Table 3. The benefits and harms of intensive versus standard systolic blood pressure control in adults with diabetes mellitus and arterial hypertension.
| Outcome | Risk with intervention/comparator per 1,000 | Attributable avoided events per 1,000 treated (95% CI) | Relative measure of association; number needed to treat (95% CI) | No. of participants (studies) |
|---|---|---|---|---|
| All-cause mortality*** | 91/82 | NS | RR: 0.94 (0.75–1.18) | 5,881 (2 RCTs) (25,36) |
| All-cause mortality, 9 years of follow-up* | 224/234 | NS | RR: 0.96 (0.78–1.17) | 1,284 (1 RCT) (42) |
| Cardiovascular death, nonfatal MI, nonfatal stroke, 9 years of follow-up* | 199/259 | Avoided 60 [14–106] | RR: 0.77 (0.63–0.94); NNTp: 17 [9–70]# | 1,284 (1 RCT) (42) |
| Coronary death, nonfatal MI, unstable angina, 9 years of follow-up* | 201/267 | Avoided 66 [20–113] | RR: 0.75 (0.62–0.92); NNTp: 15 [9–49]# | 1,284 (1 RCT) (42) |
| Cardiovascular death, 9 years of follow-up* | 58/76 | NS | RR: 0.77 (0.51–1.16) | 1,284 (1 RCT) (42) |
| Fatal myocardial infarction** | 21/17 | NS | RR: 0.80 (0.50–1.28) | 5,882 (2 RCTs) (24,25) |
| Fatal stroke** | 4/7 | NR | RR: 0.41 (0.20–0.84)# | 5,882 (2 RCTs) (24,25) |
| Any stroke** | 24/35 | Avoided 16 [7–24] | RR: 0.58 (0.43–0.78); NNTp: 63 [42–143]# | 5,881 (2 RCTs) (25,36) |
| Nonfatal stroke** | 20/29 | Avoided 12 [4–20] | RR: 0.60 (0.43–0.83); NNTp: 83 [50–250]# | 5,882 (2 RCTs) (24,25) |
| Nonfatal myocardial infarction** | 57/63 | NS | RR: 0.87 (0.71–1.07) | 5,882 (2 RCTs) (24,25) |
| Non-fatal MI, 9 years of follow-up* | 100/147 | Avoided 47 [12–83] | RR: 0.68 (0.50–0.91); NNTp: 21 [12–87]# | 1,284 (1 RCT) (42) |
| Myocardial infarction, any*** | 115/123 | NS | RR: 0.90 (0.78–1.04) | 5,881 (2 RCTs) (25,36) |
| Cancer death** | 23/19 | NS | RR: 1.17 (0.74–1.84) | 5,882 (2 RCTs) (24,25) |
| Fatal or nonfatal heart failure* | 33/41 | NS | RR: 0.67 (0.34–1.36) | 5,882 (2 RCTs) (24,25) |
| MACE**; subgroup: HbA1c ≤8.0 | 444/489 | Avoided 45 [17–73] | RR: 0.91 (0.85–0.97); NNTp: 22 [14–61]# | 4,734 (1 RCT) (24) |
| MACE**; subgroup: HbA1c >8.0 | 554/507 | Excessive 47 [76–19] | RR: 1.09 (1.04–1.15); NNT: 21 (53–13)† | 4,734 (1 RCT) (24) |
| Mortality due to congestive heart failure* | 5/4 | NS | RR: 1.10 (0.47–2.59) | 4,734 (1 RCT) (24) |
| Mortality due to fatal arrhythmia* | 1/1 | NS | RR: 1.00 (0.14–7.12) | 4,734 (1 RCT) (24) |
| Mortality related to diabetes* | 108/159 | Avoided 51 [8–93] | RR: 0.68 (0.50–0.92); NNTp: 20 [11–120]# | 1,148 (1 RCT) (25) |
| Adverse Events from blood-pressure medications* | 33/13 | Excessive 20 [11–28] | RR: 2.58 (1.70–3.91); NNT: 50 [35–87]† | 4,733 (1 RCT) (24) |
| Abnormal Q waves in ECG* | 175/231 | Avoided 55 [5–105] | RR: 0.76 (0.60–0.96); NNTp: 18 [10–182]# | 1,148 (1 RCT) (25) |
| Abnormal Q, ST, or T waves in ECG* | 38/77 | Avoided 39 [9–68] | RR: 0.50 (0.30–0.82); NNTp: 26 [15–112]# | 1,148 (1 RCT) (25) |
| Angina* | 59/56 | NS | RR: 1.05 (0.64–1.73) | 1,148 (1 RCT) (25) |
| Left ventricular hypertrophy* | 17/30 | Avoided 13 [4–22] | RR: 0.58 (0.39–0.86); NNTp: 79 [46–273]# | 4,331 (1 RCT) (43) |
| Any diabetes-related end point** | 342/436 | Avoided 94 [35–154] | RR: 0.78 (0.67–0.91); NNTp: 11 [6–29]# | 1,148 (1 RCT) (25) |
| Macroalbuminuria** | 56/78 | NR | RR: 0.77 (0.63–0.94)# | 5,527 (2 RCTs) (24,25) |
| Microalbuminuria*** | 253/296 | NS | RR: 0.92 (0.85–1.01) | 5,527 (2 RCTs) (24,25) |
| Renal failure* | 4/3 | NS | RR: 1.38 (0.18–10.81) | 5,881 (2 RCTs) (24,25) |
| Peripheral vascular disease* | 11/21 | NS | RR: 0.51 (0.19–1.36) | 1,148 (1 RCT) (25) |
| Cataract extraction* | 47/36 | NS | RR: 1.32 (0.72–2.42) | 1,148 (1 RCT) (25) |
| Vision preventing driving * | 42/62 | NS | RR: 0.69 (0.41–1.15) | 1,148 (1 RCT) (25) |
| Vitreous hemorrhage* | 4/13 | NS | RR: 0.31 (0.07–1.29) | 1,148 (1 RCT) (25) |
| Falls* | 200/206 | NS | RR: 0.97 (0.84–1.11) | 3,099 (1 RCT) (44) |
| Fatal accident* | 1/3 | NS | RR: 0.51 (0.03–8.20) | 1,148 (1 RCT) (25) |
| Fatal accident/trauma* | 2/1 | NS | RR: 2.51 (0.49–12.92) | 4,734 (1 RCT) (24) |
| All non-spine bone fractures* | 76/98 | Avoided 23 [3–43] | RR: 0.77 (0.61–0.97); NNTp: 44 [23–337]# | 3,099 (1 RCT) (44) |
| Ankle fractures* | 16/24 | NS | RR: 0.67 (0.41–1.11) | 3,099 (1 RCT) (44) |
| Distal forearm fractures* | 8/8 | NS | RR: 0.94 (0.43–2.06) | 3,099 (1 RCT) (44) |
| Foot fractures* | 6/13 | NS | RR: 0.46 (0.21–1.01) | 3,099 (1 RCT) (44) |
| Hip fractures* | 3/8 | NS | RR: 0.43 (0.15–1.20) | 3,099 (1 RCT) (44) |
| Proximal humerus fractures* | 10/12 | NS | RR: 0.81 (0.41–1.58) | 3,099 (1 RCT) (44) |
| Hives or swelling* | 88/88 | NS | RR: 1.00 (0.67–1.51) | 969 (1 RCT) (24) |
| Hyperkalemia* | 4/0 | Excessive 3 [1–6] | RR: 9.03 (1.15–71.25); NNT: 295 [166–1,299]† | 4,733 (1 RCT) (24) |
| Hypotension* | 7/0 | Excessive 7 [3–10] | RR: 17.06 (2.27–128.12); NNT: 148 [97–306]† | 4,733 (1 RCT) (24) |
Population: adults with diabetes and elevated arterial blood pressure (SBP: 130–190 mmHg); Settings: outpatient; Intervention: intensive blood pressure control [target SBP <120 versus <140 mmHg in ACCORD study and 144/82 versus 154/87 mmHg in UKPDS 38 (66) study]; Comparator: standard blood pressure control. *, very low quality evidence; **, low quality evidence; ***, moderate quality evidence; #, favors lower blood pressure target; †, favors higher blood pressure target; CI, confidence interval; ECG, electrocardiogram; GRADE, Grading of Recommendations Assessment, Development and Evaluation; NNT, number needed to treat; NNTp, number needed to treat to prevent an outcome in one patient; RCT, randomized controlled trial; RR, relative risk; SBP, systolic blood pressure; MACE, major cardiovascular events including nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes.