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PubMed1984

[Therapeutic action of Piroxicam administered rectally in rheumatic diseases. Controlled double-blind study].

In a 15 day double-blind clinical trial 39 patients affected with rheumatic disease have been enrolled to evaluate the therapeutic effect of rectal administration of Piroxicam, in comparison with Indomethacin. At the end of the study, 20 patients had been treated with Piroxicam and 19 with Indomethacin. Nine patients in the Indomethacin group and one in the Piroxicam group dropped-out. Both drugs safety resulted good in the patients who completed the study, whereas 5 out of 10 dropped-out patients stopped the trial in consequence of severe side-effects of Indomethacin. Piroxicam induced a very good improvement in 76% of the patients, moderate in 19% and no improvement in 5%; Indomethacin induced a very good improvement in 75% of the patients, moderate in 15% and no improvement in 10%. No significative modifications resulted from the control of the laboratory blood tests. Piroxicam (30 mg/die) showed a therapeutic activity similar to Indomethacin (100 mg/die). The rectal administration of Piroxicam can be then considered a very good alternative to the oral one, particularly in the patients in which oral use of NSAID is counter-indicated.

Adult↗
PubMed1985

[TTS-nitroglycerin and slow-release metoprolol: efficacy in patients with stable exercise-induced angina].

The antianginal efficacy of slow-release metoprolol (SRM) alone and associated to a transdermal therapeutic system containing nitroglycerin (TTS-TNG), was investigated in 10 patients with chronic, stable exertional angina and angiographic evidence of obstructive coronary artery disease, by means of a double blind, cross-over trial. Each patient performed a symptom-limited exercise test 4 and 24 hours after single blind placebo on day 1, and double blind SRM (200 mg) alone or SRM plus TTS-TNG, on days 3 and 5, in a randomized sequence. The protocol of Redwood was employed. Compared to the beta-blocker alone, the combined administration of SRM and TTS-TNG was associated to a significant increase in mean exercise duration 4 hours (528 +/- 180 vs 412 +/- 110 sec.; p less than 0.001) and 24 hours (432 +/- 115 vs 391 +/- 100 sec.; p less than 0.05) after drug administration. A significant increase in mean total work performance 4 hours (4626 +/- 1070 vs 3272 +/- 803 kgm; p less than 0.01) and 24 hours (3445 +/- 1045 vs 2941 +/- 773 kgm; p less than 0.01) after drug administration was observed as well. During placebo all the tests were stopped due to angina associated with ST depression greater than or equal to 1 mm. Conversely, the test was terminated due to fatigue by 8 patients at 4 hours and 5 patients at 24 hours after combined therapy, and respectively by 5 and 1 patient after SRM alone. No side effects were observed after the administration of SRM alone, whereas 5 patients complained of mild headache after SRM and TTS-TNG.(ABSTRACT TRUNCATED AT 250 WORDS)

Adrenergic beta-Antagonists↗
PubMedDate not supplied

Idebenone, a new drug in the treatment of cognitive impairment in patients with dementia of the Alzheimer type.

Alzheimer's disease (AD) is a central nervous system disorder characterized by the presence of neurofibrillary tangles, neuritic plaques and dystrophic neurones in susceptible areas of the brain. Few options for treatment of AD symptomatology are available. We conducted a multicenter, randomized, double-blind, placebo-controlled, parallel trial consisting of a 90 day treatment period followed by a 30 day single blind placebo administration and by an optional long term period of treatment up to a year with idebenone in open fashion. Ninety two patients entered the study and nine of them dropped out before the first control. Treatment with idebenone was found effective on memory, attention, and orientation and in slowing down the natural progressive worsening of the disease. The most common side effects associated with this treatment were insomnia, gastralgia, nausea, and anxiety. However, all adverse effects were of mild intensity and did not require specific therapies.

Aged↗
PubMed1995

A multiple-dose safety trial of eptastigmine in Alzheimer's disease, with pharmacodynamic observations of red blood cell cholinesterase.

A placebo-controlled multiple dose study was conducted to evaluate the safety, tolerability, and pharmacodynamics of multiple dose levels of eptastigmine in 25 patients with probable Alzheimer's disease (AD). Twenty patients (12 M, 8 F; mean age 74, range 57-84) were randomized to receive 12mg (N = 3), 20mg (N = 6), 28mg (N = 6) or placebo (N = 5) tid on a double-blind basis for 14 days, followed by seven days of single blind placebo, in successively rising dose groups. All patients completed the study without intolerable or severe adverse events. All doses significantly (p < 0.001) reduced peak and trough RBC cholinesterase (AChE) activity as compared to baseline. Percent inhibition for Day 14 peak and trough RBC AChE peak and trough values, respectively, appeared proportional to dose: 18% and 21% (12mg); 36% and 35% (20mg); 40% and 44% (28mg). In order to determine the maximum tolerated dose of eptastigmine, an additional single-blind study was performed in five patients (2 M, 3 F; mean age 78, range 72-80) utilizing a rising dose schedule of eptastigmine (N = 4) or placebo (N = 1), starting with the previously tolerated 28mg tid dose and increasing by 4mg tid up to a potential maximum of 56mg tid. Dose-limiting adverse events occurred requiring discontinuation of medication in one patient at 48mg tid and two patients at 52mg tid; RBC AChE inhibition was proportional to dose, with peak values up to 70% inhibition at 48mg tid. The maximum tolerated dose of 48mg tid was identified as a basis for potential Phase II multicenter efficacy trials.

Acetylcholinesterase↗
PubMed1990

Pharmacokinetic and pharmacodynamic comparison of metoprolol CR/ZOK once daily with conventional tablets once daily and in divided doses.

Four studies of identical design, each on 18 young healthy subjects, were undertaken to study the pharmacokinetics and beta 1-receptor blockade at steady state after a once daily dose (od) of 100, 200, 300 and 400 mg of metoprolol CR/ZOK (a new controlled release preparation) in comparison with 100 mg dosages (od, bid, tid and qid, respectively) of conventional metoprolol tablets (CT). All studies were of randomized three-way crossover design with 7-day double-blind treatment periods separated by 7-day single-blind washout periods. A number of predose plasma concentrations and assessments of beta 1-blockade were made during the study and a full pharmacokinetic and pharmacodynamic study was performed on day 7. The maximal plasma concentration, Cmax, was significantly lower after metoprolol CR/ZOK compared to CT after all doses--the most pronounced difference being observed after the 100 mg dose when both preparations were given once daily (145 nmol/L vs 606 nmol/L) and the least difference after the 400 mg dose when metoprolol CT was given every 6 hours (837 nmol/L vs 1111 nmol/L). The maximal plasma concentration occurred later after metoprolol CR/ZOK than CT in all studies (median 2.5-4.1 hours vs 1.0-1.2 hours). The trough plasma concentration, Cmin, was significantly higher after 100 mg metoprolol CR/ZOK compared to CT dosed once daily; CminS were comparable between the two preparations in the 200 mg and 300 mg studies and lower after metoprolol CR/ZOK in the 400 mg study (278 nmol/L vs 469 nmol/L). In all four studies the AUCs were significantly lower after metoprolol CR/ZOK compared to CT with the mean relative bioavailability being approximately similar (73-84%). All metoprolol treatments produced a statistically significant beta 1-blockade (measured as percent reduction of exercise induced tachycardia) throughout the whole day compared to placebo except in the 100 mg study where the effect of once daily CT did not differ from placebo during the last 6 hours. Consequently, a significantly higher beta 1-blockade was observed after metoprolol CR/ZOK compared to CT in this latter period. The maximum beta 1-blockade (Emax) after CR/ZOK 100 mg was significantly lower than after CT 100 mg once daily (12.6% vs 23.3%) but when CT was given in divided doses from 200 to 400 mg daily, Emax did not differ between the two formulations. Once daily administration of 100 mg of both products resulted in a significantly higher beta 1-blockade 24 hours after dosing with CR/ZOK compared to CT, but when CT was taken in divided doses this difference between the treatments was less pronounced.(ABSTRACT TRUNCATED AT 400 WORDS)

Adult↗
PubMed1999

The SAPASI is valid and responsive to psoriasis disease severity changes in a multi-center clinical trial.

We developed a structured Psoriasis Area Severity Index (PASI)-like instrument, the Self-administered PASI (SAPASI), that allows subjects to assess accurately the severity of their psoriasis. The major limitation of our previous SAPASI validity studies is that all were performed in a single academic center, raising questions about the generalizability of the instrument. We administered the SAPASI to 182 subjects in a 12-week, multicenter, double-blind clinical trial of topical tazarotene for psoriasis. On the same day, investigators blind to the SAPASI rating determined the degree of erythema, induration, scale, body surface area (BSA) affected, and overall lesion severity of the subjects' psoriasis. Using these data, we calculated an investigator PASI-Equivalent. Correlation analysis shows that for both initial and final assessments of psoriasis severity, the SAPASI score reflects the PASI-Equivalent score in a significant way (p = .0001), although the correlation is a modest one (r = 0.3 to 0.5). Significant (p = .0001), modest correlations were found between the subjects' reported BSAs and the investigators' reported BSAs. To assess responsiveness, the proportional changes of the SAPASI and PASI-Equivalent were found to be modestly significantly correlated (r = 0.2, p = .04). The results of this study support the general validity of the SAPASI and demonstrate that the SAPASI can detect changes in disease severity in a clinical trial. Significant correlations were also observed between SAPASI components and their investigator-reported counterparts in this multicenter trial. To the best of our knowledge, the current study represents the first multicenter validity study performed on a psoriasis severity instrument, and clearly demonstrates the value of this instrument in assessing the psoriasis severity in a population.

Adult↗
PubMed1989

A double-blind assessment of additive intolerance in children using a 12 day challenge period at home.

Alleged food-additive intolerance (respiratory, dermatological, behavioural or abdominal) was assessed in 19 children using daily challenge drinks of either, base product alone, base product plus sunset yellow/tartrazine, or base product plus sodium metabisulphite/sodium benzoate. The same type of drink was given for 12 days, double-blind and in random order. During the trial the children were maintained on an additive-free diet under supervision. Diary cards were used to record symptoms and medication usage. If there was an apparent association between symptoms and drink ingredient the trial was repeated, again double-blind. Additive intolerance was confirmed by a consistent deterioration of symptoms in only three children. In one, urticaria was induced by the colourings, in another extremely abnormal behaviour was induced by the preservatives and a third child was only free of asthma and abdominal pain on placebo. This form of individual trial, using 12 daily drinks, overcomes some of the objections to a single challenge study. Despite this, intolerance to the additives was only confirmed in 3/19 children in whom it had been believed to occur.

Adolescent↗
PubMed1998

Malignant catarrhal fever in bison, acute and chronic cases.

Acute malignant catarrhal fever (MCF) was diagnosed in 10 bison from 6 herds and ranging from 1 to 6 years of age. The pattern of clinical signs and morphologic lesions differed among bison. Combinations of corneal opacity, lacrimation, nasal discharge, depression, excess salivation, anorexia, diarrhea, melena, and hematuria were observed. Vasculitis characterized by lymphoid infiltrates in the adventia with variable extension into media and intima was found in multiple tissues in each animal. Fibrinoid vascular necrosis was rare. Ulceration in the alimentary tract was found in 9/10 bison, and ulceration or hemorrhage in the urinary bladder was found in 8/10 bison. Lymphoid infiltrates were present in 7 of 9 livers and 9 of 9 kidneys examined histologically. Hyperplasia of lymph nodes was observed in 5 bison. Chronic MCF was diagnosed in 1 bison with an 80-day course of illness that began with lacrimation, corneal opacity, mucoid nasal discharge, depression, and anorexia. These signs ceased after 15 days but circling and blindness developed on day 76. Chronic vascular lesions characterized by endothelial cell hypertrophy, intimal thickening, fragmentation of the internal elastic membrane, smooth muscle hypertrophy, and adventitial infiltrates of lymphocytes and plasma cells were found in many organs. The retinal arteries had chronic inflammation and acute transmural fibrinoid necrosis. The retinas were infarcted. Polymerase chain reaction technique for amplification of ovine herpesvirus 2 sequences was performed on formalin-fixed tissues, and viral sequences were detected in 1-7 tissues from each animal. These viral sequences were not found in tissues of 4 bison not affected by MCF.

Acute Disease↗
PubMed2006

Evaluation of levalbuterol metered dose inhaler in pediatric patients with asthma: a double-blind, randomized, placebo- and active-controlled trial.

OBJECTIVE: To evaluate the efficacy and safety of levalbuterol metered dose inhaler (MDI) in children aged 4-11 years (n = 173). RESEARCH DESIGN AND METHODS: Multicenter, randomized, double-blind 28-day study of QID levalbuterol 90 microg, racemic albuterol 180 mug, and placebo (2:1:1 ratio). Serial spirometry was performed on Days 0, 14, and 28. The primary endpoint was the double-blind average peak percent (%) change in FEV(1) from visit pre-dose; the primary comparison was with placebo. Secondary endpoints included the area under the FEV(1) percent change from pre-dose curve and peak % predicted FEV(1). Safety endpoints included adverse events, laboratory tests, rescue medication use, and electrocardiograms. RESULTS: Levalbuterol significantly improved the least square mean peak percent change in FEV(1) compared with placebo (levalbuterol 25.6% +/- 1.3% [p < 0.001]; racemic albuterol 21.8% +/- 1.8% [p = ns]; placebo 16.8% +/- 1.9%). Results for levalbuterol were similar for the other spirometry endpoints (p < 0.05 vs. placebo). No levalbuterol-treated patients had a peak percent change in FEV(1) < 10% (compared with 15.8% of racemic albuterol-treated patients and 30.3% of placebo-treated patients). The incidence of adverse events was 43.4% for levalbuterol, 56.4% for racemic albuterol, and 51.4% for placebo. The rate of discontinuation was 1.3% for levalbuterol, 2.6% for racemic albuterol, and 8.6% for placebo. The rate of asthma attacks (10.5%, 12.8%, 14.3%, respectively) was similar among treatments. Levalbuterol and racemic albuterol both reduced rescue medication use (p < 0.01 vs. placebo) and produced changes in ventricular heart rate and QT(c-F) that were similar to placebo. CONCLUSIONS: In this study, levalbuterol administered via MDI significantly improved airway function in comparison with placebo in asthmatic children aged 4-11 years with a safety profile that was similar to placebo.

Administration, Inhalation↗
PubMed1985

Erythromycin against Chlamydia trachomatis infections. A double blind study comparing 4- and 7-day treatment in men and women.

In a double-blind controlled study the treatment of erythromycin 500 mg twice daily for seven days was compared with erythromycin 500 mg twice daily for four days in 73 men and women with uncomplicated genito-urinary chlamydia trachomatis infections. At the start of the treatment, 34 of 42 men (81%) and 15 of 31 women (48%) had symptoms suggesting the presence of chlamydial infections. There was a significantly higher bacteriological cure rate with the seven-days treatment in both men and women compared with the four days treatment at the second control visit two weeks after the start of the treatment (p less than 0.0005). The bacteriological cure rate of the women was higher than that of the men, but the results for men and women did not differ significantly. It is concluded that a four day treatment with erythromycin 500 mg twice daily can not be recommended, whereas 500 mg twice daily for seven days was shown to be effective, especially in women.

Chlamydia Infections↗
PubMed1994

Effect of high-dose salbutamol on cardiac rhythm in severe chronic airflow obstruction: a controlled study.

Despite concern over possible adverse cardiac effects of high-dose beta-agonists there have been no controlled studies of the effects of such a therapy in patients with severe chronic airflow obstruction (CAO). We therefore studied 22 CAO patients (FEV < 1 litre) with continuous ambulatory cardiac monitoring. Patients received either nebulised salbutamol (5 mg) or saline each given 4 times daily for 24 h on 2 consecutive days, single blind, in random order. Supraventricular arrhythmias were common on both saline and salbutamol days (8 vs. 9 patients, p = NS), but none were clinically apparent. There were no episodes of ventricular tachycardia. Ventricular ectopic activity was highly variable but did not significantly differ between the two study days overall or between specific periods after nebulised salbutamol or saline. Serum potassium (mean) fell by 0.23 (SD 0.06) mmol/l in 10 patients after salbutamol. Baseline FEV1, PaO2, PCO2 were not predictive of arrhythmias or ectopic activity. While occasional adverse effects cannot be excluded, we conclude that high-dose salbutamol does not lead to any general increase in arrhythmogenic potential in severe CAO.

Aged↗
PubMed2000

Relative systemic dose potency and tolerability of inhaled formoterol and salbutamol in healthy subjects and asthmatics.

OBJECTIVES: To compare the relative systemic dose potency and tolerability of inhaled formoterol and salbutamol and to describe elimination of formoterol, particularly any enantioselectivity. METHODS: Twelve healthy subjects, aged 18-28 years, completed three open study days, and eleven asthmatic patients, aged 20-56 years, completed four double-blind study days in randomised, placebo-controlled and crossover fashions. The healthy subjects inhaled 13.5 + 13.5 + 27 microg formoterol (Oxis) via Turbuhaler and 300 + 300 + 600 microg salbutamol (Ventoline) via a pressurised metered dose inhaler (pMDI). The asthmatics, being on formoterol 9 microg twice daily via Turbuhaler during the study, inhaled the same single doses as the healthy subjects plus 900 + 900 + 1800 microg salbutamol via pMDI. Doses were given cumulatively 30 min apart on separate study days. Placebo was a day of no treatment in the healthy subjects. Double dummies were used for the asthmatics. Cardiovascular and metabolic effects were evaluated. Elimination of formoterol was addressed in the healthy subjects. RESULTS: Formoterol was estimated to be 28-109 times as potent as salbutamol, depending on the systemic effect variable. The duration of systemic action seemed to differ marginally at approximately equieffective doses of formoterol and salbutamol. Systemic effects were well tolerated and tended to be more pronounced in the healthy subjects than in the asthmatic patients. The half-life of the pharmacologically more active (R;R)-formoterol was longer than that of (S;S)-formoterol. CONCLUSIONS: Systemically, formoterol was shown to be 28-109 times as potent as salbutamol. Equieffective doses seemed to have a similar duration of effect. Formoterol and salbutamol were well tolerated by healthy subjects up to the tested total doses of 54 microg and 1200 microg, respectively, and by asthmatic patients up to the tested total doses of 54 microg and 3600 microg, respectively. Elimination of formoterol was enantioselective.

Administration, Inhalation↗
PubMed2002

Effect on body weight of replacing dietary fat with olestra for two or ten weeks in healthy men and women.

OBJECTIVE: To examine in two separate studies the effects of replacing dietary fat with Olestra on body composition and weight change in healthy young men and women. METHODS: Ten healthy, lean young men participated in Study One that was a 22-day single blind, within-subject design. After a control diet (40% fat) for eight days Study One subjects received an Olestra-substituted diet (31% metabolizable fat) for 14 days. Study Two was a randomized parallel-arm clinical trial with 15 healthy, lean and overweight young women. These subjects were randomly assigned to receive a control diet (40% fat), an Olestra-containing diet (31% metabolizable fat) or a reduced-fat diet (31% fat) for 10 weeks. All foods were provided to the subjects, and energy intakes were not restricted. The primary endpoint in both studies was change from baseline in body weight. In Study Two, body composition was measured by dual energy x-ray absorptiometry. In both studies, food intake and nutrient compensation were assessed. RESULTS: In Study One fat substitution by Olestra resulted in a significant 1.7 kg weight loss from baseline. In Study Two, change in body weight and body fat from baseline were statistically significant in all groups, but the group with Olestra lost significantly more weight from baseline (-5.0 kg) than the other two groups. In Study One there was partial compensation for the decreased energy intake, while in Study Two, compensation was seen only for those on the reduced-fat diet. CONCLUSION: Replacement of 1/3 of dietary fat with Olestra in periods of up to 10 weeks results in weight loss in men and women.

Absorptiometry, Photon↗
PubMed1993

A single-blind comparison of three-day azithromycin and ten-day co-amoxiclav treatment of acute lower respiratory tract infections.

The efficacy and safety of a three-day regimen of azithromycin (500 mg od) and a ten-day regimen of co-amoxiclav (625 mg tid) were compared in a single-blind study in 99 patients with acute lower respiratory tract infections. Of these, 70 (71%) suffered an infective exacerbation of their chronic obstructive pulmonary disease. Nine patients had pneumonia and 19 purulent bronchitis. Treatment success, defined as cure or improvement, occurred in 43 of 48 (90%) patients in the azithromycin group, compared with 45 of 51 (88%) patients in the co-amoxiclav group. The most common isolated pathogens were Haemophilus influenzae (25 cases; MIC range of azithromycin (A) < or = 0.06-4 mg/L; for co-amoxiclav (CA) 0.25-4 mg/L; Streptococcus pneumoniae (10 cases; A: < or = 0.06- > 128; CA: < or = 0.06); and Moraxella catarrhalis (four cases; A: < or = 0.06; CA: < or = 0.06-0.25). Microbiological response rates were comparable in the two groups. In 5% of patients, serological evidence for virus or atypical pathogens was found. Thirteen (26%) patients treated with co-amoxiclav had gastrointestinal complaints (seven with diarrhoea), compared with five (10%) treated with azithromycin (P = 0.09). Additional complaints occurred in three patients treated with co-amoxiclav and in one patient treated with azithromycin. It was concluded that a three-day regimen of azithromycin was as effective, clinically and microbiologically, as a ten-day regimen of co-amoxiclav in the treatment of acute lower respiratory tract infections.

Adult↗
PubMed1999

The role of neutrophils in the formation of peritoneal adhesions.

The most common cause of intraperitoneal adhesions which may result in infertility and intestinal obstruction is previous abdominal surgery. Surgical trauma of the peritoneum in the absence of infection elicits a rapid and transient influx of polymorphonuclear leukocytes (PMN) into the peritoneal cavity. The role of neutrophils in intraperitoneal adhesion formation has not been studied. We aimed to study the effects of PMN counts and PMN functions on peritoneal adhesion formation. Forty peritoneal adhesion-induced rats were randomly divided into three groups; group I, receiving saline; group II, receiving cyclophosphamide; and group III, receiving granulocyte-macrophage colony-stimulating factor (GM-CSF). In all groups, peritoneal lavage was performed to determine PMN counts the day after adhesion induction. Blood neutrophil counts and neutrophil functions were also determined. Adhesions were evaluated blindly 14 days after the operation. Adhesion tissue samples were microscopically evaluated. Tissue hydroxyproline and collagen concentrations were measured. The neutrophil counts and phagocytosis significantly increased in group III and neutrophil counts decreased in group II (P < 0.05). The score of adhesion formation in group II was significantly less than that in groups I and III (P < 0.05). Hydroxyproline concentrations of adhesion tissue were significantly decreased in group II when compared with group III (P < 0.05). The present study shows that neutropenia lowers the degree of postoperative adhesion formation. It is concluded that PMN may have a role to play in modulating post-operative adhesion formation.

Animals↗
PubMed1993

Laboratory and clinical evaluations of the Jordan Exact toothbrush.

A new toothbrush, the Jordan Exact, has been compared with a flat multitufted toothbrush, the Oral-B 35 toothbrush. In a laboratory study the Jordan Exact toothbrush had significantly higher interproximal access, compared to the Oral-B 35, combining all toothbrushing pressures tested, using either vertical or horizontal brushing motions on simulated molar teeth. Clinical safety and efficacy were evaluated in a 30-day single blind study. Evaluations of plaque mean scores were recorded before and after a one minute brushing at baseline, day 15 and day 30. At the same time periods, assessments of irritation, gingivitis and bleeding on probing were conducted. No oral irritation from either toothbrush was observed or reported throughout the test period. At all examinations there were no significant differences in overnight plaque scores. After brushing, an analysis of covariance on plaque area scores revealed that the Jordan Exact toothbrush removed significantly more plaque than the Oral-B 35 toothbrush. By day 30, the Jordan Exact toothbrush significantly reduced gingivitis on buccal surfaces but no significant change was observed in the Oral-B 35 group. Subjects using the Jordan Exact toothbrush had a significant decline in bleeding on probing; subjects in the Oral-B 35 toothbrush group had no significant change over the 30 days of the study.

Adolescent↗
PubMed2003

Comparison of 8 vs 15 days of antibiotic therapy for ventilator-associated pneumonia in adults: a randomized trial.

CONTEXT: The optimal duration of antimicrobial treatment for ventilator-associated pneumonia (VAP) is unknown. Shortening the length of treatment may help to contain the emergence of multiresistant bacteria in the intensive care unit (ICU). OBJECTIVE: To determine whether 8 days is as effective as 15 days of antibiotic treatment of patients with microbiologically proven VAP. DESIGN, SETTING, AND PARTICIPANTS: Prospective, randomized, double-blind (until day 8) clinical trial conducted in 51 French ICUs. A total of 401 patients diagnosed as having developed VAP by quantitative culture results of bronchoscopic specimens and who had received initial appropriate empirical antimicrobial therapy were enrolled between May 1999 and June 2002. INTERVENTION: A total of 197 patients were randomly assigned to receive 8 days and 204 to receive 15 days of therapy with an antibiotic regimen selected by the treating physician. MAIN OUTCOME MEASURES: Primary outcome measures-death from any cause, microbiologically documented pulmonary infection recurrence, and antibiotic-free days-were assessed 28 days after VAP onset and analyzed on an intent-to-treat basis. RESULTS: Compared with patients treated for 15 days, those treated for 8 days had neither excess mortality (18.8% vs 17.2%; difference, 1.6%; 90% confidence interval [CI], -3.7% to 6.9%) nor more recurrent infections (28.9% vs 26.0%; difference, 2.9%; 90% CI, -3.2% to 9.1%), but they had more mean (SD) antibiotic-free days (13.1 [7.4] vs 8.7 [5.2] days, P<.001). The number of mechanical ventilation-free days, the number of organ failure-free days, the length of ICU stay, and mortality rates on day 60 for the 2 groups did not differ. Although patients with VAP caused by nonfermenting gram-negative bacilli, including Pseudomonas aeruginosa, did not have more unfavorable outcomes when antimicrobial therapy lasted only 8 days, they did have a higher pulmonary infection-recurrence rate compared with those receiving 15 days of treatment (40.6% vs 25.4%; difference, 15.2%, 90% CI, 3.9%-26.6%). Among patients who developed recurrent infections, multiresistant pathogens emerged less frequently in those who had received 8 days of antibiotics (42.1% vs 62.0% of pulmonary recurrences, P =.04). CONCLUSIONS: Among patients who had received appropriate initial empirical therapy, with the possible exception of those developing nonfermenting gram-negative bacillus infections, comparable clinical effectiveness against VAP was obtained with the 8- and 15-day treatment regimens. The 8-day group had less antibiotic use.

Adult↗
PubMedDate not supplied

[Double-blind clinical trial comparing 5 days of dirithromycin versus 7 days of diacetylmidecamycin in acute bronchitis and acute exacerbations of chronic bronchitis].

BACKGROUND: Dirythromycin has several pharmacokinetic characteristics (long half life and high tissue concentrations) which suggest the possibility of administering shorter treatments than those conventionally used. The aim of this study was to determine and compare the efficacy of a 5 day treatment with dirythromycin once a day, versus diacetylmidecamycin twice a day over 7 days in the treatment of patients with acute bronchitis and acute exacerbations of chronic bronchitis. METHODS: A parallel, multicentric, randomized, double blind clinical study was carried out in 8 Spanish hospitals. RESULTS: One hundred seventy-four patients were included in the study, with 87 (80 evaluable) being randomly assigned to receive dirythromycin (500 mg/day over 5 days) and 87 (83 evaluable) diacetylmidecamycin (600 mg, twice daily over 7 days). A favorable symptomatic response (cure or improvement) was observed in 72/80 of the first group (90%) and in 74/83 (89.2%) of the second group. No statistically significant differences were found in the efficacy and safety between the two treatment groups in either the evaluable patients or on intention to treat analysis. CONCLUSIONS: The results of this study suggest that the administration of dirythromycin, once a day over 5 days, is as safe and effective as diacetylmidecamycin, twice a day over 7 days, in the treatment of acute bronchitis and acute exacerbations of chronic bronchitis.

Acute Disease↗