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  • 1
    Electronic Resource
    Electronic Resource
    Safety and efficacy of lifibrol upon four-week administration to patients with primary hypercholesterolaemia (1994)
    Springer
    European journal of clinical pharmacology 47 (1994), S. 133-138 
    Details
    ISSN: 1432-1041
    Keywords: Lifibrol ; hypercholesterolaemia ; hypocholesterolaemic agent ; clinical study
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract The efficacy and safety of lifibrol, a novel cholesterol-lowering drug, was investigated in a double-blind clinical study in 168 patients with primary hypercholesterolaemia. Placebo and four lifibrol dose groups (150, 300, 450 and 600 mg/day) were tested over a period of 4 weeks. The mean LDL-cholesterol changes were 5.7%, −11.1%, −27.7%, −34.5% and −35.0%, respectively, after 4 weeks of treatment. No major changes in HDL-cholesterol were seen after this period. With the present study design, a decrease in triglycerides (−28%) was significant in the highest dosage group only. Additionally, it was shown that further independent risk factors for coronary heart disease were favourably influenced. Fibrinogen decreased in all dosage groups with a maximal mean value of 18% and a tendency toward reduction in lipoprotein (a) was observed in patients with high baseline levels (〉30 mg·dl−1). Lifibrol was generally well tolerated in all dosage groups and no serious adverse events were reported. Laboratory parameters did not show any clinically relevant alterations.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00194962
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  • 2
    Electronic Resource
    Electronic Resource
    A new mesalazine foam enema (Claversal Foam) compared with a standard liquid enema in patients with active distal ulcerative colitis (2002)
    Oxford UK : Blackwell Science Ltd.
    Alimentary pharmacology & therapeutics 16 (2002), S. 0 
    Details
    ISSN: 1365-2036
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine
    Notes: Rectally administered mesalazine (5-aminosalicylic acid) is a recognized therapy for distal ulcerative colitis. It is frequently applied as a liquid enema. However, there are reasons (acceptability to the patient, more uniform topical dispersion and effective adhesion) to prefer a foam-based enema.〈section xml:id="abs1-2"〉〈title type="main"〉Aim:This study compared a foam enema (2 g mesalazine per day, Claversal Foam) with a standard liquid enema (4 g mesalazine per day, Salofalk enema).〈section xml:id="abs1-3"〉〈title type="main"〉Methods:Patients with active distal ulcerative colitis, diagnosed according to standardized criteria, were treated for 4 weeks. The primary goal was clinical remission; endoscopic remission, histological changes, global assessment and standard safety measures were also analysed. A major subset of the patients also provided quality-of-life data.〈section xml:id="abs1-4"〉〈title type="main"〉Results:Both foam and liquid enema gave good rates of clinical and endoscopic remission. The foam enema was shown to be as efficacious as the reference, even though the daily dose in the foam treatment contained only half as much active drug as in the reference treatment. Minor regional differences in efficacy were seen. The tolerabilities of the two formulations were comparable.〈section xml:id="abs1-5"〉〈title type="main"〉Conclusions:The foam enema offers a safe, efficacious and acceptable treatment for distal ulcerative colitis.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1046/j.1365-2036.2002.01199.x
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  • 3
    Electronic Resource
    Electronic Resource
    Application of a New Serum Assay for Type I Collagen Cross-Linked N-Telopeptides: Assessment of Diurnal Changes in Bone Turnover With and Without Alendronate Treatment (1998)
    Springer
    Calcified tissue international 63 (1998), S. 102-106 
    Details
    ISSN: 1432-0827
    Keywords: Key words: N-telopeptides — Alendronate.
    Source: Springer Online Journal Archives 1860-2000
    Topics: Biology , Medicine , Physics
    Notes: Abstract. Biochemical markers of bone turnover are finding increased application in the investigation and management of skeletal diseases such as osteoporosis. The present study assessed for the first time the diurnal variation of serum type I collagen cross-linked N-telopeptides (NTx), a new serum-based marker of bone resorption, and the effect of antiresorptive therapy with alendronate on this marker in elderly osteopenic women. The concentrations of serum NTx were monitored over 24 hours in a randomly selected subset of 38 women (placebo n = 13, 69 ± 3 (SD) year; alendronate n = 25, 69 ± 3 year), who had completed 12–15 months of a larger (n = 120) randomized, double-blind, parallel group, placebo-controlled trial with alendronate 5 mg/day. Blood was obtained every 4 hours for measurement of serum NTx using a new chemiluminescent-based immunoassay. There was a significant diurnal variation of serum NTx (p = 0.001) in both the placebo and alendronate groups. Mean peak levels occurred at ∼0504 h with a mean nadir at ∼1320 h in the placebo group, with no significant difference on alendronate. Serum NTx was ∼25% lower in the alendronate group over the entire 24-hour period. Mean (SE) daytime (0800–2000) and nighttime (2200–0800) serum NTx values were 6.40 ± 0.30 versus 8.45 ± 0.58 nmol BCE/liter, and 7.42 ± 0.23 versus 10.01 ± 0.53 nmol BCE/liter for alendronate versus placebo, respectively (P≤ 0.003 for both comparisons). Combining the data of both treatment groups, serum NTx was significantly (P 〈 0.05) correlated with serum osteocalcin (r = 0.753) and urine NTx (r = 0.628) measurements previously obtained over the entire 24-hour period. Serum NTx has a significant diurnal variation and is responsive to antiresorptive therapy with alendronate. Alendronate reduces the amplitude but maintains the pattern of the 24-hour serum NTx profile. These data suggest that serum NTx may be a useful new marker of bone resorption.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s002239900497
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  • 4
    Electronic Resource
    Electronic Resource
    Pharmacokinetics, COX-2 specificity, and tolerability of supratherapeutic doses of rofecoxib in humans (2000)
    Springer
    European journal of clinical pharmacology 56 (2000), S. 167-174 
    Details
    ISSN: 1432-1041
    Keywords: Key words Rofecoxib ; Pharmacokinetics ; COX-2 specificity
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract Objective: Prostaglandin synthesis is catalyzed by a constitutive cyclo-oxygenase isoform (COX-1) and an inducible isoform (COX-2). It is hypothesized that the analgesic and anti-inflammatory effects of nonsteroidal anti-inflammatory drugs (nonspecific COX-1/COX-2 inhibitors) such as ibuprofen principally derive from COX-2 inhibition. The purpose of this study was to evaluate steady-state pharmacokinetics, biochemical selectivity and tolerability of rofecoxib (VioxxTM), characterized in vitro as a COX-2 inhibitor. Methods: Four panels of healthy men (n=8 per panel) were administered rofecoxib (n=6) (25, 100, 250, 375 mg) or placebo (n=2) once daily on day 1 and days 3–14. Blood samples for assays of rofecoxib plasma concentration and COX isoform activity were obtained pre-dose and at specified time points post-dose. Results: Rofecoxib pharmacokinetics were found to be complex and nonlinear. Elimination half-life ranged from 9.9 h to 17.5 h after multiple dosing with an accumulation ratio close to 2 for all doses. COX-2 inhibitory activity as assessed by average inhibition of whole blood lipopolysaccharide-stimulated prostaglandin E2 over the 8-h post-dose period on day 14 was 0.3, 67, 96, 92 and 96% for the placebo and the 25-, 100-, 250- and 375-mg treatment groups, respectively. No treatment group showed significant inhibition of COX-1 as assessed by thromboxane B2 generation in clotting whole blood. Side effects were mild and transient. Conclusion: The results indicate that rofecoxib is a potent and specific inhibitor of COX-2 in humans even at doses more than tenfold higher than those associated with efficacy in patients with osteoarthritis.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s002280050736
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  • 5
    Electronic Resource
    Electronic Resource
    Dietary fibre: the effectiveness of a high bran intake in reducing renal calcium excretion (1992)
    Springer
    Urological research 20 (1992), S. 3-6 
    Details
    ISSN: 1434-0879
    Keywords: Hypercalciuria ; Bran ; Renal calcium ; Renal oxalic acid ; Calcium oxalate supersaturation
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary Fifteen healthy women were given a standardized calcium-rich diet (1800 mg calcium/day) with or without 36 g bran for 5 days. A similar study was also carried out with rice, soy and wheat bran. Urine samples were also collected 24 h. With all brans renal calcium excretion decreased and renal oxalic acid excretion increased. However, influence of rice bran was statistically significant. After 5 days of consuming 36 g rice bran/day 14 of 15 subject showed decreased calcium excretion, but increased oxalic acid excretion. Relative supersaturation with calcium oxalate, as a measure for the risk of calcium stone formation, increased after addition of all brans.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00294326
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  • 6
    Electronic Resource
    Electronic Resource
    Clinical pharmacology of alendronate sodium (1993)
    Springer
    Osteoporosis international 3 (1993), S. 13-16 
    Details
    ISSN: 1433-2965
    Keywords: Alendronate ; Bisphosphonates ; Osteoporosis
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Clinical studies have been performed to investigate the pharmacokinetics and pharmacodynamics of alendronate, an inhibitor of bone resorption for the treatment of osteoporosis. Alendronate is one of the most potent bisphosphonates currently undergoing clinical investigation (〉100-fold more potent than etidronate in vivo). The pharmacokinetics of alendronate are similar to those of other bisphosphonates. After a 2-h intravenous infusion, plasma concentrations of alendronate decline rapidly to ∼5% of initial values within 6 h. About 50% of a systemic dose is excreted unchanged in the urine in the 72 h following administration. By analogy to its behavior in animals the remainder is assumed to be taken up by the skeleton. After sequestration into bone, the elimination of alendronate is very prolonged. The terminal half-life was estimated to be greater than 10 years. Despite prolonged skeletal residence, the biological effects of alendronate begin to diminish post-treatment, since the duration of effect reflects factors besides dose and cumulative drug exposure. When taken after an overnight fast, 2 h before breakfast, the oral bioavailability of alendronate averages ∼0.75% of dose with substantial variability (coefficient of variation 55%–75%) both between and within subjects. Reducing the wait before food from 2 h to 1 h, or even 30 min, produces a mean reduction in absorption of 40%. Since the clinical efficacy of alendronate is indistinguishable whether it is given 30 min, 1h, or 3 h before a meal, the observed variability in bioavailability within this range is of little consequence. Dosing up to at least 2 h after a meal dramatically reduces absorption (80%–90%).
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01623002
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  • 7
    Electronic Resource
    Electronic Resource
    Rationale for the use of alendronate in osteoporosis (1995)
    Springer
    Osteoporosis international 5 (1995), S. 1-13 
    Details
    ISSN: 1433-2965
    Keywords: Alendronate ; Osteoporosis ; Paget's disease ; Pharmacology
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Bisphosphonates are being used in disorders associated with accelerated resorption of bone, particularly Paget's disease of bone and the bone disease of malignancy. Their undoubted biological efficacy and relatively low apparent toxicity make them attractive candidates for the management of osteoporosis. The bisphosphonate alendronate has many characteristics which suggest that it is suitable for use in osteoporosis. It is a potent inhibitor of osteoclast-mediated bone resorption with no adverse effect on the mineralization of bone. Earlier studies have shown it to be one of the most active bisphosphonates in Paget's disease and the hypercalcemia of malignancy. In common with other bisphosphonates tested thus far, alendronate appears to inhibit bone loss in a variety of experimental models of osteoporosis. Long-term studies are needed to determine its steady-state effects on bone mass in man. Most data indicate that alendronate is capable at least of decreasing the rate of bone loss, and might even induce increments in bone mass for many years. Since the experimental studies show that the increase in bone mass observed with alendronate is associated with an increase in bone strength, its use is likely to decrease the frequency of fractures. However, direct clinical evidence for this requires the outcome of well-designed long-term prospective studies.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01623652
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