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PubMed1990

Aldactazine/captopril combination, safe and effective in mild to moderate systemic hypertension: report on a multicenter study of 967 patients.

The safety and efficacy of a thiazide/potassium-sparing diuretic and an angiotensin-converting enzyme inhibitor used concomitantly was evaluated in a large, multicenter study. Aldactazine was administered alone for 2 months, after which time captopril was added in those whose blood pressure had not normalized (332 patients). At the end of the 6-month study, control of blood pressure was achieved in 88% of the patients with one or the other regimen. No clinically significant changes were recorded for a number of biologic parameters. Specifically, there was 1 case of hyperkalemia (6 mmol/liter), a very low incidence of hypotension (1.6%), and a low rate of adverse effects. Therefore, such a combination could provide important therapeutic benefits in hypertensive patients.

Adolescent↗
PubMed1990

Spironolactone and altizide in systemic hypertension: ambulatory multicenter study.

A multicenter study was performed in 919 hypertensive patients, 780 of whom could be evaluated. Patients in group I (n = 482) were treated with Aldactazine alone (altizide + spironolactone, 2 tablets per day). The other 298 patients (group II) were treated with 1 or 2 tablets per day of Aldactazine plus a conventional antihypertensive agent, e.g., a beta blocker, alpha-methyldopa or clonidine. After 45 days of treatment with Aldactazine alone, mean systolic and diastolic blood pressure (BP) decreased by 15 and 14%, respectively, vs baseline values. The addition of the other antihypertensive agent decreased BP further; however, the best results were obtained with the combination of Aldactazine and clonidine. With this combination, systolic and diastolic BP decreased by 16.6 and 18%, respectively, vs baseline. In terms of adverse effects, a few cases of gastrointestinal disturbances and orthostatic hypotension were reported.

Adrenergic beta-Antagonists↗
PubMed1987

Nifedipine gastrointestinal therapeutic system in stable angina pectoris. Results of a multicenter open-label crossover comparison with standard nifedipine.

To compare the clinical efficacy and dose equivalency of standard nifedipine versus a new gastrointestinal therapeutic system (GITS) formulation of nifedipine, 98 patients with chronic stable angina pectoris participated in a 14-week, multicenter, open-label, crossover trial. All patients were administered nifedipine capsules for one month prior to study entry and continued receiving other antianginal, non-calcium blocker medications. Ninety-one patients (93 percent), 80 men and 11 women, mean age 62 +/- 1 years, completed the trial, which included two weeks receiving standard nifedipine followed by 12 weeks receiving nifedipine GITS starting at a dosage equal to the 24-hour total dose of nifedipine capsules and titrated upward as necessary. However, throughout the trial, mean nifedipine dosage was similar on nifedipine GITS compared with standard nifedipine. Angina frequency was significantly less with nifedipine GITS at Weeks 6, 10, and 14 (0.8 episodes/week) compared with baseline with standard nifedipine (1.3 episodes/week, p less than 0.05). Likewise, nitroglycerin consumption was also less at Weeks 6, 10, and 14, but only significantly less at Week 6 (nifedipine 1.2/week versus nifedipine GITS at six weeks, 0.7/week; p less than 0.05). Resting hemodynamic parameters, including systolic and diastolic blood pressure and heart rate, were not significantly different with standard nifedipine versus nifedipine GITS during the 12-week study. Total incidences of side effects were similar for both treatments (standard nifedipine, 16; nifedipine GITS, 17). However, incidence of vasodilator side effects (flushing, dizziness, and light-headedness) was significantly less frequent with nifedipine GITS (standard nifedipine, 12; nifedipine GITS, six; p less than 0.05). Thus, results from this open-label, crossover trial suggest that nifedipine GITS dosing is similar to multidose standard nifedipine with equivalent 24-hour efficacy for nifedipine GITS.

Aged↗
PubMed1987

Efficacy of nifedipine gastrointestinal therapeutic system in combination with beta blockers in the management of exertional angina. A multicenter study of 54 patients.

This multicenter study assessed the efficacy of a new formulation of nifedipine in 54 patients with stable angina pectoris receiving beta-blocker therapy. This once-daily preparation of nifedipine was administered in double-blind fashion in doses of 30, 60, and 90 mg. All patients experienced pain-limited exercise at placebo baseline treadmill testing. Eight hours post-dose exercise testing resulted in a significant increase in time to onset of angina for all three dose levels of nifedipine but not for placebo. Exercise testing 24 hours after dosing showed significant improvement in time to angina and total exercise time for patients receiving 60-mg and 90-mg doses but not for the 30-mg or placebo categories. These preliminary results suggest that this new formulation of nifedipine is beneficial when added to stable doses of a beta blocker in patients in whom angina is still exhibited during exercise testing.

Adrenergic beta-Antagonists↗
PubMed1989

Multicenter, randomized trial of ciprofloxacin plus azlocillin versus ceftazidime plus amikacin for empiric treatment of febrile neutropenic patients.

In a multicenter, randomized clinical trial, the efficacy of ciprofloxacin plus azlocillin was compared with that of a standard regimen of ceftazidime plus amikacin for the initial empiric treatment of fever in neutropenic cancer patients. In addition, the efficacy of early conversion from intravenous therapy to orally administered ciprofloxacin was compared with that of continued ceftazidime plus amikacin. Seventy-one oncology patients with 79 episodes of fever and neutropenia were randomly assigned to receive initial empiric antibiotic therapy with either intravenously administered ciprofloxacin and azlocillin followed by orally administered ciprofloxacin (regimen 1, 25 episodes); ceftazidime and amikacin (regimen 2, 30 episodes); or ceftazidime and amikacin followed by oral ciprofloxacin (regimen 3, 24 episodes). Microbiologically documented infections were the cause of fever in 10 (40 percent), seven (23 percent), and nine (38 percent) episodes in regimens 1, 2, and 3, respectively, including six, five, and four episodes of bacteremia. Patient survival was 90 to 92 percent in each regimen; however, some modification of antimicrobial therapy occurred in 65, 44, and 41 percent of surviving patients in regimens 1, 2, and 3, respectively. The rate of clearance of initial bacteremia was 67 percent (four of six) in regimen 1, 100 percent (five of five) in regimen 2 and 50 percent (two of four) in regimen 3. Patients in regimens 1 and 3 were able to convert to orally administered ciprofloxacin in 32 (65 percent) of 49 episodes after a mean of six days of intravenous therapy. Superinfections occurred in 24, 10, and 12 percent of patients receiving regimens 1, 2, and 3, respectively, and occurred similarly for patients receiving orally administered ciprofloxacin, 12 percent (four of 32), and intravenous therapy, 17 percent (eight of 47). Parenteral ciprofloxacin was generally well tolerated. One (4 percent) of 25 patients receiving regimen 1 experienced oto- or nephrotoxicity, compared with eight (15 percent) of 54 patients receiving regimens 1, 2, and 3 (p = 0.15), including three patients who required premature termination of aminoglycoside therapy. Our data suggest that the combination of ciprofloxacin and azlocillin is an effective alternative to ceftazidime and amikacin for the initial empiric therapy of febrile neutropenic patients, is generally well tolerated, and avoids the oto- and nephrotoxicity associated with aminoglycoside use. In addition, a majority of patients could change to orally administered ciprofloxacin alone after six days of parenteral therapy.

Adult↗
PubMed1989

Efficacy and safety of cilazapril in elderly patients with essential hypertension. A multicenter study.

The efficacy and safety of cilazapril monotherapy was evaluated in a multicenter, open-label, ascending-dose titration study in 83 elderly essential hypertensive patients. After a four-week, single-blind, placebo run-in period, patients received 1 mg of cilazapril once daily for the first four weeks. This dose was then increased to 2.5 mg once daily for the next four weeks for patients whose pre-dose sitting diastolic blood pressure was above 90 mm Hg. Similarly, at Week 8 the dose was increased in such patients from 1 to 2.5 mg or from 2.5 to 5 mg once daily. A 12-hour blood pressure profile was performed on the first day of active treatment and of each dose increase. Mean decrease of sitting diastolic blood pressure from baseline (102.7 +/- 0.4 mm Hg) at Week 12 was 13.3 +/- 1.1 mm Hg (p less than 0.001). Seventy-five percent of patients had a decrease of 10 mm Hg or more from baseline sitting diastolic blood pressure, and in 60 percent sitting diastolic blood pressure normalized. Unexpectedly large decreases of blood pressure after the first dose were seen only in three patients and none had clinical symptoms. Fourteen patients (16.9 percent) reported adverse events, but most of these were judged unlikely to be related to therapy. Four patients with predisposing underlying diseases experienced potentially serious adverse events (angina pectoris, myocardial infarction, arrhythmia, and blood pressure elevation) whose relationship to therapy was judged remote or only possible. There was no particular pattern of changes in laboratory values. The results indicate that cilazapril is an effective, safe, and well-tolerated antihypertensive drug for the elderly.

Aged↗
PubMed1989

Twice-daily sucralfate dosing to heal acute duodenal ulcer. Multicenter Study Group.

Twice-daily dosing with sucralfate was evaluated by two multicenter trials, trial 1 (eight weeks) and trial 2 (four weeks). Both trials demonstrated significantly better ulcer healing at study completion for the 2-g twice daily (B.I.D.) regimen compared with placebo. Both trials were double-blind, randomized, and placebo-controlled, with parallel groups. Patients received two doses daily consisting of sucralfate 2 g B.I.D., placebo/sucralfate 2 g at bedtime (H.S.), or placebo/placebo. Ulcer healing was assessed by scheduled endoscopy and symptom assessment. Healing was defined as complete absence of erosion or ulceration. Trial 1 evaluations were conducted at four and eight weeks, trial 2 evaluations at two and four weeks. Interim examinations were performed at investigator discretion. Treatment groups were comparable with regard to number of patients, age, sex, smoking status, ulcer size, and presence/absence of baseline symptoms. Sucralfate 2 g B.I.D. was significantly better than H.S. or placebo dosing at the completion of each trial. H.S. dosing was better than placebo only at the four-week analysis of trial 1. At Week 4 of trial 1, 14 of 54 patients (26 percent) were healed with the B.I.D. sucralfate regimen, whereas at Week 8, 41 of 54 (76 percent) were healed (p less than 0.001). For the placebo/sucralfate H.S. group, 17 of 57 patients (30 percent) were healed at Week 4 (p less than 0.05), and 32 of 56 patients (57 percent) were healed at Week 8. For the placebo group, six of 52 (12 percent) and 20 of 51 patients (39 percent) were healed at Weeks 4 and 8, respectively. In trial 2, the B.I.D. group had a 21 percent healing rate at Week 2 (13 of 61 patients) and 62 percent were healed at Week 4 (38 of 61 patients; p less than 0.05). The H.S. group had an 8 percent healing rate (five of 66 patients) at Week 2 and 50 percent (33 of 66 patients) at Week 4. For the placebo group, 10 of 62 patients (16 percent) and 26 of 62 patients (42 percent) were healed at Weeks 2 and 4, respectively. Trial 1 demonstrated significant symptom improvement for active treatment groups at both four and eight weeks, whereas no differences were found in trial 2. Sucralfate 2 g B.I.D. was found to be safe and effective for the treatment of acute duodenal ulcer.

Acute Disease↗
PubMed1989

Multicenter isradipine diuretic atherosclerosis study (MIDAS). Design features. The Midas Research Group.

The Multicenter Isradipine Diuretic Atherosclerosis Study is a randomized, double-blind, clinical trial designed to compare the effectiveness of isradipine against hydrochlorothiazide in retarding the rate of progression of atherosclerotic lesions in the carotid arteries of hypertensive subjects. Eight hundred hypertensive men and women, 40 years of age or older, with minor plaques, are being recruited at eight clinical centers in the United States and will be followed for three years. Quantification of the atherosclerotic lesions at baseline and semiannually is done using B-mode ultrasonography. The background of the trial and its design features are discussed.

Adult↗
PubMed1989

Multicenter evaluation of the safety and efficacy of isradipine in hypertension. The Italian-Belgian Isradipine Study Group.

One hundred seventy-eight patients, aged 30 to 85, with mild-to-moderate hypertension entered a multicenter double-blind, randomized, between-patient comparison of isradipine (0.5, 1.25, or 2.5 mg twice daily) and placebo. Patients were assessed after three weeks of placebo treatment (for baseline) and after two and five weeks of active therapy. Despite a marked placebo effect, isradipine at 1.25 mg and 2.5 mg twice daily reduced blood pressure to a significantly lower level. The lowest blood pressures were recorded at four hours post-dose, and the residual antihypertensive effect at 12 hours was between 70 and 79 percent of the four-hour measurements. Isradipine did not produce more laboratory, electrocardiographic, or clinical abnormalities, or adverse events than did placebo. It is concluded that isradipine in doses of 1.25 mg and 2.5 mg twice daily is effective and well tolerated in the treatment of mild-to-moderate hypertension.

Adult↗
PubMed1989

A multicenter evaluation of the safety, tolerability, and efficacy of isradipine in the treatment of essential hypertension.

Six hundred outpatients aged between 22 and 84 years with essential hypertension (diastolic blood pressure of at least 95 mm Hg) entered a multinational, multicenter, single-blind trial with dose titration to assess the safety, tolerability, and efficacy of isradipine in doses of 1.25, 2.5, and 5.0 mg twice daily over 12 weeks, following a two-week placebo run-in period. Isradipine alone was taken by 321 patients, the remainder receiving, in addition, other antihypertensive drugs. In valid patients receiving monotherapy, the mean final isradipine dose was 3.4 mg (median, 2.5 mg) twice daily, which normalized supine diastolic blood pressure in 85 percent and 64 percent of patients two to four hours and 10 to 14 hours post-dose, respectively. Overall, 242 patients (40 percent) reported adverse events, 39 (7 percent) of whom withdrew from the study for this reason. The most common side effects were flushing (11 percent), headache (10 percent), and localized edema (4 percent). None of the pathologic changes in hematologic or biochemical values was attributable to isradipine. It is concluded that a slow titration of isradipine by increments at three-week intervals results in an effective and well-tolerated treatment for essential hypertension, both in mono- and combination therapy.

Adult↗
PubMed1989

A multicenter evaluation of the safety and efficacy of isradipine and atenolol in the treatment of hypertension. Isradipine in Hypertension Study Group.

A total of 152 patients with essential hypertension (World Health Organization classification I/II) entered a multicenter randomized study to assess the safety and efficacy of isradipine compared with, and in combination with, the beta-blocker atenolol. After a three-week placebo treatment period, patients received either isradipine (2.5, 5, 7.5, or 10 mg twice daily) or atenolol (50 or 100 mg once daily) for seven weeks. Patients who did not have an adequate response (diastolic blood pressure less than 90 mm Hg) with the maximal doses of single-drug therapy were given a combination of both drugs for a further seven weeks. Both drugs resulted in significant and clinically relevant reductions in blood pressures. Although the reduction in diastolic blood pressure was the same for patients receiving the two drugs, there was a statistically significant greater reduction in systolic blood pressure in the isradipine group, suggesting that this drug has a more favorable effect on vascular impedance. Of the 14 patients who did not attain normal blood pressure levels (sitting diastolic blood pressure less than 90 mm Hg) receiving monotherapy, 12 patients reached this goal with a combination of the two drugs.

Antihypertensive Agents↗
PubMed1989

Automated control of postoperative hypertension: a prospective, randomized multicenter study.

Hypertension after a cardiac operation is a frequent phenomenon. Complications resulting from this include bleeding, disruption of vascular suture lines, subendocardial ischemia, and possible cerebrovascular accidents. Treatment with sodium nitroprusside has become accepted practice to prevent these complications. To improve control of arterial blood pressure, a closed-loop system for sodium nitroprusside administration was developed. A prospective, randomized multicenter study was carried out postoperatively in 180 cardiac surgical patients to evaluate the performance of this system compared with manual control of infusion. Adherence of mean arterial blood pressure to +/- 10% of the target blood pressure occurred 85% of the time with the automatic system and 61% of the time with manual regulation (p less than 0.0001). With the automatic system, there was less hypertension (9% versus 22%; p less than 0.0001) and hypotension (6% versus 22%; p less than 0.0001). The superior control of hypertension was achieved more rapidly with less requirement for nurse regulation of infusion rate. The superior control of blood pressure resulted in less chest tube drainage in the automatic mode (720 mL versus 840 mL; p less than 0.05).

Aged↗
PubMed1990

Double-blind multicenter trial on a new medium molecular weight glycosaminoglycan. Current therapeutic effects and perspectives for clinical use.

The ability of glycosaminoglycans to bind to a wide number of biologically active macromolecules has already been investigated. Recent clinical trials on the possible therapeutic benefits of glycosaminoglycans must be placed in perspective, even if they appear to be particularly encouraging, especially as regards the glycosaminoglycan effects on certain coagulation factors. A multicenter, medium-term, double-blind, crossover trial was performed by several Italian Lipid Clinics to determine whether administration of a medium molecular weight glycosaminoglycan (Sulodexide) has a significant clinical effect. Patients affected by peripheral vascular disease and/or hyperlipidemia (type IIa, IIb and IV) were submitted to a 4-week wash-out period, followed by parenteral Sulodexide (S) or placebo (P) administration for 2 weeks, another 2 week wash-out period, parenteral crossover drug or P administration for 2 weeks and, finally, oral S administration for 6 months. Sulodexide lowered plasma viscosity and plasma fibrinogen in all patients. There was also a drop in triglycerides together with a rise in apo A-I and HDL-C in type IV hyperlipoproteinemics, whereas there was no significant effect on total or LDL-plasma cholesterol in type IIa and IIb patients. Moreover, there was a percent increase in peak flow and rest flow in the lower limbs of peripheral vascular disease patients. No side effects or intolerance phenomena were detected. The results indicate that Sulodexide administration may be useful in long-term treatment of patients with peripheral vascular disease and a concomitant increase in plasma triglycerides and/or fibrinogen and/or viscosity.

Adult↗
PubMed1989

A retrospective multicenter evaluation of the survival rate of osseointegrated fixtures supporting fixed partial prostheses in the treatment of partial edentulism.

Whether the excellent prognosis of the osseointegration technique also applies for the rehabilitation of partially edentulous jaws was investigated through a multicenter retrospective study. Six centers from three continents participated in the study, which included 133 fixtures in 38 patients. Forty fixtures were installed in the upper jaw and 93 in the lower jaw. The observation time varied between 6 and 36 months after prosthetic reconstruction. Clinical evaluation included mobility measurement of the restorations and control of infectious or neurologic complication. Radiologically the absence of radiolucency around the fixtures was checked by a single observer who also calculated the distance between the marginal bone and the top of the fixture. Fifty-eight percent of the prostheses were connected to natural teeth. The success rate for the individual fixtures in the upper and lower jaws was 87% and 92%, respectively. The most failures occurred before the prosthetic rehabilitation. The mean maximum distance between the margin of the bone and the fixture-abutment junction was 2.5 mm. Since only two of the 53 fixed prostheses were lost during the observation period, and since most fixture losses occurred before the prosthetic phase of the treatment, this study supports the concept that osseointegrated prostheses can also be applied to the rehabilitation of partial edentulism.

Adolescent↗
PubMed1988

A multicenter study of the safety and efficacy of naproxen: analysis of blood pressure.

A multicenter study was conducted to determine safety and efficacy of naproxen, 500 mg twice daily, administered for 4 weeks to osteoarthritis (OA) patients. OA symptoms improved in the study population. The study population included 97 patients, 43 of whom were 65 years of age or older. Forty-four of the 97 patients had a history of hypertension; 42 of these took antihypertensive medication before and during the study. Baseline blood pressure (BP) was measured in most patients while they were receiving their prior nonsteroidal antiinflammatory drug (NSAID) therapy; from that baseline, no increase in BP was seen in the hypertensive or normotensive patients after 4 weeks of naproxen therapy. In patients whose BP was controlled by antihypertensive agents, BP remained under control during naproxen therapy.

Adult↗
PubMed1990

Clinical effect of low molecular weight heparin (fragmin) on DIC: a multicenter cooperative study in Japan.

A multicenter cooperative study was carried out involving 47 nationwide institutes in Japan to assess the efficacy and safety of low molecular weight heparin (Fragmin) on DIC. Fifty-six DIC cases were challenged by Fragmin injection principally for 5 days with the doses of 75 U/kg/day in the I group (n = 27) and 150 U/kg/day in the II group (n = 29). Scoring points were defined based on the severity of bleeding symptoms, organ failures and abnormal coagulation-fibrinolytic examinations, and therapeutic effect of Fragmin was evaluated objectively according to the improvement degrees of these scores. Six cases (10.7%) died of the underlying diseases or complications other than DIC and hemorrhagic side effects occurred in 3.7 and 10.3% cases of the I and II groups, respectively. However, in bleeding symptoms, 45.5 and 31.6% cases of the I and II groups improved excellently or moderately. In organ failures and coagulation-fibrinolytic examinations, remarkable improvement was observed in 31.6 and 66.7% cases of the I group, while they remained 14.3 and 51.7% in the II group, respectively. The overall utility of Fragmin was 66.7% in the I group and 58.6% in the II group. These results demonstrate that Fragmin is effective on DIC with a dose of 75 U/kg/day.

Adult↗
PubMed1989

Immunophenotyping in a multicenter study: the Transfusion Safety Study experience.

The Transfusion Safety Study (TSS) is a cooperative investigation of factors that determine the occurrence of and modify the expression of transfusion-transmitted infections. A major component of its data is derived from lymphocyte immunophenotyping using a large panel of monoclonal antibodies and two-color flow cytometric analysis. The multicenter longitudinal character of TSS necessitates a uniformity of instrumentation, reagents, and protocols, as well as an intensive quality control program. The baseline assessment of a cohort of males 10 years of age and over with congenital clotting disorders (CCD) exemplifies the approach and some of the flow cytometry results. A comparison of anti-HIV-1 positive and negative subjects shows that more of the loss of T4+ cells was attributable to a decrease in the T4+4B4+ subset than the T4+2H4+ subset. There was an overall increase in CD8 cells, with a significant increase in the I2+T8+ and Leu7+T8+ cells, but a fall in NKH.1+T8+ cells. Monocytes, MO2+I2+ cells, increased. In CCD patients under the age of 10, both anti-HIV-1 positive and negative, there were absolute elevations in immunocytes, including CD4. There was also a distinctly different distribution of CD4 subsets. The suppressor inducer subset, 2H4+T4+, was increased relative to the helper inducer subset, 4B4+T4+, in the younger subjects.

Acquired Immunodeficiency Syndrome↗
PubMed1990

Multicenter study of superficial bladder cancer treated with intravesical bacillus Calmette-Guérin or adriamycin.

We evaluated 155 patients with superficial bladder cancers (Stages Ta, T1, and TIS) and treated them with either intravesical bacillus Calmette-Guérin (Tice strain) (BCG) or doxorubicin hydrochloride (Adriamycin), in a multicenter nonrandomized study. At present 140 of these patients in treatment Groups I and II are being followed up. With additional follow-up, BCG continued to produce a higher percentage of complete remissions (71%) than doxorubicin (54%). The percentage of incomplete remission with BCG (7%) was half that with doxorubicin (14%). Half of the patients whose initial therapy failed had complete remission after additional therapy. However, for patients with recurrence, additional follow-up shows a recurrence rate per 100 patient-months for BCG (1.0) only slightly lower than that for doxorubicin (1.1). The percentage of progressions continued to be higher with BCG (8.5%) than with doxorubicin (5%), but the difference between these results for the two drugs proved slightly less than we reported previously. Of the patients in this study, 2.5 percent (all treated with BCG) required cystectomy. A comparison of the results of our study with those of 13 other studies using BCG to treat bladder cancer indicates that therapy beyond an initial course of 6 weekly treatments increases the percentage of complete response. All of the studies showed that the greatest improvement in percentage of complete response occurred with the second course of treatment. The value of maintenance therapy cannot yet be determined, since few studies have used that protocol. The percentage of patients requiring cystectomy in studies with fewer than 20 treatments was 2.2 times higher than in studies with more than 20 treatments.

Administration, Intravesical↗