatments were effective compared to placebo. Both active treatments were well tolerated. The most common side effects with rizatriptan were dizziness, asthenia/fatigue, nausea and somnolence, while the most common side effects with naratriptan were dizziness and asthenia/fatigue.
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PMID:Comparison of rizatriptan 10 mg vs. naratriptan 2.5 mg in migraine. 1052 45


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