Biomedical subjects

Gary Ruoff

Publications and source records attributed to Gary Ruoff.

7 recordsLinked to original sources

PubMed2006

The COX-2 specific inhibitor Valdecoxib versus tramadol in acute ankle sprain: a multicenter randomized, controlled trial.

BACKGROUND: The cyclooxygenase-2 specific inhibitor valdecoxib has not been approved in the United States for treatment of acute pain. HYPOTHESIS: Valdecoxib 20 mg twice daily or once daily (both with a 40-mg loading dose) is not clinically inferior to tramadol for treating the signs and symptoms of acute ankle pain. STUDY DESIGN: Randomized, controlled clinical trial; Level of evidence, 1. METHODS: Patients (N = 829) with acute first- or second-degree ankle sprain received 7 days' treatment with valdecoxib 20 mg either twice daily or once daily (both with 40-mg loading dose), tramadol 50 mg 4 times daily, or placebo. The primary end point was Patient's Assessment of Ankle Pain visual analog scale on day 4; a test of noninferiority compared valdecoxib with tramadol. RESULTS: On day 4, both valdecoxib doses were significantly better versus placebo and were comparable with tramadol in relieving ankle pain. On day 7, valdecoxib, but not tramadol, significantly reduced pain versus placebo. On days 4 and 7, more patients resumed normal walking with valdecoxib (45%-47% and 73%-79%, respectively) than with placebo (35% and 64%, respectively) or tramadol (38% and 67%, respectively). In contrast to valdecoxib, the number of withdrawals due to adverse events was significantly higher in the tramadol group (12.2% vs 3.4%; P = .0005). CONCLUSIONS: Valdecoxib was comparable with tramadol and was significantly better than placebo in treating acute ankle sprain, and it enabled more patients to resume normal walking on days 4 and 7. Both valdecoxib and tramadol were well tolerated.

Adolescent↗

PubMed2006

Prevalence of migraine and response to sumatriptan in patients self-reporting tension/stress headache.

OBJECTIVE: This study was conducted to evaluate the prevalence of migraine and its responsiveness to migraine-specific therapy in patients with self-reported tension-type headache. METHODS: Patients were adults (n = 423) consulting one of 54 North American study sites including primary care clinics, neurology clinics, and headache clinics. The study comprised an initial diagnosis phase to determine the headache diagnosis of patients entering the study with self-reported tension/stress headache, including that previously diagnosed by a health care provider. Patients reporting tension/stress headache were evaluated and diagnosed as having migraine with or without aura, probable migraine, tension-type headache, or another headache type. Exclusion criteria included prior diagnosis of migraine or probable migraine and the presence of headache for at least 15 days monthly during either of the 2 months before screening. The initial phase was followed by a randomized, double-blind treatment phase to evaluate the efficacy of sumatriptan 100 mg tablets for the treatment of a single migraine attack in those meeting International Headache Society (IHS) criteria for migraine during the diagnosis phase. RESULTS: Of 423 patients reporting tension/stress headache at study entry, 84% (n = 357) were diagnosed at the clinic visit as fulfilling IHS criteria for migraine without aura or migraine with aura, and 65% (n = 276) were diagnosed with migraine only (i.e., with no other concurrent headache diagnosis). Three hundred thirty-two (332) patients entered the double-blind treatment phase. Headache relief rates 2h post-dose, the primary efficacy endpoint, did not significantly differ between sumatriptan and placebo (p = 0.099). However, improvements were significantly (p < 0.05) greater with sumatriptan than placebo on several other headache-related efficacy measures. CONCLUSIONS: Migraine headache may go unrecognized in patients with self-reported tension headache. Among patients having self-reported tension headache and diagnosed with migraine during the study, response to acute treatment with sumatriptan was inconclusive. Improvement with sumatriptan versus placebo was observed for some measures and not for others. The results should be interpreted in the context of study limitations including use of patient self-reports to assess headache diagnosis and possible lack of representativeness arising from the predominantly white sample.

Adolescent↗

PubMed2006

Efficacy and safety of tamsulosin for benign prostatic hyperplasia: clinical experience in the primary care setting.

OBJECTIVE: This study evaluated the efficacy and safety of the alpha(1A)/alpha(1D) subtype-selective blocker tamsulosin for the increasingly common treatment of benign prostatic hyperplasia (BPH) in the primary care setting. METHODS: A total of 493 men (age > or = 45 years), 99.6% of whom had moderate or severe BPH at baseline, were given tamsulosin 0.4 mg/day in a multicenter, open-label study conducted over 45 days by 42 primary care physicians and two urologists. RESULTS: Mean American Urological Association (AUA) Symptom Score decreased by 7.5 from a baseline of 20.0 on day 4, representing a 37.5% improvement over baseline (p < 0.001). AUA Obstructive and Irritative Scores declined significantly by day 4 (-4.7 and -2.7, respectively), as did AUA Bother Score (-5.4, p < 0.001) and mean BPH Impact Score (-2.5, p < 0.001). The Investigator's Global Assessment showed slight or greater improvement in 77.2% of patients (13.7% markedly improved). Effects were maintained from day 4 through day 45. CONCLUSIONS: Overall, patients treated with tamsulosin in a primary care setting experienced rapid, significant improvement in their signs and symptoms of BPH, based upon the change in the AUA Symptom Score. Tamsulosin was well tolerated; no new safety concerns were observed. Tamsulosin was not associated with significant effects on blood pressure or first-dose hypotension.

Adrenergic alpha-Antagonists↗

PubMed2005

Valdecoxib for treatment of a single, acute, moderate to severe migraine headache.

OBJECTIVE: To evaluate the analgesic efficacy and safety of a single 20- or 40-mg dose of valdecoxib compared with placebo in treatment of a single, acute, moderate or severe migraine headache, with or without aura. BACKGROUND: Valdecoxib, an oral COX-2 specific inhibitor, is indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis and treatment of primary dysmenorrhea. This study assessed the optimal dose of valdecoxib for treatment of a single, acute, moderate to severe migraine headache. METHODS: This was a double-blind, randomized, placebo- and active-controlled, multicenter, single-dose (primary end point) and multiple-dose (secondary end point), 56-day study of valdecoxib in the treatment of a single, acute, moderate or severe migraine headache, with or without aura. Migraine headaches were diagnosed according to International Headache Society (IHS) criteria. The primary efficacy end point was headache response (defined as reduction of headache pain intensity from moderate or severe to mild or none) at 2 hours postdose. Patients assessed their headache pain intensity and presence or absence of migraine-associated nausea, vomiting, phonophobia, and photophobia at intervals from 0 to 24 hours postdose. Sumatriptan 50 mg (encapsulated, in standard method, to maintain blinding) was included as a positive control for assay sensitivity. No statistical comparisons were performed between active treatment arms (valdecoxib 20 mg, valdecoxib 40 mg, and sumatriptan 50 mg). Adverse events and safety parameters were monitored throughout the study. RESULTS: In the intent-to-treat population of 570 patients (135 valdecoxib 20 mg, 151 valdecoxib 40 mg, 143 sumatriptan, and 141 placebo), no significant differences in baseline demographics among treatment groups were observed. The headache response rate with valdecoxib 40 mg and sumatriptan 50 mg was significantly greater than that with placebo at all time points from 2 to 24 hours postdose. With valdecoxib 20 mg, headache response rate was significantly greater than placebo from 2 to 4 hours. Significantly fewer patients treated with valdecoxib 40 mg, compared with placebo, experienced nausea, vomiting, and phonophobia at 2 hours postdose. CONCLUSIONS: A single 40-mg dose of valdecoxib is effective and well tolerated in treatment of migraine headache pain and associated symptoms.

Adolescent↗

PubMed2005

A method that dramatically improves patient adherence to depression treatment.

UNLABELLED: This study focused on increasing patient adherence to a prescribed medical regimen for depression or depressive symptoms. The goal was to demonstrate that a depression flow sheet supported by physician instruction, patient education, and diligent follow-up could enable depressed patients to better adhere to treatment. The study documented reduction in depression severity over time. In addition to depression data, sample characteristics of comorbid disorders were obtained. METHODS: Patients tentatively diagnosed with depression were asked to complete a self-administered 9-item diagnostic survey (PHQ-9) to confirm the severity of depressive symptoms. Physicians in the practice then implemented a flow sheet to record pertinent data including comorbidities. All data were kept in patients' medical charts. A second PHQ-9 survey was completed by patients after at least 4 weeks. A total of 103 subjects was analyzed during 2003-2004. Subsequently, patient charts were systematically audited throughout the study period to record adherence, reasons for nonadherence (if any), PHQ-9 survey results, and comorbidities. RESULTS: Patient adherence improved to a significantly greater extent among patients in our study compared with existing national research data on depression. CONCLUSION: Use of a flow sheet, coupled with patient education and diligent follow-up, dramatically improved the rate of medication adherence in patients who initially presented with depressive symptoms--with or without comorbidities. A clinician or small group can adapt the PHQ-9 materials with modest effort and positively impact the care of their patients, including adherence to medication regimens.

Antidepressive Agents↗

PubMed2003

Strategies in pain management: new and potential indications for COX-2 specific inhibitors.

The role of the coxibs in the management of osteoarthritis and rheumatoid arthritis has been widely discussed, but there are other potential applications for the coxibs that have received less attention. Here we consider the use of the coxibs in acute pain syndromes such as primary dysmenorrhea and the pain associated with dental extraction, as well as considering their application in chronic low back pain and cancer pain. Another area where the coxibs may prove particularly beneficial is in the management of post-surgical pain. Traditional post-surgical analgesia has involved the use of non-selective NSAIDs and opioids, but these agents can be associated with side effects such as post-operative bleeding, gastrointestinal problems, nausea, and constipation. Because the coxibs do not inhibit COX-1 dependent platelet aggregation like traditional NSAIDs, the risk of post-surgical bleeding is reduced. The careful application of coxibs as part of a multi-modal approach to pain management in the perioperative period can reduce the requirement for opioid medications and thus reduce the risk of post-operative complications such as ileus. In the future, coxibs are likely to play an important role in multi-modal perioperative analgesic regimens with the aim of reducing post-operative periods of convalescence.

Cyclooxygenase 2↗

PubMedDate not supplied

Effects of flow sheet implementation on physician performance in the management of asthmatic patients.

BACKGROUND AND OBJECTIVES: This project focused on increasing compliance, in a large family practice group, with quality indicators for the management of asthma. The objective was to determine if use of a flow sheet incorporating the Global Initiative for Asthma (GINA) guidelines could improve compliance with those guidelines if the flow sheet was placed in patients' medical records. METHODS: After review and selection of 14 clinical quality indicators, physicians in the practice implemented a flow sheet as an intervention. These flow sheets were inserted into the records of 122 randomly selected patients with asthma. Medical records were reviewed before the flow sheets were placed in the records, and again approximately 6 months later, to determine if there was a change in compliance with the quality indicators. RESULTS: Improvement of documentation was demonstrated in 13 of the 14 quality indicators. CONCLUSIONS: The results indicate that compliance with asthma management quality indicators can improve with the use of a flow sheet.

Asthma↗