Guest guest Posted September 5, 2001 Report Share Posted September 5, 2001 Please excuse me for what is probably a stupid question, but is this saying that the minocycline study was successful? --- Pierre Fontaine <pierre14f@...> wrote: > > The 1995 Kloppenburg Study > > Kloppenburg, M, Mattie, H, Douwes, N, Dijkmans, BAC, > Breedveld, FC, > Minocycline in the treatment of Rheumatoid > Arthritis: Relationship of > serum concentrations to efficacy, Journal of > Rheumatology, 1995, 22:4, > 611-616. > > > Objective: > > To determine the relationship between blood serum > concentrations of > minocycline and both the clinical efficacy and the > incidence of > toxicity when minocycline is used for the treatment > of patients with > Rheumatoid Arthritis. > > Results: > > The patients took 100 mg of minocycline, twice a > day, every day. > 72.5% of the patients completed the 26 weeks of the > trial with no dose > reduction. > 15% of the patients had a dose reduction to 100 mg > daily because of > adverse effects. > 12.5% of the patients withdrew from the trial during > the first 4 weeks > due to adverse effects. > Higher blood concentrations of minocycline lead to > better results. > The blood concentrations of minocycline are > different for each person. > No individual difference can explain the variations > in the blood > concentrations of minocycline, although this is in > contrast with > earlier studies that have described a correlation > with body size or > sex. > > Description: > > 80 patients who had definite or classical Rheumatoid > Arthritis, > according to the 1958 criteria of the American > Rheumatism Association, > were admitted to the 26-week prospective, double > blind, placebo > controlled trial if they had an active disease and > were being or had > been treated with at least one disease modifying > antirheumatic drug > (DMARD). > > Minocycline (100 mg twice a day) or placebo was > given as adjuvant > therapy. The concomitant dose of DMARD or > corticosteroids had to be > stable for at least 3 months. No alteration was > allowed in the use of > corticosteroids and DMARD during the trial. In case > of serious adverse > effects, as judged by 2 physicians, the daily dosage > was reduced to 100 > mg; if dosage reduction did not lead to a decrease > in severity of the > gastro-intestinal adverse effects, including nausea, > to a level that > was tolerated by the patient or did not lead to a > total disappearance > of the vestibular adverse effects (dizziness, > vertigo, postural > unsteadiness), the study medication was > discontinued. > > 40 patients with active RA were administered > minocycline. 29 patients > (72.5%) completed the 26 weeks of the trial at a > dose of 100 mg > minocycline twice a day. 6 patients (15%) had a dose > reduction to 100 > mg daily because of adverse effects; the dose > reduction led to a > reduction in the adverse effects. There were 5 > premature > discontinuations (12.5%) during the first 4 weeks of > the trial due to > adverse effects. > > At page 613, the Kloppenburg study states: > > " Correlation between estimated concentrations and > patient > characteristics: To analyse the possible causes of > the variations > between the minocycline concentrations explained by > the patient effect, > we analysed several patient characteristics, > including sex, age, > duration of RA, body weight, creatinine clearance > and the use of > another DMARD simultaneously with minocycline. In a > multivariate ANOVA > these characteristics were analysed separately for > each characteristic. > No statistically significant contribution to the > variation could be > demonstrated for any of these characteristics. " > > At page 614, the Kloppenburg study adds: > > " Moreover, as expected the variations in the serum > concentrations of > minocycline between the patients were significant, > as were the effects > of dose and time. In our study there were no patient > characteristics > that could explain the variation in the serum > concentrations. This is > in contrast with earlier studies that have described > a correlation with > body size or sex. " > > At page 615, the Kloppenburg study concludes: > > " Our results suggest a relationship between the > level of serum > concentrations of minocycline and the clinical > response, as expressed > by the Ritchie articular index and the number of > swollen joints. No > relationship was found between the serum > concentrations of minocycline > and the incidence of toxicity. " > > > > __________________________________________________ Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 6, 2001 Report Share Posted September 6, 2001 The way I read the excerpts that Pierre has sent, this 1995 study looks at variations in effectiveness of the treatment and side effects due to differing blood concentrations of minocycline in the subjects. The effectiveness of the treatment is more directly addressed in the 1994 study sent by Pierre, as in these excerpts: " There was a statistically significant improvement in the minocycline group over the placebo group. There was a pronounced improvement in laboratory parameters of disease activity; however, improvement in clinical parameters was less impressive. " " The results of the present study suggest that minocycline is beneficial and relatively safe in RA patients. " There are no stupid questions here except the ones not asked, in my book. : ) Hope this helps clarify. Liz G. is this saying that the minocycline > study was successful? > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 5, 2002 Report Share Posted March 5, 2002 The 1995 Kloppenburg Study Kloppenburg, M, Mattie, H, Douwes, N, Dijkmans, BAC, Breedveld, FC, Minocycline in the treatment of Rheumatoid Arthritis: Relationship of serum concentrations to efficacy, Journal of Rheumatology, 1995, 22:4, 611-616. Objective: To determine the relationship between blood serum concentrations of minocycline and both the clinical efficacy and the incidence of toxicity when minocycline is used for the treatment of patients with Rheumatoid Arthritis. Results: The patients took 100 mg of minocycline, twice a day, every day. 72.5% of the patients completed the 26 weeks of the trial with no dose reduction. 15% of the patients had a dose reduction to 100 mg daily because of adverse effects. 12.5% of the patients withdrew from the trial during the first 4 weeks due to adverse effects. Higher blood concentrations of minocycline lead to better results. The blood concentrations of minocycline are different for each person. No individual difference can explain the variations in the blood concentrations of minocycline, although this is in contrast with earlier studies that have described a correlation with body size or sex. Description: 80 patients who had definite or classical Rheumatoid Arthritis, according to the 1958 criteria of the American Rheumatism Association, were admitted to the 26-week prospective, double blind, placebo controlled trial if they had an active disease and were being or had been treated with at least one disease modifying antirheumatic drug (DMARD). Minocycline (100 mg twice a day) or placebo was given as adjuvant therapy. The concomitant dose of DMARD or corticosteroids had to be stable for at least 3 months. No alteration was allowed in the use of corticosteroids and DMARD during the trial. In case of serious adverse effects, as judged by 2 physicians, the daily dosage was reduced to 100 mg; if dosage reduction did not lead to a decrease in severity of the gastro-intestinal adverse effects, including nausea, to a level that was tolerated by the patient or did not lead to a total disappearance of the vestibular adverse effects (dizziness, vertigo, postural unsteadiness), the study medication was discontinued. 40 patients with active RA were administered minocycline. 29 patients (72.5%) completed the 26 weeks of the trial at a dose of 100 mg minocycline twice a day. 6 patients (15%) had a dose reduction to 100 mg daily because of adverse effects; the dose reduction led to a reduction in the adverse effects. There were 5 premature discontinuations (12.5%) during the first 4 weeks of the trial due to adverse effects. At page 613, the Kloppenburg study states: " Correlation between estimated concentrations and patient characteristics: To analyse the possible causes of the variations between the minocycline concentrations explained by the patient effect, we analysed several patient characteristics, including sex, age, duration of RA, body weight, creatinine clearance and the use of another DMARD simultaneously with minocycline. In a multivariate ANOVA these characteristics were analysed separately for each characteristic. No statistically significant contribution to the variation could be demonstrated for any of these characteristics. " At page 614, the Kloppenburg study adds: " Moreover, as expected the variations in the serum concentrations of minocycline between the patients were significant, as were the effects of dose and time. In our study there were no patient characteristics that could explain the variation in the serum concentrations. This is in contrast with earlier studies that have described a correlation with body size or sex. " At page 615, the Kloppenburg study concludes: " Our results suggest a relationship between the level of serum concentrations of minocycline and the clinical response, as expressed by the Ritchie articular index and the number of swollen joints. No relationship was found between the serum concentrations of minocycline and the incidence of toxicity. " __________________________________________________________ Obtenez votre adresse @.ca gratuite et en français ! courriel..ca Quote Link to comment Share on other sites More sharing options...
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