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1 ALLHAT New Research Opportunities

2 2 New Opportunities ALLHAT ( – –Largest antihypertensive treatment trial –Second largest lipid-lowering trial ever conducted, –Landmark cost-effectiveness study. Large size and diversity of participants, varied practice settings, and primary and secondary outcomes makes the ALLHAT data set highly useful for epidemiologic investigations. In the past, ALLHAT data were available only to ALLHAT investigators. Now this resource is available to the wider scientific community. New research to use this valuable data collected since 1994 is encouraged, especially for new investigators early in their research careers. ALLHAT

3 3 New Investigator A new investigator is one who Is interested in using ALLHAT data for the first time May be seeking funding for the first time, or may already have funding May be affiliated either with an institution never before associated with ALLHAT, or an institution that has participated in ALLHAT in the past. ALLHAT

4 4 Unique Strengths I Largest antihypertensive treatment trial and second largest lipid-lowering trial ever conducted. Well-designed and conducted clinical research, landmark cost-effectiveness study. Large size and diversity of participants, varied practice settings, and primary and secondary outcomes makes the ALLHAT data set highly useful for epidemiologic investigations. ALLHAT

5 5 Unique Strengths II Randomized active phase lasted 5 years Large size: –42,418 hypertensive participants enrolled –10,355 enrolled in lipid-lowering sub-cohort Varied practice setting –623 clinical sites in the US, Puerto Rico, U.S. Virgin Islands, and Canada Drug comparisons –Four antihypertensive treatment arms –Two lipid-lowering treatment arms ALLHAT

6 6 Unique Strengths III Diversity of participants –Ages ≥55 years with ≥ 1 other CVD risk factor besides hypertension –All races –Co-morbid conditions Many variables recorded Outcome data recorded for: –In-trial CVD and non-CVD events (1994-2002) –Post-trial (2002-2006). ALLHAT

7 7 Types of Data Available Data collected during the active phase of the ALLHAT clinical trial 1994-2002. Laboratory analyses conducted by the ALLHAT Central Laboratory. Outcome data collected for some ALLHAT participants during post-trial passive follow-up (2002-2006), after the active phase of the clinical trial ended. ECG data collected at baseline and biannually Frozen serum samples Genetic material ALLHAT

8 8 How You Can Use ALLHAT Data You may use ALLHAT data to either: Propose a new paper topic for publication in a peer- reviewed journal Propose a new ALLHAT-related study to an external funding agency –May involve collecting new information from outside databases (e.g., CMS) ALLHAT

9 9 How You Can Use ALLHAT Data STEP 1: Check to see that your topic has not already been addressed. STEP 2: Submit a Concept Proposal to Dr. Ellen Breckenridge ( STEP 3: If your concept is approved, a Coordinating Center liaison will be assigned. You will be invited to identify an ALLHAT sponsor and provide a more detailed proposal. Upon request, the Coordinating Center can help identify an ALLHAT sponsor. STEP 4: The ALLHAT study leadership will review the detailed proposal. If accepted, a timetable will be developed and work can proceed. ALLHAT

10 10 How You Can Obtain ALLHAT Data Collaborate with an ALLHAT sponsor and the Coordinating Center to analyze data and write a paper or a project proposal. Request a data set to produce your own data runs for your paper or project. Request a limited access data set from NHLBI at https:\\ ALLHAT

11 11 ALLHAT

12 12 Final results published in 2002. See for details on publications and presentations. Papers have addressed Blood pressure –predictors of blood pressure response overall –predictors within randomized treatment groups. Diabetes –ALLHAT results by diabetes subgroups –diabetes incidence by randomized treatment group. ALLHAT Research Already Accomplished I

13 13 Heart Failure –validity of the ALLHAT heart failure outcome, –heart failure by randomized treatment group, –heart failure with preserved and reduced ejection fraction, and –post-heart failure mortality risk. Chronic Kidney Disease –ALLHAT results by CKD subgroups, –CKD incidences by randomized treatment group, and –the prognostic value of CKD groups for cardiovascular and renal outcomes. ALLHAT Research Already Accomplished II

14 14 Atrial Fibrillation –incidence of atrial fibrillation by randomized treatment group. Metabolic Syndrome –ALLHAT results by metabolic syndrome subgroups overall –ALLHAT results by race subgroups. ALLHAT Research Already Accomplished III

15 15 Contact Us For additional information or further assistance, please contact Ellen Breckenridge, PhD, JD, MPH ALLHAT Assistant Project Manager 713-500-9508 ALLHAT

16 16 Antihypertensive Trial Design Randomized, double-blind, clinical trial of 42,418 participants with high blood pressure comparing 4 commonly-used antihypertensives. ALLHAT investigated whether there was a difference in fatal CHD & nonfatal MI among patients randomized to CCB, ACEI, or alpha- blocker compared to a diuretic. ALLHAT also examined differences in secondary endpoints, including: –All-cause mortality, stroke, combined CHD (primary outcome, coronary revascularization, hospitalized angina) –combined CVD (combined CHD, stroke, other treated angina, HF [fatal, hospitalized, or treated non-hospitalized], and peripheral arterial disease) –renal endpoints, and cancer ALLHAT


18 18 Baseline Characteristics and Follow-up BaselineFollow-up N42,418Known alive82% Mean SBP/DBP146 / 84Confirmed dead15% Mean age, y67Lost / refused3% Black, %36Person-years (% obs/exp) 99% Women, %47 Current smoking %22 History of CHD, %26 Type 2 diabetes, %36 On antihypertensive treatment, %92 ALLHAT

19 19 Doxazosin Arm Terminated Early Futility of finding a significant difference for primary CHD outcome Statistically significant 20 percent higher rate of major secondary endpoint, combined CVD outcomes (80% higher rate of heart failure) ALLHAT Hypertension. 2003;42:239-246.

20 20 BP Results by Treatment Group Compared to chlorthalidone: SBP significantly higher in the amlodipine group (~1 mm Hg) and the lisinopril group (~2 mm Hg). Compared to chlorthalidone: DBP significantly lower in the amlodipine group (~1 mm Hg), similar in the lisinopril group. ALLHAT

21 21 Amlodipine / ChlorthalidoneLisinopril / Chlorthalidone CHD0.98 (0.91, 1.08)0.99 (0.91, 1.08) Death0.96 (0.89, 1.02)1.00 (0.94, 1.08) CCHD1.00 (0.94, 1.07)1.05 (0.98, 1.11) Stroke0.93 (0.82, 1.06)1.15 (1.02, 1.30) CCVD1.04 (0.99, 1.09)1.10 (1.05, 1.16) HF1.38 (1.25, 1.52)1.19 (1.07, 1.31) Summary of Outcomes Relative Risks and 95% CI ALLHAT

22 22 Subgroup Comparisons Results were consistent across age, race, gender, and baseline diabetes subgroups, except: –Stroke Black L/C RR (95% CI) = 1.40 (1.17 – 1.68) Non-Black L/C RR (95% CI) = 1.00 (0.85 – 1.17) –Combined CVD Black L/C RR (95% CI) = 1.19 (1.09 – 1.30) Non-Black L/C RR (95% CI) = 1.06 (1.00 – 1.13) ALLHAT

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