2011 trial pmr

The interval between treatment initiation and response to it was recorded. The patients were instructed to record on a diary their clinical status and the exact day in which remission was achieved. Means were compared by the Student's t test or by one way analysis of variance if their distribution was normal and by the Kruskall Wallis test when it was non parametrical. Frequencies were compared by Fischer's exact test.

A multiple regression model was also used with response to treatment as dependent variable. In the 60 consecutive patients with PMR studied, the disease was newly diagnosed and had not been treated with steroids before. The median interval between disease onset and diagnosis was 90 days range days. None of the patients had signs or symptoms suggestive of temporal arteritis at the time of diagnosis or during the observation period.

In the responders, the mean interval between initiation of treatment and clinical remission was 6. Only body weight and gender discriminated the two groups of patients. The higher response rate observed in women was explained by their lower weight None of the features investigated by physical examination could differentiate responders from non-responders data not shown.

US examination was performed in 21 responders and 4 non-responders. This was the case also when bilateral involvement of the US pattern was considered.

Comparison of demographic, clinical, and laboratory results in PMR patients with or without response to There was a significant decrease of inflammatory parameters both in responders and non-responders.

However, responders had a more pronounced decrease than non-responders. Erythrocyte sedimentation rate ESR at baseline and at the week 1 and 4 control visits in the whole group of patients, in responders and non-responders. C-reactive protein CRP at baseline and at the week 1 and 4 control visits in the whole group of patients, in responders and non-responders. Their dose of prednisone had been increased within one month from initiation of therapy between 2.

In this group, remission was reached after a mean interval of After dose adjustment, their mean prednisone dose per kg was 0. The median dose per kg for the whole group was 0. Our results support the hypothesis that a low initial dose of prednisone is sufficient to control PMR in the majority of patients. They also suggest that 0. It is possible that, due to the open design of the study, a placebo effect increased the response rate of our patients. However, since no comparison was made between different treatments, we think it could not have biased the results.

Responders reached clinical remission in 6. This observation suggests that a close follow-up in the first days after diagnosis and treatment initiation is important to ensure that the patient is administered an adequate prednisone dosage. There is only one comparison of two different dosages of GC in the literature [ 7 ]: PMR patients were randomly assigned to an initial regimen of 10 mg or 20 mg prednisolone and followed for two months.

The patients on the low dose GC regimen had a higher incidence of relapses during the follow-up. The same incidence of giant cell arteritis was seen in both groups.

No attempt was made to correlate efficacy with body weight in this study. This observation suggested that there is a subset of a quarter of PMR patients with steroid-resistant disease [ 9 ], regardless of the initial GC dose utilized.

Other observational studies used initial GC mean doses comprised between However, due to lack of clinical information, it is impossible to derive from these papers how effective was GC in the initial period of treatment. Disease activity, evaluated by clinical, laboratory, and ultrasonographic parameters, was not important to predict response to therapy.

However, the power to test the predictive value of US was probably low because of the limited number of patients in whom the examination was performed. In univariate analysis, women showed a slightly better response to treatment than men. In contrast, previous data on PMR [ 12 ] and rheumatoid arthritis [ 13 ] have reported higher disease severity and lower rate of response to GC in women.

In fact, when multivariate analysis was performed on our cases, the association of female sex to response appeared spurious, being related to the lower mean weight of women. The observation that the optimal starting dose depends on weight and not on disease activity, and is relatively low, may confirm the view that GC action in PMR is more of replacement type than anti-inflammatory [ 14 ].

The importance of body weight in the response to prednisone treatment is not surprising, in view of the fact that GC have a high volume of distribution and are highly lypophilic [ 15 ]. One of the limitations of this study is that clinical assessors could not be blinded to patient's weight.

In addition, the design of the study limited the follow up to only one month. To partially overcome this last limitation, we performed an informal chart review to assess the presence of exacerbations within the first 6 months of treatment.

As a result, the rate of exacerbations was low in comparison with other studies using similar [ 7 ] or higher initial doses of GC [ 9 , 11 ] and response to a lower initial dose of prednisone was not correlated with a higher incidence of exacerbations. Although we cannot assume that a low GC starting dose necessarily corresponds to a low cumulative dosage, this is suggested by several observational studies [ 5 ].

Response to GC is one of the classification criteria for PMR in most studies [ 16 ], but the dose at which the drug should be administered to the effect has not been defined. Our data could help standardize the optimal starting dose. They suggest that, in low-weight patients, this dose could be lower than that previously suggested. In fact The mean time interval needed to reach remission in our cohort of responsive patients was similar to that suggested by the panel of experts.

In conclusion, in our experience low dose GC was effective in the majority of PMR patients and the main factor driving response to steroids in PMR was weight, a finding that could help to manage the clinical care of PMR patients and design prospective studies of treatment. This work was supported in part by a grant from the University of Genova Fondi di Ateneo. National Center for Biotechnology Information , U. BMC Musculoskelet Disord. Published online May Author information Article notes Copyright and License information Disclaimer.

Corresponding author. Marco A Cimmino: ti. Received Jan 26; Accepted May This article has been cited by other articles in PMC. Abstract Background the mainstay of treatment of polymyalgia rheumatica PMR is oral glucocorticoids, but randomized controlled trials of treatment are lacking. Conclusions Trial Registration ClinicalTrials. Keywords: polymyalgia rheumatica, prednisone, glucocorticoid, ultrasonography. Background Polymyalgia rheumatica PMR is a common inflammatory condition affecting elderly people and involving the girdles [ 1 ].

Results In the 60 consecutive patients with PMR studied, the disease was newly diagnosed and had not been treated with steroids before.

Open in a separate window. Figure 1. Interval between initiation of treatment and clinical remission. Table 1 Comparison of demographic, clinical, and laboratory results in PMR patients with or without response to Figure 2. Melaka Time. Mozac guestBook Catatan Pelawat Blog ini. It's a lot of little steps. Bukti akal fikiran seseorang ialah perbuatannya, dan bukti ilmunya ialah ucapannya.

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