Efficacy and safety of etoricoxib 30 mg and celecoxib 200 mg in the treatment of osteoarthritis in two identically designed, randomized, placebo-controlled, non-inferiority studies.

OBJECTIVE: To compare the efficacy of etoricoxib 30 mg with the generally maximum recommended dose of celecoxib, 200 mg, in the treatment of osteoarthritis (OA) in two identically designed studies. METHODS: Two multi-centre, 26-week, double-blind, placebo-controlled, non-inferiority studies were conducted, enrolling patients who were prior non-steroidal anti-inflammatory drug (NSAID) or acetaminophen users. There were 599 patients in study 1 and 608 patients in study 2 randomized 4:4:1:1 to etoricoxib 30 mg qd, celecoxib 200 mg qd or one of two placebo groups for 12 weeks. After 12 weeks, placebo patients were evenly distributed to etoricoxib or celecoxib based on their initial enrollment randomization schedule. The primary hypothesis was that etoricoxib 30 mg would be at least as effective as celecoxib 200 mg for the time-weighted average change from baseline over 12 weeks for Western Ontario and McMaster (WOMAC) Pain Subscale, WOMAC Physical Function Subscale and Patient Global Assessment of Disease Status. Active treatments were also assessed over the full 26 weeks. Adverse experiences were collected for safety assessment. RESULTS: In both studies, etoricoxib was non-inferior to celecoxib for all three efficacy outcomes over 12 and 26 weeks; both were superior to placebo (P < 0.001) for all three outcomes in each study over 12 weeks. The safety and tolerability of etoricoxib 30 mg qd and celecoxib 200 mg qd were similar over 12 and 26 weeks. CONCLUSIONS: Etoricoxib 30 mg qd was at least as effective as celecoxib 200 mg qd and had similar safety in the treatment of knee and hip OA; both were superior to placebo. ClinicalTrials.gov Identifiers: NCT00092768; NCT00092791.

Efficacy and safety of rofecoxib 12.5 mg and celecoxib 200 mg in two similarly designed osteoarthritis studies.

OBJECTIVE: To compare the lower osteoarthritis (OA) dose of rofecoxib to the recommended dose of celecoxib in two identically designed studies. METHODS: Patients with knee OA were randomized (2:2:1 ratio: rofecoxib 12.5 mg once daily (qd), celecoxib 200 mg qd, or placebo, respectively). The primary endpoint was patient global assessment of response to therapy (PGART) averaged over 6 weeks on a five-point scale. Rofecoxib would be declared at least as effective as celecoxib if the lower bound of the 95% confidence interval (95% CI) for difference in means was no lower than -0.5. Additional endpoints included Pain and Physical Function subscales of the Western Ontario and McMaster (WOMAC) OA Index. Adverse experiences (AEs) were recorded and combined from the two studies for analysis. RESULTS: Study 1 enrolled 395 patients (rofecoxib, n = 160; celecoxib, n = 157; placebo, n = 78). Study 2 enrolled 413 patients (rofecoxib, n = 159; celecoxib, n = 169; placebo, n = 85). Rofecoxib 12.5 mg was at least as effective as celecoxib 200 mg by PGART (Study 1 difference -0.09 [95% CI: -0.32, 0.14] and Study 2 difference 0.02 [95% CI: -0.20, 0.24]), and both were significantly (p < 0.001) more effective than placebo. Comparable efficacy was also seen for WOMAC Pain and Physical Function subscales with the active treatments. There was a significantly higher (p < 0.05) incidence of serious AEs with celecoxib than rofecoxib or placebo, none of which was drug-related. There were no significant differences in the pre-specified measurements of safety including drug-related AEs or discontinuations due to AEs, and the medications demonstrated similar safety as assessed by spontaneous reporting. CONCLUSIONS: Rofecoxib 12.5 mg and celecoxib 200 mg provided comparable efficacy over 6 weeks, and both were significantly more efficacious than placebo. The medications demonstrated similar safety compared to one another and placebo. The primary limitations of these studies were that they were only 6 weeks long and were powered for efficacy. Therefore, conclusions about long-term safety cannot be inferred.

Review article: impact of night-time reflux on lifestyle - unrecognized issues in reflux disease.

Gastro-oesophageal reflux disease (GERD), manifesting with symptoms including heartburn and regurgitation, affects people during both daytime and nocturnal hours. Night-time GERD has been reported to have a greater impact on a patient's life than daytime GERD due to prolonged oesophageal acid exposure time per reflux episode. To further understand this issue, it is important to implement quality of life (QOL) measures. QOL studies are becoming increasingly important to physicians in making clinical decisions, and generic and disease-specific health-related QOL (HRQL) tools have been developed to measure a wide variety of topics. There are currently no universally accepted guidelines on how to best measure HRQL in GERD patients. It is important to note that these surveys may not yield accurate results because many GERD sufferers may feel that their symptoms are not serious enough to seek treatment. Some surveys include the GERD-HRQL assessment, the Short Form Health Survey (SF-36), and the Gallup survey. When compared with daytime GERD patients, night-time GERD patients may suffer from sleep deprivation, which in turn leads to physical and emotional problems and a poor overall QOL. Studies indicate that the prevalence and impact of night-time heartburn have been underestimated and that adequate treatment of symptoms is often not achieved. In addition, GERD greatly affects work productivity and leads to a significant economic burden on society. Although limited studies are available on the impact of pharmacological treatment on GERD QOL, recent findings indicate that proton pump inhibitors are more effective than H(2)-receptor antagonists for the improvement of overall QOL.

Clinical efficacy of topical docosanol 10% cream for herpes simplex labialis: A multicenter, randomized, placebo-controlled trial.

BACKGROUND: Recurrent herpes simplex labialis (HSL) occurs in 20% to 40% of the US population. Although the disease is self-limiting in persons with a healthy immune response, patients seek treatment because of the discomfort and visibility of a recurrent lesion. OBJECTIVE: Our purpose was to determine whether docosanol 10% cream (docosanol) is efficacious compared with placebo for the topical treatment of episodes of acute HSL. METHODS: Two identical double-blind, placebo-controlled studies were conducted at a total of 21 sites. Otherwise healthy adults, with documented histories of HSL, were randomized to receive either docosanol or polyethylene glycol placebo and initiated therapy in the prodrome or erythema stage of an episode. Treatment was administered 5 times daily until healing occurred (ie, the crust fell off spontaneously or there was no longer evidence of an active lesion) with twice-daily visits. RESULTS: The median time to healing in the 370 docosanol-treated patients was 4.1 days, 18 hours shorter than observed in the 367 placebo-treated patients (P =.008; 95% confidence interval [CI]: 2, 22). The docosanol group also exhibited reduced times from treatment initiation to (1) cessation of pain and all other symptoms (itching, burning, and/or tingling; P =.002; 95% CI: 3, 16.5); (2) complete healing of classic lesions (P =.023; 95% CI: 1, 24.5); and (3) cessation of the ulcer or soft crust stage of classic lesions (P <.001; 95% CI: 8, 25). Aborted episodes were experienced by 40% of the docosanol recipients versus 34% of placebo recipients (P =.109; 95% CI for odds ratio: 0.95, 1.73). Adverse experiences with docosanol were mild and similar to those with placebo. CONCLUSION: Docosanol applied 5 times daily is safe and effective in the treatment of recurrent HSL. Differences in healing time compared favorably with those reported for the only treatment of HSL that has been approved by the Food and Drug Administration.

Using a flow sheet to improve performance in treatment of elderly patients with type 2 diabetes.

BACKGROUND AND OBJECTIVES: Numerous studies have shown that physicians do not provide all the preventive and therapeutic care recommended for patients with diabetes. This study determined if use of a medical record flow sheet could increase compliance with seven quality-of-care indicators developed by the American Diabetes Association. METHODS: Subjects included Medicare enrollees with type 2 diabetes. Following an analysis of baseline data, physicians in the practice used a flow sheet that contained recommended guidelines for diabetes care. Staff inserted the flow sheet into the records of patients included in the baseline sample. Physicians and staff also received education about use of the flow sheet. The post-intervention sample consisted of the same subjects, if they had been seen by the practice during a 3-month period. RESULTS: The records of 114 subjects were reviewed at baseline. Of these subjects, 109 received care during the study period. Improvement was shown in six of the seven quality indicators and was also observed in the performance of post-intervention rates for patients whose flow sheet was used, compared with those for whom it was not used. CONCLUSIONS: The results indicate that education and performance in diabetes care can improve with the use of a flow sheet.

Slowing the initial titration rate of tramadol improves tolerability.

STUDY OBJECTIVES: To examine the effect of three titration schedules on the tolerability of tramadol, and to determine whether slow titration would reduce the frequency of drug discontinuation due to adverse events. DESIGN: Multicenter, outpatient, double-blind, parallel study. SETTING: Twenty-eight outpatient study centers. SUBJECTS: Four hundred sixty-five patients with chronic joint pain Interventions. Patients were randomized into one of four treatment groups for 14 days: placebo, or tramadol dosage titrated at 1, 4, or 10 days to achieve the study target dosage of 200 mg/day. They continued taking their dosage of nonsteroidal antiinflammatory drug during the study. Each group was examined to determine if slower titration resulted in a statistically significant trend toward fewer discontinuations due to nausea and/or vomiting and dizziness and/or vertigo. Discontinuation due to any adverse event was similarly analyzed. If the trend was statistically significant, pairwise comparisons were performed to determine the statistical significance among titration rates. MEASUREMENTS AND MAIN RESULTS: A statistically significant trend was seen toward fewer discontinuations as a result of nausea/vomiting, dizziness/vertigo, and any adverse event as the titration rate decreased. Patients with 10-day titration rate required the fewest discontinuations, and this rate was statistically significantly different from both the 1- and 4-day rates for discontinuations. CONCLUSION: A slower rate of initiating tramadol therapy (50-mg increments every 3 days) improved tolerability with significantly fewer discontinuations due to dizziness or vertigo.

A multicenter, investigator-blinded, randomized comparison of oral levofloxacin and oral clarithromycin in the treatment of acute bacterial sinusitis.

A multicenter, investigator-blinded, randomized, parallel-group study was conducted to compare oral levofloxacin 500 mg once/day for 14 days with clarithromycin 500 mg twice/day for 14 days in the treatment of acute bacterial sinusitis. Of 216 adult outpatients randomized to treatment, 190 were evaluable for efficacy. The primary efficacy measure was clinical response, based on resolution of signs and symptoms 2-5 days after therapy. A secondary efficacy measure was relapse rate 1 month after therapy. Among evaluable patients, clinical success rates (cured or improved) were 96.0% and 93.3% for levofloxacin (L) and clarithromycin (C), respectively (95% CI -9.2%, 3.7%). The confidence interval (CI) for treatment difference (C-L) included zero and its upper limit was less than 15%, indicating that levofloxacin was as effective as clarithromycin. In all, 4.1% of patients receiving levofloxacin and 7.2% receiving clarithromycin had a relapse of symptoms 1 month after therapy (95% CI-12.2%, 3.2%). Long-term success (initial success, absence of relapse at 1 month, no further antibacterial therapy 2-5 days after therapy) was 79.2% in the levofloxacin group and 76.4% in the clarithromycin group (95% CI -14.7%, 9.0%). Based on investigator-assessed treatment-emergent adverse events, overall tolerability of the drugs was similar, except for a higher frequency of taste perversion and diarrhea in the clarithromycin group. Levofloxacin had an advantage over clarithromycin based on two quality-of-life (QOL) parameters: number of times taking other drugs for targeted medical conditions and mean total cost of these drugs. No statistical significance was found in other QOL variables. These findings suggest that the efficacy and tolerability of levofloxacin 500 mg once/day are comparable with those of clarithromycin 500 mg twice/day in the treatment of acute bacterial sinusitis.

Upper respiratory tract infections in family practice.

The causative pathogens in the majority of mild to moderate upper respiratory tract infections are Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis. Bacterial infections of the respiratory tract are often treated empirically; however, the recent increase in serious infections caused by S. pneumoniae and rising antimicrobial resistance rates have prompted experts to reevaluate the therapeutic approaches to treatment of these infections. Although amoxicillin continues to be considered a first line therapy, some situations warrant alternative therapies. Antimicrobial therapy must provide effective coverage of the potential pathogens, yet issues of compliance must also be addressed to ensure clinical success. Ease of administration, taste and the potential for adverse events are important considerations for the pediatric population. Clinical trials support the use of alternative therapies in the treatment of patients with upper respiratory tract infections.

Management of pain in patients with multiple health problems: a guide for the practicing physician.

Chronic pain is a universal problem that is especially prevalent in the elderly population. Current drug therapy for pain management is limited to acetaminophen, centrally acting analgesics (opioids), and nonsteroidal anti-inflammatory drugs (NSAIDs). Although NSAIDs are the most commonly used drugs for the treatment of chronic pain, their use is associated with a high degree of gastrointestinal (GI) and renal morbidity. Furthermore, practicing physicians are faced with the dual challenge of controlling chronic pain, as well as controlling the side effects of pain medication, in patients with multiple health problems. Polypharmacy and the use of over-the-counter (OTC) medications are important considerations in this cohort of patients. A comprehensive pharmacologic treatment strategy includes NSAIDs and, when NSAIDs are deemed inappropriate, other suitable pain medications.

The impact of nonsteroidal anti-inflammatory drugs on hypertension: alternative analgesics for patients at risk.

An estimated 25% of the overall population of the United States and 55% to 60% of the population aged 65 to 74 years are hypertensive. Many patients with hypertension, particularly elderly patients, also take nonsteroidal anti-inflammatory drugs (NSAIDs), the most commonly prescribed analgesic medications in the United States. It is estimated that as many as 20 million patients and 12% of the population aged > or = 60 years are taking concurrent NSAIDs and antihypertensive medication. This overlap is significant, because NSAIDs inhibit eicosanoid synthesis and can thus limit the effectiveness of antihypertensive drugs that exert all or part of their blood-pressure-lowering action through the stimulation of eicosanoid synthesis or release. Overviews of clinical trial data indicate that the blood pressure of patients with controlled hypertension can be raised by 3 to 6 mm Hg during concurrent treatment with NSAIDs, which can produce a significant increase in subsequent stroke, end-stage renal disease, or congestive heart failure. The incidence of these sequelae increases with age. Clinicians should have greater awareness of the potential impact of NSAIDs on blood pressure control, especially in high-risk patients such as the elderly and those with chronic pain or uncontrolled hypertension. Unless an NSAID is deemed absolutely necessary, the clinician should consider alternative analgesics that do not affect prostaglandin synthesis. These include acetaminophen, tramadol, and, in some cases, narcotic analgesics.

Chronic low back pain: new perspectives and treatment guidelines for primary care: Part II.

Low back pain is a leading cause of work-related disability and has important socioeconomic consequences. Although there is little evidence to determine the optimal treatment of chronic low back pain, treatment goals can be established. Primary care providers should focus simultaneously on pain management, improvement of activity and functional level, and fostering a greater understanding of chronic low back pain. This two-part article summarizes consensus guidelines developed by practitioners with expertise in pain management, family medicine, internal medicine, physical therapy, rheumatology, and managed care and provides direction for primary care providers on a multidisciplinary approach to the patient with chronic low back pain. This part examines pharmacologic methods.

Chronic low back pain: new perspectives and treatment guidelines for primary care: Part I.

Low back pain is a leading cause of work-related disability and has important socioeconomic consequences. Although there is little evidence to determine the optimal treatment of chronic low back pain, treatment goals can be established. Primary care providers should focus on pain management, improvement of activity and functional level, and fostering a greater understanding of chronic low back pain. This two-part article summarizes consensus guidelines developed by practitioners with expertise in pain management, family medicine, internal medicine, physical therapy, rheumatology, and managed care, and provides direction for primary care providers on a multidisciplinary approach to the patient with chronic low back pain.

Sustained normotension in hypertensive patients withdrawn from medication for 1 year.

BACKGROUND AND OBJECTIVES: Prior research indicates that up to 5% of hypertensive subjects can be successfully withdrawn from antihypertensive medications. This study determined if, in a family practice setting, greater than 5% of patients with mild essential hypertension could be withdrawn from their antihypertensive medication for more than 1 year and remain normotensive. METHODS: We enrolled 116 randomly chosen volunteer patients. Of these, 96% were white, and 58% were female. The mean age was 57, and the mean history of hypertension was 10.1 years. RESULTS: A total of 81 subjects completed the study; 46.9% of those 81 remained normotensive for 1 year after stopping medication. Females tended to do better than males at withdrawing from antihypertensives (58% versus 33%). CONCLUSIONS: The proportion of patients who successfully withdrew from antihypertensive medication for 1 year and remained normotensive was significantly greater than expected. Further studies are needed to identify factors that predict which patients will remain normotensive without medication.

Depression in the patient with chronic pain.

The management of patients with chronic pain is a challenging clinical problem that frequently requires a multi-disciplinary approach. Depression is a common comorbidity associated with chronic pain, occurring in as many as 50% of chronic pain patients. Depression may develop secondarily or independently of the chronic pain syndrome, or it may occur as the primary cause of chronic pain. Regardless of their etiology, evidence exists to suggest that depression and chronic pain share common biologic pathways, namely, the serotonergic (5-HT) and noradrenergic systems. Chronic pain patients who are depressed require aggressive, full-dose treatment with antidepressants. Treatment should be selected based on a prior clinical response, the side-effect profile, the dosing schedule, and the potential for drug interactions. The newer antidepressants, including the selective serotonin reuptake inhibitors venlafaxine and nefazodone, are therapeutic options for the treatment of depression in the patient with chronic pain.

Recurrent streptococcal pharyngitis. Using practical treatment options to interrupt the cycle.

Most family physicians have seen cases like this: A child is brought in with pharyngitis, which responds to antibiotic therapy. Soon the mother comes in with fever and a sore throat. She also recovers with therapy, but soon she's back with the child, who has pharyngitis again. Dr Ruoff explains why streptococcal infection recurs and how to assess probability so treatment can be started without waiting for test results. He also discusses alternatives to standard penicillin therapy, some of which may avoid the problems of noncompliance.

Effectiveness of short-course therapy (5 days) with cefuroxime axetil in treatment of secondary bacterial infections of acute bronchitis.

Five hundred thirty-seven patients were enrolled in two independent, investigator-blinded, multicenter, randomized clinical trials comparing the clinical and bacteriologic efficacies and the safety of 5- or 10-day treatment with cefuroxime axetil with those of 10-day treatment with amoxicillin-clavulanate in the treatment of secondary bacterial infections of acute bronchitis. Patients received either 5 or 10 days of treatment (n = 177 in each group) with cefuroxime axetil at 250 mg twice daily or 10 days of treatment (n = 183) with amoxicillin-clavulanate at 500 mg three times daily. Patients in the cefuroxime axetil (5 days) group received placebo on days 6 to 10. Bacteriologic assessments were based on sputum specimen cultures obtained preceding and, when possible, following treatment. Organisms were isolated from the pretreatment sputum specimens of 242 of 537 (45%) patients, with the primary pathogens being Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Streptococcus pneumoniae, and Staphylococcus aureus (28, 25, 13, 9, and 8% of isolates, respectively). Pathogens were eradicated or presumed to be eradicated in 87% (52 of 60), 91% (53 of 58), and 86% (60 of 70) of bacteriologically evaluable patients treated with cefuroxime axetil (5 days), cefuroxime axetil (10 days), and amoxicillin-clavulanate, respectively. A satisfactory clinical outcome (cure or improvement) was achieved in 82% (107 of 130), 86% (117 of 136), and 83% (130 of 157) of the clinically evaluable patients treated with cefuroxime axetil (5 days), cefuroxime axetil (10 days), and amoxicillin-clavulanate, respectively. Treatment with amoxicillin-clavulanate was associated with a significantly higher incidence of drug-related adverse events than was treatment with cefuroxime axetil for either 5 or 10 days (P = 0.001), primarily reflecting a higher incidence of drug-related gastrointestinal adverse events (37 versus 19 and 15%, respectively; P < 0.001), particularly diarrhea and nausea. These results indicate that treatment with cefuroxime axetil at 250 mg twice daily for 5 days is as effective as treatment for 10 days with either the same dose of cefuroxime axetil or amoxicillin-clavulanate at 500 mg three times daily in patients with acute bronchitis. In addition, treatment with cefuroxime axetil for either 5 or 10 days is associated with significantly fewer gastrointestinal adverse events, particularly diarrhea and nausea, than is 10-day treatment with amoxicillin-clavulanate.

Clinical comparison of cefuroxime axetil and amoxicillin/clavulanate in the treatment of patients with secondary bacterial infections of acute bronchitis.

Two independent, investigator-blinded, multicenter, randomized clinical trials compared the clinical and bacteriologic efficacy and safety of two oral antibiotics, cefuroxime axetil and amoxicillin/clavulanate, in the treatment of patients with secondary bacterial infections of acute bronchitis (hereafter denoted acute bronchitis). Three hundred sixty patients with signs and symptoms of acute bronchitis were enrolled at 22 centers and were randomly assigned to receive 10 days of treatment with either cefuroxime axetil 250 mg twice daily (BID) (n= 177) or amoxicillin/clavulanate 500 mg three times daily (TID) (n = 183). Patients were assessed for both clinical and bacteriologic responses once during treatment (at 3 to 5 days) and twice after treatment (at 1 to 3 days and at 13 to 15 days). Bacteriologic assessments were based on sputum specimen cultures obtained before treatment and, when possible, after treatment. Organisms were isolated from the pretreatment sputum specimens of 162 (45%) of 360 patients, with the primary pathogens being Haemophilus influenzae, Haemophilus parainfluenzae, Streptococcus pneumoniae, Moraxella catarrhalis, and Staphylococcus aureus (28%, 25%, 11%, 9%, and 8% of isolates, respectively). Thirty-four percent of the H influenzae isolates and 94% of the M catarrhalis isolates that were tested for beta-lactamase production were positive. A satisfactory clinical outcome (cure or improvement) was achieved in 86% (117 of 136) and 83% (130 of 157) of the clinically assessable patients treated with cefuroxime axetil or amoxicillin/clavulanate, respectively (P = 0.45). With respect to the eradication of bacterial pathogens, a satisfactory outcome (cure, presumed care, or cure with colonization) was obtained in 91% (53 of 58) and 86% (60 of 70) of bacteriologically assessable patients treated with cefuroxime axetil or amoxicillin/clavulanate, respectively (P = 0.32). Treatment with amoxicillin/clavulanate was associated with a significantly higher incidence of drug-related adverse events than was treatment with cefuroxime axetil (39% vs 23%; P = 0.001), primarily reflecting a higher incidence of drug-related gastrointestinal adverse events (37% vs 15%; P < 0.001), particularly diarrhea and nausea. Four patients in the cefuroxime axetil group and eight patients in the amoxicillin/clavulanate group withdrew from the study because of drug-related adverse events. These results indicate that cefuroxime axetil 250 mg BID is as effective as amoxicillin/clavulanate 500 mg TID in the treatment of patients with acute bronchitis but produces fewer gastrointestinal adverse events, particularly diarrhea and nausea.

Efficacy and safety of a seven-day, transdermal estradiol drug-delivery system: comparison with conjugated estrogens and placebo. The Transdermal Estradiol Patch Study Group.

OBJECTIVE: To evaluate the efficacy and safety of a new, seven-day, transdermal estradiol system in healthy postmenopausal women with hot flushes. METHODS: Two studies are described. In the first study, subjects were randomized to treatment with a 0.05 mg/day estradiol patch, a 0.1 mg/day estradiol patch, or a placebo patch; and in the second study, to treatment with either of the two estradiol patches or oral conjugated estrogens (as Premarin) 0.625 mg/day. Efficacy was evaluated on the basis of diary entries recording hot-flush frequency and severity. Subjects' and investigators' global assessments of treatment efficacy were recorded at follow-up visits. RESULTS: In Study 1, both the 0.05-mg and 0.1-mg estradiol patches were significantly more effective than placebo in reducing hot flushes and were associated with higher global assessments. In Study 2, all three active treatments produced a significant reduction in the number of hot flushes compared with base-line. There were no statistically significant between-group differences, although the response to the 0.1-mg estradiol patch was greater, and to the 0.05-mg estradiol patch less, than the response to conjugated estrogens. The patches were generally well tolerated. Skin irritation from the patch was the most common adverse experience in both studies. CONCLUSIONS: The new, seven-day, transdermal system effectively and safely treats post-menopausal vasomotor symptoms.

Double-blind comparison of itraconazole and placebo in the treatment of tinea corporis and tinea cruris.

BACKGROUND: Tinea corporis and tinea cruris are usually treated with a topical antifungal agent unless the infection is unresponsive, involves an extensive area, is chronic, or is in a difficult-to-access area. In these cases oral antifungals are frequently used. OBJECTIVE: This double-blind study was undertaken to determine whether a 2-week course of oral itraconazole would produce statistically significant clinical and mycologic improvement in the treatment of tinea corporis, tinea cruris, or both, over the results obtained with placebo. A second objective was to determine the safety of itraconazole, through routine measurements of serum chemistry profiles. METHODS: Sixty-seven patients were entered into a double-blind, multicenter study to compare the clinical and mycologic effects of itraconazole, 100 mg daily (45 patients), and placebo (22 patients) on tinea corporis and/or tinea cruris. The duration of treatment was 2 weeks. The investigators assessed signs and symptoms and performed a potassium hydroxide examination and culture at baseline, at termination of therapy, and 2 weeks after completion of treatment. RESULTS: Twenty-two (96%) of 23 evaluable patients in the itraconazole group had healed or markedly improved lesions, as compared with 5 of 13 (39%) in the placebo group (p < or = 0.01). Similarly, the condition in 13 of 23 patients (57%) in the itraconazole group was mycologically cleared at the end of treatment whereas this result occurred in only 2 (17%) of 12 patients in the placebo group (p = 0.02). The prevalence of adverse side effects was lower for the itraconazole-treated group (20%) than for the placebo-treated group (36%). CONCLUSION: Itraconazole 100 mg once daily is an effective agent for the treatment of tinea cruris and tinea corporis.