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At least 91 records · Page 5Linked to original sources
PubMed1990

A comparison of the efficacy and safety of a beta-blocker, a calcium channel blocker, and a converting enzyme inhibitor in hypertensive blacks.

A double-blind, positively controlled, forced dose titration study comparing the efficacy and safety of atenolol, captopril, and verapamil sustained release as single agents in the treatment of black patients with mild to moderate hypertension (diastolic blood pressure, 95 to 114 mm Hg) was conducted. A total of 394 patients were randomized to one of the three therapies. Mean blood pressures during a 2- to 4-week placebo treatment period (baseline) ranged from 100.4 to 100.7 mm Hg diastolic and 151.7 to 152.5 mm Hg systolic for the three groups. Of the patients, 355 (of whom 345 had assessable data) completed the first treatment period, which consisted of therapy with either 50 mg/d of atenolol, 25 mg every 12 hours of captopril, or 240 mg/d of verapamil sustained release. During the second 4-week treatment period, which 319 patients completed (307 assessable), half of the patients had their antihypertensive medication increased and the other half continued the same dose. Goal blood pressure was defined as a supine diastolic pressure of less than 90 mm Hg or a 10-mm Hg or greater drop in supine diastolic blood pressure from pretreatment levels. Atenolol, captopril, and verapamil sustained release therapy was associated with goal blood pressure achievement during the first treatment period 55.1%, 43.8%, and 65.2% of the time, respectively, and during the second treatment period 59.6%, 57.1%, and 73.0% of the time. Side effects were minimal and comparable for all three drugs.

Adult↗
PubMedDate not supplied

Recombinant human erythropoietin correction of anemia. Dialysis efficiency, waste retention, and chronic dose variables.

A clinical review of patients who were treated with recombinant human erythropoietin was undertaken to evaluate the effect of partial correction of anemia upon dialysis function and waste retention. Assessment of possible variables that might influence the dosage response was also undertaken, both in a retrospective and prospective manner. Finally, a chart review of patients' symptoms while on dialysis was done to evaluate the effect of correction of anemia. Hematologic improvement was noted in all patients placed on hormone therapy with the correction of hemoglobin and hematocrit. There was no effect on white cell count, although a slight change in the differential was noted at target and one year; platelets rose to a new steady state. Dialysis efficiency was decreased slightly for urea and markedly for creatinine, probable reflecting the distribution characteristics of the latter. Retention of urate, phosphorus, and potassium was noted at target, with a drop toward usual serum levels with minimal dialysis prescription change. Variables such as age, gender, race, and dialysis prescription were compared in an effort to establish dosage variation, but no statistically significant changes were seen. There was an inverse trend in dosage, however, with increasing dialysis efficiency. Patients also seemed to be more tolerant of their dialysis treatments when nonanemic, compared to when anemic. While there is retention of some substances with improvement of anemia, the levels were easily corrected with adjustment of the dialysis prescription. No definite relationship could be seen in any of the variables studied and hormone dose requirements. Attention must be paid to adequate dialysis prescription in the erythropoietin treated patient.

Anemia↗
PubMed1990

Spironolactone and altizide used in combination with enalapril: twenty-four-hour ambulatory recording of blood pressure.

The addition of enalapril or acebutolol to a regimen of altizide + spironolactone in patients with moderate hypotension was investigated in a multicenter study of 53 patients. The patients underwent semiambulatory 24-hour blood pressure monitoring, especially to observe hypotensive episodes. In the 25 patients uncontrolled with altizide + spironolactone alone, enalapril and acebutolol were about equally effective in reducing blood pressure. The incidence of hypotension was low and comparable for both treatment groups, provided that the initial dose of angiotensin-converting enzyme inhibitor was low (5 mg).

Acebutolol↗
PubMed1989

Efficacy and safety of loratadine (10 mg once daily), terfenadine (60 mg twice daily), and placebo in the treatment of seasonal allergic rhinitis.

A total of 317 patients received loratadine, 10 mg once daily, terfenadine 60 mg twice daily, or placebo in a 14-day, double-blind, randomized study in seasonal allergic rhinitis. Four nasal and four nonnasal symptoms were evaluated. At the end point evaluation, mean total scores of combined nasal and nonnasal symptoms decreased from baseline (improved) 46%, 44%, and 35%, respectively, for loratadine, terfenadine, and placebo. The difference between loratadine and placebo treatment was significant (p = 0.03). Loratadine was particularly effective compared with placebo in relieving nasal discharge, sneezing, and itching/burning eyes. Therapeutic response to treatment was good or excellent in 66 (64%) of 103 loratadine-treated patients, 58 (56%) of 104 terfenadine-treated patients, and 48 (47%) of 102 placebo-treated patients. Adverse experiences reported during the study were usually mild or moderate and were not significantly different among the three treatment groups. Sedation (somnolence) was reported by 10 loratadine-treated patients, seven terfenadine-treated patients, and eight placebo-treated patients. Loratadine, 10 mg once daily, was comparable to terfenadine, 60 mg twice daily, and significantly superior to placebo in the symptomatic relief of seasonal allergic rhinitis.

Adolescent↗
PubMed1990

Multicentre, double-blind comparison of terfenadine and cetirizine in patients with seasonal allergic rhinitis.

This double-blind, multicentre study was designed to compare the efficacy and tolerability of terfenadine 120 mg with cetirizine 10 mg, each taken once daily, in the treatment of seasonal allergic rhinitis. Two hundred and eighty-five patients were recruited to the study by nine general practice centres in the south of England during the 1989 hay-fever season. Symptom severity was assessed daily by the patient and before and after the one-week treatment period by the investigator. At the second clinic visit both patient and investigator assessed the overall response to treatment. The two treatment groups were well matched for all demographic variables and baseline symptom scores. Improvement in all seven symptoms (nasal congestion, sneezing, rhinorrhoea, itching nose, itching eyes, watery eyes and red eyes) and overall response to treatment were similar in both treatment groups. Adverse events were mainly of mild to moderate severity and were reported by 14 patients on terfenadine and 21 patients treated with cetirizine (p = 0.317). This study confirmed terfenadine's role as the treatment of choice in hayfever. A single 120 mg dose in the morning effectively reduced symptoms by 43 to 70 per cent of baseline values, with an acceptably low incidence of side effects. Cetirizine at a single dose of 10 mg displayed equal efficacy in controlling hayfever symptoms but, in common with other studies, had a significantly greater incidence of drowsiness (p = 0.046).

Adult↗
PubMed1990

Gabapentin in partial epilepsy. UK Gabapentin Study Group.

Gabapentin is an analogue of gamma aminobutyric acid (GABA) which has anticonvulsant properties in animals. In a multicentre, double-blind, placebo-controlled, parallel-group study of 1200 mg/day gabapentin as additional therapy in 127 patients with drug-resistant partial epilepsy, 25% of patients who received gabapentin had the number of partial seizures at least halved, compared with 9.8% of patients given placebo. The median reduction in partial seizure frequency during 12 weeks' treatment was 29.2% with gabapentin compared with 12.5% with placebo. The mean adjusted response ratio for gabapentin (-0.192) was significantly better than the ratio of -0.060 for placebo by analysis of variance. 62% of patients who received gabapentin reported mostly mild or moderate adverse effects compared with 41% on placebo; no interactions were observed between gabapentin and other standard anticonvulsants. Gabapentin is an effective additional treatment for patients with partial epilepsy refractory to standard therapy, is fairly well tolerated, and appears to have a favourable efficacy-to-toxicity ratio.

Acetates↗
PubMedDate not supplied

[Treatment using immucytal in children with recurrent respiratory infections: an Italian multicenter experience].

120 children, 71 male and 49 female, aged between 2 years and 15 years (mean 6.15 +/- 3.52 years) with recurrent respiratory infections, were treated with Immucytal, an immunomodulator of bacterial origin, based on membrane proteoglycan fractions plus bacterial ribosomes. The children, selected on the basis of the previous year's clinical score, were treated according to a random design with either Immucytal or placebo, using the same dosage of one puff per nostril plus one puff in the oropharyngeal cavity three times a day, as follows: 1st month: two weeks' treatment, one week wash out, one week's treatment. 2nd, 3rd, 4th months: two weeks' treatment, two week's wash out. Monthly throughout the treatment period the frequency and severity of airway infections episodes were assessed using the same score as for admission. Blood chemistry test, immunological assays (circulating Ig, lymphocyte subpopulations, Merieux Multitest in vivo blastization test) and respiratory tests (spirometry using a pneumotachigraph) were done before and after the treatment. 118/120 children completed treatment; the two dropouts were in the placebo group, one for compliance and the other because of headaches. Respiratory symptoms improved significantly in the actively treated children already from the first month, but not in the placebo group. This improvement consisted of reduction of the respiratory infectious episodes in both the upper and lower airways. No changes were noted in respiratory function parameters. From the immunological viewpoint, there were significant rises in serum IgA and IgM and enhanced skin response tot he Multitest; there was no change in the percentages of different circulating lymphocyte subpopulations.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed1990

Spironolactone and altizide versus converting enzyme inhibitor (enalapril).

The safety and antihypertensive effectiveness of a fixed-dose combination form of spironolactone + altizide (S/A) were compared with those of enalapril, an angiotensin-converting enzyme inhibitor in a randomized, double-blind, parallel-group study of 186 patients with moderate essential hypertension. The 2 treatment groups were comparable in terms of age, gender, duration and severity of hypertension, diastolic blood pressure (BP), serum potassium and creatinine, and 24-hour urinary sodium excretion after a 4-week washout phase. After 8 weeks of treatment, both S/A and enalapril decreased BP significantly and to about the same extent. Enalapril, however, was more effective in decreasing supine diastolic BP in patients younger than age 50, whereas S/A yielded better results in those older than 50. Laboratory values were similar after both drugs were administered, and there were no clinically significant changes. The study demonstrated that S/A safely reduces elevated BP, particularly in older patients.

Adult↗
PubMedDate not supplied

[Controlled clinical study on the effect of quazepam versus triazolam in patients with sleep disorders].

Quazepam (QZP), a new long half-life benzodiazepine, seems to have a more specific hypnotic activity and a "physiological" mechanism of action. This study assessed its clinical efficacy and any withdrawal symptoms occurring after the treatment with QZP and triazolam (TRZ). Sixty-five patients (mean age 41.4 yrs +/- 12.43 SD) with sleep disorders were included in the study. The patients were treated with placebo for 4 days (run-in period) and if no amelioration of insomnia was observed, were then randomly allocated to 15 mg QZP (33 patients) or TRZ (32 patients) for 8 weeks and finally placebo for another week. Sleep quality, efficiency, side-effects and withdrawal effects were assessed by specific rating scales. In comparing data obtained from the two treatments, the following conclusions were drawn: 1) both drugs showed a hypnoinductive efficacy but patients treated with QZP had significantly fewer night awakenings; 2) at the end of treatment only patients treated with TRZ had longer awakenings and rebound symptoms; 3) a lower withdrawal symptom incidence was observed in patients treated with QZP. Therefore, QZP seems to have a good hypnotic effect without inducing withdrawal symptoms. In contrast TRZ turned out to be a merely hypno-inducing drug presenting higher risks of rebound effects after withdrawal.

Adolescent↗
PubMed1991

Strategies for the advancement of surgical methods in cleft lip and palate.

This paper examines the clinical research methodologies used for the evaluation of cleft lip and palate therapies. A survey of clinical reports in the Cleft Palate Journal between 1964 and 1988 revealed that almost all used retrospective methods (96%). The authors examine the merits and biases associated with retrospective evaluation of therapies and compared these to prospective randomized clinical trials. The strengths and weaknesses of clinical trials are discussed in relation to the long-term evaluation of primary surgery in cleft patients. For these to be successful, further work is needed to investigate questions such as sample size, possible predictors of long-term outcome, and improved methods of presurgical assessment. The authors conclude that if the uncertainties associated with the choice of primary cleft surgery are to be resolved, the challenge of multicenter prospective clinical trials must be faced by the various disciplines involved in cleft palate clinical research.

Cleft Lip↗
PubMed1992

A clinical trials database as a research tool in health care.

OBJECTIVE: The rapid, efficient, and accurate communication of clinical research findings to both clinicians and researchers is essential to the process of improving medical care. This information should be conveyed in a form that facilitates the interpretation of the complete body of research on a specific condition. Unfortunately, the prevailing system for dissemination of clinical research fails to meet these criteria. This paper proposes a system for cataloging clinical trials and communicating their results in a comprehensive and comprehensible format. METHOD: The system involves the use of a hierarchical matrix structure that allows for the selection and evaluation of related groups of clinical trials. The format of the data is tailored to the requirements of metaanalysis. RESULTS: An example is presented using the treatment of acute Crohn's disease and including a sample metaanalysis of immunosuppressive therapy for this condition. CONCLUSIONS: The hierarchical matrix structure in conjunction with a comprehensive database of clinical trials holds the potential to facilitate access to and interpretation of clinical research.

Acute Disease↗