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PubMed1997

Therapy of hepatitis C: consensus interferon trials. Consensus Interferon Study Group.

Chronic hepatitis C is an insidious disease associated with significant morbidity and mortality. Currently, the only approved therapies for chronic hepatitis C are the alpha interferons. Consensus interferon (CIFN) is a nonnatural, synthetic, recombinant type I interferon derived by assigning the most commonly observed amino acid in each position of several alpha interferon nonallelic subtypes to generate a consensus sequence. The efficacy and safety of CIFN in the treatment of chronic hepatitis C were assessed in two large phase 3 trials. The first trial was a multicenter, randomized, double-blind, controlled study of 704 patients who were treated with one of two doses of CIFN (3 microg and 9 microg) or interferon alfa-2b (3 million units [MU]) weekly for 24 weeks and then observed for an additional 24 weeks. Treatment with CIFN at a dose of 9 microg was safe and effective, with serum alanine aminotransferase (ALT) and hepatitis C virus (HCV) RNA sustained response rates of 20% and 12%, respectively. Responses to 3 MU interferon alfa-2b were comparable to 9 microg CIFN. The response rates were lower in the 3-microg CIFN cohort. At the end of the treatment and posttreatment observation periods, an undetectable serum HCV RNA was a better predictor of a normal ALT than the converse. Serum samples from early time points were available for HCV RNA quantitation from 27 of the 28 patients who experienced a sustained response with 9 microg CIFN. Of these, 13 patients (48%) had undetectable HCV RNA at 2 weeks, 21 patients (78%) at 4 weeks, and 26 patients (96%) at 12 weeks. CIFN (9 microg) induced a significantly greater reduction in the mean serum HCV RNA concentration than interferon alfa-2b during treatment (P < .01). In patients with high viral titers (> or = 4.75 x 10(6) copies/mL), the HCV RNA sustained response rate in patients treated with CIFN (9 microg) and interferon alfa-2b was 7% and 0%, respectively (P = .03). In patients infected with HCV genotype 1, the HCV RNA end-of-treatment (24% vs. 15%; P = .04) and sustained (8% vs. 4%; P = not significant) response rates were greater in patients treated with CIFN (9 microg) than with interferon alfa-2b (3 MU). In a subsequent multicenter trial, a higher dose of CIFN (15 microg) was reinstituted in patients who either had relapsed or were nonresponders to prior CIFN or interferon alfa-2b therapy. Patients were randomized to receive 24 or 48 weeks of retreatment followed by 24 weeks of observation. Patients who had relapsed after prior interferon therapy were more likely to have a serum HCV RNA end-of-retreatment and sustained response than patients who were nonresponders to prior interferon therapy. After patients from the 3-microg CIFN cohort were excluded, the HCV RNA sustained response rates were 28% in relapsers and 5% in nonresponders, respectively, in the 24-week retreatment cohort and 58% and 13%, respectively, in the 48-week retreatment cohort. The administration of 9 or 15 microg CIFN was well tolerated, and the adverse effects were similar to those for interferon alfa-2b. These data demonstrate that CIFN at a dose of 9 microg is effective initial therapy for patients with chronic hepatitis C, and that retreatment with a higher CIFN dose of 15 microg for 48 weeks provides meaningful responses in both relapsers and nonresponders.

Antiviral Agents↗
PubMed1990

Effect of partial ileal bypass surgery on mortality and morbidity from coronary heart disease in patients with hypercholesterolemia. Report of the Program on the Surgical Control of the Hyperlipidemias (POSCH)

BACKGROUND AND METHODS: The Program on the Surgical Control of the Hyperlipidemias (POSCH), a randomized clinical trial, was designed to test whether cholesterol lowering induced by the partial ileal bypass operation would favorably affect overall mortality or mortality due to coronary heart disease. The study population consisted of 838 patients (417 in the control group and 421 in the surgery group), both men (90.7 percent) and women, with an average age of 51 years, who had survived a first myocardial infarction. The mean follow-up period was 9.7 years. RESULTS: When compared with the control group at five years, the surgery group had a total plasma cholesterol level 23.3 percent lower (4.71 +/- 0.91 vs. 6.14 +/- 0.89 mmol per liter [mean +/- SD]; P less than 0.0001), a low-density lipoprotein cholesterol level 37.7 percent lower (2.68 +/- 0.78 vs. 4.30 +/- 0.89 mmol per liter; P less than 0.0001), and a high-density lipoprotein cholesterol level 4.3 percent higher (1.08 +/- 0.26 vs. 1.04 +/- 0.25 mmol per liter; P = 0.02). Overall mortality and mortality due to coronary heart disease were reduced, but not significantly so (deaths overall [control vs. surgery], 62 vs. 49, P = 0.164; deaths due to coronary disease, 44 vs. 32, P = 0.113). The overall mortality in the surgery subgroup with an ejection fraction greater than or equal to 50 percent was 36 percent lower (control vs. surgery, 39 vs. 24; P = 0.021). The value for two end points combined--death due to coronary heart disease and confirmed nonfatal myocardial infarction--was 35 percent lower in the surgery group (125 vs. 82 events; P less than 0.001). During follow-up, 137 control-group and 52 surgery-group patients underwent coronary-artery bypass grafting (P less than 0.0001). A comparison of base-line coronary arteriograms with those obtained at 3, 5, 7, and 10 years consistently showed less disease progression in the surgery group (P less than 0.001). The most common side effect of partial ileal bypass was diarrhea; others included occasional kidney stones, gallstones, and intestinal obstruction. CONCLUSIONS: Partial ileal bypass produces sustained improvement in the blood lipid patterns of patients who have had a myocardial infarction and reduces their subsequent morbidity due to coronary heart disease. The role of this procedure in the management of hypercholesterolemia remains to be determined. These results provide strong evidence supporting the beneficial effects of lipid modification in the reduction of atherosclerosis progression.

Adult↗
PubMed1997

Clinical and socioeconomic profile of patients with malignant ventricular arrhythmias in 1993 to 1995. AVID investigators. Antiarrhythmics Versus Implantable Defibrillator.

This report summarizes the clinical and socioeconomic characteristics of the first 542 patients entered into the Antiarrhythmics Versus Implantable Defibrillator (AVID) trial. AVID is a multicenter trial comparing a strategy of initial implantable cardioverter-defibrillator placement to initial antiarrhythmic drug therapy in preventing death in patients resuscitated from cardiac arrest who were not taking amiodarone and who did not have an implantable cardioverter-defibrillator in place at the time of the index event. These patients were randomly assigned to immediate defibrillator placement or to "best" medical therapy. Clinical and socioeconomic histories were collected by interview using standard terms developed for the study. Patients without (group 1) and with (group 2) a history of prior cardiac arrest were compared. The mean age of the 542 patients was 65 +/- 10 years, most were men, white, had coronary disease, and were highly functional despite the fact that only a minority were employed. Almost all had some form of health insurance. At the time of the index event, few were taking any therapy to prevent cardiac arrest, even in the group of patients with a history of previous cardiac arrest. Thus, the clinical and socioeconomic profile of patients resuscitated from sudden cardiac death entered into the AVID study is generally as expected. There is a striking absence of any attempt at chronic therapy to prevent cardiac arrest in most patients with a prior ventricular tachycardia or ventricular fibrillation.

Aged↗
PubMed1990

The National Mucolytic Study. Results of a randomized, double-blind, placebo-controlled study of iodinated glycerol in chronic obstructive bronchitis.

Seventy-four pulmonologists and one allergist were recruited to assess the efficacy and safety of iodinated glycerol (Organidin), 60 mg qid, vs placebo in patients with stable chronic obstructive bronchitis in a randomized, double-blind, placebo-controlled, parallel design. A total of 361 patients (180 to iodinated glycerol and 181 to placebo) who complained of cough and difficulty bringing up sputum entered the eight-week study. Evaluations were based upon eight primary symptom efficacy parameters (cough frequency, cough severity, chest discomfort, dyspnea, ease in bringing up sputum, patient and physician global assessments, and a derived patients' global assessment), and six secondary parameters (frequency of aerosol bronchodilator use, incidence and duration of acute exacerbations, frequency of concomitant medication use, incidences of adverse experiences and dropouts). Cough frequency, cough severity, chest discomfort, patients' ease in bringing up sputum, patients' overall condition, and a derived subject global assessment were significantly (p less than 0.05) improved by iodinated glycerol as compared with placebo within eight weeks of treatment. Dyspnea showed a trend toward improvement and the physicians' global evaluation showed no significant difference between groups. Similar findings were noted in a subgroup analysis of moderately-to-severely affected patients. The mean duration (days) of acute exacerbations and number of dropouts attributable to adverse experiences were significantly less (p less than 0.05) in the iodinated glycerol group.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1995

Potential modification of plaque behavior through the European lacidipine study on atherosclerosis.

The European Lacidipine Study on Atherosclerosis (ELSA) has been designed to compare the effects of two antihypertensive agents, the calcium antagonist lacidipine and the beta-blocker atenolol, on the development of atherosclerosis in hypertensive patients stratified according to the presence of carotid plaques, or the presence or absence of carotid artery intima-media thickening. ELSA is a multinational, multicenter, randomized, double-blind, parallel group study that is to be conducted over a 5-year period. Recruitment and treatment will take place at 23 referral centers in seven countries. A total cohort of 3,660 patients, aged between 45 and 75 years, with diastolic blood pressure 95-115 mm Hg and systolic blood pressure < or = 210 mm Hg at enrollment, will be stratified into three groups according to a B-mode ultrasound analysis of the carotid wall morphology. After a 1-month placebo run-in period, patients will be randomized to receive either lacidipine (4-6 mg once daily) or atenolol (50-100 mg once daily). Nonresponders will be treated with hydrochlorothiazide (12.5 mg, eventually titrated to 25 mg if required), on an open basis. During the course of the study, patients will be monitored by carotid ultrasound assessment and ambulatory blood pressure monitoring. The results of this study should further understanding of the pathobiology of atherosclerosis, and its development and prevention.

Adrenergic beta-Antagonists↗
PubMed2004

A prospective, blinded, randomized, controlled clinical trial of topical negative pressure use in skin grafting.

Topical negative pressure has been demonstrated to improve graft take in a number of noncomparative studies. This study aimed to assess whether split-thickness skin graft take is improved qualitatively or quantitatively with topical negative pressure therapy compared with standard bolster dressings. A blinded, prospective, randomized trial was conducted of 22 adult inpatients of Liverpool Hospital between July of 2001 and July of 2002 who had wounds requiring skin grafting. After grafting, each wound half was randomized to receive either a standard bolster dressing or a topical negative pressure dressing. Skin graft assessment was performed at 2 weeks by a single observer blinded to the randomization. Two patients were lost to follow-up and were excluded from the study. There were 20 patients (12 men and eightwomen) in the study group. The median patient age was 64 years (range, 27 to 88 years), and the mean wound size was 128 cm2 (range, 35 to 450 cm2). The wound exposed subcutaneous fat in eight patients, muscle in six patients, paratenon in four patients, and deep fascia in two patients. At 2 weeks, wounds that received a topical negative pressure dressing had a greater degree of epithelialization in six cases (30 percent), the same degree of epithelialization in nine cases (45 percent), and less epithelialization in five cases (25 percent) compared with their respective control wounds. Graft quality following topical negative pressure therapy was subjectively determined to be better in 10 cases (50 percent), equivalent in seven cases (35 percent), and worse in three cases (15 percent). Although the quantitative graft take was not significant, the qualitative graft take was found to be significantly better with the use of topical negative pressure therapy (p < 0.05). Topical negative pressure significantly improved the qualitative appearance of split-thickness skin grafts as compared with standard bolster dressings.

Adult↗
PubMedDate not supplied

Comparison of efficacy, secondary failure rate, and complications of sulfonylureas.

The data from three clinical trials are presented, comparing the efficacy of different sulfonylureas in the treatment of type II diabetes. In a multicenter study, gliclazide improved control in 49% of patients who had failed on other drugs. When five groups of type II diabetic patients were treated concurrently with five randomly allocated different sulfonylureas over 1 year, the percentage of patients achieving normal HbA1 levels was best with gliclazide (80%) and glibenclamide (74%), when compared with chlorpropamide (17%), glipizide (40%), and gliquidone (40%). Secondary failure rate over 5 years was assessed in 248 type II diabetic patients randomly allocated to three different sulfonylureas and found to be lowest with gliclazide (7%) compared with glibenclamide (17.9%): p < 0.1) and glipizide (25.6%: p < 0.005). The incidence of hypoglycemia was significantly higher with glibenclamide than with gliclazide (p < 0.05). The differences in efficacy and secondary failure rate between sulfonylureas may be related to the mechanism of insulin release from the beta-cell and the more physiological action of gliclazide could partly explain this. These trials suggest that gliclazide is a potent sulfonylurea with a low rate of secondary failure and a low incidence of side effects and may be a better choice in long-term sulfonylurea therapy.

Clinical Trials as Topic↗
PubMed1989

Baseline characteristics in the Hypertension Prevention Trial. Hypertension Prevention Trial Research Group.

The Hypertension Prevention Trial (HPT) was a randomized, controlled, multicenter (four clinics, four resource centers) trial designed to test the feasibility of achieving and sustaining dietary changes in the intake of calories, sodium, and potassium and to assess the effect of those changes on blood pressure in a normotensive population. The trial involved 841 men and women (plus a test cohort of 78) who, at the first baseline (BL) examination were in the age range of 25-49 years and had diastolic pressure (DBP) greater than or equal to 76 but less than 100 mm Hg (average of two readings), and at the examination prior to randomization (BL 2), had DBP greater than or equal to 78 but less than 90 mm Hg (also averaged). Participants were randomly assigned to a control treatment group (no dietary counseling) or to one of four dietary treatment groups involving counseling designed to reduce calorie intake; reduce sodium intake, reduce sodium and calorie intake, and reduce sodium and increase potassium intake. This chapter presents HPT baseline characteristics by weight stratum, clinic, and treatment group for various demographic, medical history, and nutritional characteristics, for several physiologic variables used in monitoring treatment compliance, and for blood pressure. The degree of comparability observed among treatment groups was within the range expected for the randomization procedure used.

Adult↗
PubMed1990

Low-dose methotrexate compared with auranofin in adult rheumatoid arthritis. A thirty-six-week, double-blind trial.

Weekly treatment with low-dose oral methotrexate (MTX) was compared with daily auranofin (AUR) treatment in a 36-week double-blind, randomized, multicenter study of 281 patients with active, adult-onset rheumatoid arthritis. Both treatment groups showed significant improvement by the usual measures of clinical efficacy. The response with MTX occurred earlier and was consistently greater than that with AUR. An intent-to-treat analysis showed significantly greater improvement (P less than 0.01) with MTX for painful and swollen joint counts and physician and patient global assessments of disease activity. Adverse reactions were reported more frequently in the AUR group, and more AUR-treated patients were withdrawn from the study because of toxicity. MTX was thus more effective and better tolerated than AUR in this study.

Administration, Oral↗
PubMed1990

Enhancing the outcomes of low-birth-weight, premature infants. A multisite, randomized trial. The Infant Health and Development Program.

The Infant Health and Development Program is an eight-site clinical trial designed to evaluate the efficacy of a comprehensive early intervention in reducing the developmental and health problems of low-birth-weight (less than or equal to 2500 g) premature (less than or equal to 37 weeks) infants. Nine hundred eighty-five infants, stratified by site and weight (less than or equal to 2000 g or 2001 to 2500 g), were randomly assigned to receive an educational curriculum focused on child development, as well as family support and pediatric follow-up, or only pediatric follow-up. At corrected age 36 months, the intervention group had significantly higher mean IQ scores than the follow-up group (mean difference in the heavier group was 13.2 and in the lighter group 6.6), significantly fewer maternally reported behavior problems, and a small, but statistically significant, increase in maternally reported minor illnesses for the lighter-birth-weight group only, with no difference in serious health conditions.

Child Behavior↗
PubMed1990

Etoposide versus etoposide plus high-dose cisplatin in the management of advanced non-small cell lung cancer. Results of a prospective randomized FONICAP trial. Italian Lung Cancer Task Force.

Two hundred sixteen patients with unresectable non-small cell lung carcinoma were randomly allocated to receive etoposide (120 mg/m2, days 1-3) either alone or in combination with high-dose cisplatin (60 mg/m2, days 1-2). The patients' distribution and characteristics were similar in the two treatment arms. The objective response rate for etoposide was 7% versus 25.8% for etoposide plus cisplatin (P less than 0.005). Median progression-free survival in etoposide arm was 3.5 months versus 5 months in the combination arm (P = 0.43). The median survival time for etoposide was 6 months compared with 8 months for etoposide combined with cisplatin (P = 0.87). Significantly more nausea/vomiting (P less than 0.005), serum creatinine elevation (P less than 0.005), hearing loss and/or tinnitus (P less than 0.005), peripheral neuropathy (P less than 0.005), leukopenia (P less than 0.025), and anemia (P less than 0.005) occurred in the etoposide plus cisplatin arm. No statistically significant difference was recorded between the two arms in terms of performance status changes. In conclusion the addition of high-dose cisplatin to single-agent etoposide significantly increases the chance of obtaining tumor response in advanced non-small cell lung cancer at the cost of an increased toxicity without any significant long-term impact on survival and progression-free survival.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1989

A multicenter randomized trial of ionic (ioxaglate) and nonionic (iopamidol) low-osmolality contrast agents in cardiac angiography.

A multicentered double-blind randomized study was performed comparing the electrocardiographic and hemodynamic changes induced by two new low osmolar contrast agents used for cardiac angiography. The low osmolar ionic (ioxaglate) contrast agent was compared with a low osmolar nonionic (iopamidol) contrast agent in 150 patients with angina pectoris undergoing angiography. Systolic blood pressure, left ventricular end-diastolic pressure, heart rate, and QT interval were measured just before and for 90 s following the left ventricular angiography and selective coronary angiography. Each group was also evaluated for adverse events and quality of radiographic images. Following left ventricular angiography, the systolic blood pressure dropped slightly in both groups with a greater decrease seen in the iopamidol group at 5 s (p less than 0.05). After selective right and left coronary angiography, systolic blood pressure decreased transiently and equally in both treatment groups. The left ventricular end-diastolic pressure increased after the ventriculogram in both groups (15.9 +/- 6.3 to 18.9 +/- 8.6 mmHg in the ioxaglate group and 16.1 +/- 6.7 to 20.1 +/- 7.8 mmHg in the iopamidol group), the change being significant only in the iopamidol group (p less than 0.05). Heart rate increased slightly but significantly in the ioxaglate-treated patients following left ventricular angiography (71.4 +/- 15.2 to 74.4 +/- 13.7 beats/min) (p less than 0.01). QT interval transiently increased following left ventriculography with ioxaglate (407 +/- 59.5 to 420 +/- 58.3 ms) (p less than 0.05) compared with iopamidol.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed2004

A randomized controlled clinical trial of topical photodynamic therapy with methyl aminolaevulinate in the treatment of actinic keratoses in transplant recipients.

BACKGROUND: Transplant recipients have an increased propensity to develop multiple actinic keratoses, which demonstrate an increased transformation rate into invasive squamous cell carcinoma. OBJECTIVE: To evaluate the efficacy and tolerability of topical photodynamic therapy with the new highly tumour-selective photosensitizer methyl aminolaevulinate vs. placebo in the treatment of actinic keratoses in transplant recipients. METHODS: Seventeen transplant recipients with a total number of 129 mild to moderate actinic keratoses were enrolled in a prospective, randomized, double-blind, placebo-controlled study. Two lesional areas within a patient were randomized for two consecutive treatments of topical photodynamic therapy 1 week apart using either methyl aminolaevulinate or placebo cream. Sites were illuminated with 75 J cm(-2) of visible light delivered at 80 mW cm(-2) by a noncoherent light source. Complete resolution and reduction in the number or size of actinic keratoses within the lesional area relative to the initial findings were evaluated at weeks 4, 8 and 16 after treatment. RESULTS: The lesional areas treated with methyl aminolaevulinate were clinically cleared in 13 of 17 patients at 16 weeks. A partial response was recorded in a further three. No reduction in the size or number of actinic keratoses was observed in one area treated with methyl aminolaevulinate and in all placebo-treated areas. Adverse events, such as erythema, oedema and crust formation, were mild to moderate, and treatment was well tolerated by all patients. CONCLUSION: Photodynamic therapy using methyl aminolaevulinate is a safe and effective treatment for actinic keratoses in transplant recipients. It may also reduce the risk of transformation of actinic keratoses to invasive, potentially fatal, squamous cell carcinoma.

Adult↗
PubMed1990

Randomised controlled trial of recombinant human interferon -alpha A for chronic active hepatitis B.

The efficacy of interferon treatment for Australian patients with chronic active hepatitis B (CAH-B) was assessed by a three-centre randomised controlled trial in Sydney and Brisbane. Thirty patients (29 with histologically-proven CAH-B with and without cirrhosis and one with chronic persistent hepatitis) were allocated to receive either thrice weekly intramuscular injections of recombinant human leucocyte interferon -alpha A (either 2.5, 5.0 or 10.0 million units/m2) for six months followed by 12 months of observation, or to be observed for 18 months without active treatment. Three of 23 treated patients but none of seven controls underwent clinical, biochemical and histological resolution of their disease with loss of HBsAg, HBeAg and HBV-DNA from serum. An additional six treated and two control patients underwent a sustained partial remission of their disease. This was characterised by resolution of symptoms and serum aminotransferase abnormalities in association with seroconversion from HBeAg positive to negative, loss of HBV-DNA from serum but persistent hepatitis B surface antigenaemia. In such patients, there was significant improvement in histological appearances but some necroinflammatory activity remained and fibrosis was unchanged. Although total response rates were similar in treated and control subjects, they appeared to occur earlier after interferon treatment. Treatment with interferon was associated with predictable but minor side effects that usually did not necessitate dose reduction and rarely compromised the patient's life style. Interferon is thus a feasible treatment for CAH-B. Complete responses occurred only in treated patients and partial responses appeared to occur earlier in treated than in untreated patients. However, differences in the partial response rate at 18 months were not significant and seroconversion from HBeAg positive to negative was not associated with complete histological resolution of disease activity. Hence, while interferon is a promising agent for treatment of CAH-B, efforts must continue to define more optimal treatment regimes and to identify those patients most likely to respond to this agent.

Adult↗
PubMed1990

Pharmacokinetics of toremifene and its metabolites in patients with advanced breast cancer.

A multicenter phase I pharmacokinetic study of a new triphenylethylene antiestrogen, toremifene, was examined in 70 patients with advanced breast cancer. Patients were randomized to receive single daily oral doses of either 10, 20, 40, 60, 200, or 400 mg for 8 weeks. Plasma toremifene and its major metabolites. N-desmethyltoremifene and 4-hydroxytoremifene, were determined weekly during therapy and at 0, 7, 14, and 21 days after the discontinuation of therapy. The time to reach steady-state plasma concentrations was between 1 and 5 weeks, with steady-state being achieved earlier (1-2 weeks) at daily doses of 200 and 400 mg. The time to peak concentration following oral doses of toremifene ranged from 1.5 to 4.5 h. The terminal half-life of elimination was 5.0, 6.0, and 5.0 days for toremifene, desmethyltoremifene, and 4-hydroxytoremifene, respectively. Plasma concentrations of 4-hydroxytoremifene were detectable only at high doses (200 and 400 mg/day) of toremifene. The results of this phase I pharmacokinetic study show that toremifene has metabolic and kinetic patterns that are similar to those previously reported with tamoxifen.

Administration, Oral↗