Comparison of combination treatment in hypertension

Objective: The goal of this protocols is conducting comparative effectiveness research to establish evidences for optimal anti-hypertensive combination strategies among patients without cardiovascular outcome from various databases across world.

Rationale: High blood pressure is the leading global burden of death and disability. Extensive evidences support the beneficial effects in tight control of blood pressure. Since monotherapy is often insufficient or slow to reach blood pressure target quickly, combination therapy is recommended as the first-line treatment for selected patients with hypertension by the recent guideline to reduce cardiovascular risk. Retrospective observational studies and meta-analysis have suggested that initial combination hypertensive treatment confers decreased risk for cardiovascular events than monotherapy. Only a few randomized clinical trials, however, have directly compared the effects of different regimens of combination. In addition to limited number of evidences from head-to-head comparison, baseline high risk for cardiovascular outcome and previous history of anti-hypertensive medication of participants also make the findings from RCTs difficult to apply to clinical practice. To the best of our knowledge, real-world comparative effectiveness research comparing the various regimens of combination treatment in patients with essential hypertension has not been conducted until now.

Project Lead(s): Seng Chan You, MD, Ajou University, Korea Sungjae Jung, BE, Ajou University, Korea Sungha Park, MD, Yonsei university College of Medicine, Korea Rae Woong Park, MD, PhD, Ajou University, Korea

Coordinating Institution(s): Ajou University, Korea

Additional Participants:

Full Protocol: Word doc for the protocol

Initial Proposal Date: Sep 2016

Launch Date: 7 Aug 2017

Study Closure Date:

Results Submission: Via Google Drive

Requirements

CDM: V5 or over

Table Accessed: person, drug_exposure, drug_era, death, condition_occurrence, procedure_occurrence, visit_occurrence

Database Dialects: SQL Server, Postgres, Oracle

Software: R

Code

https://github.com/OHDSI/StudyProtocolSandbox/tree/master/HypertensionCombination

Discussion

http://forums.ohdsi.org/c/researchers

Datasets Run