| pathology | Demonstrated benefit and harm | k | | | |
|---|
| acute coronary syndrome | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| T1 vs T0 | | | |
| Trial | Treatments | Patients | Method |
|---|
| HINT (nifedipine vs metoprolol), 1988 | nifedipine (n=-9) vs. metoprolol (n=-9) | patients with unstable angina not pretreated with a beta-blocker and of nifedipine | ND Parallel groups Sample size: -9/-9 Primary endpoint: recurrent ischemia or myocardial infarction within 48 h FU duration: ND |
|
| acute myocardial infarction | versus No demonstrated result for efficacy | 3 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Muller, 1984 | nifedipine vs | | | all cause death 3.31 [0.71; 15.51] confirmed myocardial infarction 0.99 [0.86; 1.13] | | Gordon, 1984 | nifedipine vs | | | all cause death NaN [NaN; NaN] confirmed myocardial infarction 1.00 [1.00; 1.00] | | MI study group, 1979 | nifedipine vs | | | |
| Trial | Treatments | Patients | Method |
|---|
| Muller, 1984 | Nifedipine 20mgx6 (n=93) vs. (n=88) | | double blind Parallel groups Sample size: 93/88 Primary endpoint: infarct development FU duration: 14 days | | Gordon, 1984 | Nifedipine 10 mgx4 (n=13) vs. (n=13) | | single blind Parallel groups Sample size: 13/13 Primary endpoint: haemodynamics FU duration: 1 day | | MI study group, 1979 | Nifedipine 3-4x60mg (n=904) vs. (n=888) | | open Parallel groups Sample size: 904/888 Primary endpoint: mortality FU duration: |
|
| acute myocardial infarction | versus placebo or control No demonstrated result for efficacy | 11 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Eisenberg, 1985 | nifedipine vs placebo | | | all cause death NaN [NaN; NaN] confirmed myocardial infarction 1.22 [NaN; NaN] | | Bradagan, 1986 | nifedipine vs placebo | | | all cause death 1.59 [0.53; 4.74] confirmed myocardial infarction 1.24 [0.81; 1.89] | | Jaffe, 1987 | nifedipine vs placebo | | | all cause death ∞ [NaN; ∞] confirmed myocardial infarction 1.00 [1.00; 1.00] | | Gottlieb, 1988 | nifedipine vs placebo | | | all cause death 1.06 [0.28; 4.07] confirmed myocardial infarction 1.12 [0.97; 1.29] | | Erbel, 1988 | nifedipine vs placebo | | | all cause death 1.69 [0.65; 4.41] confirmed myocardial infarction 1.00 [1.00; 1.00] | | SPRINT I, 1988 | nifedipine vs placebo | | | all cause death 1.01 [0.73; 1.42] cardiac death 1.01 [0.70; 1.47] reinfarction 0.92 [0.63; 1.34] | | SPRINT II, 1993 | nifedipine vs placebo | | | all cause death 1.16 [0.90; 1.51] confirmed myocardial infarction 0.96 [0.92; 1.01] | | Loogna, 1985 | nifedipine vs placebo | | | confirmed myocardial infarction 1.00 [1.00; 1.00] | | TRENT (Wilcox), 1986 | nifedipine vs placebo | | | confirmed myocardial infarction 1.00 [0.95; 1.04] | | Walker, 1988 | nifedipine vs placebo | | | confirmed myocardial infarction 0.98 [0.86; 1.11] | | Sirnes, 1984 | nifedipine vs placebo | | | confirmed myocardial infarction 0.92 [0.77; 1.09] |
| Trial | Treatments | Patients | Method |
|---|
| Eisenberg, 1985 | Nifedipine 20mgx4 (n=25) vs. placebo (n=25) | patients with nontransmural myocardial infarction | double blind Parallel groups Sample size: 25/25 Primary endpoint: chest pain FU duration: 12 days | | Bradagan, 1986 | Nifedipine 10mgx4 (n=60) vs. placebo (n=61) | patients with suspected acute myocardial infarction within 6hrs | double blind Parallel groups Sample size: 60/61 Primary endpoint: infract size FU duration: 2 days | | Jaffe, 1987 | Nifedipine 6x20mg (n=13) vs. placebo (n=9) | patients with acute myocardial infarction | single blind Parallel groups Sample size: 13/9 Primary endpoint: FU duration: 7 days | | Gottlieb, 1988 | Nifedipine 10 to 30mgx4 (n=64) vs. placebo (n=68) | | double blind Parallel groups Sample size: 64/68 Primary endpoint: LV function FU duration: 42 days | | Erbel, 1988 | Nifedipine 20mgx3 (n=74) vs. placebo (n=75) | patients with acute myocardial infarction | double blind Parallel groups Sample size: 74/75 Primary endpoint: infract size FU duration: hospital stay | | SPRINT I, 1988 | Nifedipine 10mgx3 (n=1130) vs. placebo (n=1146) | patient surviving MI 7 and 21 days after admission | Double blind Parallel groups Sample size: 1130/1146 Primary endpoint: mortality FU duration: 1 year | | SPRINT II, 1993 | Nifedipine 20mgx3 started within 3hr of hopsital admission for 6 months (n=682) vs. placebo (n=676) | men and women with suspected acute MI | Double blind Parallel groups Sample size: 682/676 Primary endpoint: two primary endpoints: non fatal MI and mortality FU duration: 6 months | | Loogna, 1985 | Nifedipine 4x10mg (n=23) vs. placebo (n=34) | patients with acute myocardial infarction within 6 h from onset of symptoms | double blind Parallel groups Sample size: 23/34 Primary endpoint: infract size FU duration: | | TRENT (Wilcox), 1986 | Nifedipine 4x10mg (n=2240) vs. placebo (n=2251)
| patients with suspected myocardial infarction
| double blind Parallel groups Sample size: 2240/2251 Primary endpoint: mortality FU duration: 28 days
| | Walker, 1988 | Nifedipine 6x10mg for 48hrs (n=217) vs. placebo (n=217) | patients with suspected myocardial infarction within six hours from the onset of chest pain | double blind Parallel groups Sample size: 217/217 Primary endpoint: infract size FU duration: | | Sirnes, 1984 | Nifedipine 5x10mg (n=112) vs. placebo (n=115)
| patients with suspected acute myocardial infarction
| double blind Parallel groups Sample size: 112/115 Primary endpoint: infract size FU duration: 42 days
|
|
| diabetes type 2 | versus diuretics No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| INSIGHT (diabetic subgroup), 2000 | nifedipine vs coamilozide | | | All deaths 0.75 [0.52; 1.09] Cardiovascular death 1.01 [0.54; 1.88] Stroke 0.90 [0.47; 1.72] Fatal and nonfatal MI 1.13 [0.66; 1.91] Cardiovascular events 0.99 [0.69; 1.42] |
| Trial | Treatments | Patients | Method |
|---|
| INSIGHT (diabetic subgroup), 2000 | Nifedipine GITS 30 mg daily (n=649) vs. co-amilozide hydrochlorothiazide 25 mg plus amiloride 2.5 mg (n=653) | diabetic (subgroup) patients aged 55-80 years with hypertension (blood pressure >= 150/95 mm Hg, or >= 160 mmHg systolic) | double-blind Parallel groups Sample size: 649/653 Primary endpoint: CV events FU duration: 4 y |
|
| hypertension | versus diuretic + beta-blocker No demonstrated result for efficacy nifedipine inferior to atenolol+chlorthalidone in terms of all cause death in Castel, 1994 nifedipine inferior to atenolol+chlorthalidone in terms of heart failure in Castel, 1994 nifedipine inferior to atenolol+chlorthalidone in terms of Major cardiovascular events in Castel, 1994 | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Castel, 1994 | nifedipine vs atenolol+chlorthalidone | | all cause death 1.72 [1.20; 2.46] heart failure 3.16 [1.41; 7.07] Major cardiovascular events 1.73 [1.08; 2.77] | coronary heart disease 1.09 [0.42; 2.87] stroke (fatal & non fatal) 1.40 [0.41; 4.76] |
| Trial | Treatments | Patients | Method |
|---|
| Castel, 1994 | Nifedipine 20mg/d (n=146) vs. Clonidine 0.15mg/d (n=61) or atenolol 100mg/d + chlorthalidone 25mg/d (n=205) | | Sample size: 146/205 Primary endpoint: FU duration: |
|
| hypertension | versus diuretics No demonstrated result for efficacy nifedipine inferior to hydrochlorothiazide+amiloride in terms of fatal MI in INSIGHT, 2000 | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| INSIGHT, 2000 | nifedipine vs hydrochlorothiazide+amiloride | Diabetes onset 0.70 [0.54; 0.91] | fatal MI 3.21 [1.18; 8.74] | all cause death 1.03 [0.84; 1.26] coronary heart disease 1.10 [0.83; 1.46] cardiovascular death 1.17 [0.84; 1.63] heart failure 1.75 [0.95; 3.24] fatal stroke 1.09 [0.48; 2.47] non fatal stroke 0.87 [0.61; 1.25] non fatal MI 1.09 [0.76; 1.56] stroke (fatal & non fatal) 0.94 [0.70; 1.28] Major cardiovascular events 1.07 [0.89; 1.29] | | INSIGHT (diabetic subgroup), 2000 | nifedipine vs coamilozide | | | All deaths 0.75 [0.52; 1.09] Cardiovascular death 1.01 [0.54; 1.88] Stroke 0.90 [0.47; 1.72] Fatal and nonfatal MI 1.13 [0.66; 1.91] Cardiovascular events 0.99 [0.69; 1.42] |
| Trial | Treatments | Patients | Method |
|---|
| INSIGHT, 2000 | nifedipine GITS 30mg/d (n=3157) vs. hydrochlorothiazide 25mg/d + amiloride 2.5mg/d (n=3164) | HBP + RF | Double blind Parallel groups Sample size: 3157/3164 Primary endpoint: Total CV morbidity FU duration: at least 3 years | | INSIGHT (diabetic subgroup), 2000 | Nifedipine GITS 30 mg daily (n=649) vs. co-amilozide hydrochlorothiazide 25 mg plus amiloride 2.5 mg (n=653) | diabetic (subgroup) patients aged 55-80 years with hypertension (blood pressure >= 150/95 mm Hg, or >= 160 mmHg systolic) | double-blind Parallel groups Sample size: 649/653 Primary endpoint: CV events FU duration: 4 y |
|
| percutaneous coronary intervention | versus control or placebo No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Whitworth, 1986 | nifedipine vs placebo | | | restenosis 0.95 [0.61; 1.47] |
| Trial | Treatments | Patients | Method |
|---|
| Whitworth, 1986 | nifedipine (10 mg qid) (n=100) vs. placebo (n=98) | | double blind Sample size: 100/98 Primary endpoint: FU duration: 6 months |
|
| post myocardial infarction | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| MI study group, 1979 | nifedipine vs | | | |
| Trial | Treatments | Patients | Method |
|---|
| MI study group, 1979 | Nifedipine 3-4x60mg (n=904) vs. (n=888) | | open Parallel groups Sample size: 904/888 Primary endpoint: mortality FU duration: |
|
| post myocardial infarction | versus placebo or control No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| SPRINT I, 1988 | nifedipine vs placebo | | | all cause death 1.01 [0.73; 1.42] cardiac death 1.01 [0.70; 1.47] reinfarction 0.92 [0.63; 1.34] | | SPRINT II, 1993 | nifedipine vs placebo | | | all cause death 1.16 [0.90; 1.51] confirmed myocardial infarction 0.96 [0.92; 1.01] |
| Trial | Treatments | Patients | Method |
|---|
| SPRINT I, 1988 | Nifedipine 10mgx3 (n=1130) vs. placebo (n=1146) | patient surviving MI 7 and 21 days after admission | Double blind Parallel groups Sample size: 1130/1146 Primary endpoint: mortality FU duration: 1 year | | SPRINT II, 1993 | Nifedipine 20mgx3 started within 3hr of hopsital admission for 6 months (n=682) vs. placebo (n=676) | men and women with suspected acute MI | Double blind Parallel groups Sample size: 682/676 Primary endpoint: two primary endpoints: non fatal MI and mortality FU duration: 6 months |
|
