| pathology | Demonstrated benefit and harm | k | | | |
|---|
| acute myocardial infarction | versus No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| VALIANT (valsartan alone), 2003 | Valsartan vs Captopril | | | Cardiovascular death 1.00 [0.91; 1.09] | | VALIANT (valsartan+capropril), 2003 | Valsartan+ACE inhibitor vs ACE inhibitor only | | | Cardiovascular death 1.00 [0.92; 1.09] |
| Trial | Treatments | Patients | Method |
|---|
| VALIANT (valsartan alone), 2003 | Valsartan, 160 mg twice daily (n=4909) vs. Captopril, 50 mg 3 times daily (n=4909) | patients within 10 days of a MI complicated by HF | Double blind Parallel groups Sample size: 4909/4909 Primary endpoint: mortality from any cause FU duration: Median, 24.7 mo | | VALIANT (valsartan+capropril), 2003 | Valsartan, 40 mg twice daily, plus captopril, 25 mg three times daily (n=4885) vs. Captopril, 25 mg 3 times daily (n=4909) | patients within 10 days of a MI complicated by HF | Double blind Parallel groups Sample size: 4885/4909 Primary endpoint: mortality from any cause FU duration: Median, 24.7 mo |
|
| atrial fibrillation | versus placebo No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Val-HeFT (AF ancillary study), 2003 | valsartan vs placebo | AF 0.67 [0.54; 0.83] | | |
| Trial | Treatments | Patients | Method |
|---|
| Val-HeFT (AF ancillary study), 2003 | valsartan (n=2506) vs. placebo (n=2494) | Heart failure | Sample size: 2506/2494 Primary endpoint: FU duration: 1.92 y |
|
| atrial fibrillation | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| GISSI-AF (Disertori), 2009 | valsartan vs placebo | | | AF recurrence 0.99 [0.89; 1.09] more than 1 recurrence 0.96 [0.81; 1.14] |
| Trial | Treatments | Patients | Method |
|---|
| GISSI-AF (Disertori), 2009 | valsartan (n=722) vs. placebo (n=720) | patients in sinus rhythm but with either two or more documented episodes of atrial fibrillation in the previous 6 months or successful cardioversion for atrial fibrillation in the previous 2 weeks
and with underlying cardiovascular disease, diabetes, or left atrial enlargement | double blind Parallel groups Sample size: 722/720 Primary endpoint: AF recurrence FU duration: 1 year |
|
| diabetes type 2 | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| NAVIGATOR valsartan, 2010 | valsartan vs placebo | diabetes 0.90 [0.85; 0.95] | | death 0.91 [0.78; 1.06] CV death 1.11 [0.87; 1.43] fatal and non fatal stroke 0.80 [0.62; 1.03] fatal and non fatal MI 1.00 [0.79; 1.25] hospitalization for heart failure 0.98 [0.73; 1.30] cardiovasculaire events 0.98 [0.89; 1.08] |
| Trial | Treatments | Patients | Method |
|---|
| NAVIGATOR valsartan, 2010 | valsartan up to 160 mg daily (n=4631) vs. placebo (n=4675) factorial design: patuents were also randomized between nateglinide or placebo | subjects with impaired glucose tolerance and either CV disease or CV risk factors | double-blind Factorial plan Sample size: 4631/4675 Primary endpoint: 3 coprimary: diabetes, CV events FU duration: 5 years |
|
| heart failure | versus placebo or control No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Mazayev et al. (vs placebo), 1998 | valsartan vs placebo | | | | | VALIDD, 2007 | valsartan vs no valsartan | | | cancer 5.32 [0.63; 45.15] |
| Trial | Treatments | Patients | Method |
|---|
| Mazayev et al. (vs placebo), 1998 | valsartan 40, 80 or 160 mg twice daily (n=75) vs. Placebo (n=26) | patients with chronic heart failure previously untreated with ACE inhibitors | Double blind Parallel groups Sample size: 75/26 Primary endpoint: pulmonary capillary wedge pressure FU duration: 4 wk | | VALIDD, 2007 | valsartan titrated up to 320 mg once daily (n=186) vs. placebo (n=198) | Patients with hypertension and evidence of diastolic dysfunction | double blind Parallel groups Sample size: 186/198 Primary endpoint: diastolic relaxation velocity FU duration: 38 weeks |
|
| heart failure | versus angiotensin-converting enzyme inhibitors No demonstrated result for efficacy valsartan+ACE inhibitor inferior to ACE inhibitor only in terms of Adverse effect leading to treatment discontinuation in Val-HeFT, 2001 valsartan+ACE inhibitor inferior to ACE inhibitor only in terms of Increase in creatinine in Val-HeFT, 2001 | 4 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| HEAVEN, 2002 | valsartan vs enalapril | | | | | V-HeFT, 1999 | valsartan+ACE inhibitor vs ACE inhibitor only | | | Hypotension ∞ [NaN; ∞] Hyperkalaemia ∞ [NaN; ∞] Increase in creatinine 1.02 [0.10; 10.75] | | Val-HeFT, 2001 | valsartan+ACE inhibitor vs ACE inhibitor only | Death from Any Cause, Cardiac Arrest with Resuscitation, Hospitalization for Worsening Heart Failure, or Therapy with Intravenous Inotropes or Vasodilators 0.90 [0.83; 0.98] hospital admission for heart failure 0.76 [0.67; 0.86] | Adverse effect leading to treatment discontinuation 1.46 [1.20; 1.77] Increase in creatinine 6.73 [2.36; 19.19] | cancer death 1.00 [0.60; 1.65] all cause death 1.02 [0.91; 1.14] Hypotension 1.68 [0.95; 2.95] | | Mazayev et al. (vs lisinopril, 1998 | valsartan vs Lisinopril | | | |
| Trial | Treatments | Patients | Method |
|---|
| HEAVEN, 2002 | Valsartan, 160 mg daily (n=70) vs. Enalapril, 10 mg twice daily (n=71) | Men and women with mild/moderate heart failure stabilised on an angiotensin-converting enzyme inhibitor and left ventricular ejection fraction 0.45 or less | Double blind Parallel groups Sample size: 70/71 Primary endpoint: exercise capacity, FU duration: 12 wk | | V-HeFT, 1999 | Valsartan 80 mg and 160mg twice daily (plus ACE inhibitor) (n=55) vs. Placebo (plus usual ACE inhibitor) (n=28) | Patients with stable symptomatic congestive heart failure (CHF) receiving long-term ACE inhibitor therapy (NYHA functional class II,III, or IV) and PCWP >or=to 15 mm Hg | Double blind Parallel groups Sample size: 55/28 Primary endpoint: change from baseline in PCWP FU duration: 4 wk | | Val-HeFT, 2001 | Valsartan, 160 mg twice daily (plus ACE inhibitor) (n=2511) vs. Placebo (plus ACE inhibitor) (n=2499) | patients with heart failure of New York Heart Association (NYHA) class II, III, or IV | Double blind Parallel groups Sample size: 2511/2499 Primary endpoint: moratlity and morbidity FU duration: 23 mo | | Mazayev et al. (vs lisinopril, 1998 | Valsartan, 40 mg, 80mg, 160mg twice daily (n=75) vs. lisinopril 10mg once daily (n=15) | patients with chronic heart failure | NA Parallel groups Sample size: 75/15 Primary endpoint: pulmonary capillary wedge pressure FU duration: 4 wk |
|
| hypertension | versus ACEIs No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| VALIANT/Val, 2003 | Valsartan vs Captopril | | | all-cause mortality 1.02 [0.94; 1.11] cardiovascular mortality 1.00 [0.91; 1.09] stroke 0.85 [0.70; 1.04] MI 1.00 [0.91; 1.09] |
| Trial | Treatments | Patients | Method |
|---|
| VALIANT/Val, 2003 | Valsartan (n=4909) vs. Captopril (n=4909) | patients with myocardial infarction complicated by left ventricular systolic dysfunction, heart failure, or both | double-blind Parallel groups Sample size: 4909/4909 Primary endpoint: death FU duration: 2.1 y |
|
| impaired fasting glucose | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| NAVIGATOR valsartan, 2010 | valsartan vs placebo | diabetes 0.90 [0.85; 0.95] | | death 0.91 [0.78; 1.06] CV death 1.11 [0.87; 1.43] fatal and non fatal stroke 0.80 [0.62; 1.03] fatal and non fatal MI 1.00 [0.79; 1.25] hospitalization for heart failure 0.98 [0.73; 1.30] cardiovasculaire events 0.98 [0.89; 1.08] |
| Trial | Treatments | Patients | Method |
|---|
| NAVIGATOR valsartan, 2010 | valsartan up to 160 mg daily (n=4631) vs. placebo (n=4675) factorial design: patuents were also randomized between nateglinide or placebo | subjects with impaired glucose tolerance and either CV disease or CV risk factors | double-blind Factorial plan Sample size: 4631/4675 Primary endpoint: 3 coprimary: diabetes, CV events FU duration: 5 years |
|
