Summary of findings 2. Summary of findings: repaglinide versus placebo for CFRD.
| Repaglinide versus placebo for CFRD | ||||||
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Patient or population: adults with CFRD Settings: outpatients Intervention: repaglinide (2.0 mg) orally 3 times daily Comparison: oral placebo 3 times daily | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Placebo | Repaglinide | |||||
|
HbA1c Follow‐up: 12 months |
1 trial reported that HbA1C levels did not significantly change in either the repaglinide or the placebo group (Moran 2009). | N/A | 38 (1) |
⊕⊝⊝⊝ very lowa,b | No data were available for this outcome and results have been reported narratively (Moran 2009). | |
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FEV1 % predicted; change from baseline Follow‐up: 12 months |
The mean change in FEV1 % predicted in the control group was ‐3% predicted. | The mean change in FEV1 % predicted in the intervention group was 1.7% higher (5.1% lower to 8.5% higher). | MD 1.70 (‐5.13 to 8.53) | 38 (1) | ⊕⊕⊝⊝ lowb,c | No difference was observed between groups, P = 0.6 for overall effect (Moran 2009). |
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FVC % predicted: change from baseline Follow‐up: 12 months |
The mean change in FVC % predicted in the control group was ‐1.1% predicted. | The mean change in FVC % predicted in the intervention groups was 1.0% higher (7.4% lower to 5.4% higher). | MD ‐1.00 (‐7.40 to 5.40) | 38 (1) | ⊕⊕⊝⊝ lowb,c | No difference was observed between groups, P = 0.76 for overall effect (Moran 2009). |
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BMI (kg/m²): change from baseline Follow‐up: 12 months |
The mean change in BMI in the control group was ‐0.02 kg/m². | The mean change in BMI in the intervention groups was 0.2 kg/m² higher (0.5 kg/m² lower to 0.8 kg/m² higher). | MD 0.17 (‐0.47 to 0.81) | 38 (1) | ⊕⊕⊝⊝ lowb,c | There was no significant difference between the placebo group and intervention group, P = 0.6 for overall effect (Moran 2009). |
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Hypoglycemia: number of episodes Follow‐up: 3 months |
There were mild hypoglycemic events reported in 23% of repaglinide participants, but no placebo participants reported hypoglycemia (P < 0.04); therefore it is not possible to calculate the corresponding risk. | RR 12.52 (0.74 to 211.20) | 51 (1) | ⊕⊝⊝⊝ very lowa,d | The earlier Moran study also reported on this outcome but at 2 months. These data did not give a significant result, RR 2.00 (95% CI 0.23 to 17.34) (Moran 2001). | |
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). BMI: body mass index; CFRD: cystic fibrosis‐related diabetes; CI: confidence interval; HbA1c: glycated hemoglobin; FEV1: forced expiratory volume in 1 second; FVC: forced vital capacity; MD: mean difference; RR: risk ratio. | ||||||
| GRADE Working Group grades of evidence High quality: further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: we are very uncertain about the estimate. | ||||||
a. Downgraded twice due to risk of bias in the included study, particularly around the domains of allocation concealment and selective outcome reporting. No data were reported for this outcome.
b. Downgraded once due to imprecision from small sample size. This was a 3‐armed study which therefore reduces the number of participants in each arm.
c. Downgraded once due to an unclear risk of bias in the single included trial. Although the study was deemed to be at low risk across the domains of randomisation and blinding, the allocation process was not clearly described. The trial was also deemed to be at high risk of bias due to selective reporting although that does not affect this particular outcome.
d. Downgraded once due to imprecision from both small sample size and low event rates.