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Cited by 94Blood Pressure and Hypertension StudiesDiabetes Treatment and ManagementSodium Intake and Health

Achieving Goal Blood Pressure in Patients With Type 2 Diabetes: Conventional Versus Fixed‐Dose Combination Approaches

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Bakris, George L., Weir, Matthew R., on behalf of the Study of Hypertension and the Efficacy of Lotrel in Diabetes (SHIELD) Investigators·2003·The Journal of Clinical Hypertension
DOI 10.1111/j.1524-6175.2002.2041.xPMC PMC8101800
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Abstract

Data from the Third National Health and Nutrition Examination Survey (NHANES III) demonstrate that only 11% of people with diabetes who are treated for high blood pressure achieve the blood pressure goal of <130/85 mm Hg recommended in the sixth report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VI). The current study tests the hypothesis that initial therapy with a fixed‐dose combination will achieve the recommended blood pressure goal in patients with type 2 diabetes faster than conventional monotherapy. This randomized, double‐blind, placebo‐controlled study had as a primary end point achievement of blood pressure <130/85 mm Hg. Participants (N=214) with hypertension and type 2 diabetes received either amlodipine/benazepril 5/10 mg (combination) or enalapril 10 mg (conventional) once daily for 4 weeks, titrated to 5/20 mg/day or 20 mg/day, respectively at this time, if target blood pressure was not achieved. Hydrochlorothiazide (HCTZ) 12.5 mg/day was added for the final 4 weeks, if target blood pressure was still not reached. Time from baseline to achieve blood pressure <130/85 mm Hg was shorter in the combination group (5.3±3.1 weeks combination vs. 6.4±3.8 weeks conventional; p=0.001). At 3 months, more participants in the combination group achieved treatment goal (63% combination vs. 37% conventional; p=0.002). Data analysis at 3 months comparing blood pressure control rates between the fixed‐dose combination group (with out HCTZ) to the conventional group (receiving HCTZ) showed an even greater disparity in blood pressure goal achievement (87% combination without HCTZ vs. 37% conventional group with HCTZ; p=0.0001). We conclude that initial therapy with a fixed‐dose combination may be more efficacious than conventional monotherapy approaches for achieving blood pressure goals in the diabetic patient. A fixed‐dose combination approach appears as safe as the current conventional approaches.

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  • For individuals with blood pressure $150/90 mmHg, initial pharmacologic treatment with two antihypertensive medications is recommended to more effectively achieve blood pressure goals.

    “For individuals with blood pressure $150/90 mmHg, initial pharmacologic treatment with two antihypertensive medications is recommended to more effectively achieve blood pressure goals (63-65).”

    From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [63]

    The Discussion supports initial two-drug, fixed-dose therapy as a first-line strategy for high-risk patients with lower blood-pressure goals, and the Abstract reports better goal achievement than with initial monotherapy. The study concerns patients with type 2 diabetes; it does not establish a recommendation for all individuals at 150/90 mmHg or identify that reading as a treatment threshold. Page numbers were not available in our copy. (LLM, conf=0.87)

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Authors
Bakris, G. L., Weir, M. R., & on behalf of the Study of Hypertension and the Efficacy of Lotrel in Diabetes (SHIELD) Investigators
Affiliations
Rush University Medical Center (US)
ORCID
Bakris, George L.
Venue
The Journal of Clinical Hypertension
Publisher
Wiley
Published
2003-05
Volume
5
Issue
3
Pages
202-209
ISSN
  • 1524-6175 (ISSN-L)
  • 1751-7176
DOI
10.1111/j.1524-6175.2002.2041.x
PMC
PMC8101800
OpenAlex
W2019386940
Cited by
94
References
3
Citations by year
2025: 5 · 2024: 5 · 2023: 3 · 2022: 4 · 2021: 1 · 2020: 5 · 2019: 1 · 2018: 3 · 2017: 3 · 2016: 1 · 2015: 1 · 2013: 1 · 2012: 4
FWCI
5.29
Type
journal article
Language
en
Open access
Licence
onlinelibrary.wiley.com/termsAndConditions#vor (vor, 1481 d)
Locations
  • Journal of Clinical Hypertension (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
  • Health Sciences › Nursing › Nutrition and Dietetics › Sodium Intake and Health
Keywords
type 2 diabetes, hypertension, blood pressure control, fixed-dose combination, enalapril, hydrochlorothiazide, JNC VI guidelines, antihypertensive monotherapy, antihypertensive drug safety
MeSH terms
Aged, Antihypertensive Agents, Benzazepines, Diabetes Mellitus, Type 2, Double-Blind Method, Drug Administration Schedule, Drug Combinations, Drug Therapy, Combination, Enalapril, Female, Humans, Hypertension, Male, Middle Aged, Treatment Outcome, Amlodipine

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