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Therefore, we speculate that a longer study duration could show a beneficial effect on HbA1c. Compared to glucose metabolism, the role of glucocorticoids in lipid metabolism is more controversial.

Patients with endogenous overproduction of glucocorticoids are prone to develop dyslipidaemia 2. Similarly, glucocorticoid administration has been associated with the deterioration of lipid metabolism Interestingly, in a large observational study, glucocorticoids were associated with higher HDL levels and glucocorticoid treatment was shown to normalise HDL levels in rheumatoid arthritis 37 , 38 , This positive effect of glucocorticoids may be due to the reduction of the inflammatory burden rather than a direct impact on lipid metabolism.

Although the role of glucocorticoids on lipids remains unclear, metformin presumably has a beneficial effect by decreasing triglycerides and LDL cholesterol while increasing HDL cholesterol independent of glucose metabolism 40 , 41 , In our trial, we did not observe a change in triglycerides or LDL; however, HDL cholesterol levels increased in both study groups.

This finding may be due to a direct effect of glucocorticoids or rather an indirect effect of lowering the inflammatory status. Central obesity is another characteristic feature of chronic high-dose glucocorticoid exposure 43 , In the Diabetes Prevention Program Study, metformin reduced body weight for around 2 kg during a 2-year study period in diabetic patients Thus, metformin exerts opposite effects to glucocorticoids regarding weight.

Consequently, no effect of metformin could be observed. Possibly, the study duration was too short and the sample size was too small; longer treatment duration with corticosteroids and metformin or placebo respectively, may provide different results.

Gastrointestinal adverse events occurred in similar number in both treatment groups. Several other studies found metformin to be safe and well tolerated Our study has some limitations. First, the study was prematurely terminated, which led to a rather small sample size.

This was due to a combination of slow and difficult recruitment and time to expiry of the trial drug.

Metformin prevents metabolic side effects during systemic glucocorticoid treatment

Nevertheless, due to higher than expected effect of metformin, the sample size was sufficient to demonstrate a significant effect on the primary and several secondary endpoints. As we show a highly significant result, lack of statistical power is not an issue. Second, more and predominantly male patients were in the metformin group. Third, causes of glucocorticoid administration were very variable, and the study design did not allow stratification of diseases.

Although overall glucocorticoid doses were not different between groups, some participants in the placebo group received the highest doses. Importantly, variability of indications and administration of glucocorticoid treatment mirror real life practice and make the results more generalisable. Fourth, baseline HbA1c was slightly higher in the placebo group, potentially putting these patients at higher risk for development of diabetes. Importantly, the difference in HbA1c was not significant between groups, and the primary endpoint remained highly significant after adjustment for HbA1c.

Our results indicate that metformin prevents deterioration of glucose metabolism if treatment is timed with the initiation of glucocorticoids. This study provides the basis for metformin as a preventive treatment in patients newly receiving glucocorticoid therapy. Further studies are needed to test if occurrence of glucocorticoid-induced diabetes can be reduced and if metformin has similar beneficial effects in patients with continuous glucocorticoid treatment.

As our patient number was too small to identify unique characteristics distinguishing responders from non-responders, this remains to be investigated in future studies.

In summary, this is the first randomised controlled trial showing that metformin has a beneficial preventive effect on glycaemic control in non-diabetic patients receiving systemic glucocorticoid therapy.

Declaration of interest The authors declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research reported.

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