American journal of therapeutics
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Randomized Controlled Trial Multicenter Study Comparative Study
A double-blind, controlled, multicenter, randomized study comparing the antihypertensive effectiveness and tolerance of a daily dose of two nifedipine formulations: nifedipine microgranules versus nifedipine osmotic pump.
Controlled clinical studies have clearly established the advantages of blood pressure (BP) reduction. However, optimal control of BP in the population is still not adequate. Monotherapy is ineffective in the majority of hypertensive patients, and multidrug therapy increases costs. ⋯ Target BP was reached in more than 70% of patients receiving monotherapy with either formulation. Both formulations were tolerated well.
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Multicenter Study Comparative Study Clinical Trial
Comparing patient telephone callback rates for different hormonal birth control delivery systems.
This study was conducted to determine the number of office telephone callbacks in the first 3 months after initiating use of the vaginal ring, the transdermal patch, or an oral contraceptive. If a patient called back, the reason for her call was noted. Patients were prospectively followed from sites in New Jersey and Florida for 3 months after initiation of hormonal contraception (oral, transdermal, vaginal) and the number of callbacks for each method was assessed. ⋯ Rate of callbacks after initiation of hormonal contraception was the least with the vaginal ring. Use of oral contraception, often considered the gold standard, resulted in a callback rate that was midway between the number of callbacks for the vaginal ring and the number of callbacks for the transdermal patch. The lower observed rate of callbacks with the vaginal ring compared with oral and transdermal contraception may provide clinicians the confidence that this method is well tolerated by their patients.
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Multicenter Study Clinical Trial
Lidocaine patch treatment in patients with low back pain: results of an open-label, nonrandomized pilot study.
This prospective, 6-week, multicenter, open-label, nonrandomized pilot study was designed to assess the effectiveness and safety of a lidocaine patch 5% in patients with low back pain (LBP). Patients with moderate to severe LBP, defined as acute/subacute (< 3 months, n = 21), short-term chronic (3-12 months, n = 33), or long-term chronic (> 12 months, n = 77), were recruited from 5 clinics; participants applied < or = 4 patches (560 cm total) once daily to area of maximal LBP as add-on treatment through week 2, with the option to taper concomitant analgesics during weeks 3-6. Scores on Brief Pain Inventory (BPI) were obtained at weeks 2 and 6. ⋯ Most common AEs were dizziness and rash (n = 5, 3.8%), and most AEs (80%) were mild to moderate in intensity. Significant improvement in pain intensity and QOL in this cohort of LBP patients was noted during treatment with the lidocaine patch 5%. Controlled clinical trials are warranted.
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Multicenter Study Clinical Trial
Safety, tolerability, and effectiveness of oxymorphone extended release for moderate to severe osteoarthritis pain: a one-year study.
A 52-week, multicenter, open-label extension study was performed to evaluate the safety, tolerability, and effectiveness of oxymorphone extended release (ER), a novel tablet formulation of oxymorphone hydrochloride, in 153 patients with moderate to severe chronic osteoarthritis-related pain. Sixty-one patients (39.9%) completed the study. Common opioid-related nonserious adverse events (AEs) caused most withdrawals. ⋯ Mean pain scores initially decreased as previously opioid-naive patients achieved adequate pain relief, reached stable levels after the first 6 weeks, and remained stable at mild levels throughout the remainder of the study (average pain, 20-25 mm on 100-mm Visual Analog Scale). Average daily dosing remained stable throughout the study (median, 40 mg/d). At each assessment, at least 80% of patients rated their global satisfaction with oxymorphone ER as "excellent," "very good," or "good." Oxymorphone ER provides a new 12-hour analgesic for the treatment of moderate to severe chronic osteoarthritis-related pain in patients who may require long-term opioid therapy.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Analgesic efficacy and safety of nonprescription doses of naproxen sodium compared with acetaminophen in the treatment of osteoarthritis of the knee.
Nonprescription doses of naproxen sodium, acetaminophen, and placebo were compared to determine their efficacy and safety in osteoarthritis of the knee. In two identical multicenter, randomized, double-blind, placebo-controlled, multidose, parallel-design studies, patients with osteoarthritis aged (mean +/- SD) 60.6 +/- 12.8 years were randomized to daily doses of 660 mg naproxen sodium (440 mg naproxen sodium in patients >or=65 years), 4000 mg acetaminophen, or placebo for 7 days. Naproxen sodium (440/660 mg) provided significantly greater improvements in pain at rest, on passive motion, on weight-bearing, stiffness after rest (morning), day and night pain compared with placebo, and significantly greater relief from resting pain than acetaminophen (P < 0.05). ⋯ Naproxen sodium and acetaminophen had similar safety profiles to placebo. Nonprescription doses of naproxen sodium (440/660 mg) effectively relieve pain and other symptoms of osteoarthritis. Naproxen sodium is an alternative in the initial treatment of osteoarthritis and may be preferred to acetaminophen as first-line therapy in patients with moderate or severe pain.