Depression and Myocardial Infarction:  Findings of the  SADHART Group June 23, 2004 Tracy Ann Rydel, MD
Influence of Depression and Effect of Treatment with Sertraline on Quality of Life after Hospitalization for Acute Coronar...
The SADHART Group <ul><li>SADHART = Sertraline Antidepressant Heart Attack Randomized Trial </li></ul><ul><li>Trial conduc...
Relevance of SADHART <ul><li>Depression as a risk factor for mortality post-MI 1 </li></ul><ul><li>Older antidepressants p...
The Groundwork <ul><li>Initial study entitled: Sertraline Treatment of Major Depression in Patients with Acute MI or Unsta...
METHODS: The Subjects <ul><li>369 patients </li></ul><ul><li>74% post-acute MI; 26% unstable angina </li></ul><ul><li>100%...
METHODS: The 2 Subgroups PLACEBO SERTRALINE Recurrent Depression Subgroup N = 52 Recurrent Depression Subgroup N = 60 Tota...
METHODS: Why 2 groups? <ul><li>Intent-to-treat vs. Recurrent Depression subgroup </li></ul><ul><li>Definition </li></ul><u...
METHODS: The Subjects <ul><li>Exclusion criteria: </li></ul><ul><li>Cardiovascular: </li></ul><ul><li>-uncontrolled HTN </...
METHODS: The Subjects (cont.) <ul><li>Exclusion criteria (cont.) </li></ul><ul><li>Psychiatric </li></ul><ul><li>-alcohol ...
METHODS:  The Treatment <ul><li>Patients randomized to receive 24 weeks of double-blind Rx: Sertraline or placebo </li></u...
METHODS: Outcome Measures <ul><li>2 Effect-on-Depression measures : </li></ul><ul><li>HAM-D </li></ul><ul><li>(Hamilton Ra...
RESULTS: The Statistics <ul><li>2 patient groups analyzed  </li></ul><ul><li>2 outcome domains investigated </li></ul><ul>...
RESULTS: Depression Measures <ul><li>The HAM-D scale : </li></ul><ul><li>Significantly greater improvement seen with Sertr...
RESULTS: Quality of Life Measures <ul><li>SF-36 : </li></ul><ul><li>Sertraline showed clinically significant improvement o...
Efficacy in Post-ACS Depression <ul><li>Week 24  </li></ul><ul><li>Responder </li></ul><ul><li>Rates for  </li></ul><ul><l...
Improvement in SF-36 scores <ul><li>Significant </li></ul><ul><li>difference </li></ul><ul><li>shown in </li></ul><ul><li>...
SF-36 subscale scores: Sertraline vs. placebo in the recurrent group <ul><ul><ul><ul><ul><li>* p < 0.05;  **p < 0.001;  † ...
DISCUSSION: Indications for Clinical Practice <ul><li>Results of study especially relevant for Recurrent Depression subgro...
DISCUSSION:  Limitations of the Current Study <ul><li>Conclusions cannot be generalized to all patients:  </li></ul><ul><l...
DISCUSSION:  Limitations of the Current Study (cont.) <ul><li>Sertraline as only SSRI tested </li></ul><ul><li>Drug not ad...
DISCUSSION: Areas for Further Investigation <ul><li>Repeat trial with larger cohort similar to Recurrent Depression subgro...
THANK YOU! Dr. David Thom Julie Haugen
REFERENCES <ul><li>1  Bush DE, et al.  Even minimal symptoms of depression increase mortality risk after acute myocardial ...
 
Upcoming SlideShare
Loading in …5
×

Depression and Myocardial Infarction: Findings of the SADHART ...

492 views

Published on

0 Comments
1 Like
Statistics
Notes
  • Be the first to comment

No Downloads
Views
Total views
492
On SlideShare
0
From Embeds
0
Number of Embeds
1
Actions
Shares
0
Downloads
13
Comments
0
Likes
1
Embeds 0
No embeds

No notes for slide

Depression and Myocardial Infarction: Findings of the SADHART ...

  1. 1. Depression and Myocardial Infarction: Findings of the SADHART Group June 23, 2004 Tracy Ann Rydel, MD
  2. 2. Influence of Depression and Effect of Treatment with Sertraline on Quality of Life after Hospitalization for Acute Coronary Syndrome American Journal of Cardiology . Dec 2003. 92: 1271-1276.
  3. 3. The SADHART Group <ul><li>SADHART = Sertraline Antidepressant Heart Attack Randomized Trial </li></ul><ul><li>Trial conducted in 40 outpatient cardiology centers and psychiatry clinics in U.S., Canada, Australia, and Europe </li></ul><ul><li>Study financially supported by Pfizer </li></ul>
  4. 4. Relevance of SADHART <ul><li>Depression as a risk factor for mortality post-MI 1 </li></ul><ul><li>Older antidepressants potentially cardiotoxic and/or proarrythmic </li></ul><ul><li>SSRIs not previously established as safe or beneficial post-MI </li></ul>
  5. 5. The Groundwork <ul><li>Initial study entitled: Sertraline Treatment of Major Depression in Patients with Acute MI or Unstable Angina. </li></ul><ul><li>Presented in JAMA , August 2002. 288 (6): 701-710. </li></ul><ul><li>Established safety of SSRIs in patients with recent MI or unstable angina </li></ul>
  6. 6. METHODS: The Subjects <ul><li>369 patients </li></ul><ul><li>74% post-acute MI; 26% unstable angina </li></ul><ul><li>100% with current episode of MDD, based on DSM-IV criteria with Beck Depression Inventory Score > 10 </li></ul><ul><li>2 groups: 1. Intent-to-Treat (Total) </li></ul><ul><li>2. Recurrent Depression </li></ul>
  7. 7. METHODS: The 2 Subgroups PLACEBO SERTRALINE Recurrent Depression Subgroup N = 52 Recurrent Depression Subgroup N = 60 Total N = 183 Total N = 186
  8. 8. METHODS: Why 2 groups? <ul><li>Intent-to-treat vs. Recurrent Depression subgroup </li></ul><ul><li>Definition </li></ul><ul><li>Determined a priori </li></ul><ul><li>Overlap of symptomatology between MDD and physical illness </li></ul><ul><li>Most post-MI depression considered similar to an adjustment disorder </li></ul><ul><li>**Recurrent depression is associated with persistent depression in the year following MI </li></ul>
  9. 9. METHODS: The Subjects <ul><li>Exclusion criteria: </li></ul><ul><li>Cardiovascular: </li></ul><ul><li>-uncontrolled HTN </li></ul><ul><li>-cardiac surgery candidates (next 6 months) </li></ul><ul><li>-MI or UA less than 3 months post-CABG </li></ul><ul><li>-bradycardia (resting HR < 40) </li></ul><ul><li>Other medical: </li></ul><ul><li>-persistent clinically significant laboratory abnormalities </li></ul><ul><li>-significant renal or hepatic disease or other noncardiac disease </li></ul>
  10. 10. METHODS: The Subjects (cont.) <ul><li>Exclusion criteria (cont.) </li></ul><ul><li>Psychiatric </li></ul><ul><li>-alcohol or substance abuse in past 6 mo </li></ul><ul><li>-psychotic symptoms, h/o psychosis, bipolar d/o, organic brain syndrome, dementia </li></ul><ul><li>-significant suicide risk </li></ul>
  11. 11. METHODS: The Treatment <ul><li>Patients randomized to receive 24 weeks of double-blind Rx: Sertraline or placebo </li></ul><ul><li>Patients in Sertraline group received 50 mg daily for first 6 weeks; titration to 200 mg permitted </li></ul><ul><li>Compliance checked using pill counts </li></ul>
  12. 12. METHODS: Outcome Measures <ul><li>2 Effect-on-Depression measures : </li></ul><ul><li>HAM-D </li></ul><ul><li>(Hamilton Rating </li></ul><ul><li>Scale for Depression) </li></ul><ul><li>CGI-I score </li></ul><ul><li>(Clinical Global Impression, Improvement Scale) </li></ul><ul><li>2 Quality of Life measures : </li></ul><ul><li>Q-LES-Q </li></ul><ul><li>(Quality of Life Enjoyment and Satisfaction Scale) </li></ul><ul><li>SF-36 </li></ul><ul><li>(Medical Outcomes Study Short Form 36) </li></ul>
  13. 13. RESULTS: The Statistics <ul><li>2 patient groups analyzed </li></ul><ul><li>2 outcome domains investigated </li></ul><ul><li>2 scales within each domain evaluated </li></ul><ul><li>Mixed-model repeated measures analysis of covariance utilized to assess changes in scores over the treatment period </li></ul>
  14. 14. RESULTS: Depression Measures <ul><li>The HAM-D scale : </li></ul><ul><li>Significantly greater improvement seen with Sertraline in the Recurrent Depression subgroup (p=0.002) as compared to placebo </li></ul><ul><li>No significant difference demonstrated in the total randomized group </li></ul><ul><li>The CGI score : </li></ul><ul><li>Sertraline had significant effect in both the Recurrent Depression subgroup (p<0.001) AND in the total randomized group (p<0.01) as compared to placebo </li></ul>
  15. 15. RESULTS: Quality of Life Measures <ul><li>SF-36 : </li></ul><ul><li>Sertraline showed clinically significant improvement over placebo in the Mental Component of the SF-36 in the Recurrent Depression subgroup (p=0.010) </li></ul><ul><li>Q-LES-Q : </li></ul><ul><li>Significant effect of Sertraline relative to placebo shown in Recurrent Depression subgroup (p=0.037) </li></ul>
  16. 16. Efficacy in Post-ACS Depression <ul><li>Week 24 </li></ul><ul><li>Responder </li></ul><ul><li>Rates for </li></ul><ul><li>Sertraline vs. </li></ul><ul><li>Placebo: </li></ul><ul><li>The CGI-I </li></ul><ul><li>* p < 0.01; **p < 0.003 </li></ul>
  17. 17. Improvement in SF-36 scores <ul><li>Significant </li></ul><ul><li>difference </li></ul><ul><li>shown in </li></ul><ul><li>mental </li></ul><ul><li>component </li></ul><ul><li>of recurrent </li></ul><ul><li>group </li></ul><ul><li>(p=0.010) </li></ul>
  18. 18. SF-36 subscale scores: Sertraline vs. placebo in the recurrent group <ul><ul><ul><ul><ul><li>* p < 0.05; **p < 0.001; † p < 0.10 </li></ul></ul></ul></ul></ul>
  19. 19. DISCUSSION: Indications for Clinical Practice <ul><li>Results of study especially relevant for Recurrent Depression subgroup </li></ul><ul><li>Findings to be considered “exploratory” given small sample size </li></ul><ul><li>Depression as strongest predictor of baseline quality-of-life impairment following acute coronary syndrome 5 </li></ul>
  20. 20. DISCUSSION: Limitations of the Current Study <ul><li>Conclusions cannot be generalized to all patients: </li></ul><ul><li>Exclusion of pts with renal or hepatic dysfunction </li></ul><ul><li>Exclusion of pts with psychiatric comorbidities </li></ul><ul><li>Exclusion of pts with alcohol or substance abuse in past 6 months </li></ul>
  21. 21. DISCUSSION: Limitations of the Current Study (cont.) <ul><li>Sertraline as only SSRI tested </li></ul><ul><li>Drug not administered until 1 month post-MI </li></ul><ul><li>No discussion of absence of significant effects on physical functioning (SF-36) </li></ul><ul><li>Non-pharmacologic measures not explored 4 </li></ul>
  22. 22. DISCUSSION: Areas for Further Investigation <ul><li>Repeat trial with larger cohort similar to Recurrent Depression subgroup needed </li></ul><ul><li>Study examining differences in long-term post-MI mortality between SSRI and placebo </li></ul><ul><li>Depression or MI: which came first? Or, how are these factors interrelated? </li></ul>
  23. 23. THANK YOU! Dr. David Thom Julie Haugen
  24. 24. REFERENCES <ul><li>1 Bush DE, et al. Even minimal symptoms of depression increase mortality risk after acute myocardial infarction. American Journal of Cardiology . 2001. 88: 337-41. </li></ul><ul><li>2 Glassman AH, et al. Sertraline Treatment of Major Depression in Patients with Acute MI or Unstable Angina JAMA , August 2002. 288 (6): 701-10. </li></ul><ul><li>3 Glassman AH, et al. Influence of Depression and Effect of Treatment with Sertraline on Quality of Life after Hospitalization for Acute Coronary Syndrome. American Journal of Cardiology .Dec 2003. 92: 1271-6. </li></ul><ul><li>4 Lavie CJ and Milani RV. Cardiac rehabilitation and depression. Letter in American Journal of Cardiology . 2004. 93: 1080. </li></ul><ul><li>5 Rumsfeld JS, et al. Predictors of quality of life following acute coronary syndromes. American Journal of Cardiology . 2001. 88: 781-4. </li></ul>

×