Italy: last position both in use of statins therapy and in the sensitivity of own coronary risk assessment chart
Walley and co-workers reported that Italy has the lowest
use of statins ofEurope, with
only 14.74 daily doses/1000 of population covered/day, against 23.86 in
England, 26.47 in Germany, 30.85 in France, 59.28 in Norway [1]. They suppose
that this low use may reflect low coronary morbidity of o poor adherence of
Italian patients to statins, worse than elsewhere in Europe. Really, the
reference to this sentence proved only that the adherence to statins is worse
in Bologna (Italy) than in Funen (Denmark), and ten years ago, from 1994 to
1996 [2].
On
the contrary, national guidance and policies, could be the major causes of the
Italian situation too. In the same number of the BMJ Raithatha and Smith reported that may people who could benefit from
statins are not currently receiving them, largely for economic reason [3]. In
Italy the reimbursement of the statins therapy is regulated by the Unique
Commission of Drugs (CUF). The rule number 13 of the CUF recommends the
statins treatment only for people with high global risk and recommends also to
use the Italian Risk Chart to estimate the global risk.
In
a previous experience we demonstrate that the first edition of the Italian
Risk Chart[4] had a very low
sensitivity, since more than 80% of patients at risk for coronary disease, so
classified by the Framingham equation[5], were misdiagnosed.
To
this aim, we employed the Italian chart to estimate how many subjects would
have been treated with statins in a population including 536 healthy blood
donors and 213 patients with non-insulin dependent diabetes mellitus. Results
were compared with those calculated by using the Framingham equation as
reference method and with alternative risk assessment screening methods,
including the New Zealand chart [6], the new Sheffield tables [7], the chart
of the Joint Task Force of European Societies on Coronary Prevention [8], and
criteria of the Joint British Societies [9].
Only
1,7% of a donors population and only 9,5% of a diabetic population should have
been admitted the a statins therapy, according to the chart (table). But only
a private prescription could be proposed to the other 80% of patient with high
risk.
In
the last weeks the Italian High Institute of Health, who realized the first
risk Chart, modified the risk classes, improving the sensibility.
Notwithstanding this change, it remain one of the lowest sensitive, compared
with other European or international ones.
Table:
Comparison of the Framingham equation with alternative screening methods and
estimated risk assessment.
Donors
Diabetic
subjects
risk
N.
N.
pos.
%
pos
N.
N.
pos
%
pos
Framingham
Study equation
³15%
10y
536
54
10,1%
213
141
66.2%
New
Zealand
³15%
5y
536
31
5.8%
213
102
47.9%
New
Zealand
³20% 5y
536
6
1.1%
213
51
23.9%
New
Sheffield table
³15%
10y
536
68
12.7%
213
148
69.5%
New
Sheffield table
³30%
10y
536
0
0.0%
213
20
9.4%
Joint
Task Force of EuropeanSocieties
on Coronary Prevention
³20%
10y
536
65
12.1%
213
99
46.5%
American
Heart Association
³20%
10y
536
11
2.1%
Joint
British Societies
³15%
y
536
46
8.6%
213
134
62.9%
Italian
risk assessment chart
M: ³20%
10y;
F: ³7%
5y
536
9
1.7%
210
20
9.5%
New
Italian risk assessment chart
M: ³20%
10y.
F: ³7%
5y
536
20
3.7%
210
143
34.0%
References
1.
Walley T, Folino-Gallo P, Schwabe U, van Ganse E; EuroMedStat group.
Variations and increase in use of statins across Europe: data from
administrative databases. BMJ. 2004 Feb 14;328:385-6.
2. Larsen J, Vaccheri A, Andersen M, Montanaro N, Bergman U. Lack of adherence
to lipid-lowering drug treatment. A comparison of utilization patterns in
defined populations in Funen, Denmark and Bologna, Italy.Br J Clin Pharmacol.
2000 May;49:463-71.
3. Raithatha N, Smith RD.Paying
for statins. BMJ. 2004 Feb 14;328:400-2. 4.
Menotti A, Lanti M, Puddu PE, Carratelli L, Mancini M, Motolese M, Prati P,
Zanchetti A. An Italian chart for cardiovascular risk prediction. Its
scientific basis. Ann Ital Med Int 2001;16:240-51.
5.
Anderson KM, Odell PM, Wilson WF, Kannel WB. Cardiovascular disease risk
profile. Am Hearth J 1990;121:293-8.
6.
Wallis EJ, Ramsay LE, Ul Haq I, Ghahramani P, Jackson PR, Rowland-Yeo K, Yeo
WW. Coronary and cardiovascular risk estimation for primary prevention:
validation of a new Sheffield table in the 1995 Scottish health survey
population. BMJ. 2000;320:671-6.
7.
Jackson R. Updated New Zealand cardiovascular disease risk-benefit prediction
guide. BMJ. 2000 Mar 11;320(7236):709-10.
8.
Wood D, De Backer G, Faergeman O, Graham I, Mancia G, Pyorala K. Prevention of
coronary heart disease in clinical practice: recommendations of the Second
Joint Task Force of European and other Societies on Coronary Prevention.
Atherosclerosis. 1998;140:199-270
9.
British Cardiac Society, British Hyperlipidaemia Association, British
Hypertension Society, and British Diabetic Association. Joint British
recommendations on prevention of coronary heart disease in clinical practice:
summary. BMJ 2000; 320: 705-708.
Rapid Response:
Italy: last position both in use of statins therapy and in the sensitivity of own coronary risk assessment chart
use of statins of Europe, with
only 14.74 daily doses/1000 of population covered/day, against 23.86 in
England, 26.47 in Germany, 30.85 in France, 59.28 in Norway [1]. They suppose
that this low use may reflect low coronary morbidity of o poor adherence of
Italian patients to statins, worse than elsewhere in Europe. Really, the
reference to this sentence proved only that the adherence to statins is worse
in Bologna (Italy) than in Funen (Denmark), and ten years ago, from 1994 to
1996 [2].
On
the contrary, national guidance and policies, could be the major causes of the
Italian situation too. In the same number of the BMJ
Raithatha and Smith reported that may people who could benefit from
statins are not currently receiving them, largely for economic reason [3]. In
Italy the reimbursement of the statins therapy is regulated by the Unique
Commission of Drugs (CUF). The rule number 13 of the CUF recommends the
statins treatment only for people with high global risk and recommends also to
use the Italian Risk Chart to estimate the global risk.
In
a previous experience we demonstrate that the first edition of the Italian
Risk Chart[4] had a very low
sensitivity, since more than 80% of patients at risk for coronary disease, so
classified by the Framingham equation[5], were misdiagnosed.
To
this aim, we employed the Italian chart to estimate how many subjects would
have been treated with statins in a population including 536 healthy blood
donors and 213 patients with non-insulin dependent diabetes mellitus. Results
were compared with those calculated by using the Framingham equation as
reference method and with alternative risk assessment screening methods,
including the New Zealand chart [6], the new Sheffield tables [7], the chart
of the Joint Task Force of European Societies on Coronary Prevention [8], and
criteria of the Joint British Societies [9].
Only
1,7% of a donors population and only 9,5% of a diabetic population should have
been admitted the a statins therapy, according to the chart (table). But only
a private prescription could be proposed to the other 80% of patient with high
risk.
In
the last weeks the Italian High Institute of Health, who realized the first
risk Chart, modified the risk classes, improving the sensibility.
Notwithstanding this change, it remain one of the lowest sensitive, compared
with other European or international ones.
Table:
Comparison of the Framingham equation with alternative screening methods and
estimated risk assessment.
Donors
Diabetic
subjects
risk
N.
N.
pos.
%
pos
N.
N.
pos
%
pos
Framingham
Study equation
³15%
10y
536
54
10,1%
213
141
66.2%
New
Zealand
³15%
5y
536
31
5.8%
213
102
47.9%
New
Zealand
³20%
5y
536
6
1.1%
213
51
23.9%
New
Sheffield table
³15%
10y
536
68
12.7%
213
148
69.5%
New
Sheffield table
³30%
10y
536
0
0.0%
213
20
9.4%
Joint
Task Force of European Societies
on Coronary Prevention
³20%
10y
536
65
12.1%
213
99
46.5%
American
Heart Association
³20%
10y
536
11
2.1%
Joint
British Societies
³15%
y
536
46
8.6%
213
134
62.9%
Italian
risk assessment chart
M:
³20%
10y;
F:
³7%
5y
536
9
1.7%
210
20
9.5%
New
Italian risk assessment chart
M:
³20%
10y.
F:
³7%
5y
536
20
3.7%
210
143
34.0%
References
1.
Walley T, Folino-Gallo P, Schwabe U, van Ganse E; EuroMedStat group.
Variations and increase in use of statins across Europe: data from
administrative databases. BMJ. 2004 Feb 14;328:385-6.
2. Larsen J, Vaccheri A, Andersen M, Montanaro N, Bergman U. Lack of adherence
to lipid-lowering drug treatment. A comparison of utilization patterns in
defined populations in Funen, Denmark and Bologna, Italy.Br J Clin Pharmacol.
2000 May;49:463-71.
3. Raithatha N, Smith RD. Paying
for statins. BMJ. 2004 Feb 14;328:400-2.
4.
Menotti A, Lanti M, Puddu PE, Carratelli L, Mancini M, Motolese M, Prati P,
Zanchetti A. An Italian chart for cardiovascular risk prediction. Its
scientific basis. Ann Ital Med Int 2001;16:240-51.
5.
Anderson KM, Odell PM, Wilson WF, Kannel WB. Cardiovascular disease risk
profile. Am Hearth J 1990;121:293-8.
6.
Wallis EJ, Ramsay LE, Ul Haq I, Ghahramani P, Jackson PR, Rowland-Yeo K, Yeo
WW. Coronary and cardiovascular risk estimation for primary prevention:
validation of a new Sheffield table in the 1995 Scottish health survey
population. BMJ. 2000;320:671-6.
7.
Jackson R. Updated New Zealand cardiovascular disease risk-benefit prediction
guide. BMJ. 2000 Mar 11;320(7236):709-10.
8.
Wood D, De Backer G, Faergeman O, Graham I, Mancia G, Pyorala K. Prevention of
coronary heart disease in clinical practice: recommendations of the Second
Joint Task Force of European and other Societies on Coronary Prevention.
Atherosclerosis. 1998;140:199-270
9.
British Cardiac Society, British Hyperlipidaemia Association, British
Hypertension Society, and British Diabetic Association. Joint British
recommendations on prevention of coronary heart disease in clinical practice:
summary. BMJ 2000; 320: 705-708.
Competing interests: None declared
Competing interests: