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PubMed1989

A multicenter, randomized, double-blind study comparing a daily bedtime administration of famotidine and ranitidine in short-term treatment of active duodenal ulcer.

The efficacy and safety of famotidine and ranitidine in the treatment of active duodenal ulcer were compared in a multicenter, randomized double-blind study. The study was carried out in 5 centers which included a total of 143 patients with endoscopically documented active duodenal ulcer. The patients received either famotidine (1 tablet of 40 mg at night) or ranitidine (2 tablets of 150 mg at night). Endoscopic examinations were performed at 4 and 6 weeks of active treatment. Day and nocturnal pain were also monitored and the laboratory and clinical profiles evaluated. One hundred and thirty-three patients fulfilled the evaluation criteria (66 patients in the famotidine group and 67 in the ranitidine group). Healing rates at weeks 4 or 6 of treatment showed no significant differences between the famotidine and the ranitidine groups. The healing rates were 79% at week 4 and 96% at week 6 in the famotidine group, and 77% at week 4 and 95% at week 6 in the ranitidine group. Similar results were observed in both treatment groups with regard to pain resolution, decrease in antacid intake and safety profile.

Adult↗
PubMed1989

Postoperative recurrence of Crohn's disease in relation to radicality of operation and sulfasalazine prophylaxis: a multicenter trial.

Recurrence rate is high after operation for Crohn's disease. A multicenter trial was performed to study the effect of radical or nonradical operation and of sulfasalazine prophylaxis versus placebo on postoperative recurrence rate in 232 patients with Crohn's disease. Sixteen medical and surgical centers participated in the study, 7 operating radically and 9 nonradically. The follow-up period lasted 3 years, the allocation to drug treatment was randomized and double blind. Recurrence was significantly less frequent and occurred later in patients who were operated nonradically. Patients on sulfasalazine prophylaxis had a better prognosis than on placebo. This effect was statistically significant in the first 2 years of treatment. Both strategies were additive: nonradical operation and sulfasalazine had the best prognosis, radical operation and placebo was worst. It is concluded that postoperative recurrence is best prevented by resecting nonradically and prescribing 3 g of sulfasalazine daily at least over 2 years.

Adolescent↗
PubMed1989

A multicenter comparative trial of aztreonam in the treatment of gram-negative infections in compromised intensive-care patients.

A multicenter comparative trial was conducted in 4 university hospitals to evaluate the efficacy of aztreonam, a new monobactam antibiotic. All patients enrolled in the study were admitted to the intensive-care unit with severe underlying conditions. A total of 167 infections were documented in 157 patients (78 pneumonia, 26 urinary tract infection, 23 peritonitis, and 40 septicemia). The study was performed in 2 phases. In phase 1, 49 patients receiving aztreonam were compared with 26 receiving amikacin. These two drugs were administered as the sole coverage against gram-negative bacilli. In phase 2, 48 patients treated with aztreonam were compared with 34 who received a synergistic combination of amikacin and a broad-spectrum beta-lactam. The results suggest that aztreonam can be used as monotherapy in the treatment of systemic gram-negative infections with an efficacy comparable with that of standard antimicrobial therapy. Aztreonam is probably more effective than amikacin in treating respiratory tract infections and it is at least as effective as a beta-lactam-aminoglycoside combination. An adequate standard dosage of aztreonam could be established as 3-4 g/day in compromised patients, and it should be combined with gram-positive coverage when used empirically.

Adult↗
PubMed1989

Aztreonam in the treatment of urinary tract infections: a multicenter trial.

A multicenter trial involving several urologic units in Italy provided pooled data on 1,427 patients with urinary tract infections to evaluate the efficacy and safety of aztreonam, a new monobactam antibiotic. Microbiologic and clinical data were collected methodically in all cases. A majority of the patients (79.9%) were hospitalized during the study period, an associated pathology was noted in 29.1%, and 16.7% were receiving additional therapy. Aztreonam was administered by different routes and in different dosages according to the severity of the pathology. At the end of treatment, 93.6% of the patients showed a positive microbiologic response. Eradication percentages of the 6 main pathogens determined from cultures taken within the seventh day after the end of treatment were as follows: 93.9% for Escherichia coli (n = 415), 86.3% for Pseudomonas sp. (n = 207), 91.6% for Proteus sp. (n = 192), 89.8% for Providencia sp. (n = 59), 96.2% for Klebsiella sp. (n = 56), and 98.1% for Serratia sp. (n = 56). Aztreonam was well tolerated. Of the 1,427 patients evaluated for safety, only 54 (3.8%) reported 55 adverse reactions, necessitating the withdrawal of therapy in 5 (0.2%) instances.

Adolescent↗
PubMed1989

Multicenter study of aztreonam in the prophylaxis of colorectal, gynecologic and urologic surgery.

The preliminary results of four multicenter, comparative protocols on the efficacy and safety of aztreonam are discussed. This monobactam antibiotic was used as short-term prophylaxis in patients undergoing colorectal, gynecologic or urologic surgery. When compared with gentamicin in a group of 295 patients undergoing colorectal surgery, aztreonam significantly reduced the incidence of abdominal wound infection (p less than 0.025); it also reduced the incidence of perineal wound and intra-abdominal infections, although these differences were not statistically significant. In patients undergoing abdominal and vaginal hysterectomy, aztreonam was compared with cefotaxime (both combined with clindamycin) in 170 and 142 patients, respectively. No difference in the incidence of infection was found between the two treatment regimens. In the 175 patients undergoing transurethral resection of the prostate, aztreonam was compared with placebo. The prophylactic regimen significantly reduced the number of urinary tract infections (p less than or equal to 0.0001). Its efficacy was particularly evident during the first 10 postoperative days. Side effects experienced by patients taking aztreonam were minor and similar in all three treatment groups studied. Aztreonam (alone or combined with clindamycin) offers a new and efficacious alternative to the standard antibiotic regimens currently used prophylactically in the high-risk postoperative patient.

Abdomen↗
PubMed1989

Multicenter comparative study of aztreonam and gentamicin in the treatment of renal and urinary tract infections.

A multicenter comparative study was carried out to evaluate the efficacy of aztreonam and gentamicin in 186 patients with symptomatic renal or urinary tract infections. Patients were divided randomly into two groups: 94 patients received aztreonam 1 g/day intramuscularly and 92 patients received gentamicin 80 mg i.m. twice daily. The clinical and microbiologic results found a single daily dose of aztreonam to be more effective than gentamicin b.i.d. Furthermore, no evidence of side effects was seen with aztreonam. Such results are generally thought to ensure better compliance in outpatients.

Adult↗
PubMed1990

Surgical treatment of stage-I non-seminomatous germ cell testis tumor. Final results of a prospective multicenter trial 1982-1987. Testicular Tumor Study Group.

Final results of a prospective multicenter trial are presented comparing modified (ipsilateral) and radical retroperitoneal lymph node dissection (RLND) with regard to staging accuracy, curativity, and preserved ejaculation in stage-I non-seminomatous testis tumor. In 168 patients after modified and 67 patients after radical RLND, no differences were found in relapse rates (17 and 15%, respectively; median follow-up 30 months); in frequency of retroperitoneal relapse (2.4 and 1.5%, respectively), and intra-/postoperative complications (12 and 10%, respectively). Postoperative ejaculation was antegrade in 74 and 34%, (p less than 0.001), retrograde in 11 and 12% respectively. Normozoospermia was found in 50% of patients postoperatively vs. 20% preoperatively. Results are discussed in view of other alternatives. Modified RLND is considered an optimal approach to stage-I non-seminomatous germ cell testis tumor, outside specific trials.

Adult↗
PubMed2002

Effect of implantable defibrillators on arrhythmic events and mortality in the multicenter unsustained tachycardia trial.

BACKGROUND: The Multicenter Unsustained Tachycardia Trial (MUSTT) was designed to evaluate an antiarrhythmic treatment strategy, including drugs and implantable defibrillators (ICDs), guided by electrophysiological (EP) testing. We performed several statistical analyses to assess the contribution of defibrillators to the observed treatment benefit. METHODS AND RESULTS: First, the effects of defibrillators were indirectly examined by comparing the randomized treatment arms (EP-guided therapy versus no antiarrhythmic therapy) within subgroups that varied according to ICD usage. Use of ICDs increased during the trial; hence, the randomized treatments were compared according to date of enrollment. There were also site-specific differences in ICD use; hence, the randomized arms were compared within groups of sites defined by level of ICD use. There was a distinct "dose response" in relation to ICD use. Where ICD use was high, EP-guided therapy produced significant reductions in arrhythmic death or cardiac arrest (P<0.004). Where ICD use was low, there was no benefit of EP-guided therapy. Finally, outcomes of EP-guided therapy patients who received an ICD were directly compared with outcomes of other patients using the Cox proportional hazards model with receipt of an ICD as a time-dependent covariate. Adjusted for other prognostic factors, patients who received an ICD had risk reductions of >70% in arrhythmic death or cardiac arrest and >50% in total mortality (P<0.001 for both end points). CONCLUSIONS: The benefit of EP-guided antiarrhythmic therapy observed in MUSTT was due to improved outcomes among patients who received an ICD but not among patients who received antiarrhythmic drugs.

Anti-Arrhythmia Agents↗
PubMed2002

Effect of beta-blocking therapy on outcome in the Multicenter UnSustained Tachycardia Trial (MUSTT).

BACKGROUND: Beta-blockers are known to reduce total mortality and sudden death in survivors of recent myocardial infarction. The effects of these agents in patients at high risk for sudden death with remote infarction are not clear. METHODS AND RESULTS: We analyzed the effect of beta-blockers on outcomes in 2096 patients with coronary artery disease, ejection fraction < or =40%, and spontaneous nonsustained ventricular tachycardia enrolled in the Multicenter UnSustained Tachycardia Trial (MUSTT). Forty-five percent of 702 patients with inducible sustained ventricular tachyarrhythmia and 35% of 1394 patients without inducible tachycardia were discharged from hospital receiving beta-blockers. Patients treated with beta-blockers were younger and had higher ejection fractions, higher rates of recent angina, and more recent infarction. beta-Blockers were associated with decreased total mortality for the entire study population (5-year mortality 50% with beta-blockers versus 66% without beta-blockers; adjusted P=0.0001). The mortality benefit associated with beta-blockers was present in patients with and without inducible tachycardia, except those treated with implantable defibrillators. There was no significant effect of beta-blocker therapy on the rate of arrhythmic death or cardiac arrest (adjusted P=0.2344). CONCLUSIONS: beta-Blocking agents have beneficial effects on survival of patients having characteristics of those enrolled in the MUSTT trial. These effects do not appear to be due to a specific antiarrhythmic effect of beta-blockers. The beneficial effects of beta-blockers were demonstrable in all patients except those treated with implantable defibrillators.

Adrenergic beta-Antagonists↗
PubMed2003

Racial differences in outcome in the Multicenter UnSustained Tachycardia Trial (MUSTT): a comparison of whites versus blacks.

BACKGROUND: The Multicenter UnSustained Tachycardia Trial (MUSTT) demonstrated the benefit of implantable cardioverter-defibrillators (ICDs) in patients with coronary disease, asymptomatic nonsustained ventricular tachycardia, and reduced left ventricular function. Previous studies have shown racial differences in risk of sudden death in patients with ischemic heart disease. METHODS AND RESULTS: We analyzed the influence of race on results of MUSTT. Whites were more likely to have prior revascularization and inducible, randomizable sustained ventricular arrhythmias and less likely to have left ventricular hypertrophy than were blacks. Compared with blacks, whites randomly assigned to electrophysiologically (EP)-guided therapy had a lower risk of arrhythmic death/cardiac arrest (adjusted P=0.003) and lower total mortality rates (adjusted P=0.051). In contrast, there was no racial difference in the risk of arrhythmic death/cardiac arrest among patients randomly assigned to no EP-guided therapy (adjusted P=0.477). Among whites, EP-guided therapy resulted in a survival benefit compared with no EP-guided therapy. However, survival of blacks randomly assigned to no EP-guided therapy was better than blacks receiving EP-guided therapy. This difference is partially explained by a higher ICD implantation rate in whites versus blacks (50% versus 28%, P=0.034). Whites were more likely to remain inducible after serial EP-guided drug testing (67% versus 42%, P=0.011), making them more likely to become eligible for ICDs. CONCLUSIONS: The outcome in this trial and the benefit of EP-guided therapy appeared to be influenced by race. In addition to differences in ICD implantation rates, differences in arrhythmic substrates and proarrhythmic responses to antiarrhythmic drugs may have influenced outcome.

Aged↗
PubMed1990

Antiplatelet treatment with ticlopidine in unstable angina. A controlled multicenter clinical trial. The Studio della Ticlopidina nell'Angina Instabile Group.

We conducted a controlled multicenter trial with central randomization and evaluation of events under blind conditions involving 652 patients with unstable angina. Patients were treated either with conventional therapy alone (group C) (n = 338) or with conventional therapy combined with an inhibitor of platelet aggregation, ticlopidine 250 mg b.i.d. (group C + T) (n = 314). Patients were assigned randomly within 48 hours of admission and followed up for 6 months. With the "intention-to-treat" approach, the primary end points, vascular death and nonfatal myocardial infarction, were observed in 13.6% of the patients in group C and in 7.3% of the patients in group C + T, which is a reduction in risk of 46.3% (p = 0.009). Vascular mortality was 4.7% in patients in group C and 2.5% in patients in group C + T, which is a reduction in risk of 46.8% (p = 0.139). The risk of nonfatal myocardial infarction was reduced by 46.1% (p = 0.039), with a frequency of 8.9% in patients in group C and 4.8% in patients in group C + T. New Q wave myocardial infarction occurred with a frequency of 6.8% in patients in group C and 3.8% in patients in group C + T, which is a reduction in risk of 44.1% (p = 0.091). Fatal and nonfatal myocardial infarction was 10.9% in patients in group C and 5.1% in patients in group C + T, which is a reduction in risk of 53.2% (p = 0.006). These findings confirm the importance of platelets in the pathogenesis of unstable angina and the usefulness of antiplatelet treatment for the prevention of cardiovascular events.

Angina Pectoris↗
PubMed2006

Causes and consequences of heart failure after prophylactic implantation of a defibrillator in the multicenter automatic defibrillator implantation trial II.

BACKGROUND: Implantable cardioverter-defibrillator (ICD) therapy may be associated with an increased risk for heart failure (HF). The present study evaluated the frequency, causes, and consequences of HF after ICD implantation. METHODS AND RESULTS: We performed a retrospective analysis of the clinical factors and outcomes associated with postenrollment HF events in 1218 patients enrolled in the Multicenter Automatic Defibrillator Implantation Trial II. The adjusted hazard ratios (HRs) of ICD:conventional therapy for first and recurrent HF events were 1.39 (P=0.02) and 1.58 (P<0.001), respectively. The risk was increased among patients who received single-chamber or dual-chamber ICDs. Development of HF was associated with an increased mortality risk (HR, 3.80; P<0.001). Among patients who received a single-chamber ICD, there was a similar survival benefit before and after the development of HF (HR, 0.59 and 0.61, respectively; P=0.92 for difference), whereas among patients with dual-chamber devices, there was a significant reduction in survival benefit after HF (HR, 0.26 and 0.83, respectively; P=0.01 for difference). Within the defibrillator arm of the trial, patients who received life-prolonging therapy from the ICD had an increased risk for first and recurrent HF events (HR, 1.90; P=0.01 and 1.74; P<0.001, respectively). CONCLUSIONS: Patients with chronic ischemic heart disease who are treated with either single-chamber or dual-chamber ICDs have improved survival but an increased risk of HF. The present data suggest that ICD therapy transforms sudden death risk to a subsequent HF risk. These findings should direct more attention to the prevention of HF in patients who receive an ICD.

Adrenergic beta-Antagonists↗
PubMed1989

High doses of inhaled corticosteroids in unstable chronic asthma. A multicenter, double-blind, placebo-controlled study.

In a multicenter, randomized, double-blind study, inhaled beclomethasone dipropionate (BDP) 1,500 micrograms/day was compared to placebo in 43 chronic asthmatic patients uncontrolled by inhaled salbutamol and oral theophylline. During the prestudy period, a test of maximal steroid reversibility with oral prednisolone 0.5 mg/kg/day for 14 days was performed. The therapeutic response was measured over an 8-wk period as the ability to maintain the clinical improvement and the optimal pulmonary function induced by prednisolone. During the study, severe asthma exacerbation occurred in one (5%) of the 21 patients who received BDP and in 15 (78%) of the 22 patients who received placebo (p less than 0.001). In patients who received BDP, FEV1 and peak expiratory flow (PEF) remained above the optimal postprednisolone value, with a trend to improvement during the 8-wk study period. In patients who received placebo, FEV1 and PEF decreased and remained below the optimal value. We conclude that, in chronic asthma, inhaled BDP 1,500 micrograms/day maintains the optimal pulmonary function in addition to the clinical benefit induced by a short course of oral corticosteroids.

Administration, Inhalation↗
PubMed1989

Intravenous treatment of chronic peripheral occlusive arterial disease: a double-blind, placebo-controlled, randomized, multicenter trial of pentoxifylline.

A multicenter, prospective, placebo-controlled, double-blind trial was conducted to investigate the efficacy of intravenous infusion therapy with pentoxifylline over fourteen days in patients suffering from angiographically confirmed chronic peripheral occlusive arterial disease, Fontaine stage II, with at least a six-month history. After a washout phase of one week, the patients received in accordance with a randomization scheme either an i.v. infusion of 300 mg of pentoxifylline (15 mL ampoules) or 15 mL of a 0.9% NaCl solution in 250 mL of 5% laevulose, administered over three hours twice daily. The main efficacy parameters were treadmill-assessed initial claudication distance (ICD) and absolute claudication distance (ACD). Baseline testing revealed a mean ICD of 131 m in the pentoxifylline group and 126 m in the placebo cohort; mean ACD values were 239 m and 225 m respectively. The group of patients treated with pentoxifylline (n = 75) displayed a significantly greater improvement (p less than 0.0001) in ICD (+70%) and ACD (+60%) than the placebo group did (+33%) and 32%, respectively) (n = 79). The infusions were well tolerated in both groups.

Adult↗
PubMedDate not supplied

A multicenter study on the results of anterior cruciate ligament reconstruction using a Dacron ligament prosthesis in "salvage" cases.

A multicenter study is presented on 80 patients who underwent ACL reconstruction using a Dacron (E.I. Du Pont de Nemours and Co., Wilmington, DE) ligament prosthesis. Patient selection was based on a history of a failed autologous reconstruction and/or primary repair of the ACL. These selection criteria are unique and have not been previously reported in the literature. The frequency of prior intraarticular ACL surgery was 1.24 procedures per patient and 1.68 when combined with prior extraarticular reconstructions. Forty-one patients had a mean followup of 28 months (24 to 42 months). The mean followup for all of the patients was 21 months. The graft was augmented with autologous tissue in 59 cases and used as a pure prosthesis in the rest. Functionally, the mean Lysholm score improved from 40 to 81 points. The percentage of a combined excellent/good Lysholm rating increased from 6% to 60%. The Tegner activity rating level improved from 2 to 4. The percentage of a negative Lachman sign, anterior drawer, and pivot shift was approximately 75% at followup. There was no significant difference between the results of augmentation and nonaugmentation cases, indicating that the graft acts as a permanent prosthesis rather than as a scaffold or stint. The patients showed a significant improvement considering their preoperative global instability.

Adult↗
PubMed2002

Leading prognostic relevance of the BCR-ABL translocation in adult acute B-lineage lymphoblastic leukemia: a prospective study of the German Multicenter Trial Group and confirmed polymerase chain reaction analysis.

The BCR-ABL fusion, the molecular equivalent of the Philadelphia translocation, gains importance for treatment stratification in adult acute lymphoblastic leukemia (ALL). In this prospective study, samples from 478 patients with CD10(+) B-cell precursor ALL (c-ALL and pre-B ALL) underwent BCR-ABL reverse transcription-polymerase chain reaction (RT-PCR) analysis with double testing of positive samples. Patients were stratified according to the PCR result and treated in 2 German Multicenter Trials of Adult ALL. The outcome was followed and the prognostic impact of BCR-ABL was compared to clinical risk features. Of the 478 samples, 432 had an evaluable BCR-ABL result. Thirty-seven percent of the c-ALL and pre-B ALL patients were BCR-ABL(+) (p190, 77%; p210, 20%; simultaneous p190/p210, 3%). BCR-ABL positivity was associated with the high-risk features of older age (45 years versus 30 years median age; P =.0001) and higher white blood cell counts (23 500/microL versus 11 550/microL; P =.0001). Univariate and multivariate analyses revealed BCR-ABL as the leading factor for a poor prognosis (P =.0001) in comparison to clinical risk criteria. Irrespective of the breakpoint, presence of any BCR-ABL transcript predicted a lower chance of initial treatment response (68.4% versus 84.6%; P =.001) and a lower probability of disease-free survival at 3 years (0.13 versus 0.47; P =.0001). This bad outcome was not influenced by postinduction high-dose treatment stratifications. The results show a high prevalence of BCR-ABL fusion transcripts with predominance of p190. BCR-ABL RT-PCR is confirmed as a sensitive, rapid method to diagnose t(9;22), and p190 and p210 are unequivocally demonstrated as the most important predictors of poor long-term survival despite intensified chemotherapy.

Adolescent↗
PubMed1990

Treatment of isolated testicular relapse in childhood acute lymphoblastic leukemia: an Italian multicenter study. Associazione Italiana Ematologia ed Oncologia Pediatrica.

Between May 1980 and April 1987, 49 children with acute lymphoblastic leukemia (ALL) in isolated testicular and first leukemia relapse (ITR) were enrolled in the Associazione Italiana Ematologia ed Oncologia Pediatrica (AIEOP) multicenter study REC80-ITR. According to the Rome Workshop criteria, 77% were at standard and 23% at high initial prognostic risk. In 33% of the cases, ITR occurred during first treatment. The REC80-ITR protocol consisted of an induction phase regimen of vincristine (VCR), cytarabine (ARA-C), methotrexate (MTX), and asparaginase (L-asp), and bilateral testicular irradiation, and CNS prophylaxis with intrathecal MTX and a maintenance phase with a multidrug rotating regimen. Total treatment duration was 30 months. The median time of observation after ITR was 51 months. The Kaplan-Meier estimates of survival and disease-free survival (DFS) at 4 years were 67.7% and 41%, respectively. Patients who had an ITR on therapy or within the first off-therapy year showed the poorest outcome. The DFS at 3 years was 20%, 47.6%, and 100%, respectively, for children who had an ITR on treatment (n = 16), within the first year of treatment withdrawal (n = 22), or later (n = 10) (P = .001). Patients with an asymptomatic occult testicular infiltrate at treatment discontinuation had a very unfavorable prognosis. Eighty-one percent of second relapses involved the bone marrow. In our experience, children presenting an early ITR (ie, within 6 months of treatment withdrawal) need a very aggressive treatment because of the high probability of an underlying systemic disease. On the other hand, patients with a late ITR seem to have a truly local recurrence and can apparently be cured by standard protocols, as shown in protocol REC80-ITR.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1990

Neuropsychological performance in HIV-1-infected homosexual men: The Multicenter AIDS Cohort Study (MACS)

We administered a battery of standardized neuropsychological measures to assess cognitive functions in a group of 769 HIV-1 seronegative, 727 asymptomatic HIV-1 seropositive (CDC Groups 2 and 3), and 84 symptomatic HIV-1 seropositive (CDC Group 4) homosexual/bisexual men enrolled in the Multicenter AIDS Cohort Study (MACS). Measures included tests of attention, memory, and psychomotor speed. Comparison of group means revealed significant differences in performance between HIV-1 seronegative and symptomatic HIV-1 seropositive subjects on measures of memory and on measures with strong motor and psychomotor timed components. These findings support the sensitivity of these neuropsychological instruments for detecting cognitive changes that may be related to HIV-1, and are consistent with other reports of neuropsychological abnormalities in symptomatic HIV-1-infected individuals. Asymptomatic seropositive men, on the other hand, did not differ significantly from seronegative subjects on any of the neuropsychological measures. Only 5.5% of the asymptomatic HIV-1 seropositive men showed abnormal performance on individual tests. This proportion did not differ significantly from that of seronegative controls. Further, among asymptomatic seropositive subjects, we found no statistically significant differences as a function of duration of HIV infection or level of immune system functioning. Thus, results from this study support the hypothesis that the frequency of neuropsychological abnormalities in asymptomatic HIV-1-infected homosexual men is low, and not statistically different from that of seronegative controls.

Adult↗