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Biomedical subjects

G E Ruoff

Publications and source records attributed to G E Ruoff.

At least 19 recordsLinked to original sources

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.

Adult↗

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.

Acute Disease↗

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.

Aged↗

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.

Absenteeism↗

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.

Analgesics↗

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.

Adult↗

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.

Anti-Bacterial Agents↗

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.

Acute Disease↗

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.

Acute Disease↗

Headache in elderly patients. How to recognize and manage benign types.

Headaches in elderly persons are usually benign. Nevertheless, the possibility of underlying organic disease increases with age. To facilitate diagnosis and determine suitable treatment, primary care physicians should become familiar with diagnostic criteria for common causes of headache in elderly persons. Thorough physical examination and history taking can help rule out many underlying diseases. Benign headaches can usually be managed successfully with available non-pharmacologic and/or pharmacologic interventions. When organic disease (eg, temporal arteritis, cerebrovascular disease, tumor) is suspected, referral to an appropriate specialist may be indicated.

Aged↗

Loracarbef (LY163892) versus cefaclor in the treatment of bacterial skin and skin-structure infections in an adult population.

Loracarbef (LY163892), a member of the class of beta-lactam antibiotics known as carbacephems, is characterized by a high level of chemical stability and a broad spectrum of antibacterial activity that persists in the presence of beta-lactamase. The efficacy and safety of loracarbef, 200 mg (twice daily), and cefaclor, 250 mg (three times daily) (one patient received 178 mg of cefaclor suspension, three times daily), were compared in a randomized, double-blind, multicenter trial conducted in adults with skin and skin-structure infections due predominantly to Staphylococcus aureus. Examination within 72 hours after the completion of therapy indicated a favorable clinical response in 84 (93.3%) of the 90 loracarbef-treated patients evaluable for efficacy and in 79 (95.2%) of the 83 evaluable patients treated with cefaclor. Pathogens were eradicated in 83 (92.2%) of the patients in the loracarbef group and 74 (89.2%) of those in the cefaclor group. Only four adverse events--headache/migraine, diarrhea, abdominal pain, and nausea--occurred in greater than 2% of the total study population. The overall incidence of adverse events in the 201 loracarbef-treated and 192 cefaclor-treated patients evaluated for safety was 19.9% and 24.5%, respectively. Adverse events that required hospitalization or discontinuation of treatment occurred in four patients in the cefaclor group but in none of those treated with loracarbef. There were no statistically significant differences in the clinical or bacteriologic response or the incidence of side effects between the two treatment groups. These findings indicate that loracarbef given twice daily is comparable in safety and efficacy to cefaclor given three times daily in the treatment of adults with skin and skin-structure infections.

Adolescent↗

Dose-dependent effects of betaxolol in hypertension: a double-blind, multicenter study.

This study determined the dose-response relationship among three doses of betaxolol compared with placebo in patients with mild-to-moderate hypertension. In this double-blind, placebo-controlled trial, 317 hypertensive patients were randomly assigned to receive placebo or betaxolol 5, 10, or 20 mg once daily for 4 weeks. A significant (P less than .05) decrease in supine diastolic blood pressure (BP) compared with concurrent placebo was evident with all three doses of betaxolol after 1 week of active treatment. Each dose of betaxolol maintained a significant reduction in diastolic and systolic BP and heart rate responses throughout the 4-week treatment period. At the fourth week (final treatment evaluation), BP and heart rate were significantly (P less than .05) reduced by all three doses of betaxolol compared with placebo. For supine systolic and diastolic BP, the decreases with betaxolol 20 mg were significantly (P less than .05) greater than with the 5 mg dose, but there was no statistically significant difference between the 10-mg and either the 5- or 20-mg doses. For standing diastolic BP, the effect of betaxolol 5 mg once daily was significantly (P less than .05) less than that of 10 and 20 mg. The overall supine diastolic BP response to betaxolol was dose dependent, and more patients responded to the 10- and 20-mg doses of betaxolol (66% and 76%, respectively) than to the 5-mg dose (59%). For each efficacy variable, the absolute magnitude of the reduction was greater with increasing dose. In subgroup analyses, BP responses were analyzed by race, age, baseline BP, and age combined with baseline BP.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

Reducing fat intake with fat substitutes.

Many Americans should reduce their dietary consumption of fat to lower their risk of conditions such as heart disease, cancer and obesity. Physicians can coordinate a comprehensive management plan for patients who need to reduce their fat intake. The newest fat substitutes offer a potentially valuable addition to such traditional diet strategies as low-fat foods and total calorie reduction.

Chemical Phenomena↗

Aetiology of acute pharyngitis and clinical response to empirical therapy with erythromycin versus amoxicillin.

One hundred and eighty-nine adults with acute pharyngitis had culture and serological evaluation for group A beta haemolytic streptococci (GABHS), Mycoplasma pneumoniae, and Branhamella catarrhalis. Sixteen patients had evidence for infection with GABHS, none for M. pneumoniae, and one for B. catarrhalis. For those with GABHS, there was no significant difference between empirical treatment by erythromycin or amoxicillin. For those without GABHS, empirical treatment with erythromycin appeared to result in a statistically significant reduction in cough and a noticeable but less than significant reduction of other symptoms when compared to empirical treatment with amoxicillin. The new formulation of erythromycin utilized in this study (PCE) may be associated with a reduction in gastrointestinal intolerance from that reported with other erythromycin products.

Amoxicillin↗

Low-dose captopril in mild to moderate geriatric hypertension.

The safety and efficacy of captopril in geriatric patients with mild to moderate hypertension was examined in an eight-week multicenter study of 99 patients. Following a placebo period, patients were treated with captopril 25 mg twice daily. Patients who were uncontrolled after two weeks of active therapy were randomized to either captopril 25 mg plus hydrochlorothiazide 15 mg or captopril 50 mg twice daily. The average decrease in blood pressure at study completion was--16.9/11.9 mmHg. At the conclusion of the trial, 75.8% of patients responded to therapy. Captopril was well tolerated and believed to be a good therapeutic alternative for treating hypertension in the elderly population.

Black or African American↗

Chronic pain. Characteristics, assessment, and treatment plans.

Management of chronic pain is not a simple task. Pain is a complex, multifaceted perceptual experience. For effective management, the physician needs the patient's cooperation and personal commitment. Many chronic pain patients become preoccupied with their pain and gradually lose interest in social activities, or they may use their pain to avoid anxiety-producing situations. Chronic pain therapy instituted by the primary care physician demands a coordinated approach using pharmacologic and nonpharmacologic treatment methods. When necessary, appropriate treatment by subspecialty physicians and by psychologists and other paramedical personnel should be coordinated.

Analgesics↗