fluvastatin trial summary

Acute coronary syndrome

Early initiation: 3 trials - LIPS (sub groups) - FLORIDA - Czech trial

No demonstrated result

Endpoint	TE [95% CI]	p val	I2	n	k	trials
Deaths or MI	no data
cardiovascular events at 1 month	1.32 [0.44 3.95]	p=1.00	0	1364	2	LIPS (sub groups),FLORIDA,
cardiovascular events at 4 months	1.38 [0.66 2.90]	p=1.00	0	1364	2	LIPS (sub groups),FLORIDA,
PTCA	no data
recurrent angina	1.04 [0.54 1.98]	p=1.00	0	540	1	FLORIDA,
cardiovascular events	1.03 [0.70 1.50]	p=1.00	0	1364	2	LIPS (sub groups),FLORIDA,
myocardial infarction (fatal and non fatal)	no data
stroke (fatal and non fatal)	0.52 [0.04 6.27]	p=1.00	0	1364	2	LIPS (sub groups),FLORIDA,
cardiac death	0.57 [0.19 1.70]	p=1.00	0	1364	2	LIPS (sub groups),FLORIDA,
CABG	0.66 [0.31 1.38]	p=1.00	0	540	1	FLORIDA,
Fatal MI	0.29 [0.03 3.14]	p=1.00	0	1364	2	LIPS (sub groups),FLORIDA,
Non fatal MI	1.47 [0.72 3.01]	p=1.00	0	1364	2	LIPS (sub groups),FLORIDA,
Revascularization	0.89 [0.67 1.17]	p=1.00	0	1364	2	LIPS (sub groups),FLORIDA,
All cause death	0.68 [0.30 1.53]	p=1.00	0	1364	2	LIPS (sub groups),FLORIDA,
Non fatal stroke	no data

TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients

CABG surgery

Cardiovascular prevention

All chronical situations: 7 trials - LIPS - ALERT - ALERT - LCAS - Riegger et al. - BCAPS - FLARE

fluvastatin vs placebo

No demonstrated result

suggested Coronary event by 33% (not demonstrated)

suggested Coronary death by 37% (not demonstrated)

suggested cardiac death by 37% (not demonstrated)

suggested MACE by 15% (not demonstrated)

suggested Non fatal MI by 35% (not demonstrated)

Endpoint	TE [95% CI]	p val	I2	n	k	trials
Venous thromboembolism	no data
cardiovascular events	0.84 [0.64 1.09]	p=1.00	0	2102	1	ALERT,
Cardiovascular death	0.67 [0.43 1.03]	p=1.00	0	2102	1	ALERT,
stroke (fatal and non fatal)	1.18 [0.83 1.67]	p=1.00	0	2102	1	ALERT,
Coronary death and non fatal MI	0.69 [0.46 1.04]	p=1.00	0	1677	1	LIPS,
Coronary event	0.67 [0.53 0.85]	p=0.04	0	4100	3	LIPS,ALERT,LCAS,
Coronary death	0.63 [0.44 0.90]	p=0.04	0	3779	2	LIPS,ALERT,
cardiac death	0.63 [0.44 0.89]	p=0.04	0	5258	5	LIPS,ALERT,LCAS,Riegger et al.,BCAPS,
MACE	0.85 [0.73 0.99]	p=0.04	0	4613	3	LIPS,ALERT,FLARE,
Non fatal MI	0.65 [0.45 0.95]	p=0.04	0	2936	2	ALERT,FLARE,
Revascularization	no data
All cause death	0.97 [0.83 1.14]	p=1.00	0	8194	7	LIPS,ALERT,ALERT,LCAS,Riegger et al.,BCAPS,FLARE,
non cardiovascular death	1.13 [0.91 1.40]	p=1.00	0	7360	6	LIPS,ALERT,ALERT,LCAS,Riegger et al.,BCAPS,
Fatal stroke	no data
Haemmorhagic stroke	no data
new-onset diabetes	no data
Death from cancer	no data
Rhabdomyolysis	0.98 [0.14 6.99]	p=1.00	0	3197	4	LIPS,Riegger et al.,LCAS,FLARE,
Myopathy	no data
Cancer	no data
Adverse events	no data

TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients

See more clinical conditions

Diabetic patients : 2 trials - LIPS (diabetic sub group) - ALERT (diabetic sub group)

fluvastatin vs placebo

No demonstrated result

Endpoint	TE [95% CI]	p val	I2	n	k	trials
cardiovascular events	no data
Cardiovascular death	no data
stroke (fatal and non fatal)	no data
Coronary event	0.57 [0.31 1.07]	p=1.00	0	202	1	LIPS (diabetic sub group),
retinopathy	no data
vision loss	no data
All cause death	no data

TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients

Elderly: 2 trials - FLARE (elderly subgroup) - LIPS (elderly subgroup)

fluvastatin vs placebo

No demonstrated result

Endpoint	TE [95% CI]	p val	I2	n	k	trials
cardiovascular events	no data
myocardial infarction (fatal and non fatal)	no data
stroke (fatal and non fatal)	no data
Coronary death	0.53 [0.24 1.15]	p=1.00	0	989	2	FLARE (elderly subgroup),LIPS (elderly subgroup),
Non fatal MI	0.65 [0.35 1.23]	p=1.00	0	989	2	FLARE (elderly subgroup),LIPS (elderly subgroup),
Revascularization	0.69 [0.47 1.02]	p=1.00	0	623	1	LIPS (elderly subgroup),
All cause death	0.62 [0.36 1.05]	p=1.00	0	989	2	FLARE (elderly subgroup),LIPS (elderly subgroup),

TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients

Hypertensive patients: 1 trials - HYRIM

fluvastatin vs placebo

No demonstrated result

Endpoint	TE [95% CI]	p val	I2	n	k	trials
Venous thromboembolism	no data
cardiovascular events	0.74 [0.33 1.64]	p=1.00	0	568	1	HYRIM,
Cardiovascular death	no data
stroke (fatal and non fatal)	no data
Coronary event	no data
Coronary death and non fatal MI	no data
Coronary death	no data
cardiac death	no data
MACE	no data
Non fatal MI	no data
All cause death	0.81 [0.21 3.03]	p=1.00	0	568	1	HYRIM,
non cardiovascular death	no data
Fatal stroke	no data
Haemmorhagic stroke	no data
new-onset diabetes	no data
Death from cancer	no data
Rhabdomyolysis	no data
Myopathy	no data
Cancer	no data
Adverse events	no data

TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients

Patient with related disease: 1 trials - ALERT

fluvastatin vs placebo

No demonstrated result

suggested Coronary event by 33% (not demonstrated)

Endpoint	TE [95% CI]	p val	I2	n	k	trials
Venous thromboembolism	no data
cardiovascular events	no data
Cardiovascular death	no data
stroke (fatal and non fatal)	1.18 [0.83 1.67]	p=1.00	0	2102	1	ALERT,
Coronary event	0.67 [0.49 0.92]	p=0.04	0	2102	1	ALERT,
Coronary death and non fatal MI	no data
Coronary death	0.67 [0.43 1.03]	p=1.00	0	2102	1	ALERT,
cardiac death	0.67 [0.43 1.03]	p=1.00	0	2102	1	ALERT,
MACE	0.84 [0.64 1.09]	p=1.00	0	2102	1	ALERT,
Non fatal MI	0.70 [0.47 1.03]	p=1.00	0	2102	1	ALERT,
All cause death	1.04 [0.81 1.33]	p=1.00	0	2102	1	ALERT,
non cardiovascular death	1.19 [0.84 1.67]	p=1.00	0	2102	1	ALERT,
Fatal stroke	no data
Haemmorhagic stroke	no data
new-onset diabetes	no data
Death from cancer	no data
Rhabdomyolysis	no data
Myopathy	no data
Cancer	no data
Adverse events	no data

TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients

Patients with other atherosclerotic localisation: 1 trials - BCAPS

fluvastatin vs placebo

No demonstrated result

Endpoint	TE [95% CI]	p val	I2	n	k	trials
Venous thromboembolism	no data
cardiovascular events	no data
Cardiovascular death	no data
stroke (fatal and non fatal)	no data
Coronary event	no data
Coronary death and non fatal MI	no data
Coronary death	no data
cardiac death	0.50 [0.05 5.58]	p=1.00	0	793	1	BCAPS,
MACE	no data
Non fatal MI	no data
All cause death	1.01 [0.32 3.15]	p=1.00	0	793	1	BCAPS,
non cardiovascular death	1.26 [0.34 4.73]	p=1.00	0	793	1	BCAPS,
Fatal stroke	no data
Haemmorhagic stroke	no data
new-onset diabetes	no data
Death from cancer	no data
Rhabdomyolysis	no data
Myopathy	no data
Cancer	no data
Adverse events	no data

TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients

Patients with prior MI or with CHD: 6 trials - LIPS (sub groups) - FLORIDA - LCAS - Riegger et al. - FLARE - Czech trial

fluvastatin vs placebo

No demonstrated result

Endpoint	TE [95% CI]	p val	I2	n	k	trials
Deaths or MI	no data
cardiovascular events at 1 month	1.32 [0.44 3.95]	p=1.00	0	1364	2	LIPS (sub groups),FLORIDA,
cardiovascular events at 4 months	1.38 [0.66 2.90]	p=1.00	0	1364	2	LIPS (sub groups),FLORIDA,
PTCA	no data
recurrent angina	1.04 [0.54 1.98]	p=1.00	0	540	1	FLORIDA,
Venous thromboembolism	no data
cardiovascular events	1.03 [0.70 1.50]	p=1.00	0	1364	2	LIPS (sub groups),FLORIDA,
Cardiovascular death	no data
myocardial infarction (fatal and non fatal)	no data
stroke (fatal and non fatal)	0.52 [0.04 6.27]	p=1.00	0	1364	2	LIPS (sub groups),FLORIDA,
Coronary event	0.62 [0.34 1.14]	p=1.00	0	321	1	LCAS,
Coronary death and non fatal MI	no data
Coronary death	no data
cardiac death	0.61 [0.25 1.49]	p=1.00	0	2050	4	LIPS (sub groups),FLORIDA,LCAS,Riegger et al.,
MACE	0.97 [0.70 1.33]	p=1.00	0	834	1	FLARE,
CABG	0.66 [0.31 1.38]	p=1.00	0	540	1	FLORIDA,
Fatal MI	0.29 [0.03 3.14]	p=1.00	0	1364	2	LIPS (sub groups),FLORIDA,
Non fatal MI	1.03 [0.55 1.92]	p=1.00	0	2198	3	LIPS (sub groups),FLORIDA,FLARE,
Revascularization	0.89 [0.67 1.17]	p=1.00	0	1364	2	LIPS (sub groups),FLORIDA,
All cause death	0.63 [0.35 1.14]	p=1.00	0	2884	5	LIPS (sub groups),FLORIDA,LCAS,Riegger et al.,FLARE,
non cardiovascular death	0.68 [0.13 3.52]	p=1.00	0	686	2	LCAS,Riegger et al.,
Fatal stroke	no data
Non fatal stroke	no data
Haemmorhagic stroke	no data
new-onset diabetes	no data
Death from cancer	no data
Rhabdomyolysis	0.98 [0.10 9.47]	p=1.00	0	1520	3	Riegger et al.,LCAS,FLARE,
Myopathy	no data
Cancer	no data
Adverse events	no data

TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients

Patients with renal insufficiency (on hemodialysis or transplant): 1 trials - ALERT

fluvastatin vs placebo

No demonstrated result

Endpoint	TE [95% CI]	p val	I2	n	k	trials
cardiovascular events	0.84 [0.64 1.09]	p=1.00	0	2102	1	ALERT,
Cardiovascular death	0.67 [0.43 1.03]	p=1.00	0	2102	1	ALERT,
Coronary event	no data
Revascularization	no data
All cause death	1.04 [0.81 1.33]	p=1.00	0	2102	1	ALERT,
non cardiovascular death	1.19 [0.84 1.67]	p=1.00	0	2102	1	ALERT,

TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients

Primary prevention: 3 trials - ALERT - BCAPS - HYRIM

fluvastatin vs placebo

No demonstrated result

suggested Coronary event by 33% (not demonstrated)

Endpoint	TE [95% CI]	p val	I2	n	k	trials
Venous thromboembolism	no data
cardiovascular events	0.74 [0.33 1.64]	p=1.00	0	568	1	HYRIM,
Cardiovascular death	no data
stroke (fatal and non fatal)	1.18 [0.83 1.67]	p=1.00	0	2102	1	ALERT,
Coronary event	0.67 [0.49 0.92]	p=0.04	0	2102	1	ALERT,
Coronary death and non fatal MI	no data
Coronary death	0.67 [0.43 1.03]	p=1.00	0	2102	1	ALERT,
cardiac death	0.66 [0.43 1.01]	p=1.00	0	2895	2	ALERT,BCAPS,
MACE	0.84 [0.64 1.09]	p=1.00	0	2102	1	ALERT,
Non fatal MI	0.70 [0.47 1.03]	p=1.00	0	2102	1	ALERT,
All cause death	1.03 [0.81 1.31]	p=1.00	0	3463	3	ALERT,BCAPS,HYRIM,
non cardiovascular death	1.19 [0.86 1.66]	p=1.00	0	2895	2	ALERT,BCAPS,
Fatal stroke	no data
Haemmorhagic stroke	no data
new-onset diabetes	no data
Death from cancer	no data
Rhabdomyolysis	no data
Myopathy	no data
Cancer	no data
Adverse events	no data

TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients

Secondary prevention: 4 trials - LIPS - LCAS - Riegger et al. - FLARE

fluvastatin vs placebo

No demonstrated result

suggested Coronary event by 33% (not demonstrated)

Endpoint	TE [95% CI]	p val	I2	n	k	trials
Venous thromboembolism	no data
cardiovascular events	no data
Cardiovascular death	no data
stroke (fatal and non fatal)	no data
Coronary death and non fatal MI	0.69 [0.46 1.04]	p=1.00	0	1677	1	LIPS,
Coronary event	0.67 [0.48 0.94]	p=0.04	0	1998	2	LIPS,LCAS,
Coronary death	0.53 [0.27 1.06]	p=1.00	0	1677	1	LIPS,
cardiac death	0.56 [0.30 1.04]	p=1.00	0	2363	3	LIPS,LCAS,Riegger et al.,
MACE	0.85 [0.71 1.03]	p=1.00	0	2511	2	LIPS,FLARE,
Non fatal MI	0.31 [0.09 1.14]	p=1.00	0	834	1	FLARE,
All cause death	0.69 [0.47 1.03]	p=1.00	0	3197	4	LIPS,LCAS,Riegger et al.,FLARE,
non cardiovascular death	0.84 [0.48 1.47]	p=1.00	0	2363	3	LIPS,LCAS,Riegger et al.,
Fatal stroke	no data
Haemmorhagic stroke	no data
new-onset diabetes	no data
Death from cancer	no data
Rhabdomyolysis	0.98 [0.14 6.99]	p=1.00	0	3197	4	LIPS,Riegger et al.,LCAS,FLARE,
Myopathy	no data
Cancer	no data
Adverse events	no data

TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients

Diabetes type 2

Diabetic patients with or withour hypercholesterolemia: 2 trials - LIPS (diabetic sub group) - ALERT (diabetic sub group)

fluvastatin vs placebo

No demonstrated result

Endpoint	TE [95% CI]	p val	I2	n	k	trials
cardiovascular events	no data
Cardiovascular death	no data
stroke (fatal and non fatal)	no data
Coronary event	0.57 [0.31 1.07]	p=1.00	0	202	1	LIPS (diabetic sub group),
retinopathy	no data
vision loss	no data
All cause death	no data

TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients

See more clinical conditions

Secondary prevention: 1 trials - LIPS (diabetic sub group)

fluvastatin vs placebo

No demonstrated result

Endpoint	TE [95% CI]	p val	I2	n	k	trials
cardiovascular events	no data
Cardiovascular death	no data
stroke (fatal and non fatal)	no data
Coronary event	0.57 [0.31 1.07]	p=1.00	0	202	1	LIPS (diabetic sub group),
retinopathy	no data
vision loss	no data
All cause death	no data

TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients

Hypertension

All type of patients: 1 trials - HYRIM

fluvastatin vs placebo

No demonstrated result

Endpoint	TE [95% CI]	p val	I2	n	k	trials
Venous thromboembolism	no data
cardiovascular events	0.74 [0.33 1.64]	p=1.00	0	568	1	HYRIM,
Cardiovascular death	no data
stroke (fatal and non fatal)	no data
Coronary event	no data
Coronary death and non fatal MI	no data
Coronary death	no data
cardiac death	no data
MACE	no data
Non fatal MI	no data
All cause death	0.81 [0.21 3.03]	p=1.00	0	568	1	HYRIM,
non cardiovascular death	no data
Fatal stroke	no data
Haemmorhagic stroke	no data
new-onset diabetes	no data
Death from cancer	no data
Rhabdomyolysis	no data
Myopathy	no data
Cancer	no data
Adverse events	no data

TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients

Percutaneous coronary intervention

All type of patients: 2 trials - FLARE - LIPS

fluvastatin vs placebo

No demonstrated result

Endpoint	TE [95% CI]	p val	I2	n	k	trials
MI (CK-MB >3x ULN at 6 and 12 hours after PCI)	no data
MI (troponin I >3x ULN at 6 and 12 hours after PCI)	no data
Cardiovascular death	0.53 [0.27 1.06]	p=1.00	0	1677	1	LIPS,
stroke (fatal and non fatal)	1.97 [0.18 21.81]	p=1.00	0	1677	1	LIPS,
MACE	no data
Non fatal MI	0.70 [0.44 1.10]	p=1.00	0	2511	2	FLARE,LIPS,
Revascularization	0.92 [0.76 1.12]	p=1.00	0	2511	2	FLARE,LIPS,
All cause death	0.69 [0.45 1.05]	p=1.00	0	2511	2	FLARE,LIPS,

TE: treatment effect; CI: confidence interval; k: nulmber of trials; n: total number of patients

Fluvastatin cholesterol lowering intervention

fluvastatin sodium salt - fluvastatin sodium - XU 62320 - XU-62320 - XU 62-320 - Lescol - fluindostatin - fluvastatin

Acute coronary syndrome

CABG surgery

Cardiovascular prevention

Diabetes type 2

Hypertension

Percutaneous coronary intervention