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At least 109 records · Page 6Linked to original sources
PubMed1989

A double-blind clinical trial of fenticonazole (2%) spray versus naftifine (1%) spray in patients with cutaneous mycoses.

A multi-centre, double-blind trial was carried out in 100 patients with cutaneous mycotic infections, confirmed by direct microscopy and/or culture, to compare the efficacy and tolerability of spray formulations of 2% fenticonazole and 1% naftifine. On entry, patients were allocated at random to receive once daily topical applications of one or other drug over a period of 2 to 4 weeks, treatment being stopped when patients had recovered or substantially improved. Clinical and mycological assessments were made before (baseline), at weekly intervals during treatment and, if possible, 2 to 3 weeks after the end of treatment (drug-free period). Treatment was continued for 19.25 days with fenticonazole and 19.62 days with naftifine. All patients had positive mycological findings on entry. The most frequently isolated pathogens were dermatophytes, mainly Trichophyton rubrum; however, Candida albicans was present in 33.3% of patients in the fenticonazole group and in 20.8% of those treated with naftifine. At the end of treatment, only 3 (6.3%) and 5 (10.4%) patients, respectively, of the 48 patients assessed in each group still had positive mycological findings. Assessments of symptoms indicated comparable, significant improvement in both groups, and at the end of treatment the overall opinion of doctors and patients was that about 90% of patients were cured or greatly improved. The end of the drug-free period evaluation showed that, of the patients assessed as cured or greatly improved at the end of treatment, only 1 (3.2%) patient who had received fenticonazole and 2 (6.3%) who had received naftifine were confirmed mycologically as having relapsed.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Topical↗
PubMed1999

Relationship of extent of revascularization with angina at one year in the Bypass Angioplasty Revascularization Investigation (BARI).

OBJECTIVES: To determine the relative degree of revascularization obtained with bypass surgery versus angioplasty in a randomized trial of patients with multivessel disease requiring revascularization (Bypass Angioplasty Revascularization Investigation [BARI]), one-year catheterization was performed in 15% of patients. BACKGROUND: Complete revascularization has been correlated with improved outcome after coronary artery bypass grafting (CABG) but not with percutaneous transluminal coronary angioplasty (PTCA). Relative degrees of revascularization after PTCA and surgery have not been previously compared and correlated with symptoms. METHODS: Consecutive patients at four BARI centers consented to recatheterization one year after revascularization. Myocardial jeopardy index (MJI), the percentage of myocardium jeopardized by > or =50% stenoses, was compared and correlated with angina status. RESULTS: Angiography was completed in 270 of 362 consecutive patients (75%) after initial CABG (n = 135) or PTCA (n = 135). Coronary artery bypass grafting patients had 3+/-0.9 distal anastomoses and PTCA patients had 2.4+/-1.1 lesions attempted at initial revascularization. At one year, 20.5% of CABG patients had > or =1 totally occluded graft and 86.9% of vein graft, and 91.6% of internal mammary artery distal anastomotic sites had <50% stenosis. One year jeopardy index in surgery patients was 14.1+/-11%, 46.6+/-20.3% improved from baseline. Initial PTCA was successful in 86.9% of lesions and repeat revascularization was performed in 48.4% of PTCA patients by one year. Myocardial jeopardy index one year after PTCA was 25.5+/-22.8%, an improvement of 33.8+/-26.1% (p<0.01 for greater improvement with CABG than PTCA). At one year, 29.6% of PTCA patients had angina versus 11.9% of surgery patients, p = 0.004. One-year myocardial jeopardy was predictive of angina (odds ratio 1.28 for the presence of angina per every 10% increment in myocardial jeopardy, p = 0.002). Randomization to PTCA rather than CABG also predicted angina (odds ratio 2.19, p = 0.03). CONCLUSIONS: In this one-year angiographic substudy of BARI, CABG provided more complete revascularization than PTCA, and CABG likewise improved angina to a greater extent than PTCA.

Angina Pectoris↗
PubMed1990

Can a new beta 2-agonist reduce the mortality of asthma?

Tulobuterol is a synthetic beta-adrenergic agonist which, when administered orally, is a potent, long-acting bronchodilator. The safety and efficacy of 2 mg tulobuterol tablets taken twice daily was compared to that of 4 mg salbutamol tablets taken three times daily for a period of 12 weeks in outpatients with stable chronic asthma in a randomized, double-blind, multi-center study conducted in Australia. Strict entry criteria were employed; only those patients whose baseline FEV1 value was between 40-70% of the predicted normal value and increased at least 20% after two inhalations of a metered dose (250 micrograms per dose) of terbutaline aerosol at a screening visit were included. Treatment with active study drug was preceded by a 2 week single-blind, placebo lead-in period. The onset and duration of the bronchodilating effect was studied on the first day of the placebo lead-in period and on the first and last days of the 12 week parallel design treatment period. Of 140 patients enrolled, 73 had tulobuterol and 67 had salbutamol. Of these, 61 tulobuterol and 59 salbutamol treated patients could be evaluated for efficacy. Of the 140 patients, 129 completed the study. All patients were issued a mini peak flow meter and diary cards to record daily PEFRs and symptoms of airways obstruction throughout the study. The demographics of the patients in both treatment groups were similar in all modalities: they were comparable in age, duration of asthma, mean FEV1 (expressed as percent of predicted normal), and reversibility (as demonstrated by an increase in FEV1 after administration of a beta 2-agonist aerosol).(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Oral↗
PubMed1997

The effects of simvastatin on the incidence of heart failure in patients with coronary heart disease.

BACKGROUND: Although treatment of myocardial overload effectively reduces death from progression of heart failure, it is not known whether the retardation of progressive coronary artery disease obtained with lipid lowering treatment will prevent the onset and consequences of heart failure in patients without previous symptoms of heart failure. METHODS AND RESULTS: In the Scandinavian Simvastatin Survival Study, 4444 patients with coronary heart disease without evidence of heart failure were randomized to placebo (n = 2223) or simvastatin 20-40 mg (n = 2221) and followed for more than 5 years. Among the patients who received placebo, 228 (10.3%) were diagnosed with heart failure during follow-up evaluation compared with 184 (8.3%) of patients who received simvastatin (P < .015). Mortality was 31.9% in the placebo group and 25.5% in the simvastatin group among patients who developed heart failure. These compare with 9.2 and 6.6%, respectively, among non-heart failure patients. There were 45 hospitalizations because of acute heart failure in the placebo group and 23 in the simvastatin group (NS). Patients who developed heart failure were more likely to have suffered a recurrent myocardial infarction and have a history of diabetes, peripheral artery disease, and hypertension than patients who did not develop congestive heart failure. CONCLUSION: Long-term prevention with simvastatin reduces the occurrence of heart failure in a cohort of patients with coronary heart disease without previous evidence of congestive heart failure.

Adult↗
PubMed1990

A randomized clinical study of cefoperazone and sulbactam versus gentamicin and clindamycin in the treatment of intra-abdominal infections.

This report summarizes the experience of investigators in four medical centres who compared the combination of cefoperazone/sulbactam against gentamicin/clindamycin in the treatment of intra-abdominal infections. One hundred and fifty-two patients were enrolled in the study and all were evaluable for safety and tolerance, 110 were evaluable for efficacy. Of the 76 patients (49 male, 27 female) treated with cefoperazone/sulbactam 66 (86.8%) were cured, five (6.6%) improved and five (6.6%) failed to respond to treatment. Of 34 patients treated with gentamicin/clindamycin, 21 (61.8%) were cured, four (11.8%) improved and nine (26.4%) failed. Cure rates for patients receiving cefoperazone/sulbactam were significantly higher than those of patients receiving gentamicin/clindamycin (P less than 0.006). Failures in both groups were attributable in part to pseudomonal and enterococcal infection and abscess formation. The addition of sulbactam to cefoperazone rendered cefoperazone-resistant organisms susceptible to cefoperazone in 11 of the 76 cases (14.4%) and thus permitted treatment with this agent. The present study confirms the safety and clinical efficacy of cefoperazone/sulbactam and suggests that this combination is a viable alternative to an aminoglycoside plus clindamycin for intra-abdominal infections.

Abdomen↗
PubMed1990

The effect of captopril and metoprolol as monotherapy or combined with bendroflumethiazide on blood lipids.

In a 24-week randomized multicentre single-blind study, including mild to moderate hypertensives free from other diseases, the effect on blood lipids of captopril (n = 51) was studied and compared with that of metoprolol (n = 53). In order to keep the diastolic pressure less than 95 mm Hg, bendroflumethiazide was added to the medication for 11 patients in the captopril group and 11 patients in the metoprolol group. Neither captopril nor metoprolol altered total cholesterol significantly. Captopril as monotherapy increased HDL-cholesterol by 6.2% (P less than 0.01) and decreased triglycerides by 10.6% (P less than 0.05). Metoprolol as monotherapy decreased HDL-cholesterol by 5.6% (P less than 0.01) and increased triglycerides by 10.3% (P less than 0.05). When bendroflumethiazide was added the favourable effect of captopril on the blood lipids disappeared while the undesirable effect of metoprolol became more pronounced.

Adult↗
PubMed1990

Vincristine, doxorubicin and cyclophosphamide with and without etoposide in limited small cell lung cancer.

A total of 80 patients with limited disease of small cell lung cancer were randomized to receive either vincristine 1 mg/m2 (max. 2 mg), doxorubicin 50 mg/m2 and cyclophosphamide 750 mg/m2 (VAC) i.v. on day 1, or the same drugs and etoposide 80 mg/m2 i.v. daily for 3 days (VACE) every 3 weeks for nine courses. Chest irradiation was given in both regimens after the second course. The response rate was 84% for VAC (41% complete responses) and 75% for VACE (46% complete responses). The median survival time was 10 months with VAC regimen, and 14 months with VACE (difference statistically not significant). The median duration of remission was 8 months with VAC and 14 months with VACE (p = 0.03), and the median survival for complete or partial responders was 12 months and 20 months respectively (p = 0.006). Myelosuppression was significantly greater in the VACE group, and there was one treatment related death in the group receiving VACE. In this study the addition of etoposide to VAC improved the duration of response, but did not lead to longer survival of patients with limited disease of small cell lung cancer.

Adult↗
PubMed1989

Comparison between low-dose simvastatin and cholestyramine in moderately severe hypercholesterolemia.

In a 6-week multicenter study, we compared the efficacy and tolerance of a treatment with 10 mg of simvastatin, a new inhibitor of the HMG-CoA reductase to that of 12 g cholestyramine in 145 patients whose total cholesterol remained between 250 and 350 mg/dl after 4 weeks of a standard lipid-lowering diet. The decrease in total cholesterol reached 21% in the simvastatin group and 16% in the cholestyramine group (p less than 0.01) while the LDL-cholesterol decreased respectively by 30% and 25%. HDL cholesterol increased by 11% in the simvastatin group and by 7% in the cholestyramine group. The ratios of total to HDL cholesterol and LDL to HDL cholesterol decreased by 28.1% and 35.8% respectively with simvastatin and by only 19.5% and 27.9% respectively with cholestyramine. Triglycerides decreased by 5.8% with simvastatin and increased by 8.5% with cholestyramine. Significantly less adverse experiences were observed with simvastatin than with cholestyramine. Simvastatin at the dosage of 10 mg appeared to be at least as efficient as 12 g of cholestyramine and generally better tolerated.

Adolescent↗
PubMed1989

Clinical efficacy of Broncho-Vaxom in adult patients with chronic purulent sinusitis--a multi-centric, placebo-controlled, double-blind study.

This study was designed to test the clinical effectiveness of Broncho-Vaxom (an orally applicable bacterial lysate) in a large number of adult patients suffering from chronic purulent sinusitis. Broncho-Vaxom or placebo was administered to 284 patients presenting with chronic purulent sinusitis within the bounds of a multicentric, randomized double-blind study. Patients were clinically examined before admittance to the study and at 1, 2, 3 and 6 months after treatment initiation (one capsule daily for a period of 10 days per month during 3 consecutive months). The sinuses were x-rayed before and at 3 and 6 months after therapy began. Patients assessed the severity of their symptoms on a scale of 0 to 4: 0 = no symptoms, 1 = light symptoms, 2 = moderate symptoms, 3 = severe symptoms, 4 = very severe symptoms. The average severity score for coughing during the course of Broncho-Vaxom therapy decreased in the third month of treatment from 2.34 before treatment to 0.85, compared to placebo before treatment (2.41) and after treatment (1.24). The score decreased further to 0.61 in the sixth month after the initiation of Broncho-Vaxom therapy, with no further decrease as a result of placebo therapy (1.25). Comparable average score courses for expectorations and headache also occurred. In the first month of Broncho-Vaxom therapy, a decrease was already apparent in the severity of the main sinusitis symptom: purulent nasal discharge. The score was 1.55 in the first month of Broncho-Vaxom treatment compared to 1.80 in the placebo group.(ABSTRACT TRUNCATED AT 250 WORDS)

Adjuvants, Immunologic↗
PubMed1994

Role of etoposide (VP-16) in preparatory regimens for patients with leukemia or lymphoma undergoing allogeneic bone marrow transplantation.

In 1983, we began a series of clinical trials with the goal of reducing the relapse rate following allogeneic BMT for hematologic malignancies. Because of its anti-leukemic activity, the drug VP-16 was chosen and combined with total body irradiation (TBI). The first series (trial I) consisted of patients who had advanced leukemia. This trial showed a relapse rate of 32% and a disease-free survival rate of 43%. Thereafter, this regimen was tested in a randomized trial (trial II) under the auspices of the Southwest Oncology Group (SWOG study 8612). The FTBI/VP-16 regimen was compared with the combination of busulfan and cyclophosphamide (BU/CY). A recent analysis indicates a disease-free advantage for patients prepared with FTBI/VP-16; however this difference is not statistically significant. In another trial (trial III), patients in their first remission of leukemia were prepared with the FTBI/VP-16 regimen and long-term disease-free survival was found to be 60-70% with a relapse rate of approximately 10%. These results compare favorably with data obtained with alternative preparatory regimens. The FTBI/VP-16 regimen is currently being compared to the 'standard' regimen, FTBI/CY, in a prospective trial (trial IV). Since the regimen-related toxicity has been relatively low, we have added one dose of CY 60 mg/kg to the FTBI/VP-16 combination. This regimen (trial V) is currently being tested in patients with advanced leukemia. The preliminary results of this ongoing trial indicate further improvement in disease-free survival through a reduction of the post-transplant relapse rate.

Actuarial Analysis↗
PubMed1990

A multicenter clinical trial of oral ribavirin in HIV-infected patients with lymphadenopathy. The Ribavirin-LAS Collaborative Group.

A double-blind, randomized, placebo-controlled trial comparing two daily doses of oral ribavirin and placebo was conducted at four medical centers. One hundred sixty-four adult men with lymphadenopathy were enrolled over a 2-month period and randomized to receive ribavirin 800 mg (53 subjects), ribavirin 600 mg (55 subjects), or placebo (56 subjects). Active treatment was administered for 24 weeks followed by a 4-week washout period. Nine subjects receiving placebo, four receiving ribavirin 600 mg, and none in the 800 mg group developed AIDS during the 24 weeks of active treatment. One patient randomized to the 800 mg group had Kaposi's sarcoma at study entry and was included in the intent-to-treat analysis. An overall significant difference in progression to AIDS was observed among the three treatment groups (p = 0.028) with patients randomized to receive 800 mg having a significantly longer time to AIDS than placebo patients (p = 0.012; relative risk, 9.0; 95% confidence interval, 1.1 to 70.8). There was no significant difference between the 600 mg and placebo groups (p = 0.15; relative risk, 2.3; 95% confidence interval, 0.7 to 7.6). Baseline CD4 cell count and hematocrit made independent contributions and formed a multivariate prognostic set for these progression data. The significant treatment superiority of 800 mg compared to placebo remained after adjustment for these factors (p = 0.019). After deletion of patients with major protocol violations at entry, the difference between the 800 mg and placebo treatment remained significant (p = 0.021).(ABSTRACT TRUNCATED AT 250 WORDS)

Acquired Immunodeficiency Syndrome↗
PubMed1990

Pharmacologic and nutritional treatment of mild hypertension: changes in cardiovascular risk status.

OBJECTIVE: To evaluate the 6-month change in cardiovascular (coronary heart disease) risk as a function of diet and drug therapy for mild hypertension. DESIGN: Collaborative randomized, controlled clinical trial to assess the efficacy of alternative regimens in treating mild hypertension. SETTING: Three university-based tertiary care centers-the Trial of Antihypertensive Interventions and Management (TAIM). PATIENTS: Six hundred and ninety-two men and women ages 21 to 65 years with diastolic blood pressure between 90 and 100 mm Hg and weight between 110% and 160% of ideal weight. MEASUREMENTS AND MAIN RESULTS: Patients stratified by clinical center and race were randomized into diet (usual, low sodium-high potassium, weight loss) and drug (placebo, chlorthalidone, and atenolol) groups resulting in nine diet plus drug combinations. The cardiovascular risk at 6-month follow-up was estimated relative to baseline in 692 participants using the Framingham Study model. Due to the blood pressure reduction, cardiovascular risk declined from baseline for all treatment groups (except the usual diet plus chlorthalidone group because of increased cholesterol levels). The relative cardiovascular risk at 6 months compared to baseline ranged from 0.83 in the weight loss plus atenolol subgroup to 1.03 in the usual diet plus chlorthalidone subgroup. The active drug plus weight loss groups showed the lowest relative cardiovascular risk at 6 months. CONCLUSIONS: Mild hypertension was generally reduced to desirable levels within 6 months by monotherapy. Evaluating blood pressure changes together with the risk factors indicated a differential effect on overall cardiovascular risk depending on the diet and drug used. Dietary therapy, particularly weight reduction, was important adjunctive treatment in reducing overall cardiovascular risk.

Adrenergic beta-Antagonists↗