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Query: UMLS:C0018681 (headache)
 56,091 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

A review was conducted of the safety and tolerability of fluvoxamine in 54 worldwide marketing studies that enrolled 24,624 patients, the majority of whom were treated with fluvoxamine in uncontrolled studies in depression. In accordance with the general epidemiologic distribution of depressive disorder, female patients and patients aged between 30 and 50 years predominated. The majority of patients were treated for 6 weeks, the most frequent, or modal, total daily dose being 100 mg. Overall, 57.4% of the patients exposed to fluvoxamine did not have any adverse experiences. The greatest proportion of adverse experiences, as defined using COSTART body systems, affected the digestive system (24.1%), the nervous system (23.7%), and the body as a whole (15.3%). The only adverse experience with an incidence greater than 10% was nausea (15.7%); somnolence (6.9%) and asthenia (6.2%) were the next most frequent adverse experiences. Notably, the rates of agitation and anxiety were only 1.4% and 1.3%, respectively. The incidences of adverse experiences generally increased with age and were slightly higher in females than in males. In total, 15.1% of patients discontinued treatment prematurely as a result of adverse experiences, principally nausea, dizziness, vomiting, somnolence, abdominal pain, and headache. The overall incidence of serious adverse events in association with fluvoxamine treatment was 2.5% when U.S. Food and Drug Administration criteria and the most conservative approach, without causality judgments, were used.(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:Safety database on fluvoxamine: analysis and report. 837 16

A postmarketing surveillance study in 2273 Canadian office practices provided the largest body of clinical experience to date with the angiotensin-converting enzyme (ACE) inhibitor lisinopril in the treatment of mild to moderate essential hypertension. The principal emphasis in this uncontrolled study was safety, assessed in 10,289 patients. Patients with a diastolic blood pressure > 90 mmHg were considered for the study. Both previously untreated patients and those who were experiencing adverse effects from their current antihypertensive regimen were included. Lisinopril was begun at a dose of 10 mg/day. Subsequent dose adjustments, to a maximum of 40 mg/day, were made to achieve optimal blood pressure control (diastolic blood pressure < or = 90 mmHg or > or = 10 mmHg below baseline for > or = 4 weeks at the same dose). Therapy was continued for a minimum of 4 weeks to a maximum of 12 weeks, with patients examined every 2 weeks. The frequencies of adverse effects and laboratory abnormalities were analyzed in all treated patients. All 10,289 patients enrolled were considered in the analysis of safety. One or more adverse effects were reported for 1593 (15.5%) patients, and 802 (7.8%) withdrew from the study because of adverse effects. The most frequent adverse effects were cough (4.0%), dizziness (2.3%), headache (2.1%), asthenia (1.7%), and nausea (1.0%). The physicians' global assessment rated overall tolerability as very good or good for 77.1% of the patients. Antihypertensive effect was evaluated in 5886 patients who met the criteria for efficacy analysis. The criterion response was attained in 5141 (87.3%) patients, with 68.6% responding to 10 mg/day of lisinopril, 26.3% to 20 mg/day, and 3.2% to 40 mg/day (the other 1.9% responded at nonstandard doses). Lisinopril was safe and well-tolerated. Except for cough, class effects of ACE inhibitors were rarely encountered. The results of the efficacy analysis confirm the established efficacy of lisinopril in patients with mild to moderate essential hypertension.
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PMID:Lisinopril in the treatment of hypertension: a Canadian postmarketing surveillance study. 839 Sep 18

We report on a tourist returning from Thailand, who presented with classical dengue fever. While in Thailand a 36-year-old Swiss female laboratory assistant suddenly developed fever, devastating headache, retro-ocular pain, myalgia and arthralgia, photophobia, nausea and diarrhea. In addition she suffered from epistaxis, urogenital and skin bleeding, and a morbilliform exanthema. After her return to Switzerland we noted lymphadenopathy and splenomegaly, enanthema and laboratory findings of mild hepatitis, thrombocytopenia and leukopenia. The diagnosis of dengue virus infection was verified serologically. Apart from a long lasting convalescent asthenia we observed restitutio ad integrum within days under symptomatic therapy. Epidemiological clinical and diagnostic aspects of dengue virus infection are discussed.
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PMID:[Imported dengue fever following a stay in the tropics]. 842 57

A total of 217 patients with essential hypertension were enrolled by 25 Canadian centers in this double-blind, parallel study to compare the efficacy and safety of enalapril administered alone or in combination with hydrochlorothiazide. After a 4-week placebo period, patients were given 10 mg of enalapril for 2 weeks. At the end of the 2 weeks of therapy, patients were maintained on the same dose of enalapril, titrated to a higher dose of enalapril, or received combination therapy with hydrochlorothiazide if their diastolic blood pressure remained > 90 mmHg. Patients in group 1 received enalapril 10 mg or 20 mg and those in group 2 received enalapril 10 mg alone or combined with hydrochlorothiazide 25 mg. The maintenance phase lasted 8 weeks. A standard mercury sphygmomanometer was used to measure blood pressure at each visit. The mean decrease in supine diastolic blood pressure (SDBP) was 16 mmHg in groups 1 and 2; the mean decrease in supine systolic blood pressure (SSBP) was 19 mmHg in group 1 and 20 mmHg in group 2. Eighty percent of the patients in group 1 and 81% of those in group 2 had an SDBP < or = 90 mmHg at the final visit. To achieve this control, 67% of the patients received enalapril 10 mg and 33% received enalapril 20 mg in group 1. In group 2, 70% of the patients received enalapril 10 mg and 30% received enalapril 10 mg plus hydrochlorothiazide 25 mg. Eighteen patients in group 1 and 17 patients in group 2 experienced one or more minor adverse events. The most frequently reported adverse events were headache, asthenia, abdominal pain, nausea, and dizziness. No major adverse events were observed. We conclude that enalapril used alone reduces blood pressure in the majority of patients with mild to moderate essential hypertension. When blood pressure is not controlled by enalapril alone, hydrochlorothiazide can safely be added to the regimen.
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PMID:Enalapril and enalapril-hydrochlorothiazide in the treatment of essential hypertension. The Enalapril-Hydrochlorothiazide in Essential Hypertension Canadian Working Group. 851 44

In this pilot study, the effect of dosing schedule on the efficacy and safety of the long-acting alpha 1-adrenergic blockers, terazosin (TER) and doxazosin (DOX), was evaluated in 43 consecutive normotensive men (mean age 59.6 years) with symptoms of prostatism. Patients were randomized to one of four treatment groups: (1) TER 5 mg once in the morning (AM; n = 10), (2) TER 5 mg once in the evening (PM; n = 11), (3) DOX 4 mg once AM (n = 11), and (4) DOX 4 mg once PM (n = 11). Patients were titrated to their final dose over 3 weeks. Parameters evaluated included Boyarsky symptom score (Sx), peak uroflow (Qmax), blood pressure and occurrence of adverse events. Once stabilized, patients were seen at 3-month intervals; follow-up ranged from 4 to 17 months (mean 9.7). Clinical improvement as determined by Sx and Qmax was similar for all four treatment groups. Mean decreases in Sx at 3 months were 4.6, 5.4, 4.9, and 5.0 for TER-AM, TER-PM, DOX-AM, and DOX-PM, respectively. Mean peak uroflow increased 3.0, 3.1, 2.8, and 3.1 ml/s for TER-AM, TER-PM, DOX-AM, and DOX-PM, respectively (p < 0.05 vs. baseline). Eight patients (18%) were withdrawn from the study because of adverse events (fatigue 1, asthenia 1, headache 3, dizziness 4): 5 during the titration phase (TER-AM: 2, DOX-AM: 2, TER-PM: 1) and 3 during the treatment phase (TER-AM: 2, DOX-AM: 1). In these 8 patients, the mean decreases in sitting and standing blood pressure were approximately 7/5 and 10/8 mm Hg, respectively. These data suggest that efficacy of TER and DOX was similar at the dosages employed and not affected by the dosing schedule. Adverse events in this small population were significantly decreased (p < 0.05) by dosing in the PM. These preliminary results suggest that a larger prospective study is warranted to determine (1) the comparative efficacy of TER and DOX in the treatment of symptomatic benign prostatic hyperplasia and (2) optimal timing of the medication.
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PMID:Terazosin and doxazosin in normotensive men with symptomatic prostatism: a pilot study to determine the effect of dosing regimen on efficacy and safety. 853 76

This study investigated the anti-hypertensive efficacy and tolerability of once-daily losartan potassium (50 mg titrated to 100 mg), an angiotensin II receptor antagonist, compared with once daily felodipine extended release (ER) (5 mg titrated to 10 mg), a calcium channel blocker, after 12 weeks of therapy in elderly hypertensive patients. Following a 4-week, single-blind, placebo baseline period, qualifying patients were randomly allocated to 12 weeks of double-blind treatment with losartan potassium or felodipine ER. After 6 weeks, patients with a 24 h post-dose sitting diastolic blood pressure > or = 90 mm Hg had their dose doubled for the remaining 6 weeks. At 6 weeks, there was a greater BP response for felodipine ER than losartan potassium in elderly patients with mild to moderate hypertension. However, after 12 weeks of therapy, losartan potassium reduced BP as effectively as felodipine ER with no differences in mean BP reduction or anti-hypertensive response category between treatment groups. In this study, both treatments were well tolerated; felodipine ER was associated with a numerically higher incidence of headache and oedema while the incidence of asthenia was numerically higher in losartan-treated patients.
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PMID:Randomised, double-blind, parallel study of the anti-hypertensive efficacy and safety of losartan potassium compared with felodipine ER in elderly patients with mild to moderate hypertension. 855 92

In the last ten years ivermectin appeared an efficient and safe alternative to diethylcarbamazine which is known to induce severe adverse reactions in loiasis, including encephalitis. After these results, large scale ivermectin treatments against onchocerciasis were carried out in Central Africa where loiasis is also endemic; and seven cases of severe reaction were reported in Cameroon since 1991, during these mass ivermectin treatments. In order to study adverse reactions in patients harbouring high load of Loa loa microfilariae (mf), we realized careful hospital based treatment in 112 patients with more than 3,000 mf/ml (ml) blood. Patients received once 200 micrograms ivermectin per kilogram at day 0 (D0). Clinical examination was made daily during the four following days (D1 to D4). Blood and urine samples were analysed before treatment and at D1 and D3. Lumbar puncture was made at D1 for 39 patients with more than 10,000 mf/ml; at D3 for the 49 following patients without consideration for the level of parasitaemia, and at D0 and D3 for ten voluntary patients. For analysis the patients were distributed in 3 groups according to initial parasitaemia: the first group included 50% out of the patients, those whose parasitaemia was fewer than 15,000 mf/ml blood; the second group included 25% patients whose parasitaemia was between 15,000 and 30,000 mf/ml; the third group included the last 25% patients whose parasitaemia was higher than 30,000 mf per ml blood. Adverse reactions were observed in 71% out of the patients. Symptoms described were fever, pruritus, headache, arthralgia. Most symptoms appeared 24 to 36 hours after treatment. Temperature increased significantly in group 3. Microfilaraemia decreased by 85% in the 3 groups during the 4 days following treatment. C-reactive-protein increased dramatically after treatment in all patients (p < 10(-4)). Some patients presented blood in urine in three groups but haematuria reached 35% of patients in group 3. Proteinuria is noted among 33% of all patients but 20% in group 1 and 2 versus 70% in group 3. Loa loa mf were observed in urine of half the patients, but in low amounts (< 10 mf per 50 ml urine). In cerebro-spinal fluid (CSF), some mf appeared at D1 or D3 in people heavily infected with Loa loa, reaching 80% of the patients of group 3. LP made at D0 in ten patients with parasitaemia higher than 30,000 mf/ml blood confirmed that CSF was naturally microfilaria free before treatment. One patient presented severe troubles with fever, asthenia and conscience troubles beginning at D3, reactive coma at D4, renal impairment with transitory anuria; progressive improvement in 2 weeks and complete recovery at D22; he presented 102 mf/ml CSF at D6. The study confirmed that ivermectin treatment is generally well tolerated. Among people with high Loa loa parasitaemia the symptoms after treatment are frequent but mild. However severe cases with conscience troubles are possible, and may occur in about 1% of subjects with more than 3,000 mf/ml blood. Severity of adverse reactions was linked to level of parasitaemia before treatment. The critical parasitaemia level which could lead to expect serious adverse effects seems to be 30,000 ml/ml blood. These informations should induce carefulness to carry out large scale treatments against filariosis in endemic areas of Loa loa.
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PMID:[Secondary effects of the treatment of hypermicrofilaremic loiasis using ivermectin]. 855 62

396 adult and adolescent patients with seasonal allergic rhinitis participated in this randomised double-blind parallel-group study in which the efficacy and tolerability of ebastine 10 or 20mg administered once daily in the morning or evening for 3 weeks were compared with those of placebo. Clinical efficacy was assessed by measuring improvement in rhinitis symptoms (nasal discharge, nasal stuffiness, sneezing, itchy nose and itchy/watery eyes) recorded by patients twice daily on diary cards. The improvement in individual and total symptom scores at the end of the 3-week treatment period in patients treated with ebastine 10mg in the morning or ebastine 20mg in the morning or evening was significantly greater than the improvement in placebo recipients. The 20mg dose of ebastine administered in the morning was associated with the greatest improvement in symptom scores. There was no significant effect with the 10mg evening dose compared with placebo. Ebastine was well tolerated by the majority of patients - the incidence of adverse events, including headache, dry mouth, somnolence and asthenia being similar to that reported in placebo recipients. Electrocardiograms showed no evidence of any clinically relevant changes in QTc intervals. In a subsequent nonblinded 4-month study that included 230 patients from the initial study, global evaluations at monthly intervals showed overall symptom improvement in > or = 72% of patients who received ebastine 10mg or 20mg once daily. The drug was well tolerated during prolonged therapy, with adverse events being similar in nature and incidence to those reported in the 3-week double-blind study. In conclusion, ebastine 10mg once daily in the morning is an appropriate starting dose for the treatment of rhinitis, and this can be increased to 20mg as required.
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PMID:Clinical studies of the efficacy and tolerability of ebastine 10 or 20 mg once daily in the treatment of seasonal allergic rhinitis in the US. 882 22

202 children aged 2 months to 17 years, undergoing elective paediatric operations below the umbilicus, were allocated randomly to receive either spinal (SA) or epidural anaesthesia (EA). SA was more efficacious since 8 children of 102 needed supplementation with general anaesthesia, in contrast to EA where 24 children of 100 were supplemented with general anaesthesia and 6 with fentanyl. The haemodynamic stability was maintained during EA, whereas during SA 6 patients were given medication to increase heart rate/blood pressure. EA provided longer pain relief than SA in the recovery room. The incidence of postoperative side effects was similarly low following SA and EA. Complaints after discharge were also similar. General weakness (7% vs 8% after SA and EA, respectively), low back pain (6% vs 6%), headache (7% vs 4%), fever (6% vs 4%) and positional headache (PDPH) (5% vs 3%) were the most frequent side effects. PDPH was only observed following SA in children aged 11 years or older. Following EA, PDPH was also observed in the younger age group after accidental dural puncture. In conclusion, we prefer SA for minor paediatric operations due to its high efficacy.
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PMID:Comparison of spinal anaesthesia with epidural anaesthesia in paediatric surgery. 884 88

Beside well-established clinical benefits, the current doses of oestrogens may induce clinical side-effects leading to non-compliance and loss of efficacy. During a normal menstrual cycle the incidence of any cyclic discomfort is consistently reported to be lowest during the mild-follicular phase when plasma E2 remains between 60 and 150 pg/ml. The incidence of pregnancy-like symptoms such as bloating, breast tenderness and mood swings tends to increase in mid-luteal phase when E2 increases upto 150 pg/ml. On the other hand incidence of asthenia, sleep disturbances, depressive mood, headaches and migraines increase during perimenstrual days when E2 drops to 40 pg/ml or below. Accordingly experimental and human studies in castrated animals and postmenopausal women suggest that plasma E2 around 100 pg/ml is optimal for treatment of hot flushes, prevention of bone loss and cardiovascular protection. Due to large interindividual variation in estrogen clearance rate, it is unlikely that any standardized unique dose of oral or non-oral formulations will reproduce the optimal levels in all postmenopausal users. Efforts for individual titration are mandatory to improve compliance and actual efficacy on a long term. Because older postmenopausal women tend to have a better clinical tolerance to low E2 levels, objective markers of efficacy should also be identified when the aim of HRT is the prevention of osteoporosis or vascular diseases. In addition clinical and metabolic side-effects related to added progestins can be substantially reduced by the use of lower dose inducing amenorrhea and by progesterone instead of synthetic steroids.
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PMID:Hormone replacement therapy: clinical benefits and side-effects. 886 37


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