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A double-blind, randomized, placebo-controlled trial was conducted to evaluate the efficacy and safety of fleroxacin for one or two days as treatment for patients with travellers' diarrhoea. A total of 195 patients who were suffering with acute diarrhoea of less than six days' duration were enrolled. One hundred and fifty-one patients, of whom 49 received placebo, 54 received fleroxacin 400 mg for one day and 48 received fleroxacin 400 mg for two days, were included in the analysis of efficacy. The results showed that fleroxacin was significantly superior to placebo, but that there was no significant difference in terms of efficacy between the one- and two-day regimens. Adverse events, particularly minor neuropsychiatric disturbances such as headache and insomnia, were significantly more common amongst patients receiving active treatment. In conclusion, a single dose of fleroxacin 400 mg could be recommended as self-treatment for visitors to high-risk countries who develop travellers' diarrhoea.
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PMID:Treatment of travellers' diarrhoea with fleroxacin: a case study. 833 4

The objective of this open-label, randomized, multicenter study was to compare the efficacy and safety of fleroxacin, 400 mg administered orally once daily, and amoxicillin/clavulanate potassium (AMX/CP), 500 mg/125 mg administered orally three times daily, for 4-21 days to patients with skin and soft tissue infections (SSTIs). The specific diagnoses in both groups were primarily skin abscess, impetigo, and skin ulcer, as well as wound infection erysipelas, folliculitis, cellulitis, and lymphangitis. A total of 285 patients were randomized to treatment in a 2:1 ratio, 190 in the fleroxacin group and 95 in the AMX/CP group. Adult male or female inpatients or outpatients were included in the trial and were followed up after 3-5 days of therapy and 3-9 days after completion of therapy for assessment of bacteriologic, clinical, and safety parameters. The most frequently isolated pathogen in both treatment groups was Staphylococcus aureus. Bacteriologic cures were observed in 87 (76%) of 115 evaluable patients in the fleroxacin group and in 41 (72%) of 57 evaluable patients in the AMX/CP group. Clinical cure was seen in 86 (75%) of 114 patients in the fleroxacin group and 45 (79%) of 57 patients in the AMX/CP group. Clinical adverse events related to the trial medication were reported by 40 (21%) of 189 patients in the fleroxacin group and by 16 (17%) of 95 patients in the AMX/CP group. In both groups, most adverse events were mild or moderate in severity and involved the digestive system (primarily diarrhea, nausea, and vomiting). In the fleroxacin group, adverse events affecting the central nervous system (mainly dizziness, insomnia, somnolence) also were reported. In this study, both fleroxacin and amoxicillin/clavulanate potassium were effective and well tolerated in the treatment of skin and soft tissue infections.
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PMID:Comparative efficacy and safety of oral fleroxacin and amoxicillin/clavulanate potassium in skin and soft tissue infections. 845 74

The efficacy and safety of fleroxacin in brief self-treatment of travelers' diarrhea were studied. In The Gambia, 195 tourists with acute diarrhea were randomized in a double-blind, controlled trial into three treatment groups: fleroxacin 400 mg for 1 day, fleroxacin 400 mg daily for 2 days, and placebo. Microbiology of stools was assessed only at recruitment. In the fleroxacin-treated groups, stool consistency was normal in 67% and 71% of the volunteers after 48 hours, as compared to 37% in the placebo group (p < 0.01). The time to total relief of diarrhea and of all symptoms was also significantly shorter in fleroxacin-treated patients. Adverse events, particularly slight neuropsychiatric reactions (headache, insomnia) were more frequent in the fleroxacin-treated groups (p < 0.05). There was no statistically significant difference in efficacy and tolerance if fleroxacin was administered for 1 or 2 days. A single dose of fleroxacin 400 mg may be recommended for the self-treatment of travelers' diarrhea.
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PMID:Efficacy and toxicity of fleroxacin in the treatment of travelers' diarrhea. 845 78

A 35-year-old man presented with cough, expectoration of green sputum, and right-sided pleuritic chest pain. Symptoms had begun the previous day and he had vomited the night before. The patient also complained of chronic fatigue, a 12-lb. weight loss, insomnia, right-sided back pain, and lower extremity myalgias. He denied having had fever, chills, diaphoresis, dyspnea, diarrhea, dysuria, abdominal pain, skin lesions, or jaundice.
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PMID:A liver-lung connection. 859 9

In an open randomized study 218 outpatients (159 males and 59 females) ranging between 18 and 85 years of age (mean 61.9) suffering from bacterial exacerbation of chronic bronchitis have been randomly treated: 79 with co-amoxiclav (amoxicillin 875 mg+clavulanic acid 125 mg) twice daily, 69 with cefixime (400 mg) once daily, and 70 with ciprofloxacin (500 mg) twice daily for an average period of 10 days. Before treatment start, 234 bacterial strains (105 Gram-positive and 129 Gram-negative) were isolated as the cause of exacerbation; the leading pathogens were Streptococcus pneumoniae and Haemophilus spp. Eradication rates at the end of treatment were 82.2% for the co-amoxiclav group, 77.6% for the cefixime group, and 81.2% for ciprofloxacin group. Clinical success (cure+improvement) was obtained in 90.8% of the cases treated with co-amoxiclav, in 80.9% for the cefixime group and in 85.7% of patients treated with ciprofloxacin. Seven adverse events (8.9%) of which 4 cases of diarrhea and 3 of itching, were recorded in the co-amoxiclav group. Eleven adverse events (14.7%) were recorded in the cefixime group including gastrointestinal disturbances in 6 patients and mild to moderate increase of liver function in 2. Nine adverse events (12.9%) occurred in the ciprofloxacin group, including insomnia in 3 patients, gastrointestinal disturbances in 2, and serious increase of liver function tests in one patient. It can be concluded that there were no statistically significant differences among the three treatment groups. However, co-amoxiclav demonstrated a higher efficacy rate than cefixime and ciprofloxacin and was better tolerated. Therefore, it can be used as a first-choice drug in the treatment of exacerbation of chronic bronchitis.
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PMID:Comparative evaluation of the clinical and microbiological efficacy of co-amoxiclav vs cefixime or ciprofloxacin in bacterial exacerbation of chronic bronchitis. 859 27

Demographic trends reveal the elderly to be the fastest growing segment of the population. Physicians can therefore anticipate encountering increasing numbers of older patients with alcohol-related problems. These problems include liver disease, dementia, confusion (masquerading as dementia), peripheral neuropathy, insomnia, late-onset seizure disorder, poor nutrition, incontinence, diarrhea, myopathy, inadequate self-care, macrocytosis, depression, fractures, and adverse reactions to medications. Despite the prevalence of alcohol use in older people, their risks and problems are often unrecognized. We reviewed published literature on the determinants and consequences of alcohol-related problems in persons aged 65 years and older and the usefulness of available screening measures. Thirteen of 25 eligible studies on determinants and consequences met quality criteria and were reviewed. Nine additional studies on screening tests were also evaluated. Determinants include history of alcohol use and abuse, social isolation, and reduced mobility; consequences consist of risks of hip fracture from falls, neoplasms, and psychiatric illness. Currently accessible screening tests focus on high levels of alcoholic beverage use and abuse and dependence. They are not useful in screening for hazardous consumption that may result from relatively low levels of alcohol use alone or in combination with medications, medical illness, or preexisting diminished physical, emotional, or social function. Research is needed on the consequences of lower levels of alcohol consumption on the physical and psychosocial health of older individuals and on methods for distinguishing alcohol-related from age-related problems. Existing screening tests should be expanded or new screening methods developed in anticipation of a growing public health problem.
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PMID:Alcohol-related problems in older persons. Determinants, consequences, and screening. 900 85

Couvade is a phenomenon, where the expectant father or another relative experiences somatic and/or psychiatric symptoms during a woman's pregnancy. Although epidemiological studies report a frequency of couvade symptoms between 11 and 36% during all pregnancies, psychotic couvade cases are very rare with few case reports. The authors report 2 cases of psychotic couvade and give a psychodynamic interpretation of the cases. They emphasize the important role of ego defect and double identification in the development of the cases. Couvade is a phenomenon, where the expectant father or another relative experiences somatic and/or psychiatric symptoms during a woman's pregnancy. The term couvade was first coined by Tylor in 1865. Somatic symptoms can include indigestion or colic, gastritic symptoms, food cravings, nausea and vomiting, increased or decreased appetite, diarrhea, toothache, headache, itch, muscle tremors, nosebleed or other pains. Abdominal bloating and pseudocyesis have also been reported. Although the psychiatric symptoms most often observed are depression, anxiety, insomnia, irritability, tension and hypochondria there are some reports on psychotic couvade too. In our article we present 2 cases of psychotic couvade.
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PMID:Psychotic couvade: 2 case reports. 886 58

The clinical trial development programme of mirtazapine (Org 3770), performed in Europe and the United States, demonstrated an outstanding safety profile of this compound. The evaluation of the safety was based on data from all patients who took at least one dose of study medication during studies comparing mirtazapine with placebo, amitriptyline or other active comparators. A general indication of mirtazapine's safety is the significantly lower percentage of patients (65%) who complained of any adverse clinical experiences compared with the placebo- (76%) or amitriptyline-treated group (87%). Moreover, drop-out rates due to adverse clinical experiences were significantly lower than in the amitriptyline-treatment group. Mirtazapine has virtually no anticholinergic, adrenergic or typical selective serotonin reuptake inhibitor (SSRI) side effects. The only significantly higher incidences versus placebo were seen in the adverse clinical effects of drowsiness (23% versus 14%), excessive sedation (19% versus 5%), dry mouth (25% versus 16%), increased appetite (11% versus 2%) and weight increase (10% versus 1%). These complaints were typically mild and transient in nature, and decreased over time despite increased doses of mirtazapine. In contrast, significantly higher incidences of headache (5% versus 10%) and weight decrease (2% versus 6%), symptoms commonly seen in depressed patients, were recorded in the placebo-treated patients. Also, typical SSRI adverse events, such as nausea, vomiting, diarrhoea and insomnia, and symptoms of sexual dysfunction were registered less frequently in mirtazapine-treated patients than in the placebo-treated patients. Approximately 10% of the mirtazapine-treated patients in the clinical trial programme were older than 65 years. The pattern of adverse clinical experiences seen in this group of patients is fully in line with that seen in the overall patient population. The analysis of vital sign indices, i.e. blood pressure and heart rate, showed that no changes occurred with mirtazapine treatment; this pattern was fully comparable to that seen with placebo. Furthermore, very low incidences of clinically relevant changes in laboratory indices, such as the liver enzymes alanine aminotransferase and aspartate aminotransferase or neutropenia, were recorded in each treatment group. Mirtazapine has a very low seizure-inducing potential: only one case was recorded in a patient with a history of seizures during previous treatment with clomipramine. The low seizure-inducing potential combined with a lack of cardiotoxic properties allows safety in an overdose of mirtazapine, even in elderly patients. The only symptom seen in the patients taking an overdose of mirtazapine alone or in combination with other drugs was excessive but transient somnolence, which resolved spontaneously within a few hours. In conclusion, the new antidepressant mirtazapine offers clinicians a unique combination of strong efficacy and good safety.
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PMID:Safety of mirtazapine: a review. 893 8

An investigator-blind, parallel-group, multicentre study was undertaken to compare the efficacy and tolerability of once-daily, sustained-release (s-r) ibuprofen and diclofenac sodium in patients (mean age 59.8 years) suffering from painful osteoarthritis affecting chiefly the knee and/or hip. Patients attending eight Swiss centres received either two s-r tablets of ibuprofen (daily dose 1600 mg; n = 30) or a single s-r diclofenac 100 mg tablet (n = 31) each evening for 21 days. Clinical assessments were performed prior to initiating therapy and after 7 and 21 days of treatment. Both treatments were efficacious, but statistically significant differences in favour of s-r ibuprofen were observed for the principal measure of efficacy, the investigator's assessment of the overall change in clinical condition; by Day 21, 37% of ibuprofen-treated patients vs 10% of diclofenac-treated patients were 'much improved' (p = 0.04). Patients' assessments of the efficacy of their treatment also favoured s-r ibuprofen at Day 7 for the relief of night pain (p = 0.048), at Day 21 for alleviation of day pain (p = 0.006) and for the ability to carry out normal activities (p = 0.01), and at both Days 7 and 21 for quality of sleep (p = 0.04 and 0.03, respectively). The patients' overall opinion of treatment was also significantly in favour of s-r ibuprofen, which was rated 'good or excellent' by 80% (24/30), compared with only 38% of patients (11/29) receiving s-r diclofenac sodium (p = 0.002). Two patients (6%) receiving s-r diclofenac sodium ceased treatment owing to dizziness and severe diarrhoea, respectively; there were no withdrawals in the ibuprofen-treated group. Ten (32%) patients in the s-r diclofenac group reported a total of 12 adverse events (mostly gastrointestinal in nature), compared with three (10%) patients in the s-r ibuprofen group who reported only three events (abdominal pain, insomnia and constipation). In conclusion, although both NSAID treatments improved the clinical condition of patients with painful osteoarthritis, statistically significant differences in favour of once-daily s-r ibuprofen (1600 mg) were demonstrated in terms of efficacy, indicating a potential therapeutic advantage for this formulation. Ibuprofen was also better tolerated than diclofenac sodium (100 mg/day), the latter being associated with gastrointestinal side effects in a significant proportion of patients. Sustained-release ibuprofen (Brufen Retard) thus represents an important addition to the available therapeutic armamentarium of once-daily NSAID formulations.
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PMID:Ibuprofen and diclofenac sodium in the treatment of osteoarthritis: a comparative trial of two once-daily sustained-release NSAID formulations. 901 Jun 10

The pharmacology, pharmacokinetics, efficacy, and adverse effects of dexfenfluramine hydrochloride are reviewed. Dexfenfluramine, the dextrorotatory isomer of fenfluramine, is indicated for use in the management of obesity in patients with a body mass index of > or = 30 kg/m2, or > or = 27 kg/m2 in the presence of other risk factors. Unlike fenfluramine, dexfenfluramine is a pure serotonin agonist. Dexfenfluramine may mimic the effect of carbohydrate intake. Systemic bioavailability is about 68%, and the drug is metabolized in the liver. In randomized, placebo-controlled trials, dexfenfluramine was effective in reducing weight in obese patients given the drug for three or six months. In trials lasting one year, the statistically significant weight loss occurred during months 4 to 6. Dexfenfluramine reduces blood pressure, percent glycosylated hemoglobin, and concentrations of blood glucose and blood lipids, but these benefits may be indirect. Dexfenfluramine may also be of some value in controlling eating habits in diabetic patients, preventing weight gain after smoking cessation, and treating bulimia, seasonal affective disorder, neuroleptic-induced obesity, and premenstrual syndrome. Dexfenfluramine's most frequent adverse effects are insomnia, diarrhea, and headache; it has also been associated with primary pulmonary hypertension. The drug should not be combined with other serotonergic agonists because of the risk of serotonin syndrome. The recommended dosage is 15 mg twice daily. Dexfenfluramine is effective in the treatment of obesity in selected patients. Because its efficacy is lost after six months of continuous treatment, it should be viewed primarily as an adjunct to diet and exercise.
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PMID:Dexfenfluramine hydrochloride: an anorexigenic agent. 937 5


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