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Landon Stewart
Landon Stewart


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To limit renal impairment, several approaches have been explored in renal, cardiac, and liver transplantation. Immunosuppressive regimens have used mycophenolate mofetil (MMF) in combination with a calcineurin inhibitor (CNI) [7]. These efficient strategies foster the use of reduced CNI doses after the first high-risk rejection period after transplantation. In long-term heart transplant recipients with chronic renal dysfunction, a significant improvement in renal function and metabolic profile with no increased risk of acute rejection episodes was observed [8, 9].

Strategy tolerance was assessed by the incidence of adverse events. Vital signs (weight and clinical manifestations) and cardiovascular risk factors (blood pressure, lipid, and glucose profiles) were closely monitored at each outpatient visit.

Several reasons may explain these results. First, the observed difference at 12 months (12 μmol/L) was lower than expected (24 μmol/L for an 18% reduction). Second, during the period under different dose regimens, the two group distributions of blood CsA values overlapped. During the first three months in the low-dose group, the C0 level remained at the upper end of the target range reflecting difficulties for physicians to significantly reduce CsA doses. This difficulty has already been reported [9]. Third, the primary endpoint was assessed at 12 months; that is, after nine months of identical dose regimens but the observed difference decreased after three months under the same regimen. Therefore, the low-dose strategy was not long enough to have a strong impact on the results at 12 months. Fourth, the important heterogeneity of individual responses over time has probably affected the power of the analysis. Finally, the lower frequency of high creatinine values (upper quartile) between three and twelve months in the low-dose group suggests different response profiles possibly linked to the severity of renal impairment. Even though less patients with severe renal impairment (creatinine >120 μmol/L) were seen at three months in the low-dose group, the post hoc analysis was not able to show a statistically significant effect, possibly because of a lack of power.

Several limitations of our study have to be acknowledged. These include the small number of new heart transplantations in France, possible biases related to the open-label design of the study, the choice of an endpoint devoid of direct clinical relevance, and the insufficient power to address all dimensions of the risk/benefit ratio of the newly proposed strategy. Nevertheless, this study is the first French multicentre trial in heart transplantation that addressed this daily specialist concern. Obviously, our results cannot be viewed as a definitive answer to the issue of the risk/benefit ratio of the CsA reduction strategy, but they may foster future research in the same direction and orient future studies towards a success/failure approach. They explore whether patients fitting particular individual profiles are more likely to benefit from a low-dose CsA strategy.

Of the 1075 respondents to the rectal bleeding question, 332 (31%) reported ever experiencing this symptom with 60 (18%) respondents never having consulted a doctor. Additional file 2 presents the univariate (Pearson χ2) associations between socio-demographic, clinical and psychosocial characteristics and ever seeking medical advice for rectal bleeding. Multiple logistic regression modelling identified the following significant predictors of ever seeking medical advice for rectal bleeding: being male and persons that had ever received screening advice from a doctor or other health professional (See Table 2).

Additional file 2: Simple logistic regression analyses of the factors associated with ever seeking medical advice for rectal bleeding and change in bowel habit. Simple logistic regression analyses of socio-demographic, clinical and psychosocial factors association with early medical advice seeking. (DOCX 25 KB) 041b061a72


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