Clinical evaluation of zomepirac in the treatment of acute orthopedic pain.
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Adult↗
Biomedical subjects
G E Ruoff
Publications and source records attributed to G E Ruoff.
Ibuprofen in osteoarthritis.
In a double-blind, multiclinic study, 437 patients with osteoarthritis were treated sequentially with ibuprofen, 1,800 mg/day, and placebo, or with aspirin, 3,600 mg/day, and placebo. Each treatment was given for four weeks. Considering relief of pain, ability to function, and general well-being, the patients preferred drug to placebo, usually by a statistically significant margin. Combined results showed no significant differences between ibuprofen and aspirin. Patients' evaluations of exercise-related pain, ability to perform a selected activity, and total discomfort and disability, and physicians' evaluations of discomfort and disability, all favored drug over placebo, and the differences were significant for a number of endpoints. The results indicated ibuprofen, 1,800 mg/day, offers about the same antiarthritic benefit as aspirin, 3,600 mg/day. Both drugs are superior to placebo. The incidence of gastrointestinal complaints with ibuprofen was similar to that with placebo and significantly lower than that with aspirin.
Activities of Daily Living↗
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.
Acute Disease↗
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.
Analgesics↗
Loracarbef (LY163892) versus cefaclor in the treatment of acute bacterial bronchitis.
In this double-blind study, 319 patients (133 men, 186 women) with acute bronchitis were randomly assigned to receive 200 mg of loracarbef twice daily (n = 160; mean age, 42 years) or 250 mg of cefaclor thrice daily (n = 159; mean age, 43 years) for seven days. Clinical and bacteriologic responses were assessed in 63 loracarbef-treated and 56 cefaclor-treated patients in whom pretreatment positive cultures of pathogens susceptible to loracarbef and cefaclor were found. Among these evaluable patients, a clinical cure was found in 68.3% of the loracarbef-treated patients and in 66.1% of the cefaclor-treated patients and improvement in 27.0% and 28.6%, respectively; the pathogen was eliminated in 7.9% and 10.7% and presumed eliminated in 82.5% and 82.1%, respectively. Three in the loracarbef group discontinued treatment because of adverse events, two of which (nausea, nausea/diarrhea/vomiting) were presumably related to the drug. Headache was reported by 9.4% of the 160 patients in the loracarbef group and 6.9% of the 159 patients in the cefaclor group; diarrhea by 5.6% and 6.9%, respectively; and dyspepsia/abdominal pain/gastrointestinal disorders by 5.6% and 4.4%, respectively. It is concluded that both loracarbef and cefaclor are safe and effective in the treatment of acute bacterial bronchitis.
Acute Disease↗
Long-term safety of zomepirac: a double-blind comparison with aspirin in patients with osteoarthritis.
Zomepirac at daily doses of 400 to 600 mg was well tolerated and provided continuing effective analgesia in the relief of chronic pain associated with osteoarthritis. In this long-term safety study, patients treated with zomepirac had significantly fewer adverse reactions and fewer limiting adverse reactions than did patients treated with aspirin. Thus zomepirac, which has previously shown efficacy in single-dose studies as well as good patient acceptability and efficacy in circumstances typical of clinical practice, has been found in this study to compare favorably to aspirin in a long-term (12-week) study in 238 patients with chronic pain secondary to osteoarthritis.
Analgesics↗
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.
Administration, Cutaneous↗