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Intensive Blood Pressure Control, Falls, and Fractures in Patients with Type 2 Diabetes: The ACCORD Trial

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.

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Sources of Funding

The ACCORD Trial was funded by the National Heart, Lung and Blood Institute, and ACCORD-BONE was funded by the National Institute of Diabetes and Digestive and Kidney Diseases (R01 DK069514, Ann Schwartz, PI), Trial Registration: ClinicalTrials.gov Identifier: NCT00000620.

Financial Disclosure

Ann Schwartz has research funding from GLAXOSMITHKLINE (GSK). Margaret Tiktin consults for NovoNordisk.

Conflicts of Interest

The authors declare that they do not have a conflict of interest.

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Correspondence to Karen L. Margolis MD, MPH.

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Margolis, K.L., Palermo, L., Vittinghoff, E. et al. Intensive Blood Pressure Control, Falls, and Fractures in Patients with Type 2 Diabetes: The ACCORD Trial. J GEN INTERN MED 29, 1599–1606 (2014). https://doi.org/10.1007/s11606-014-2961-3

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KEY WORDS

  • type 2 diabetes mellitus
  • hypertension
  • falls
  • fractures