{"title":"Skeletal benefit after one year of risedronate therapy in patients with rheumatoid arthritis and glucocorticoid-induced osteoporosis: a prospective study.","authors":"U Lange, U Illgner, J Teichmann, H Schleenbecker","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Glucocorticoid therapy is an important risk factor for osteoporosis in rheumatoid arthritis. Reduction in fracture risk is the most important endpoint for osteoporosis treatments. The aim of this study was to evaluate whether skeletal benefit (increases in osteosonogrammetry parameters, reduction in bone turnover and fracture incidence) are maintained during a follow-up of 1 year with risedronate therapy (5 mg/day). During the study period osteosonogrammetry parameters showed a significant increase and no new osteoporotic fractures were reported, suggesting an antifracture effect of risedronate therapy. Urine crosslinks (as a bone resorption marker) significantly decreased during the follow-up, suggesting a positive balance in the bone remodeling process. The tolerability of risedronate was good and only seven out of 51 patients presented minimal adverse effects. In summary, risedronate significantly decreased new osteoporotic fractures in patients with rheumatoid arthritis and glucocorticoid-induced osteoporosis and is an effective and well-tolerated treatment.</p>","PeriodicalId":13940,"journal":{"name":"International journal of clinical pharmacology research","volume":"24 2-3","pages":"33-8"},"PeriodicalIF":0.0,"publicationDate":"2004-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25106662","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Y Hirooka, C Li, J Takagi, M Gotoh, S Habu, T Yasaka-Nomura, R Ishihara, Y Nakasone, R Nakamura, R Morikawa, K Otake, T Nogimori, Y Ishizuki
{"title":"Comparison of new different assay systems for thyrotropin receptor antibodies with reference to thyroid-stimulating antibodies and thyroid stimulation-blocking antibodies in Graves' disease.","authors":"Y Hirooka, C Li, J Takagi, M Gotoh, S Habu, T Yasaka-Nomura, R Ishihara, Y Nakasone, R Nakamura, R Morikawa, K Otake, T Nogimori, Y Ishizuki","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The aim of our study was to evaluate the diagnostic sensitivity of the new thyrotropin receptor antibody (TRAb) assays (Cosmic TRAb CT, ELISA and Yamasa DYNOtest TRAb). TRAb was positive in 43 of 44 (97.7%) untreated patients with Graves' disease by both TRAb CT and/or ELISA and NYNOtest TRAb. Thus the new TRAb assays were clearly more sensitive than the conventional assay (positivity: 85%). There was a strong positive correlation between the data obtained in TRAb CT and/or ELISA and those obtained in DYNOtest TRAb (r = 0.942, p < 0.0001). There was a significant correlation between the new TRAb and TSAb (r = 0.696, p < 0.0001). Although there was a significant correlation between the new TRAb and thyroid stimulation-blocking antibody (TSBAb), the correlation coefficient was low (r = 0.605, p < 0.0001). The increased sensitivity of the new TRAb assays for Graves' disease provides an advantage over conventional assay.</p>","PeriodicalId":13940,"journal":{"name":"International journal of clinical pharmacology research","volume":"24 4","pages":"111-6"},"PeriodicalIF":0.0,"publicationDate":"2004-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24995858","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
L G De Filippis, S Gulli, A Caliri, G D'Avola, R Lo Gullo, S Morgante, C Romano, F Munaò, G Trimarchi, D La Torre, C Fichera, A Pappalardo, G Triolo, M Gallo, G Valentini, G Bagnato
{"title":"Factors influencing pain, physical function and social functioning in patients with osteoarthritis in southern Italy.","authors":"L G De Filippis, S Gulli, A Caliri, G D'Avola, R Lo Gullo, S Morgante, C Romano, F Munaò, G Trimarchi, D La Torre, C Fichera, A Pappalardo, G Triolo, M Gallo, G Valentini, G Bagnato","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The aim of this study was to assess factors influencing bodily pain (BP), physical function (PF) and social functioning (SF) in patients with osteoarthritis (OA) from southern Italy A total of 1,782 patients (mean age 66.08 years, 570 men and 1,212 women) with knee, hip, spine or hand OA underwent a structured assessment comprising demographic data and the Short Form 36 (SF-36) BP, PF and SF scales. Separate multiple linear regression models were employed for statistical analysis. The mean disease duration was 9.18 years and the mean body mass index (BMI) was 27.06. The mean BP, PF and SF scores of 34.93 (SD 19.37), 63.58 (SD 26.53) and 47.89 (SD 21.83) for the study subjects were substantially lower than those expected for the general Italian population. Subjects who were younger with a shorter disease duration and lower BMI had better PF and SF Younger subjects with a lower BMI and a longer disease duration had less BP. Female sex was associated with more BP, worse SF and better PF. In conclusion, demographic and disease-related factors influence BP, PF and SF in southern Italian patients with OA.</p>","PeriodicalId":13940,"journal":{"name":"International journal of clinical pharmacology research","volume":"24 4","pages":"103-9"},"PeriodicalIF":0.0,"publicationDate":"2004-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24995857","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
M L Arruzazabala, R Mas, V Molina, D Carbajal, L Fernández, J Illnait, G Castaño, J Fernández, S Mendoza
{"title":"Effects of d-003, a new substance purified from sugar cane wax, on platelet aggregation and plasma levels of arachidonic acid metabolites in healthy volunteers.","authors":"M L Arruzazabala, R Mas, V Molina, D Carbajal, L Fernández, J Illnait, G Castaño, J Fernández, S Mendoza","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>D-003 is a mixture of very high molecular weight aliphatic acids purified from sugar cane wax showing cholesterol-lowering and antiplatelet effects proven in experimental and clinical studies. Experimental evidence indicates that inhibition of platelet aggregation induced by D-003 is associated with a reduction of thromboxane B2 (TxB2) and an increase of prostacyclin (Pgl2) serum levels. This double-blinded, randomized, placebo-controlled study was undertaken to investigate whether D-003 (20 mg/day) modifies serum levels of TxB2 and Pgl2 and inhibits platelet aggregation in human healthy volunteers. Thirty-one subjects were randomized to placebo or D-003 at 20 mg/day for 14 days. Serum levels of TxB2 and Pgl2 and platelet aggregation to arachidonic acid (AA) (1.75 mM) and collagen (1 microg/ml) were assessed. D-003 (20 mg/day) significantly reduced (p < 0.001) TxB2by 36.4% and increased Pgl2 serum levels by 31% compared with baseline, and these changes were different from placebo. As expected, D-003 significantly inhibited (p < 0.001) platelet aggregation to AA (81.9-65.6%) and to collagen (75.3-62.3%). No subject withdrew from the study. No drug-related disturbances were observed. We conclude that D-003 at 20 mg/day for 14 days significantly inhibited platelet aggregation to AA and collagen and reduced TxB2 and increased Pgl2 serum levels. These results are consistent with those observed in experimental models, indicating that the antiplatelet effect of D-003 is associated with the observed changes on the levels of AA metabolites. Further studies, however, should explore the mechanism involved in this action in greater depth.</p>","PeriodicalId":13940,"journal":{"name":"International journal of clinical pharmacology research","volume":"24 2-3","pages":"55-63"},"PeriodicalIF":0.0,"publicationDate":"2004-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25106665","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Molecular mechanism for accelerated atherosclerosis in diabetes and its potential therapeutic intervention.","authors":"S Yamagishi, K Nakamura, M Takeuchi, T Imaizumi","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Diabetes is associated with a marked increase in the risk of atherosclerotic vascular disorders, including coronary, cerebrovascular and peripheral artery disease. Macrovascular complications could account for disabilities and high mortality rates in patients with diabetes. There is a growing body of evidence to indicate that tight blood glucose control has no more than a marginal impact on cardiovascular disease in diabetes. In this review, we discuss the molecular mechanisms for accelerated atherosclerosis in diabetes and the potential therapeutic interventions, especially focusing on postprandial hyperglycemia and advanced glycation end products (AGEs).</p>","PeriodicalId":13940,"journal":{"name":"International journal of clinical pharmacology research","volume":"24 4","pages":"129-34"},"PeriodicalIF":0.0,"publicationDate":"2004-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24994568","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Accelerated cardiomyopathy in maternally inherited diabetes and deafness.","authors":"R A Mangiafico, M Zeviani, G Bartoloni, C E Fiore","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The clinical features and course of cardiac involvement in a patient with maternally inherited diabetes and deafness associated with the mitochondrial DNA 3243 mutation are reported. A 45-year-old woman with maternally transmitted diabetes mellitus and deafness presented with congestive heart failure. The patient showed a short P-R interval on electrocardiogram (ECG) and had developed progression from left ventricular hypertrophy to a hypokinetic cardiomyopathy pattern over the course of 10 months. Rapid cardiac change was accompanied by left ventricular remodeling, as shown by wall thinning on echocardiogram and decrease in QRS voltages on ECG. Coronary arteriography revealed no significant stenosis. In the endomyocardial biopsy specimens, light microscopy showed nonspecific cardiomyopathic changes. Genetic testing for mitochondrial DNA mutations in peripheral blood lymphocytes revealed an adenine (A)-to-guanine (G) substitution at nucleotide 3243 in the mitochondrial DNA encoding the transfer RNA for leucine (tRNA Leu (UUR)). The proportion of mutant mitochondrial DNA was 25%. Two of the patient's daughters, aged 13 and 21 years, who were symptom free, were found to carry the same point mutation. A short P-R interval on ECG in the younger of them was the sole manifestation of the mutation. Unfortunately, 6 months after diagnosis, the patient died suddenly at home. Accelerated cardiomyopathy can occur as a mitochondria-related complication in patients with maternally inherited diabetes and deafness associated with the 3243 mutation.</p>","PeriodicalId":13940,"journal":{"name":"International journal of clinical pharmacology research","volume":"24 1","pages":"15-21"},"PeriodicalIF":0.0,"publicationDate":"2004-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24841291","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
M Takeuchi, S Yamagishi, M Iwaki, K Nakamura, T Imaizumi
{"title":"Advanced glycation end product (age) inhibitors and their therapeutic implications in diseases.","authors":"M Takeuchi, S Yamagishi, M Iwaki, K Nakamura, T Imaizumi","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Nonenzymatic modification of proteins by reducing sugars, a process that is also known as the Maillard reaction, leads to the formation of advanced glycation end products (AGEs) in vivo. There is a growing body of evidence that formation and accumulation of AGEs progress during normal aging, and at an extremely accelerated rate under diabetes, and are thus involved in the pathogenesis of various diseases such as diabetic vascular complications and neurodegenerative diseases. Therefore, inhibition of AGE formation may be a promising target for therapeutic intervention in AGE-related disorders. In this review, we discuss several types of AGE inhibitors and their therapeutic implications in diseases.</p>","PeriodicalId":13940,"journal":{"name":"International journal of clinical pharmacology research","volume":"24 2-3","pages":"95-101"},"PeriodicalIF":0.0,"publicationDate":"2004-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24939367","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
V S Saxena, K Venkateshwarlu, P Nadig, H C Barbhaiya, N Bhatia, D M Borkar, R S Gill, R K Jain, S K Katiyar, K V Nagendra Prasad, K M Nalinesha, K Nasiruddin, J P Rishi, J Roy Chowdhury, P S Saharia, B Thomas, D Bagchi
{"title":"Multicenter clinical trials on a novel polyherbal formulation in allergic rhinitis.","authors":"V S Saxena, K Venkateshwarlu, P Nadig, H C Barbhaiya, N Bhatia, D M Borkar, R S Gill, R K Jain, S K Katiyar, K V Nagendra Prasad, K M Nalinesha, K Nasiruddin, J P Rishi, J Roy Chowdhury, P S Saharia, B Thomas, D Bagchi","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Allergic rhinitis is the most frequently occurring immunological disorder. It affects men, women and children and represents significant cost in terms of suffering and loss of productivity. Allergy is termed as an excessive reaction to an environmental allergen. Pollen, mold, dust, mite and animal allergens that contact the nasal or eye lining cause sneezing, nasal congestion and itchy, watery, swollen, red eyes. Although a broad spectrum of therapeutic options is available, the treatment of allergic rhinitis appears to be far from satisfactory. A novel polyherbal formulation (PF; Aller-7/NR-A2) comprising seven medicinal herbal extracts was assessed in a multicenter clinical trial involving 545 patients (321 males and 224 females) aged 18-59 years for 12 weeks to evaluate its clinical efficacy in patients suffering from allergic rhinitis. A total of 171 patients participated in double-blind, randomized, placebo-controlled studies in three centers, while 374 patients were included in the open-label studies in 11 centers. The three major symptoms (sneezing, rhinorrhea and nasal congestion) of allergic rhinitis were significantly reduced. Significant improvement was also observed in absolute eosinophil count, mucociliary clearance time, peak expiratory flow rate and peak nasal flow rate. No serious adverse events that warranted cessation of treatment were observed. Minor adverse effects were noted in both the treatment and placebo groups. Thus, this study demonstrates that Aller-7/NR-A2 is well tolerated and efficacious in patients with allergic rhinitis.</p>","PeriodicalId":13940,"journal":{"name":"International journal of clinical pharmacology research","volume":"24 2-3","pages":"79-94"},"PeriodicalIF":0.0,"publicationDate":"2004-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24939366","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Working women are better responders to beta-blocker monotherapy of mild hypertension than men.","authors":"R Dabrowski, J Wozniak, I Kowalik, H Szwed","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The aim of this single-blind study was to compare the efficacy of betaxolol treatment (20 mg/day) on 24-h blood pressure profiles in working men and women with mild hypertension (grade 1 acc. ESH/ESC/JNC 2003), A group of 11 men and 11 women with a mean age 47+/-5 years underwent 24-h blood pressure monitoring after 8 days of placebo and after 20 days of treatment. A significant reduction (p < 0.05) in blood pressure was found for 11 h in men and 15 h in women (systolic) and 9 h in men and 13 h in women (diastolic). There was a tendency for a greater mean reduction in women (9.6/8.0 mmHg in men versus 12.9/7.4 mmHg in women). Diastolic blood pressure variability was significantly reduced in women (9.9 versus 13.1, respectively, p < 0.002) with a tendency for systolic blood pressure variability reduction (13.0 versus 15.1). The smoothness index for systolic blood pressure was higher in women (1.0/0.74 versus 0.64/0.61). A better response for betaxolol treatment 20 mg/day was observed in women in terms of target organ damage: a longer period of significant blood pressure reduction, lower variability and a tendency toward a greater reduction.</p>","PeriodicalId":13940,"journal":{"name":"International journal of clinical pharmacology research","volume":"24 4","pages":"123-8"},"PeriodicalIF":0.0,"publicationDate":"2004-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24994566","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
G Castaño, R Mas, R Gámez, J Fernández, J Illnait, L Fernández, S Mendoza, M Mesa, J A Gutiérrez, E López
{"title":"Concomitant use of policosanol and beta-blockers in older patients.","authors":"G Castaño, R Mas, R Gámez, J Fernández, J Illnait, L Fernández, S Mendoza, M Mesa, J A Gutiérrez, E López","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Policosanol is a cholesterol-lowering drug with concomitant antiplatelet effects. It is safe and well tolerated, even in populations with high consumption of concomitant drugs. These data suggest that adverse events (AE) due to drug-to-drug interactions (DDI) with policosanol are not relevant. Experimental data indicate that potential DDI between policosanol and drugs metabolized through the cytochrome P450 hepatic system are not expected, but pharmacodynamic DDI cannot be excluded. Several clinical studies have shown that policosanol decreased arterial pressure compared with placebo, and a pharmacological interaction with beta-blockers was experimentally proven. Therefore, clinical DDI between policosanol and beta-blockers can be expected. This study investigated whether policosanol reinforces the antihypertensive effects of beta-blockers and/or whether this combination impairs some safety indicators or induces specific AE in older patients. After 5 weeks on a diet-only baseline period, 205 older hypercholesterolemic patients taking beta-blockers were randomized to policosanol 5 mg/day or placebo for 3 years. After 1 year on therapy, policosanol significantly reduced (p < 0.00001 versus placebo) low-density lipoprotein-cholesterol (LDL-C) (20.9%), total cholesterol (TC) (19.3%) and triglycerides (TG) (25.7%), whereas it increased (p < 0.01 and p < 0.001 versus placebo) high-density lipoprotein-cholesterol (HDL-C) levels (4.1%). Treatment effects did not to wear off during the 3-year follow-up. At study completion, policosanol lowered (p < 0.00001 versus placebo) LDL-C (34.3%), TC (23.2%) and TG (21.2%) and raised (p < 0.00001 versus placebo) HDL-C (12.3%). Thirty-one patients (15.1%) discontinued the study, 22 in the placebo group (20.6%) and nine in the policosanol group (9.2%). Of these, 20 patients (16 in the placebo group and four in the policosanol group) withdrew from the study due to AE. The frequency of serious adverse events (SAE), mostly vascular, in policosanol patients (3/98, 3.1%) was lower than in the placebo group (15/107, 14.0%). No impairment of safety indicators was observed. Nevertheless, reductions in systolic and diastolic blood pressure were observed in policosanol patients compared with those in the placebo group. The frequency of policosanol patients reporting mild or moderate AE (18/98, 18.4%) was also lower than in the placebo group (30/107, 28.0%). In conclusion, policosanol was well tolerated in elderly patients taking beta-block- ers and did not increase AE. Additional reduction of blood pressure and a lower frequency of SAE were observed in policosanol patients compared with those taking placebo. The cholesterol-lowering efficacy of policosanol was that expected. These results provide support that policosanol therapy added to hypercholesterolemic elderly individuals taking beta-blockers could provide additional benefits in lowering blood pressure; SAE were not more frequent in the policosanol group than in the","PeriodicalId":13940,"journal":{"name":"International journal of clinical pharmacology research","volume":"24 2-3","pages":"65-77"},"PeriodicalIF":0.0,"publicationDate":"2004-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"25106666","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}