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PubMed1990

[Tolerance and effectiveness of transdermal nitroglycerin in angina pectoris. A multicenter study. Adesitrin Italian Study Group].

A multicenter open study was carried out in order to evaluate the tolerability and antianginal efficacy of the nitroglycerin "multilayer transdermal system". Forty eight cardiologic centers enrolled 506 outpatients (123 females and 383 males), mean age: 61 +/- 8 (SD) years, with effort angina (43%), angina at rest (17%) and mixed angina (40%), not well controlled by their previous antianginal therapy (greater than or equal to 2 anginal attacks a weeks). The duration of the treatment with 5 or 10 mg/die was 10 weeks with a control every 2 weeks. At the end of the study, the weekly frequency of anginal attacks was reduced by 88%, and 60% of the patients were free from anginal attacks. In 117 patients, studied by ergometer test, the exercise time increased by 31% (p less than 0.001) and the ST depression decreased by 63% (p less than 0.001). The treatment was interrupted in 9.1% of the patients: in 4.55% for unwanted effects (headache and/or local intolerance) and in 4.55% for other reasons. The same unwanted effects, but of mild or moderate severity, were observed in 18.4% of the patients, most of them during the first 2 weeks of the treatment. In conclusion, the "multilayer system" for delivering transdermal nitroglycerin showed a good clinical and ergometer efficacy and was well tolerated and accepted by the anginal patients in study.

Administration, Cutaneous↗
PubMed1990

[Long-term antihypertensive therapy with urapidil. A 3-year open, multicenter trial of tolerance, safety and effectiveness].

Within the framework of an open, multicenter study of 16 physicians treated 206 hypertensive patients with a daily dose of 2 x 30 mg to 2 x 90 mg of urapidil over a period of 3 years. Data are available on 182 patients for the entire study period. 24 patients discontinued the study due to adverse effects (n = 2), an inadequate effect (n = 2), or for reasons unrelated to therapy (n = 20); 58 (28.2%) patients had complaints. The most frequently reported symptoms were nausea, dizziness, drowsiness and fatigue. No relevant changes in laboratory values were observed. Average body weight remained constant and there were no signs of sodium or water retention. In the first year systolic blood pressure was reduced by 25 mm Hg from 174 +/- 13 mm Hg to 149 +/- 10 mm Hg (mean value +/- SD), and diastolic pressure by 17 mm Hg from 103 +/- 6 mm Hg to 86 +/- 6 mm Hg. At the same average dose this drop in BP persisted in the second year (150 +/- 12/86 +/- 7 mm Hg) and the third year (146 +/- 10/85 +/- 7 mm Hg), indicating that there was no decrease in urapidil effect. The pulse rate fell from 77 +/- 8 beats/minute to 74 +/- 6 beats/minute and remained virtually constant over the next 2 years.

Adult↗
PubMed1990

[French multicenter study of Triatec (ramipril) in ambulatory patients: methodology and trial structure].

Triatec is a new ACE inhibitor. The initial recommended dose is a single daily intake of 2.5 to 10 mg. In order to validate a dose escalation schedule allowing each patient to be treated with the minimal effective dose, a multicenter clinical trial has been conducted by 102 general practitioners, under conditions close to their habits, on 770 mild hypertension patients with a 16 weeks follow-up. The trial consisted in 4 periods: after a placebo run-in period, the patients whose hypertension remained (supine diastolic blood pressure -DBP-between 95 and 115 mmHg) would receive 2.5 mg of Triatec a day, for 3 weeks. After completion of this first treatment period, non-responders (DBP greater than 90 mmHg) to Triatec 2.5 mg would receive 5 mg of Triatec a day, during 3 weeks. Non responders to Triatec 5 mg a day would then be randomized into a 6 weeks double-blind parallel group trial comparing monotherapy by 10 mg of Triatec to the association of Triatec 5 mg with Lasilix 20 mg. In France, Good Clinical Practice (GCP) is a set of recommendations aiming to ensure a high quality standard for clinical trials. To put these recommendations into practice within the context of a large study of Triatec, national and local structures were implemented for a computer-assisted follow-up. Real-time data control for the 770 patients enrolled in this trial made a first presentation of the results to the Scientific Committee possible a mere 10 weeks after the last visit of the last patient was recorded. It also ensured the most reliable data to be processed.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1990

[Efficacy of Triatec in monotherapy and in combination with Lasilix in a French multicenter study].

The 770 subjects enrolled into the French multicenter trial of Triatec (ramipril) presented the usual characteristics of moderate hypertension. After a low rate of response to placebo (9.1 p. 100), over half the active treatment patients responded to Triatec 2.5 mg (57 p. 100). Later on, Triatec 5 mg achieved control of half the remaining patients (55.6 p. 100); lastly, among non-responders to that posology, no difference was noted between monotherapy with 10 mg of Triatec, and the combination of 20 mg of Lasilix (furosemide) and Triatec 5 mg (respectively 44.7 p. 100 and 47.4 p. 10 responders). As a whole, more than 90 p. 100 of the patients responded to the proposed treatment plan.

Adult↗
PubMed1990

[Tolerance to Triatec in monotherapy and in combination with Lasilix in a French multicenter study].

In a multicenter study in general practice, the tolerability and safety of ramipril alone and in combination with a low dose of furosemide were assessed in moderate hypertension. After a placebo run-in period involving 770 patients, 661 were included in the active treatment period and received ramipril alone (2.5-5 mg/day). After 6 weeks, the nonresponders entered in a double-blind period and they received daily ramipril 10 mg or ramipril 5 mg in combination with furosemide 20 mg. In this hypertensive population, the adverse events more commonly reported were headache, cough, dizziness, asthenia, cramps diarrhea and nausea, but not all these events were related to ramipril. There was seemingly a relation between cough prevalence and rampiril dosage; an increased incidence was also observed during the outbreaks of flu-syndrome in our country. 38 patients discontinued the active treatment due to non-serious adverse events, mainly cough, dizziness or diarrhea. No serious adverse drug reaction was observed. Laboratory data (blood cells count, electrolytes, serum creatinine, fasting blood glucose, apolipoproteins AI and B) remained most commonly unaffected. In moderate hypertension in general practice, this study confirms that ramipril is well tolerated, especially with regard to the class effects of the angiotensin converting enzyme inhibitors.

Adult↗
PubMed1990

[Efficacy and tolerance of low molecular weight heparin in the prevention of deep venous thrombosis during non-emergent total hip arthroplasty. A prospective, multicenter trial].

A multicenter prospective trial was conducted on 149 patients to test the efficacy and tolerance of low molecular weight heparin (LMWH) in the preventive treatment of deep venous thrombosis consecutive to total hip arthroplastic surgery. An original dose-adjusted protocol was tested, whereby the patients were injected a single dose of LMWH daily, determined on a weight and operation date basis; the prophylactic efficacy of this protocol was assessed by bilateral phlebography performed systematically on the 10th postoperative day. Only 12.9% of patients developed deep venous thrombosis of the lower extremities, and the thrombus formation site was proximal in 3.6% of cases. These rates are low compared with published data and considering the diagnostic criterion used. The low incidence of premature treatment withdrawal and hemorrhagic complication (2%) cases is indicative of the good tolerance of this preventive treatment.

Adult↗
PubMed1990

Treatment of hypertension by enalapril and hydrochlorothiazide separately and together: a multicenter study.

The efficacy and safety of enalapril and hydrochlorothiazide was investigated in a multicenter study of 81 patients with mild to moderate essential hypertension. The subjects were randomly assigned to one of three groups and, following a placebo period, given enalapril maleate (20 mg), hydrochlorothiazide (12.5 mg), or a combination of the two drugs (32.5 mg). A significant decrease in blood pressure was observed after only 2 weeks in the enalapril and enalapril-hydrochlorothiazide groups. A double dose was required to achieve a satisfactory response in one-third of the patients in both the enalapril (9 of 27) and the enalapril-hydrochlorothiazide groups (8 of 27). Adverse reactions included cough in one patient and mild hyperkalemia in another, both of whom received enalapril. Two patients on the drug combination developed side effects--symptomatic orthostatic hypotension in one and impotence in the second. Enalapril alone and in combination with hydrochlorothiazide appears to be effective and well tolerated.

Adult↗
PubMed1990

[Multicenter study of long-term management of HIV exposed and HIV infected children. Study organization and aims].

In order ot improve and standardize medical and psychosocial care for infants born to HIV-positive mothers, a prospective multicenter study has been initiated at 6 university hospitals in West-Germany in 1987. Aims of the study are: 1) determination of the rate of vertical HIV-transmission, relevant maternal risk factors and the clinical symptomatology of pre-or perinatally acquired HIV-infections, 2) identification of immunological and virological laboratory markers important for the verification and staging of HIV-infections in infants, 3) elaboration of an interdisciplinary approach to the care of HIV-infected children and their families, integrating medical care, social and psychological attendance.

AIDS Serodiagnosis↗
PubMed1990

Clinical experience with ciprofloxacin: analysis of a multicenter study.

In a multicenter study of 132 patients treated with ciprofloxacin for a variety of infections, 35 were microbiologically proven. Of these, bacteriologic cure equaled 85.7%, while improvement equaled 11.4%; failure was 2.9%. Clinical cure equaled 65.8%, while improvement was 26.3%. Failure was reported for 7.9% of cases. A total of 46 (35.9%) infections were classified as chronic. Overall, six of the 132 patients had adverse reactions. Two were related definitely to ciprofloxacin therapy. Therapy with ciprofloxacin was discontinued in two (1.5%) patients because of adverse effects.

Adolescent↗
PubMed1990

[Multicenter study in the Campania region on the clinical effectiveness and tolerance of nimesulide in gynecologic inflammatory diseases].

Two-hundred and twenty patients, aged between 18 and 71 years, participated in a multicenter study in order to assay the efficacy and tolerability of nimesulide in gynecological inflammatory diseases. Forty and two patients were affected by adnexitis, 37 by cervicitis, 12 by endometritis, 9 by myometritis and 120 patients presented more pathologies associated. All the patients were treated with nimesulide 100 mg granular (sachets) b.i.d. for a mean period of 19.5 days. The treatment with nimesulide produced good results in all pathologies, significantly reducing the intensity of symptomatology. The tolerability of the drug resulted to be good.

Adolescent↗
PubMed1990

Multicenter trial of single-dose modified bovine surfactant extract (Survanta) for prevention of respiratory distress syndrome. Ross Collaborative Surfactant Prevention Study Group.

A multicenter, prospective randomized controlled trial was performed comparing the efficacy of a single intratracheal dose of modified bovine surfactant extract (Survanta, 100 mg/kg, Abbott Laboratory, North Chicago, IL) with air placebo in preventing respiratory distress syndrome. Infants were enrolled if they were estimated to be between 24 and 30 weeks' gestation, weighed between 750 and 1250 g, and were intubated and stabilized within 15 minutes after birth. A total of 160 infants were treated (79 with surfactant, 81 with air placebo) between 4 and 37 minutes after birth (median time 12 minutes). Of these, 5 infants were excluded from the final analysis. The 72-hour average values for the arterial-alveolar oxygen ratio, fraction of inspired oxygen, and mean airway pressure were calculated from the area under the curve of scheduled values measured throughout 72 hours. Clinical status was classified using five ordered categories (no supplemental oxygen or assisted ventilation, supplemental oxygen only, continuous positive airway pressure or assisted ventilation with intermittent mandatory ventilation less than or equal to 6 breaths/min, assisted ventilation with intermittent mandatory ventilation greater than 6 breaths/min, death). Chest radiographs at 24 hours were graded for severity of respiratory distress syndrome. Infants receiving Survanta had less severe radiographic changes at 24 hours of age and decreased average fraction of inspired oxygen (31% vs 42%, P = .002) compared with control infants. No differences were noted in the average arterial-alveolar oxygen ratio, mean airway pressure, or clinical status on days 7 and 28. A beneficial effect was noted in the incidence of pneumothorax (P = .057) and an increase was noted in the incidence of necrotizing enterocolitis (P = .052). No differences in incidence of patent ductus arteriosus, intraventricular hemorrhage, sepsis, or bronchopulmonary dysplasia were seen. According to results of a secondary analysis, there was improvement in the fraction of inspired oxygen and a greater number of survivors without bronchopulmonary dysplasia in the subgroup of infants weighing less than 1000 g who were treated with surfactant. It was concluded that a single dose of Survanta given shortly after birth resulted in decreased severity of chest radiographic findings 24 hours after treatment and improved oxygenation during 72 hours after treatment, but did not improve other acute measures of disease severity or clinical status later in the neonatal period. The group at highest risk for respiratory distress syndrome (infants with birth weights between 750 and 999 g) may benefit the most from preventive therapy.

Animals↗
PubMed1990

[Roxithromycin versus doxycycline in the treatment of cervicitis. Prospective randomized multicenter study under practice-related conditions].

In a prospective randomized multicenter study Roxithromycin 150 mg or Doxycycline 100 mg was given b.i.d. p.o. for ten days to women with clinically diagnosed cervicitis. All women were seen as outpatients by one of eight licensed gynecologists in their private office in the Essen city area. With a cure and improvement rate of 100% in those women who completed therapy, Roxithromycin (n = 106) was as effective as Doxycycline (n = 104; 98%). At 90% Roxithromycin was as well tolerated as Doxycycline at 93%. Both drugs were clinically and microbiologically effective in eradicating Chlamydia trachomatis.

Adult↗
PubMed1990

Dermatomyositis and malignancy. A multicenter cooperative study.

A retrospective analysis of 118 cases of dermatomyositis (DM) collected in 22 departments of dermatology over a 5-year period is presented. 34 cases (28%) were associated with a cancer that was diagnosed more than 1 year prior to (7 cases), concomitantly (22 cases) or more than 1 year after (5 cases) the occurrence of DM. There was a clear correlation between the evolution of DM and a cancer paraneoplastic evolution in 8 cases only (22%). In most of the cases, no extensive diagnostic procedures were necessary for identifying the tumors. 58% of the patients with cancer-associated DM died 20 (8-29) months after the diagnosis of DM. This multicenter study based on a short period of time confirms and extends previous observations based on retrospective single-center analyses.

Dermatomyositis↗
PubMed1990

[Immunosuppression with cyclosporin induces clinical remission and improved beta cell function in patients with newly diagnosed insulin-dependent diabetes. A national and international multicenter study].

A prospective, randomized, double-blind, placebo-controlled international multicenter trial including 188 newly diagnosed insulin-dependent diabetic (IDDM) patients was undertaken with the aim of investigating whether immunosuppression for one year with ciklosporin (Cs) could induce and maintain clinical remission and improvement of beta-cell function. The relative odds for non-insulin-requiring remission at one year were increased approximately five times in the Cs-treated group. After three months Cs-treated patients achieved more than a doubling of beta-cell function compared to baseline than did placebo-treated patients, and the Cs-treated group maintained this improvement in beta-cell function for 12 months, whereas the placebo-group lost beta-cell function during the same period. Short duration of disease (less than or equal to six weeks of symptoms, less than or equal to two weeks of insulin treatment) was associated positively with remission, as was an elevated proinsulin/C-peptide ratio, especially in patients with the tissue-type HLA-DR 3,4; 4,X and X,X. Cs-treatment inhibited the formation of antibodies against insulin and islet cell components, but islet cell antibody status at entry was not predictive of remission. Cs-treatment caused a reversible decrement of kidney function as measured with serum creatinine and the calculated creatinine clearance, but studies of renal physiology and kidney biopsies performed on a limited subset of patients indicated that Cs treatment in IDDM patients for one year induced a slight chronic nephropathy in some of these.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed1990

Clinical predictors of treatment response in obsessive compulsive disorder: exploratory analyses from multicenter trials of clomipramine.

Two multicenter, double-blind trials were conducted in adults with DSM-III (American Psychiatric Association 1980) defined Obsessive Compulsive Disorder (OCD), comparing clomipramine (Anafranil, CMI) up to 300 mg daily with placebo. Of 519 patients evaluated, 260 received CMI for up to 10 weeks. More than half of the CMI treated patients were significantly improved, approximately 30 percent were minimally improved, and 15 percent showed no improvement after CMI treatment. The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) was used to assess treatment effects and attempts were made to correlate change in Y-BOCS score from baseline with a number of baseline characteristics, including age, sex, duration of OCD, baseline Y-BOCS score, baseline Hamilton Rating Scale for Depression (HAM-D) score, presence or absence of secondary depression, and predominance of obsessions or compulsions. Pearson and/or Spearman correlations failed to reveal any statistically significant correlations between outcome and any of the baseline characteristics studied. While the differences were not statistically significant, it did appear that male patients and patients with a longer duration of illness may be less likely to respond to CMI treatment; however, the overall conclusion from this analysis is that none of the variables studied is a reliable predictor of responses to treatment with CMI.

Adult↗
PubMed1990

[Preventive pentamidine inhalation of Pneumocystis carinii pneumonia in patients with immune deficiency. Preliminary evaluation of a multicenter study].

In the first evaluation of an uncontrolled multicenter study on inhalative pentamidine prophylaxis (300 mg pentamidine-isethionate monthly) of pneumocystis carinii pneumonia in immunocompromised patients, 48 patients (all 48 patients HIV1-infected, 36 without preceding pneumocystis carinii pneumonia (primary prophylaxis), twelve after pneumocystis carinii pneumonia (secondary prophylaxis); age 20 to 68 years (median 38); 45 male, two female, one unknown; 22 patients AIDS) were observed for 0 to 8.5 months (mean 4 +/- 2 months, intended observation time twelve months). No proven pneumocystis carinii pneumonia was found in the observed patients. One patient was treated with cotrimoxazole because of a suggested pneumocystis carinii pneumonia-relapse, which could not be proven. Out of seven (14.6%) patients, whose therapy was discontinued, three patients died, three refused further therapy, one patient had a relapse of a cerebral toxoplasmosis. Six patients (12.5%) reported adverse reactions (cough, metallic or bitter taste, slight nausea). New opportunistic infections appeared in four patients (8.3%).

Acquired Immunodeficiency Syndrome↗
PubMed1990

[A Sicilian multicenter study of the clinical effectiveness and tolerability of nimesulide in gynecologic inflammatory diseases].

Hundred-eighty patients, aged between 18 and 58 years, participated in a multicenter study, in order to assay the efficacy and tolerability of nimesulide in gynaecological inflammatory diseases. Thirty patients were affected by adnexitis, 41 patients by cervicitis, 6 by endometritis, 13 by myometritis and 90 patients presented more pathologies associated. Al the patients were treated with nimesulide 100 mg granular (sachets) bid for a mean period of 19 days. Treatment with nimesulide produced good results in all pathologies, significantly reducing the intensity of symptomatology. The tolerability of the drug was always good.

Adult↗
PubMed1990

[Multicenter Belgian study of the results of total arthroplasty for persistent congenital hip dislocation].

The SO.B.C.O.T. proposed a multicenter study of the results of total hip replacement performed in Belgium for treatment of severe congenital dislocation. Eleven departments with about 30 surgeons contributed to this retrospective analysis, in which cases treated in different centers with various techniques are reviewed. Difficulties in data collection are discussed. Owing to the variety of data, the article is divided in 2 sections: an inquiry or descriptive analysis of congenital dislocation of the hip treated in Belgium between January 1972 and December 1987; the midterm results achieved by different techniques.

Adult↗