International journal of clinical pharmacology research
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Int J Clin Pharmacol Res · Jan 2004
Comparative StudyHealth-economic comparison of three recommended drugs for the treatment of osteoporosis.
Osteoporosis is a large and growing disease with significant health consequences. Based on an evaluation of clinical evidence, the German osteology umbrella organization DVO (Dachverband Osteologie deutschsprachiger wissenschaftlicher Fachgesellschaften) published guidelines in March 2003 for the diagnosis and treatment of osteoporosis. For prevention of fractures in women with postmenopausal and senile osteoporosis, these guidelines recommend three treatment options as first-line therapy: risedronate, alendronate and raloxifene. ⋯ From the perspective of statutory health insurance, the cost per averted hip fracture is 37,348 euro for risedronate and 48,349 euro for alendronate (costs for raloxifene were not calculated due to a nonsignificant effect on prevention of hip fractures); and cost per QALY gained is 32,092 euro for risedronate, in comparison to patients in Germany with no therapy (alendronate 41,302 euro; raloxifene 1,247,119 euro). This cost-effectiveness analysis gives evidence that bisphosphonates are cost effective. Under consideration of current prices and the published clinical evidence, risedronate dominates the comparison of DVO-recommended drugs.
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Int J Clin Pharmacol Res · Jan 2003
Clinical Trial Controlled Clinical TrialLow-dose schema of isotretinoin in acne vulgaris.
In severe papulopustular and in nodulocystic/conglobate acne, oral isotretinoin is the treatment of choice. It is also required for patients with moderate to severe acne, especially when acne scars start to occur A new therapeutic approach consists of a low-dose regimen of isotretinoin. We performed a comparative study of high- and low-dose schemas of isotretinoin per os for the treatment of acne. ⋯ The low-dose schema produced fewer adverse effects and offered a very beneficial effect on pre-existing scarring. Our results confirm the beneficial effect of the low-dose schema. We recommend a total dose > or = 120 mg/kg, as this therapeutic regimen of isotretinoin has proven to be the most successful in preventing relapses and scarring.
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Int J Clin Pharmacol Res · Jan 2003
ReviewRole of advanced glycation end products (AGEs) and their receptor (RAGE) in the pathogenesis of diabetic microangiopathy.
Diabetic vascular complication is a leading cause of acquired blindness, end-stage renal failure, a variety of neuropathies and accelerated atherosclerosis, which could account for disabilities and high mortality rates in patients with diabetes. Chronic hyperglycemia is essentially involved in the pathogenesis of diabetic micro- and macrovascular complications via various metabolic derangements. In this review, we discuss the molecular mechanisms of diabetic retinopathy and nephropathy, especially focusing on advanced glycation end products (AGEs) and their receptor (RAGE) system. Several types of AGE inhibitors and their therapeutic implications in diseases, including diabetic microangiopathy, will be discussed in the next review article.
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Int J Clin Pharmacol Res · Jan 2003
Comparative Study Clinical TrialInterindividual variation in the ratio between plasma morphine and its metabolites in cancer patients.
In 25 cancer patients treated with slow-release oral morphine and in 10 cancer patients treated with continuous infusion of morphine, plasma steady-state concentrations of morphine (M), morphine-3-glucuronide (M-3-G) and morphine-6-glucuronide (M-6-G) were determined by high-performance liquid chromatography. Blood samples were withdrawn at 0, 2 and 6 h after oral administration in patients treated with slow-release oral morphine and once or twice a day in patients treated with continuous infusion of morphine. In four cancer patients treated with continuous infusion of morphine, in order to analyze chronopharmacokinetic variability, the M-3-G/M ratio was observed at 12:00 h and 24:00 h. ⋯ There was an approximately 10-fold interindividual variation in the M-3-G/M ratio both in the continuous infusion group and in the oral morphine group. These results suggest that the activity of UDP glucuronosyltransferase 2B7 in the intestinal metabolism of morphine may play an active part in a large interindividual variation in the ratio of metabolites to morphine. Further studies are needed to clarify this hypothesis.
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Int J Clin Pharmacol Res · Jan 2003
Kineret: efficacy and safety in daily clinical practice: an interim analysis of the Kineret response assessment initiative (kreative) protocol.
Data from 166 patients who had completed 6 months of anakinra (Kineret, r-metHuIL-1Ra) therapy under the conditions of daily clinical practice showed an efficacy and safety profile comparable to the data known from clinical trials. Patients significantly responded as early as 1 month following initiation of therapy. The data suggest that anakinra may also be effective in patients who have failed tumor necrosis factor (TNF)-blocking agents. Injection-site reactions were reported less frequently than in clinical trials, indicating that these reactions seem to require less therapeutic attention under non-clinical trial conditions.