Appendix Table 22KQ4 Study withdrawals—Comparative effectiveness of medical therapies with or without ACEI or ARBs for stable ischemic heart disease.

Study, yearReport WithdrawalsGroupnReasons
HOPE, 200038YesRamipril 10mg/d1511 (32.5%)Cough (n=340, 7.3%)
Hypotension/Dizziness (n=88, 1.9%)
Angioedema (n=17, 0.4%)
Uncontrolled HTN (n=109, 2.3%)
Clinical Events (n=309, 6.7%)
Other (n=1101, 23.7%)
Placebo1430 (30.7%)Cough (n=85, 1.8%)
Hypotension/Dizziness (n=70, 1.5%)
Angioedema (n=7, 0.2%)
Uncontrolled HTN (n=183, 3.9%)
Clinical Events (n=418, 9.0%)
Other (n=1074, 23.1%)
PART-2, 200041YesRamipril 5–10mg/d53 (17.2%)Suspected ADE (n=31, 10%)
Patient preference (n=22, 7%)
Placebo25 (8.1%)Suspected ADE (n=3, 1%)
Patient preference (n=22, 7%)
SCAT, 200042NoEnalapril 20mg/dN/AN/A
Placebo
EUROPA, 200343YesPerindopril 8mg/d1391 (22.8%)Cough (n=162, 2.7%)
Hypotension (n=60, 1.0%)
Kidney failure (n=20, 0.3%)
Intolerance (n=144, 2.4%)
Study endpoint (n=376, 6.2%)
Hypertension (n=22, 0.4%)
Refusal to continue (n=261, 4.3%)
Other (n=347, 5.7%)
Placebo1266 (20.7%)Cough (n=32, 0.5%)
Hypotension (n=17, 0.3%)
Kidney failure (n=16, 0.3%)
Intolerance (n=80, 1.3%)
Study endpoint (n=460, 7.5%)
Hypertension (n=46, 0.8%)
Refusal to continue (n=257, 4.2%)
Other (n=359, 5.9%)
Kondo et al, 200344YesCandesartan 4mg/d9 (4.4%)Dizziness/Lightheadedness (n=9, 4.4%)
Control2 (1.0%)Relocation (n=2, 1.0%)
CAMELOT, 200445YesEnalapril 20mg/d236 (35.0%)ADE (n=102, 15.1%)
Withdrew consent (n=33, 4.9%)
Death (n=4, 0.6%)
Protocol violation (n=6, 0.9%)
Laboratory abnormality (n=3, 0.4%)
Lost to follow-up (n=22, 3.3%)
Insufficient response (n=5, 0.7%)
Other (n=61, 9.0%)
Amlodipine 10mg/d194 (29.2%)ADE (n=87, 13.1%)
Withdrew consent (n=38, 5.7%)
Death (n=2, 0.3%)
Laboratory abnormality (n=2, 0.3%)
Lost to follow-up (n=18, 2.7%)
Insufficient response (n=2, 0.3%)
Other (n=45, 6.8%)
Placebo204 (31.1%)ADE (n=71, 10.8%)
Withdrew consent (n=50, 7.6%)
Death (n=5, 0.8%)
Protocol violation (n=8, 1.2%)
Laboratory abnormality (n=3, 0.5%)
Lost to follow-up (n=16, 2.4%)
Insufficient response (n=3, 0.5%)
Other (n=48, 7.3%)
JMIC-B, 200446YesACEI[proportional, variant]143 (17.4%)ADE (n=72, 8.8%)
No effect (n=20, 2.4%)
Withdrawal of consent (n=10, 1.2%)
Protocol deviation (n=5, 0.6%)
Alleviating symptoms (n=11, 1.3%)
Others (n=25, 3.0%)
Nifedipine 10–20mg/d107 (12.9%)ADE (n=41, 5.0%)
No effect (n=11, 1.3%)
Withdrawal of consent (n=9, 1.1%)
Protocol deviation (n=9, 1.1%)
Alleviating symptoms (n=17, 2.1%)
Others (n=20, 2.4%)
PEACE, 200447NoTrandolapril 4mg/dN/AN/A
Placebo
FOSIDIAL, 200648YesFosinopril 20mg/d7 (3.6%)Renal transplantation (n=7, 3.6%)
Placebo10 (5.0%)Renal transplantation (n=8, 4.0%)
Protocol violations (n=2, 1.0%)
Takahashi et al, 200649YesCandesartan 4–8mg/d0 (0%)
0 (0%)
N/A
Control
SMILE-ISCHEMIA, 200750YesZofenopril 60mg/d46 (13.2%)Major protocol violation (n=15, 4.3%)
Lost to follow-up (n=3, 0.9%)
Inability to perform treadmill test (n=31, 8.9%)
Placebo
TRANSCEND, 200851YesTelmisartan 80mg/d1090 (36.9%)Hypotensive symptoms (n=29, 1.0%)
Syncope (n=1, 0.03%)
Cough (n=15, 0.5%)
Diarrhea (n=7, 0.2%)
Angioedema (n=2, 0.07%)
Renal abnormalities (n=24, 0.8%)
Placebo1143 (38.5%)Hypotensive symptoms (n=16, 0.5%)
Syncope (n=0, 0%)
Cough (n=18, 0.6%)
Diarrhea (n=2, 0.07%)
Angioedema (n=3, 0.1%)
Renal abnormalities (n=13, 0.4%)
[proportional, variant]

= Patients in the ACEI group were given enalapril 5–10mg/d, imidapril 5–10mg/d, or lisinopril 10–20mg/d;

= Listed as side effects leading to discontinuation of the study medication

= Patients in the ACEI group were given enalapril 5–10mg/d, imidapril 5–10mg/d, or lisinopril 10–20mg/d;

= Listed as side effects leading to discontinuation of the study medication

From: Appendix C, Additional Evidence Tables and Analyses

Cover of Comparative Effectiveness of Angiotensin Converting Enzyme Inhibitors or Angiotensin II Receptor Blockers Added to Standard Medical Therapy for Treating Stable Ischemic Heart Disease
Comparative Effectiveness of Angiotensin Converting Enzyme Inhibitors or Angiotensin II Receptor Blockers Added to Standard Medical Therapy for Treating Stable Ischemic Heart Disease [Internet].
Comparative Effectiveness Reviews, No. 18.
Coleman CI, Baker WL, Kluger J, et al.

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