Kostis JB, Wilson AC, Freudenberger RS, Cosgrove NM, Pressel SL, Davis BR.
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Kostis JB, Wilson AC, Freudenberger RS, Cosgrove NM, Pressel SL, Davis BR. SHEP Investigators UMDNJ-Robert Wood Johnson Medical School (J.B.K., A.C.W., R.S.F., N.M.C.) and the University of Texas School of Public Health at Houston (S.L.P., B.R.D.).

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Kostis JB, Wilson AC, Freudenberger RS, Cosgrove NM, Pressel SL, Davis BR.

SHEP Investigators

UMDNJ-Robert Wood Johnson Medical School (J.B.K., A.C.W., R.S.F., N.M.C.)

and the University of Texas School of Public Health at Houston (S.L.P., B.R.D.)

Long Term Effect of Diuretic Based Therapy in Subjects with Isolated Systolic Hypertension With and Without DiabetesFourteen-Year Follow-up of the Systolic Hypertension in the Elderly Program (SHEP)


Context
Context SL, Davis BR.

  • In randomized clinical trials diuretic based antihypertensive therapy has resulted in improved cardiovascular outcomes.

  • In these trials diuretic therapy has also been associated with the development of new onset diabetes.

  • It has been speculated that this diabetes did not result in worse outcomes because of relatively short periods of observation.


Objective
Objective SL, Davis BR.

To assess the long term (14.3 years) mortality of Systolic Hypertension in Elderly Program (SHEP) participants by diabetes status:

  • No diabetes

  • Diabetes at baseline

  • New onset diabetes (during SHEP)


Shep design results
SHEP Design & Results SL, Davis BR.

  • Double blind randomized placebo controlled stepped care therapy with chlorthalidone 12.5-25.0 mg daily and double blind atenolol 25-50 mg or reserpine as step 2 drug (4.4 yrs).

  • At the end of SHEP all were advised to receive active Rx (14.3 yrs total follow up).


Methods
Methods SL, Davis BR.

  • Determination of vital status and cause of death of SHEP participants through the year 2000, by National Death Index matching.

  • Cardiovascular and total mortality.

  • Diabetes defined as DM Rx or fasting glucose level 126 mg/dL at baseline or 1st or 2nd annual visit.


Methods1
Methods SL, Davis BR.

  • Survival and Cox proportional hazards analysis according to initial randomization and diabetes status:

    • 799 with diabetes at baseline

    • 427 new onset diabetes

    • 3506 without diabetes



CV Death (%) – Total and CVD Mortality

14.3 yrs Follow up

*

* = p< 0.05 vs active treatment; the RR in B-L DM and no BL DM are not significantly different

Kostis JB, Wilson AC, Freudenberger RS, et al. Am J Cardiol 2005;95:29-35


CV Death (%) – Total and CVD Mortality

14.3 yrs Follow up

* = p< 0.05 vs no diabetes

Kostis JB, Wilson AC, Freudenberger RS, et al. Am J Cardiol 2005;95:29-35


Total Mortality (%) – Total and CVD Mortality

14.3 yrs Follow up

* = p< 0.05 vs no diabetes

Kostis JB, Wilson AC, Freudenberger RS, et al. Am J Cardiol 2005;95:29-35


Effect of DM on Mortality – Total and CVD Mortality

14.3 Years Follow-Up

Baseline diabetes / No diabetes

Adjusted RR (95% CI)

All-cause mortality

Active

1.38 (1.16 – 1.63)

Placebo

1.63 (1.40 – 1.91)

CVD mortality

Active

1.46 (1.14 – 1.87)

Placebo

1.84 (1.48 – 2.28)

Follow-up diabetes / No diabetes

All-cause mortality

Active

1.15 (0.93 – 1.43)

Placebo

1.35 (1.05 – 1.73)

CVD mortality

Active

1.04 (0.75 – 1.46)

Placebo

1.56 (1.12 – 2.18)

0.50

1

2

Survival better Survival worse

3


Limitations
Limitations Total and CVD Mortality

  • Hypotheses for SHEP extended not pre-specified

  • Only mortality data

  • Rx and BP during follow up unknown

  • No metabolic data (HbA1c, serum potassium, weight/BMI/abdominal fat) to evaluate mechanisms

  • Diabetes development after SHEP unknown


Interpretation
Interpretation Total and CVD Mortality

  • Milder long-term course of diabetes that occurred during diuretic therapy is likely related to lesser degree of metabolic disturbance.

  • Different underlying mechanisms for diabetes due to diuretic and diabetes occurring in the placebo group:


Conclusions
Conclusions Total and CVD Mortality

  • Chlorthalidone based treatment of hypertension results in improved long-term outcomes.

  • The diabetes related to chlorthalidone therapy has better prognosis than diabetes at baseline.

  • The benefit of chlorthalidone-based therapy on long-term total and CV mortality is most pronounced in hypertensive patients with diabetes.


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