Biomedical subjects
Charles A Cefalu
Publications and source records attributed to Charles A Cefalu.
A second course of hylan G-F 20 for the treatment of osteoarthritic knee pain: 12-month patient follow-up.
This prospective open-label study evaluated the efficacy and tolerability of a second course of hylan G-F 20 for the treatment of osteoarthritic knee pain over a 12-month period in patients who previously experienced a beneficial initial course of therapy. Men or women aged > or = 40 years with knee osteoarthritis received 3 weekly injections of hylan G-F 20. Consecutive patients requesting a second course of therapy were enrolled from October 2000 to January 2001. The mean time between the first and second courses of hylan G-F 20 was 19.6 months. All efficacy parameters significantly improved (P<.001) from baseline at weeks 1, 2, 4, 8, 12, 26, and 52. Improvements from baseline to weeks 26 and 52 for the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) index question A1, WOMAC domain C, and total WOMAC were 1.39+/-0.11 and 1.1+/-0.12, 18.50+/-1.43 and 13.69+/-1.54, and 26.77+/-1.97 and 19.8+/-2.13, respectively. Significant improvements from baseline were maintained for patient and physician VAS to week 26 (patient: 48.66+/-2.52; investigator: 51.51+/-2.34) and week 52 (patient: 46.10+/-2.73; investigator: 47.23+/-2.52). A second course of hylan G-F 20 therapy was generally well-tolerated; the types of local events observed in this study were not qualitatively different from those in the current product information and published literature. For continued relief of osteoarthritic knee pain, this study supports repeat use of hylan G-F 20 in patients who had a previous successful course of therapy.
Controlling hypoglycemia in type 2 diabetes: which agent for which patient?
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Is bone mineral density predictive of fracture risk reduction?
Bone mineral density (BMD) measurement is a widely available noninvasive means of identifying individuals with osteoporosis and, possibly, those at high risk for fracture. This nonsystematic review examines the relationship between BMD increase and fracture risk reduction in clinical trials evaluating osteoporosis therapy. The trials examined here are predominantly in postmenopausal women. BMD increase correlates poorly with fracture risk reduction in clinical trials of osteoporosis therapy conducted in postmenopausal women. Although BMD may increase with therapy, the increase is not measurable until later, and the overall increase is too small to account for the timing and magnitude of fracture risk reduction. BMD is only one of many contributors to bone strength and fracture risk reduction. Bone strength is derived from bone quantity, which consists of density and size, and bone quality, which, in turn, consists of structure (micro- and macroarchitecture), material properties, and turnover. Data are beginning to accrue suggesting that changes in bone turnover markers may be an accurate predictor of fracture risk reduction. Future research will elucidate the link between changes in bone turnover markers and bone architecture as a measure of osteoporosis treatment efficacy. Until then, physicians will continue to rely on fracture risk reduction data from well-designed clinical trials when judging the efficacy of different treatments for osteoporosis.
An open-label study of a second course of hylan G-F 20 for the treatment of pain associated with knee osteoarthritis.
OBJECTIVE: To evaluate the efficacy and tolerability of a second course of hylan G-F 20 for the treatment of osteoarthritic knee pain in patients who experienced a clinical benefit with an initial course of therapy. RESEARCH DESIGN AND METHODS: In this prospective, open-label study, men or women (>/=40 years of age) with knee osteoarthritis (OA) received three weekly injections of hylan G-F 20. Consecutive patients who requested a second course of hylan G-F 20 therapy due to OA knee pain subsequent to pain relief with a first course of therapy were enrolled between October 26, 2000 and January 18, 2001. MAIN OUTCOME MEASURES: Pain while walking on a flat surface (Western Ontario and McMaster's Universities Osteoarthritis Index, WOMAC, question A1), WOMAC domain C (physical functioning), full WOMAC, and patient and investigator overall visual analog scales (VAS). Efficacy variables were measured at baseline and at weeks 1, 2, 4, 8, 12 and 26. An analgesic washout was required before all efficacy evaluations. RESULTS: Patients receiving at least one injection of hylan G-F 20 (n = 71) were predominantly Caucasian (84.5%) and female (64.8%), with a mean age of 65.5 years and mean weight of 200.1 pounds. The mean time between the first and second courses of hylan G-F 20 was 19.6 months (median 17.6 months). With hylan G-F 20, pain while walking on a flat surface was significantly lower (p < 0.001) than baseline at all time points up to week 26 (mean +/- SEM: -1.40 +/- 0.10 at week 26). Actual scores decreased from 2.4 +/- 0.10 at baseline to 0.97 +/- 0.11 at week 26. Scores for the WOMAC domain C, full WOMAC and patient and investigator overall VAS also significantly improved (p < 0.001) at all time points. A second course of hylan G-F 20 was generally well-tolerated, based on the low incidence of local adverse events (AEs) - only one patient (1.4%) experienced a severe event, the types of AEs, and the fact that no patients discontinued the study due to these AEs. The types of related AEs observed were not qualitatively different from those listed in the current product information and published literature. CONCLUSION: A second course of hylan G-F 20 therapy is an appropriate therapy for the treatment of OA knee pain in patients who had a previous favorable clinical response. For continued relief of osteoarthritis knee pain, this study supports repeat use of hylan G-F 20 in these patients.
Geriatric medical education in Louisiana: current status and future needs.
Despite the impending explosion in the size of American's elderly population, physicians remain undertrained in geriatric medicine. In Louisiana, this training is especially important for the family physician and internist, many of whom practice primarily in rural areas and carry the bulk of nursing home patient care on their shoulders. Louisiana's medical schools offer little in the way of training in geriatric medicine, despite the author's finding that there is a strong interest for such training among practitioners and residents. Meanwhile, at the national level, leaders in geriatric medicine are working to develop new ways to encourage participation in geriatric educational opportunities.