Effect of the treatment of Type 2 diabetes mellitus on the development of cognitive impairment and dementia

Almudena Areosa Sastre; Robin WM Vernooij; Magali González‐Colaço Harmand; Gabriel Martínez

doi:10.1002/14651858.CD003804.pub2

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Figure 1

Study flow diagram.

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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Analysis 1.1

Comparison 1 Glibenclamide (glyburide) versus repaglinide, Outcome 1 MMSE at 12 months.

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Analysis 1.2

Comparison 1 Glibenclamide (glyburide) versus repaglinide, Outcome 2 Cognition composite score at 12 months.

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Analysis 2.1

Comparison 2 Intense glycaemic control versus standard glycaemic control, Outcome 1 Global cognitive function measured by MMSE 40 months.

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Analysis 2.2

Comparison 2 Intense glycaemic control versus standard glycaemic control, Outcome 2 Global cognitive function (defined as reduction of at least 3 points in the MMSE).

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Analysis 2.3

Comparison 2 Intense glycaemic control versus standard glycaemic control, Outcome 3 Executive function measured by Stroop test at 40 months.

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Analysis 2.4

Comparison 2 Intense glycaemic control versus standard glycaemic control, Outcome 4 Episodic memory measured by RAVLT at 40 months.

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Analysis 2.5

Comparison 2 Intense glycaemic control versus standard glycaemic control, Outcome 5 Speed measured by DDST at 40 months.

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Analysis 2.6

Comparison 2 Intense glycaemic control versus standard glycaemic control, Outcome 6 Incidence of dementia (defined as dementia according to DSM‐IV).

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Analysis 2.7

Comparison 2 Intense glycaemic control versus standard glycaemic control, Outcome 7 Hypoglycaemia.

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Analysis 2.8

Comparison 2 Intense glycaemic control versus standard glycaemic control, Outcome 8 All cause mortality.

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Analysis 3.1

Comparison 3 Rosiglitazone plus metformin versus glibenclamide (glyburide) plus metformin, Outcome 1 Composite outcome: working memory.

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Analysis 3.2

Comparison 3 Rosiglitazone plus metformin versus glibenclamide (glyburide) plus metformin, Outcome 2 Composite outcome: learning ability.

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Analysis 3.3

Comparison 3 Rosiglitazone plus metformin versus glibenclamide (glyburide) plus metformin, Outcome 3 Composite outcome: cognitive efficiency.

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Analysis 3.4

Comparison 3 Rosiglitazone plus metformin versus glibenclamide (glyburide) plus metformin, Outcome 4 CANTAB Paired AssociatesLearning (PAL) test.

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Analysis 3.5

Comparison 3 Rosiglitazone plus metformin versus glibenclamide (glyburide) plus metformin, Outcome 5 CANTAB Pattern recognition memory (delayed) test.

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Analysis 3.6

Comparison 3 Rosiglitazone plus metformin versus glibenclamide (glyburide) plus metformin, Outcome 6 Working memory measured by Spatial working memory test.

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Analysis 3.7

Comparison 3 Rosiglitazone plus metformin versus glibenclamide (glyburide) plus metformin, Outcome 7 CANTAB Rapid visual information processing test.

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Analysis 3.8

Comparison 3 Rosiglitazone plus metformin versus glibenclamide (glyburide) plus metformin, Outcome 8 CANTAB Reaction time test.

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Analysis 3.9

Comparison 3 Rosiglitazone plus metformin versus glibenclamide (glyburide) plus metformin, Outcome 9 Episodic memory measured by RAVLT (immediate).

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Analysis 3.10

Comparison 3 Rosiglitazone plus metformin versus glibenclamide (glyburide) plus metformin, Outcome 10 Speed measured by DSST.

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Analysis 3.11

Comparison 3 Rosiglitazone plus metformin versus glibenclamide (glyburide) plus metformin, Outcome 11 Working memory measured by Spatial working memory test.

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Summary of findings for the main comparison. Glibenclamide (glyburide) compared to Repaglinide for Type 2 diabetes

Glibenclamide (glyburide) compared to Repaglinide for Type 2 diabetes
Patient or population: patients with Type 2 diabetes Settings: general population Intervention: Glibenclamide (glyburide) Comparison: Repaglinide
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No. of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Repaglinide	Glibenclamide (glyburide)
Global cognitive function measured by MMSE at 12 months		The mean MMSE at 12 months in the intervention groups was 0.90 lower (0.12 to 1.68 lower)	‐	156 (1 study)	⊕⊕⊝⊝ low^1,2	Evidence of a small effect on the MMSE favouring glibenclamide (glyburide) at 12 months.
Incidence of MCI	No evidence identified.
Incidence of dementia	No evidence identified.
Adverse events (Hypoglycaemia)	No evidence identified.
Mortality	No evidence identified.
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). CI: Confidence interval;
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.
¹ Abbatecola et al (2006) has an unclear risk of bias due to no description on the random sequence generation, allocation concealment, blinding of participants and personnel, and selective reporting. ² Single study with a small sample size: 156 patients.

Summary of findings for the main comparison. Glibenclamide (glyburide) compared to Repaglinide for Type 2 diabetes

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Summary of findings 2. Intensive glycaemic control compared to standard glycaemic control for Type 2 diabetes

Intense glycaemic control compared to standard glycaemic control for Type 2 diabetes
Patient or population: patients with Type 2 diabetes Settings: general population Intervention: intense glycaemic control Comparison: standard glycaemic control
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Standard glycaemic control	Intense glycaemic control
Global cognitive function (defined as reduction of at least 3 points in MMSE)	164 per 1000	160 per 1000 (144 to 177)	RR 0.98 (0.88 to 1.08)	11,140 (1 study)	⊕⊕⊕⊝ moderate¹	Evidence of no significant difference between intensive and standard glycaemic control.
Global cognitive function measured by MMSE at 40 months		The mean general cognitive function measured by MMSE at 40 months in the intervention groups was 0.01 lower (0.18 lower to 0.16 higher)	‐	2794 (1 study)	⊕⊕⊕⊝ moderate²	Evidence of no significant difference between intensive and standard glycaemic control.
Incidence of MCI	No evidence identified.
Incidence of dementia (defined as dementia according to DSM‐IV)	9 per 1000	11 per 1000 (7 to 16)	RR 1.27 (0.87 to 1.85)	11,140 (1 study)	⊕⊕⊝⊝ low^1,3	Evidence of no significant difference between intensive and standard glycaemic control.
Adverse events (Hypoglycaemia)	17 per 1000	36 per 1000 (25 to 52)	RR 2.18 (1.52 to 3.14)	12,931 (2 studies)	⊕⊕⊝⊝ low^1,4	Evidence of a significantly higher incidence of hypoglycaemic events for intensive glycaemic control compared with standard glycaemic control.
Mortality	81 per 1000	81 per 1000 (64 to 102)	RR 1.0 (0.79 to 1.26)	15,888 (3 studies)	⊕⊕⊕⊝ moderate¹	Evidence of no significant difference between intensive and standard glycaemic control.
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). CI: Confidence interval; 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.
¹ The ADVANCE study has an unclear risk of bias due to no description in the random sequence generation, allocation concealment, and blinding of participants and personnel. ² Launer et al has a high risk of bias in the blinding of participants and personnel and an unclear risk of bias due to no description in the blinding of outcome assessors and incomplete outcome data. ³ Event rate low (61 in the intervention group and 48 in the control group). ⁴ Wide 95% confidence interval around the pooled estimate of effect.

Summary of findings 2. Intensive glycaemic control compared to standard glycaemic control for Type 2 diabetes

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Summary of findings 3. Rosiglitazone plus metformin compared to glibenclamide (glyburide) plus metformin for Type 2 diabetes

Rosiglitazone plus metformin compared to glibenclamide (glyburide) plus metformin for Type 2 diabetes
Patient or population: patients with Type 2 diabetes Settings: general population Intervention: rosiglitazone plus metformin Comparison: glibenclamide (glyburide) plus metformin
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Glibenclamide (glyburide) plus metformin	Rosiglitazone plus metformin
Global cognitive function	No evidence identified.
Incidence of MCI	No evidence identified.
Incidence of dementia	No evidence identified.
Adverse events (Hypoglycaemia)	No evidence identified.
Mortality	No evidence identified.
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). CI: Confidence interval
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.

Summary of findings 3. Rosiglitazone plus metformin compared to glibenclamide (glyburide) plus metformin for Type 2 diabetes

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Comparison 1. Glibenclamide (glyburide) versus repaglinide

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 MMSE at 12 months Show forest plot	1	156	Mean Difference (IV, Random, 95% CI)	‐0.90 [‐1.68, ‐0.12]

2 Cognition composite score at 12 months Show forest plot	1	156	Mean Difference (IV, Random, 95% CI)	‐0.00 [‐0.01, 0.01]

Comparison 1. Glibenclamide (glyburide) versus repaglinide

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Comparison 2. Intense glycaemic control versus standard glycaemic control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Global cognitive function measured by MMSE 40 months Show forest plot	1	2794	Std. Mean Difference (IV, Random, 95% CI)	‐0.00 [‐0.08, 0.07]

2 Global cognitive function (defined as reduction of at least 3 points in the MMSE) Show forest plot	1	11140	Odds Ratio (M‐H, Random, 95% CI)	0.98 [0.88, 1.08]

3 Executive function measured by Stroop test at 40 months Show forest plot	1	2794	Mean Difference (IV, Random, 95% CI)	‐0.61 [‐1.62, 0.40]

4 Episodic memory measured by RAVLT at 40 months Show forest plot	1	2794	Mean Difference (IV, Random, 95% CI)	‐0.01 [‐0.14, 0.12]

5 Speed measured by DDST at 40 months Show forest plot	1	2794	Mean Difference (IV, Random, 95% CI)	0.32 [‐0.28, 0.92]

6 Incidence of dementia (defined as dementia according to DSM‐IV) Show forest plot	1	11140	Risk Ratio (M‐H, Random, 95% CI)	1.27 [0.87, 1.85]

7 Hypoglycaemia Show forest plot	2	12931	Risk Ratio (M‐H, Random, 95% CI)	2.18 [1.52, 3.14]

8 All cause mortality Show forest plot	3	15888	Risk Ratio (M‐H, Random, 95% CI)	0.99 [0.87, 1.13]

Comparison 2. Intense glycaemic control versus standard glycaemic control

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Comparison 3. Rosiglitazone plus metformin versus glibenclamide (glyburide) plus metformin

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Composite outcome: working memory Show forest plot	1	136	Mean Difference (IV, Random, 95% CI)	‐0.10 [‐0.69, 0.49]

2 Composite outcome: learning ability Show forest plot	1	136	Mean Difference (IV, Random, 95% CI)	0.0 [‐0.54, 0.54]

3 Composite outcome: cognitive efficiency Show forest plot	1	136	Mean Difference (IV, Random, 95% CI)	‐0.1 [‐0.64, 0.44]

4 CANTAB Paired AssociatesLearning (PAL) test Show forest plot	1	136	Mean Difference (IV, Random, 95% CI)	‐3.10 [‐3.71, ‐2.49]

5 CANTAB Pattern recognition memory (delayed) test Show forest plot	1	136	Mean Difference (IV, Random, 95% CI)	‐0.2 [‐0.30, ‐0.10]

6 Working memory measured by Spatial working memory test Show forest plot	1	136	Mean Difference (IV, Random, 95% CI)	0.4 [‐0.24, 1.04]

7 CANTAB Rapid visual information processing test Show forest plot	1	136	Mean Difference (IV, Random, 95% CI)	‐11.7 [‐15.71, ‐7.69]

8 CANTAB Reaction time test Show forest plot	1	136	Mean Difference (IV, Random, 95% CI)	9.3 [6.76, 11.84]

9 Episodic memory measured by RAVLT (immediate) Show forest plot	1	137	Mean Difference (IV, Random, 95% CI)	‐0.20 [‐0.50, 0.10]

10 Speed measured by DSST Show forest plot	1	136	Mean Difference (IV, Random, 95% CI)	‐1.4 [‐1.70, ‐1.10]

11 Working memory measured by Spatial working memory test Show forest plot	1	136	Mean Difference (IV, Random, 95% CI)	0.4 [‐0.24, 1.04]

Comparison 3. Rosiglitazone plus metformin versus glibenclamide (glyburide) plus metformin

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