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Randomized Controlled Trial
. 2014 Dec;29(12):1599-606.
doi: 10.1007/s11606-014-2961-3. Epub 2014 Aug 16.

Intensive blood pressure control, falls, and fractures in patients with type 2 diabetes: the ACCORD trial

Karen L Margolis  1 , Lisa Palermo, Eric Vittinghoff, Gregory W Evans, Hal H Atkinson, Bruce P Hamilton, Robert G Josse, Patrick J O'Connor, Debra L Simmons, Margaret Tiktin, Ann V Schwartz
Affiliations
Randomized Controlled Trial

Intensive blood pressure control, falls, and fractures in patients with type 2 diabetes: the ACCORD trial

Karen L Margolis et al. J Gen Intern Med. 2014 Dec.

Abstract

Background: There are few rigorous studies to confirm or refute the commonly cited concern that control of blood pressure to lower thresholds may result in an increased risk of falls and fractures.

Objective: To compare falls and fractures in participants with type 2 diabetes in the intensive (targeting a systolic blood pressure of < 120 mmHg) and standard (targeting a systolic blood pressure of < 140 mmHg) blood pressure control arms of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) randomized trial (N = 4,733).

Participants: A subset of 3,099 participants self-reported annually on the occurrence of falls and non-spine fractures. Fractures were centrally adjudicated.

Main measures: The incidence of falls in the two treatment groups was compared using a random-effects negative binomial model, and fracture risk was compared using Cox proportional hazards models.

Key results: At enrollment in both groups, the mean age was 62 years, 44% were women, 25% were Black, and mean blood pressure was 138/75 mmHg. During follow-up, all classes of medications, particularly thiazide diuretics, were more commonly prescribed in the intensive group. After 1 year of follow-up, the mean systolic blood pressure was 133 ± 15 mmHg in the standard group and 119 ± 14 mmHg in the intensive group. The adjusted rate of falls did not differ in the intensive and standard groups (62.2/100 person-years vs. 74.1/100 person-years, RR = 0.84, 95% CI 0.54-1.29, p = 0.43). The risk of non-spine fractures was nonsignificantly lower in the intensive than in the standard blood pressure group (HR 0.79, 95% CI 0.62-1.01, p = 0.06).

Conclusions: We conclude that intensive antihypertensive treatment that lowered mean systolic blood pressure to below 120 mmHg was not associated with an increased risk of falls or non-spine fractures in patients age 40 to 79 years with type 2 diabetes.

Trial registration: ClinicalTrials.gov NCT00000620.

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Figures

Figure 1
Figure 1
a Systolic blood pressure (SBP) of ACCORD-BONE participants in the intensive and standard treatment groups of the ACCORD Blood Pressure trial. b Diastolic blood pressure (DBP) of ACCORD-BONE participants in the intensive and standard treatment groups of the ACCORD Blood Pressure trial.
Figure 2
Figure 2
Proportion of participants treated with various antihypertensive drug classes at the 12-month visit in intensive and standard treatment groups of the ACCORD Blood Pressure Trial (ARB angiotensin receptor blocker, CCB calcium channel blocker).
Figure 3
Figure 3
Proportion of participants who fell in previous year at each visit, by blood pressure treatment group.
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