The ACCORD BP trial was a nonblinded trial in which participants were randomly assigned to intensive therapy that targeted systolic blood pressures of less than 120 mm Hg or standard therapy that targeted systolic blood pressures of less than 140 mm Hg. Treatment strategies that are currently available in clinical practice were used to lower blood pressure. Randomization was performed centrally on the study’s Web site with the use of permuted blocks to maintain concealment of future study-group assignments.
The approach to the management of blood pressure has been described elsewhere.4 The schedules of visits for the assessment and management of blood pressure differed according to treatment group. For participants in the intensive-therapy group, visits to assess blood pressure were scheduled once a month for 4 months and every 2 months thereafter; for participants in the standard-therapy group, visits were scheduled at months 1 and 4 and every 4 months thereafter. Additional visits were scheduled as needed in both groups to monitor and ensure appropriate implementation of the study intervention strategies. In both blood-pressure groups, participants who were assigned to intensive glycemic therapy had more frequent contacts for the management of glycemia, but blood pressure was not monitored at these additional visits.
The ACCORD BP trial was a study of a treatment strategy to achieve specific systolic blood-pressure goals, rather than an evaluation of any specific drug regimen. However, all the antihypertensive regimens were to include drug classes that had been shown to result in a reduction in cardiovascular events among participants with diabetes. Details of the assessment of blood pressure, the adjustment of medication doses, and antihypertensive drug regimens are provided in Sections 8 and 9 in Supplementary Appendix 1. Antihypertensive drugs were donated by Abbott Laboratories, AstraZeneca Pharmaceuticals, Glaxo-SmithKline Pharmaceuticals, King Pharmaceuticals, Sanofi-Aventis U.S., and Novartis Pharmaceuticals. Sphygmomanometers were donated by Omron Healthcare. The companies that donated the drugs and devices had no role in the design of the study, the accrual or analysis of the data, or the preparation of the manuscript.
At the 4-month visits that both treatment groups were scheduled to attend, information on study outcomes and adverse events was ascertained, blood samples were obtained, and clinical examinations were performed. The occurrence of self-reported symptoms of swelling or of dizziness on standing during the previous month was assessed as part of a standardized symptom checklist that was administered at baseline and at 1, 3, and 4 years after randomization to a random sample of 969 participants who were assessed for health-related quality of life.
The approach to the management of blood pressure has been described elsewhere.4 The schedules of visits for the assessment and management of blood pressure differed according to treatment group. For participants in the intensive-therapy group, visits to assess blood pressure were scheduled once a month for 4 months and every 2 months thereafter; for participants in the standard-therapy group, visits were scheduled at months 1 and 4 and every 4 months thereafter. Additional visits were scheduled as needed in both groups to monitor and ensure appropriate implementation of the study intervention strategies. In both blood-pressure groups, participants who were assigned to intensive glycemic therapy had more frequent contacts for the management of glycemia, but blood pressure was not monitored at these additional visits.
The ACCORD BP trial was a study of a treatment strategy to achieve specific systolic blood-pressure goals, rather than an evaluation of any specific drug regimen. However, all the antihypertensive regimens were to include drug classes that had been shown to result in a reduction in cardiovascular events among participants with diabetes. Details of the assessment of blood pressure, the adjustment of medication doses, and antihypertensive drug regimens are provided in Sections 8 and 9 in Supplementary Appendix 1. Antihypertensive drugs were donated by Abbott Laboratories, AstraZeneca Pharmaceuticals, Glaxo-SmithKline Pharmaceuticals, King Pharmaceuticals, Sanofi-Aventis U.S., and Novartis Pharmaceuticals. Sphygmomanometers were donated by Omron Healthcare. The companies that donated the drugs and devices had no role in the design of the study, the accrual or analysis of the data, or the preparation of the manuscript.
At the 4-month visits that both treatment groups were scheduled to attend, information on study outcomes and adverse events was ascertained, blood samples were obtained, and clinical examinations were performed. The occurrence of self-reported symptoms of swelling or of dizziness on standing during the previous month was assessed as part of a standardized symptom checklist that was administered at baseline and at 1, 3, and 4 years after randomization to a random sample of 969 participants who were assessed for health-related quality of life.
