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At least 109 records · Page 6Linked to original sources

Does the new angiotensin converting enzyme inhibitor cilazapril prevent restenosis after percutaneous transluminal coronary angioplasty? Results of the MERCATOR study: a multicenter, randomized, double-blind placebo-controlled trial. Multicenter European Research Trial with Cilazapril after Angioplasty to Prevent Transluminal Coronary Obstruction and Restenosis (MERCATOR) Study Group.

BACKGROUND: Cilazapril is a novel angiotensin converting enzyme inhibitor with antiproliferative effects in the rat model after balloon injury. METHODS AND RESULTS: We conducted a randomized, double-blind placebo-controlled trial to assess the effect of cilazapril in angiographic restenosis prevention after percutaneous transluminal coronary angioplasty (PTCA). Patients received cilazapril 2.5 mg in the evening after successful PTCA and 5 mg b.i.d. for 6 months or matched placebo. In addition, all patients received aspirin for 6 months. Coronary angiograms before PTCA, after PTCA, and at 6-month follow-up were quantitatively analyzed. In 94% of 735 recruited patients, PTCA was successful and all inclusion and exclusion criteria were met. For the per-protocol analysis, quantitative angiography after PTCA and at follow-up was available in 595 patients who complied with the treatment regimen (309 control, 286 cilazapril). The mean difference in minimal coronary lumen diameter between post-PTCA and follow-up angiogram (primary end point) was -0.29 +/- 0.49 mm in the control group and -0.27 +/- 0.51 mm in the cilazapril group. Clinical events during 6-month follow-up, analyzed on an intention-to-treat basis, were ranked according to the most serious clinical event ranging from death (control, two; cilazapril, three), nonfatal myocardial infarction (control, eight; cilazapril, 5), coronary revascularization (control, 51; cilazapril, 53), or recurrent angina requiring medical therapy (control, 67; cilazapril, 68) to none of the above (control, 224; cilazapril, 212). There were no significant differences in ranking. CONCLUSIONS: Long-term angiotensin converting enzyme inhibition with cilazapril in a dose of 5 mg b.i.d. does not prevent restenosis and does not favorably influence the overall clinical outcome after PTCA.

Angioplasty, Balloon, Coronary↗

Catheter ablation of accessory pathways, atrioventricular nodal reentrant tachycardia, and the atrioventricular junction: final results of a prospective, multicenter clinical trial. The Atakr Multicenter Investigators Group.

BACKGROUND: The purpose of this study was to evaluate the safety and efficacy of a temperature-controlled radiofrequency catheter ablation system. METHODS AND RESULTS: The patient population included 1050 patients who had undergone ablation of atrioventricular nodal reentrant tachycardia (AVNRT), an accessory pathway (AP), or the atrioventricular junction (AVJ). Ablation was successful in 996 patients. The probability of success was highest among patients who had undergone ablation of the AVJ, lowest in patients who had undergone ablation of an AP, and in between for patients who had undergone ablation of AVNRT. A major complication occurred in 32 patients. Four variables predicted ablation success (AVJ, AVNRT, or left free wall AP ablation and an experienced center). Four factors predicted arrhythmia recurrence (right free wall, posteroseptal, septal, and multiple APs). Two variables predicted development of a complication (structural heart disease and the presence of multiple targets), and 3 variables predicted an increased risk of death (heart disease, lower ejection fraction, and AVJ ablation). CONCLUSIONS: These findings may serve as a guide to clinicians considering therapeutic options in patients who are candidates for ablation.

Adolescent↗

Adjunctive medications in patients receiving thrombolytic therapy: a multicenter prospective assessment. The Virginia Multicenter Thrombolytic Study Group.

OBJECTIVE: To describe the use of adjunctive therapies in patients with acute myocardial infarction receiving thrombolytic agents. DESIGN: Data were collected prospectively by the study-site investigator or the emergency department physician caring for the patient. Study participation did not influence thrombolytic regimen selection or the adjunctive therapies ordered. SETTING: Thirteen Virginia hospitals representing a cross-section of hospitals in the state. Eleven are urban medical centers; four have graduate medical education programs. PARTICIPANTS: Patients were included in the study if the decision to administer thrombolytic therapy was made in the emergency department. MAIN OUTCOME MEASURES: Concomitant medications administered during the first six hours after initiation of thrombolytic therapy. RESULTS: Two hundred ten patients (aged 57 +/- 14.1 y) were evaluated. Ninety-five percent of these patients were treated with tissue plasminogen activator, 3 percent received anisoylated plasminogen streptokinase activator complex, and 2 percent received streptokinase. Ninety-one percent of the patients also received heparin, the most commonly used adjunctive medication; 77 percent concomitantly received lidocaine; 62 percent received aspirin; and only 19 percent received a beta-blocker. CONCLUSIONS: Our data provide a reference point for future studies to determine factors that influence the selection of adjunctive agents for treating patients with acute myocardial infarction receiving thrombolytics.

Adrenergic beta-Antagonists↗

Effectiveness and tolerability of slow release lanreotide treatment in active acromegaly: six-month report on an Italian multicenter study. Italian Multicenter Slow Release Lanreotide Study Group.

The objective of the study was to determine the tolerability and effectiveness of the slow release (SR) somatostatin analog lanreotide in active acromegaly. Fifty-seven patients, unselected in terms of their previous responsiveness to octreotide therapy, were included in a prospective, open label study carried out at 6 Italian endocrinological centers. The effects of 6 months of SR lanreotide, given at first every 14 days at a dosage of 30 mg, im, were recorded. In some patients (33%), drug dosage was adjusted by increasing the dose (to 60 mg, im) and/or shortening the time interval (every 10 days) of SR lanreotide administration. Fifty patients completed the 6-month period of therapy; 2 subjects dropped out because of adverse events, and 5 dropped out because of ineffectiveness after changes in drug administration. The first SR lanreotide injection produced more than 50% suppression of GH levels from the basal value in 93% of patients. Thirteen days later, baseline GH levels were reduced by over 50% in 25% of patients. Mean GH values were normalized in 85% of patients after 6 months, whereas insulin-like growth factor I (IGF-I) levels were normalized in 38% of patients. No correlation was found between pretreatment GH levels and GH response to SR lanreotide or between changes in GH and IGF-I during therapy. During treatment, there was a significant reduction in the percentage of patients complaining of joint pain, hyperhydrosis, and paresthesias. Changes in soft tissue swelling were documented by significant decreases in finger measurements. Diarrhea and abdominal pain were the most frequent side-effects when therapy was started; these progressively decreased. After the first month of therapy, moderate, mild, and no side-effects were reported by 3%, 40%, and 53% of patients. A nonsignificant increase occurred in asymptomatic gallstones and amylase levels. Minimal changes were noted in carbohydrate tolerance, consisting of a slight increase in glycosylated hemoglobin, a rise in glucose and a decrease in pre- and postprandial insulin levels. No effects on PRL, free cortisol, TSH, or free thyroid hormone levels were noted. No significant change in the percentage of visual field abnormalities was noted. Decreases in pituitary tumor size occurred in 3 of 17 patients reevaluated after 6 months of therapy. The 6-month period of SR lanreotide therapy was compared, on an anamnestic basis, with a 6-month or longer period of sc octreotide therapy (median, 300 micrograms/day) in 34 patients. There were no differences in effectiveness or tolerability between the 2 somatostatin analogs. These data indicate that SR lanreotide at a dose of 30 mg, im, every 14 days is an effective treatment in most unselected acromegalic patients. When administered to a group of poorly responsive patients, an increase in drug dose (60 mg im) and/or a shortening of the drug interval (10 days) seem to improve the GH/IGF-I response. Tolerability to SR lanreotide therapy is high. The use of a new sustained release formulation of somatostatin analog is clearly advantageous in improving patient compliance with medical treatment for acromegaly.

Acromegaly↗

Fluconazole vs itraconazole-flucytosine association in the treatment of esophageal candidiasis in AIDS patients. A double-blind, multicenter placebo-controlled study. The Candida Esophagitis Multicenter Italian Study (CEMIS) Group.

STUDY OBJECTIVE: To assess the role and the therapeutic efficacy of fluconazole and itraconazole-flucytosine association compared with placebo, in the treatment of endoscopically diagnosed esophageal candidiasis in a selected population of AIDS patients. DESIGN: Double-blind, placebo-controlled study. SETTING: University Hospitals and AIDS Centers. PATIENTS: Eighty-five HIV-positive patients (53 men and 32 women; mean age, 28 years) at first episode of esophageal candidiasis diagnosed by endoscopy (grades I to II of Kodsi's endoscopic classification and grades I to IIa of Barbaro's clinical classification). All the patients selected for the study provided informed consent. INTERVENTIONS: The patients have been double blindly randomized in 3 groups of patients in relation to pharmacologic therapy: (1) the patients of the first group (n = 30) received fluconazole (3 mg/kg daily orally) and placebo (100 mg/kg/daily orally); (2) the patients of the second group (n = 30) received itraconazole (3 mg/kg daily orally) and flucytosine (100 mg/kg daily orally); and (3) the patients of the third group (n = 25) received placebo (3 mg/kg daily orally) and placebo (100 mg/kg daily orally). After 2 weeks of treatment, the patients previously randomized to receive placebo only were double blindly randomized to receive fluconazole+placebo or itraconazole+flucytosine. To evaluate the efficacy of pharmacologic therapy, clinical and endoscopic examinations were performed at weeks 2 and 4 and at the end of follow-up (3 months). RESULTS: At week 2, endoscopic cure (grade 0) was observed in 68.9% of the fluconazole+placebo group and in 72.4% of the itraconazole+flucytosine group (relative risk, 0.95; 95% confidence interval [CI], 0.68 to 1.33; p = 0.772); partial endoscopic response (grade I) was observed in 22.7% of the placebo group. Clinical cure (grade 0) was observed in 75.8% of fluconazole+placebo group and in 72.4% of itraconazole+flucytosine group (relative risk, 1.05; 95% CI, 0.77 to 1.42; p = 0.764), with a difference statistically significant for both treatments in comparison to placebo group (p < 0.001). Partial clinical response (grade I) was observed in 27.3% of the placebo group. At the end of follow-up, endoscopic cure was observed in 89.8% of the fluconazole+placebo group and in 94.8% of the itraconazole+flucytosine group (relative risk, 0.97; 95% CI, 0.83 to 1.08; p = 0.695). Clinical cure was observed in 94.8% of the fluconazole+placebo group and in 97.3% of the itraconazole+flucytosine group (relative risk, 0.97; 95% CI, 0.89 to 1.07; p = 0.981). CONCLUSIONS: The results of this study have demonstrated that both fluconazole and itraconazole+flucytosine association are efficacious in short-term treatment of esophageal candidiasis in AIDS patients with a statistically significant difference in comparison to placebo. Both therapeutic regimens demonstrated a good therapeutic efficacy, without statistically significant difference, between them, in the rate of endoscopic and clinical cure. Itraconazole+flucytosine association may represent an alternative therapeutic regimen for patients with fluconazole-resistant Candida esophagitis.

AIDS-Related Opportunistic Infections↗

Effects of treatment with octreotide in acromegalic patients--a multicenter Italian study. Italian Multicenter Octreotide Study Group.

Treatment of acromegaly is effective in reversing the reduced life-span of patients only when serum growth hormone (GH) concentrations are lowered to less than 2.5 micrograms/l. Usual treatments achieve this goal in no more than 50-60% of patients. The effects of octreotide were studied in a prospective, open label study with 68 acromegalic patients enrolled in 10 Italian centers. Octreotide was administered sc at a dose of 100 micrograms t.i.d. for 1 year. After 3 months of therapy, octreotide was effective in decreasing serum GH levels below 2.5 micrograms/l in 16 out of 64 acromegalic patients (25%). Fifteen of them had pretreatment GH levels below 25 micrograms/l. Insulin-like growth factor I (IGF-I) levels normalized in about 40% of patients. No further GH reduction was observed after 1 year of treatment. The presence of abnormal GH responses to thyrotropin-releasing hormone (TRH) and gonadotropin-releasing hormone was reduced from 54 to 24% and from 16 to 12%, respectively. Tumor shrinkage was observed in 50% of 26 non-irradiated patients after 12 months of treatment. Both basal and TRH-stimulated serum prolactin levels significantly decreased in the 11 hyperprolactinemic patients. Although serum thyrotropin, free triiodothyronine and free thyroxine concentrations were not modified, a significant reduction of thyrotropin response to TRH was observed in the 9th month of therapy. In non-diabetic patients, an increase of mean blood glucose levels without modifications of fasting morning concentrations was found. About one-quarter of the patients with overt diabetes mellitus had an impairment of their metabolic control. Main clinical symptoms of acromegaly improved in 70-80% of patients.(ABSTRACT TRUNCATED AT 250 WORDS)

Acromegaly↗

Low dose interferon-alpha2b combined with PUVA is an effective treatment of early stage mycosis fungoides: results of a multicenter study. Cutaneous-T Cell Lymphoma Multicenter Study Group.

BACKGROUND AND OBJECTIVE: The early stages of mycosis fungoides (MF) can be treated but not cured by photochemotherapy (PUVA) alone; some recent studies of the effect of a combination of human interferon-alpha (IFN(alpha)) and PUVA reported a high degree of response. The aim of our study was to evaluate the activity of a low dose of IFN-alpha2b combined with PUVA. DESIGN AND METHODS: Twenty-five patients were included: 16 men and 9 women aged between 23-80 years; 19 patients ahd stage I and 6 stage II disease. In the induction phase, the dose of IFNalpha was gradually raised over 6-8 weeks to the target dose of 18 MU/week; in the maintenance phase, the combination with PUVA allowed IFNalpha to be reduced to a maximum dose of 6 MU/week; in this way the cumulative administration of IFNalpha and PUVA was considerably lower than in similar combination protocols. Treatment success was analyzed in terms of freedom from treatment failure (FFTF). RESULTS: After the induction phase 9/25 patients (36%) achieved complete remission (CR) and 15/25 (56%) achieved partial remission (PR). One to five months from the beginning of the maintenance phase, a CR was recorded in 19/25 patients (76%) and a PR in 5/25 patients (20%) accounting for an overall response rate of 96%. The median of FFTF was not reached; probability of FFTF was 82% at 12 months and 62% at 24 months. Disease free survival projected to 48 months was 75%. INTERPRETATION AND CONCLUSIONS: Even with low doses of IFNalpha plus PUVA it is possible to achieve excellent clinical responses,many of which are long-lasting, in patients with early MF.

Adult↗

[Renal osteodystrophy in Spain. Multicenter survey. (I). Collaborative Centers of the Multicenter Study on Renal Osteodystrophy].

In order to know the current management of renal osteodystrophy in Spain we collected data from 172 centres (10,724 patients) obtained from a 30 questions enquiry designed to show different aspects of the current management of renal osteodystrophy. The levels considered the "goal" for treatment were: Calcium 10-10.5 mg/dL (53% of centres), 9.5-10 mg/dL (28%), 10.5-11 mg/dL (14%) and 9-9.5 mg/dL (5% of centres). Phosphorus: between 4.5 and 5.5 mg/dL (77% of centres), between 5.5 and 6.5 mg/dL (15%) and less than 4.5 mg/dL (8% of centres). Parathormone (PTH): between 120 and 250 pg/mL (75% of centres), between 60 and 120 pg/mL (19% of centres). The calcium concentration used in the dialysis fluids was 2.5 in 44% of centres, 3 in 28%, 3.5 in 26% and 2 mEq/L in the remaining 2% of centres. Pulse therapy was started with PTH higher than 750 in 16% of centres; with PTH higher than 500 pg/mL in 52% and with PTH higher than 250 pg/mL in 28% of the centres. Only 51% of centres decreased the calcium concentration in dialysis fluids when the patients were receiving parenteral calcitriol. Fifty-nine percent of centres considered a positive response to treatment any reduction in PTH levels, 24% of centres considered response a decrease of at least 20%, 78% of centres maintained the treatment with calcitriol 6 months before deciding if the patient was a "responder" or a "non-responder". Parathyroidectomy was performed when PTH was higher than 1,000 pg/mL in 38% of the centres; in 41% when PTH was between 1,000 and 750; in 19% when PTH was between 750 and 500; and when PTH was between 500 and 250 pg/mL in the remaining 2% of the centres. Five percent of the patients had a parathyroidectomy.

Chronic Kidney Disease-Mineral and Bone Disorder↗

Labyrinthotomy with streptomycin infusion: early results of a multicenter study. The LSI Multicenter Study Group.

Early results for hearing and vertigo are reported for 47 labyrinthotomies with streptomycin infusion (LSI) by 13 coinvestigator-surgeons. Sixty-eight percent of patients had worse hearing after surgery (10 dB or 15% word recognition). Patients with a preoperative pure-tone average better than or equal to 40 dB appeared to suffer less postoperative hearing loss than those with a greater preoperative deficit. Severe to profound postoperative hearing loss was experienced by 27 patients (57%), all of whom had preoperative pure-tone averages worse than 40 dB. Opening the endolymphatic space was associated with a deleterious effect on hearing. Because of persistent vertigo, 17 percent of patients required a secondary procedure during the period of observation. These early results indicate that LSI is associated with a significant risk of postoperative hearing loss. Of the 13 coinvestigator-surgeons, four have stopped using LSI, while one considers his results satisfactory. The remaining surgeons have taken an intermediate position and feel it is useful in selected cases. Longer follow-up is required to judge the efficacy of LSI for controlling vertigo. We are currently studying these long-term results.

Adult↗

[MIPS: multicenter Italian pneumonia study. Results of an observational, prospective and multicenter study on the clinical approach to community-acquired pneumonia].

In a survey of 25 Divisions of Internal Medicine and Pneumology throughout Italy, our study aimed to ascertain the diagnostic and therapeutic pathway, the gravity in accordance with Fine's score (PSI), the median hospital length of stay and mortality rate among patients consecutively hospitalized for community-acquired pneumonia (CAP), from January 1 to March 31, 2002. Overall 407 patients were evaluated, with a mean age of 69 years; the following Fine's scores: 28% less than 70, 21.4% between 71 and 90, 31.25% between 91 and 130, 19.4% more than130. A single chest radiography was performed in 27.2% of the patients, two chest radiographs in 55.2% of the patients, more than two chest radiographs in 13.2% of the patients. A CT scan of the thorax was performed in 20.1% of the patients; arterial blood gas tensions were measured in 73.4% of the patients. Antibiotics were used as follows: beta-lactams in 46.5% of the patients, fluoroquinolones in 30% of the patients, macrolides in 13.2% of the patients, glycopeptides in 2.2% of the patients, others in 2.9% of the patients. Mean hospital stay was 11 days; the 30-day in-hospital mortality was 9.6%. This study showed that a large number of patients with low-risk CAP were unnecessarily hospitalized.

Adolescent↗

Peritonitis occurrence in a multicenter study of icodextrin and glucose in CAPD. MIDAS Study Group. Multicenter Investigation of Icodextrin in Ambulatory Dialysis.

OBJECTIVE: To compare peritonitis occurrence and outcome in a large U.K. study Multicentre Investigation of Icodextrin in Ambulatory Dialysis (MIDAS). DESIGN: Prospective, randomized, controlled 6-month comparison of icodextrin with glucose for the long dwell in continuous ambulatory peritoneal dialysis (CAPD) patients. SETTING: Eleven CAPD units in U.K. teaching hospital. PATIENTS: A total of 209 patients established on CAPD for at least 3 months (103 control, 106 icodextrin). Twenty-three control (C) and 22 icodextrin (I) patients experienced peritonitis during the study. INTERVENTION: Patients who had peritonitis remained on treatment (unless CAPD was withdrawn, temporarily or permanently). MAIN OUTCOME MEASURES: The main outcome measures were the rate of peritonitis and duration of CAPD treatment prestudy; the rate of peritonitis episodes and their outcome during study; the effect of peritonitis on laboratory variables, serum icodextrin metabolites, and ultrafiltration efficacy. RESULTS: Prestudy: Nine (39%) of C but 14 (64%) of I patients had suffered previous peritonitis episode(s), with overall rates of 0.58 and 0.78 episodes per patient-year, respectively. DURING STUDY: There were 31 C episodes and 35 I episodes, with overall rates of 0.76 and 0.93 per patient-year, respectively. The increase in the C and I groups was 31% and 19%, respectively. Serum osmolality and sodium levels were unaffected by peritonitis, and there was no increase in serum icodextrin metabolites during peritonitis. Overnight ultrafiltration volume during peritonitis (mean +/- SD) declined slightly from 218 +/- 354 mL to 185 +/- 299 mL (NS) in the control group, but increased in the icodextrin group from 570 +/- 146 mL to 723 +/- 218 mL (p < 0.01). CONCLUSIONS: Using icodextrin for the long dwell in CAPD does not increase the rate of peritonitis, nor does it alter the outcome of peritonitis. Peritonitis does not affect uptake of icodextrin from the peritoneum.

Chlorides↗

Immunoradiometric versus enzymatic renin assay: results of the Italian Multicenter Comparative Study. Italian Multicenter Study for Standardization of Renin Measurement.

OBJECTIVES: The measurement of plasma renin activity (PRA) is very convenient for estimating the action of the renin system, but its interlaboratory reproducibility is notoriously poor. This multicentre study aimed to examine whether an immunoradiometric assay which quantifies renin directly with monoclonal antibodies can reduce this limitation of the enzymatic assay. The study also aimed to establish the reference values of immunoreactive renin (IrR) in a large sample of normotensive subjects and patients with various pathophysiological conditions. DESIGN AND METHODS: PRA and IrR were measured once in each of the eight participant centres in eight pool plasma samples with a wide range of renin content; in seven centres these measurements were repeated twice more in order to compare the intralaboratory interassay reproducibility of both methods. Finally, PRA and IrR were measured in the supine and standing positions in 503 subjects including normal controls, patients with various forms of hypertension, patients with Cushing's and Bartter's syndromes, patients with hepatic cirrhosis and pregnant women. RESULTS: We found that both the inter- and intralaboratory coefficients of variation for PRA measurements were higher than those for IrR. In plasma samples from normal subjects and from patients, mean +/- SEM supine PRA and IrR ranged, respectively, from 0.08 +/- 0.03 ng/ml per h and 2.6 +/- 0.5 pg/ml in patients with Conn's syndrome to 7.2 +/- 2.5 ng/ml per h and 138 +/- 51 pg/ml in patients with hepatic cirrhosis. PRA and IrR were found to be significantly correlated in all laboratories (mean +/- SEM of correlation coefficients 0.84 +/- 0.03) and for all of the conditions (correlation coefficient ranging from 0.98 in patients with Cushing's syndrome to 0.50 in pregnant women). However, for the pregnant women the slope of the regression line depicting the PRA-IrR relationship was significantly steeper than for all of the other conditions. CONCLUSIONS: In our experience the inter- and intralaboratory reproducibilities of the immunoradiometric assay appear to be greater than can be achieved with the enzymatic assay, the difference being probably due to the greater complexity of the latter. The two methods provide superimposable information on the renin-angiotensin system activity, except in pregnancy, during which the PRA:IrR ratio is much higher than in the other conditions. Therefore, in this and other pathophysiological situations associated with marked angiotensinogen concentration alterations, the enzymatic assay may be still preferable for assessing the activity of the system accurately.

Adolescent↗

Efficacy and safety of enalapril versus extended-release nifedipine for the treatment of mild-to-moderate essential hypertension: a multicenter 22-week study. Multicenter Cooperative Study Group.

The antihypertensive effects and tolerability of single daily doses of enalapril and extended-release nifedipine (nifedipine-ER) were compared in an open-label, randomized, parallel-group, 22-week treatment study involving 230 men and women (mean age, 55 years). Following a 3-week washout period, mean +/- SD blood pressure levels were 153 +/- 17/99 +/- 4 mmHg in the enalapril group (n = 117) and 157 +/- 17/100 +/- 5 mmHg in the nifedipine-ER group (n = 113). Beginning at 5 mg once daily for enalapril and 30 mg once daily for nifedipine-ER, the dosage was titrated every 4 weeks for 16 weeks, up to a maximum of 40 mg for enalapril and 120 mg for nifedipine-ER. The treatment goal (satisfactory response) was to lower trough sitting diastolic blood pressure to < 90 mmHg or by at least 10 mmHg to a level of < 100 mmHg. At a mean daily dose of 16 mg of enalapril and 57 mg of nifedipine-ER, more than three quarters of each treatment group achieved a satisfactory response. The mean reductions in trough sitting blood pressure levels at the end of 22 weeks of treatment were 15/11 mmHg for enalapril and 21/13 mmHg for nifedipine-ER. The difference between treatments was significant only for the change in systolic blood pressure (P < 0.05). However, enalapril was better tolerated than nifedipine-ER. The numbers of patients with adverse experiences and withdrawals from the study because of an adverse experience were significantly lower for enalapril than for nifedipine-ER (P < 0.05). The incidence of abnormal laboratory findings was small and considered of no clinical importance in either group. These data suggest that enalapril and nifedipine-ER had approximately equal efficacy as once-daily antihypertensive treatments, but enalapril was better tolerated.

Delayed-Action Preparations↗

Therapy for oropharyngeal candidiasis in HIV-infected patients: a randomized, prospective multicenter study of oral fluconazole versus clotrimazole troches. The Multicenter Study Group.

A total of 334 HIV-infected patients with oral candidiasis were randomly assigned to receive 14 days of treatment with either 100 mg of oral fluconazole once daily or 10 mg clotrimazole five times daily. Both treatments were clinically effective: 98% of evaluable fluconazole-treated patients and 94% of evaluable clotrimazole-treated patients were cured or showed improvement (p = NS). Fluconazole was more effective than clotrimazole in eradicating Candida from the oral flora by the end of therapy (65% versus 48%) (p = 0.005). In addition, patients in the fluconazole-treated group were more likely to remain asymptomatic through the second week of follow-up (82.3% versus 50.0%) (p < 0.001). This difference was no longer evident by the post-therapy visit during week 4. Seven patients treated with clotrimazole and two patients treated with fluconazole discontinued therapy because of side effects. Two patients in the fluconazole group were withdrawn from therapy because of elevated serum glutamic-oxaloacetic transaminase levels, one considered possibly related to drug therapy. Fluconazole was as effective as clotrimazole in the treatment of oral candidiasis and temporarily provided a more prolonged disease-free state. Future studies are needed to define the optimal regimen for both the treatment and prevention of recurrent oral candidiasis in HIV-infected patients, addressing special attention to the issue of compliance, cost, and emergence of resistance.

AIDS-Related Opportunistic Infections↗