natgillin/translations-raw huggingface dataset:
1 Member State Austria Austria Austria Austria Belgium Belgium Belgium Belgium Denmark Denmark Denmark Denmark Finland Finland Finland Finland Germany Germany Germany Germany Greece Greece
Imetnik dovoljenja za promet z zdravilom Pfizer Corporation Austria Ges. m. b. H.
Marketing Authorisation Holder Pfizer Corporation Austria Ges. m. b. H.
Farmacevtska oblika Filmsko obložena tableta
Pfizer S. A.
Peroralna uporaba
Pfizer S. A.
Belgija
Pharmaceutical form Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Filmsko obložena tableta
Route of administration Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Peroralna uporaba
2 Member State Greece Greece Italy Italy Italy Italy Luxembourg Luxembourg Luxembourg Luxembourg Netherlands Netherlands Netherlands Netherlands Portugal Portugal Portugal Portugal Spain Spain Spain Spain
Belgija
Pfizer S. A.
20mg
PARKE-DAVIS, S. L.
Filmsko obložena tableta
PARKE-DAVIS, S. L.
Peroralna uporaba
3 Member State Sweden Sweden Sweden Sweden
Belgija
Pharmaceutical form Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Filmsko obložena tableta
Route of administration Oral use Oral use Oral use Oral use
Peroralna uporaba
4 ANNEX II
Danska
The currently approved indications for atorvastatin are:
Filmsko obložena tableta
- as an adjunct to diet for reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein
Peroralna uporaba
B, and tryglicerides in patients with primary hypercholesterolemia including familial hypercholesterolemia (heterozygous variant) or combined (mixed) hyperlipidaemia (corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate.
Danska
This wording was based on the results of 2 randomised controlled trials performed with atorvastatin 10 mg for the primary prevention of cardiovascular disease (CVD).
Filmsko obložena tableta
In the Final Assessment report (1 November 2005) the Reference Member State proposed, and the MAH agreed to, the following indication: “ Prevention of cardiovascular events in patients with type 2 diabetes and one additional risk factor with normal to mildly elevated cholesterol level without clinically evident coronary heart disease”.
Peroralna uporaba
thus restricting the indication to the population included in the CARDs trial and relegating the results of the ASCOT-LLA trial to a description in section 5.1. of the SPC, based on the lack of demonstrated efficacy in the female subgroup.
Danska
3.
Filmsko obložena tableta
4.
Peroralna uporaba
5.
Danska
The main issue discussed by the CHMP has been the results of the ASCOT-LLA trial, most importantly the lack of established benefit and adverse mortality trends in the female subgroup and, secondly, the impact of the observed interaction between the antihypertensive amlodipine and atorvastatin on the main trial outcomes for certain subgroups.
Zarator
The Applicant has presented arguments for the view that the results for women in ASCOT-LLA based on subgroup analyses are most likely chance findings and are not considered scientifically robust enough to form the basis for regulatory actions.
80mg
The main concern relates to the “ risk of CVD”.
Filmsko obložena tableta
It is obvious that the age-adjusted absolute benefit of primary CVD prevention is much lower in women than in men, as women have a lower CVD risk at the same age.
Peroralna uporaba
Regarding the interaction observed between atorvastatin and amlodipine, the body of data assessed indicates that this interaction is of questionable clinical relevance, if it exists at all, and does not warrant regulatory action dictating the prescription of the product.
Finska
In the light of the above the CHMP concludes that the indication for atorvastatin “ Prevention of cardiovascular events in patients estimated to have a high risk for a first cardiovascular event, as an adjunct to correction of other risk factors .” adequately reflects the available data.
Filmsko obložena tableta
Overall conclusion on benefit/ risk
Peroralna uporaba
At its meeting of 20-23 March 2006, the CHMP considered the data on efficacy presented by the MAHs and concluded that it had been shown that atorvastatin, as an adjunct to correction of other risk factors, was effective in the prevention of CV events in patients estimated to have a high risk for a first CV event.
Finska
- It is proposed to add the following indication in section 4.1:
Filmsko obložena tableta
Prevention of cardiovascular events in patients estimated to have a high risk for a first cardiovascular event (see section 5.1), as an adjunct to correction of other risk factors.
Peroralna uporaba
-
Finska
8 Patients were treated with anti-hypertensive therapy (either amlodipine or atenolol-based regimen) and either atorvastatin 10 mg daily (n=5168) or placebo (n=5137).
Filmsko obložena tableta
The absolute and relative risk reduction effect of atorvastatin was as follows:
Peroralna uporaba
Relative
Finska
Events
Peroralna uporaba
Risk
Nemčija
Reduction1
Filmsko obložena tableta
Event
Peroralna uporaba
(%)
Nemčija
p-value
20mg
Fatal CHD plus non-fatal MI Total cardiovascular events
Filmsko obložena tableta
36%
Nemčija
154
PARKE- DAVIS GmbH
1.1%
Sortis
0.0005
40mg
and revascularization procedures Total coronary events 1
Filmsko obložena tableta
20% 29%
Peroralna uporaba
389 vs.
Nemčija
483 178 vs 247
PARKE- DAVIS GmbH
1.9% 1.4%
Sortis
0.0008 0.0006
80mg
CHD = coronary heart disease; MI = myocardial infarction.
Filmsko obložena tableta
212 events, p=0.17 and 74 vs.
Peroralna uporaba
The effect of atorvastatin on fatal and non-fatal cardiovascular disease was also assessed in a randomised, double-blind, multicentre, placebo-controlled trial, the Collaborative Atorvastatin Diabetes Study (CARDS) in patients with type 2 diabetes, 40-75 years of age, without prior history of cardiovascular disease, and with LDL-C ≤ 4.14 mmol/ l (160 mg/ dl) and TG≤ 6.78 mmol/ l (600 mg/ dl).
10mg
The absolute and relative risk reduction effect of atorvastatin were as follows:
Filmsko obložena tableta
Relative
Peroralna uporaba
No. of
Grčija
Absolute
Pfizer Hellas AE
Risk
Lipitor
Events
20mg
Risk
Filmsko obložena tableta
Reduction
Peroralna uporaba
(Sortis vs
Izmišljeno ime Lipitor
Reduction1
Jakost 40mg
Event Major cardiovascular events (fatal and non-fatal AMI, silent MI, acute CHD death, unstable angina, CABG, PTCA,
Farmacevtska oblika Filmsko obložena tableta
(%)
Grčija
Placebo)
Pfizer Hellas AE
p-value
80mg
revascularisation, stroke) MI (fatal and non-fatal AMI, silent MI) Strokes (Fatal and non-fatal) 1
Filmsko obložena tableta
37% 42% 48%
Peroralna uporaba
83 vs.
Italija
3.2% 1.9% 1.3%
PARKE- DAVIS SpA
0.0010 0.0070 0.0163
Xarator
Based on difference in crude events rates occurring over a median follow-up of 3.9 years.
10mg
61 deaths in the atorvastatin group, p=0.0592).
Filmsko obložena tableta
• no untoward safety findings related to the extension of the indication have been identified.
Peroralna uporaba
• the CHMP, as a consequence, considered the benefit/ risk balance for the above-mentioned extension of indication to be favourable,
Italija
The CHMP has recommended the granting of the variation of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and Package Leaflet are set out in Annex III for atorvastatin (Sortis and related names - see Annex I).
PARKE- DAVIS SpA
10 ANNEX III
Xarator
SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
20mg
11 SUMMARY OF PRODUCT CHARACTERISTICS
Filmsko obložena tableta
NAME OF THE MEDICINAL PRODUCT
Peroralna uporaba
< [See Annex I - To be completed nationally] > [For referral procedures] {PRODUCT NAME} 10 mg film-coated tablet
Italija
QUALITATIVE AND QUANTITATIVE COMPOSITION
PARKE- DAVIS SpA
Each film-coated tablet contains 10 mg atorvastatin (as atorvastatin calcium (trihydrate)).
Xarator
Excipients:
40mg
Each {PRODUCT NAME} 10 mg film-coated tablet contains 32.80 mg lactose monohydrate.
Filmsko obložena tableta
For a full list of excipients, see section 6.1.
Peroralna uporaba
3.
Italija
PHARMACEUTICAL FORM
PARKE- DAVIS SpA
Film-coated tablet White elliptical, film-coated tablets debossed "10" on one side and "PD 155" on the other.
Xarator
4.
80mg
4.1 Therapeutic indications
Filmsko obložena tableta
Hypercholesterolaemia
Peroralna uporaba
{PRODUCT NAME} is indicated as an adjunct to diet for reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B, and triglycerides in patients with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (Corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate.
Luksemburg
LDL apheresis) or if such treatments are unavailable.
Pfizer S. A.
Prevention of cardiovascular disease
Lipitor
Prevention of cardiovascular events in patients estimated to have a high risk for a first cardiovascular event (see section 5.1), as an adjunct to correction of other risk factors.
10mg
4.2 Posology and method of administration
Filmsko obložena tableta
The patient should be placed on a standard cholesterol-lowering diet before receiving {PRODUCT NAME} and should continue on this diet during treatment with {PRODUCT NAME}.
Peroralna uporaba
Dosage should be individualized according to baseline LDL-C levels, the goal of therapy, and patient response.
Luksemburg
The maximum dose is 80 mg once a day.
Pfizer S. A.
Each daily dose of atorvastatin is given all at once and may be given at any time of day with or without food.
Lipitor
13 For patients with established coronary heart disease or other patients at increased risk of ischemic events, the treatment goal is LDL-C < 3 mmol/ l (or < 115 mg/ dl) and total cholesterol < 5 mmol/ l (or < 190 mg/ dl).
20mg
Adapted from “ Prevention of coronary heart disease in clinical practice:
Filmsko obložena tableta
Primary hypercholesterolaemia and combined (mixed) hyperlipidaemia
Peroralna uporaba
The response is maintained during chronic therapy.
Pfizer S. A.
Heterozygous familial hypercholesterolaemia
Lipitor
Patients should be started with {PRODUCT NAME} 10 mg daily.
40mg
Homozygous familial hypercholesterolaemia
Filmsko obložena tableta
Atorvastatin was administered at doses up to 80 mg/ day.
Peroralna uporaba
The dosage of atorvastatin in patients with homozygous familial hypercholesterolemia is 10 to 80 mg daily.
Luksemburg
Prevention of cardiovascular disease
Pfizer S. A.
In the primary prevention trials the dose was 10 mg/ day.
80mg
Dosage in patients with renal insufficiency
Filmsko obložena tableta
Renal disease has no influence on the atorvastatin plasma concentrations nor lipid effects of {PRODUCT NAME}; thus, no adjustment of dose is required.
Peroralna uporaba
Geriatric use
Nizozemska
Pediatric use should only be carried out by specialists.
10mg
4.3 Contraindications
Filmsko obložena tableta
14 {PRODUCT NAME} is contraindicated in patients: − with hypersensitivity to the active substance or to any of the excipients of this medication − with active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal − with myopathy − during pregnancy − while breast-feeding − in women of child-bearing potential not using appropriate contraceptive measures.
Peroralna uporaba
4.4 Special warnings and precautions for use
Nizozemska
Liver effects
Pfizer bv
Liver function tests should be performed before the initiation of treatment and periodically thereafter.
Lipitor
{PRODUCT NAME} should be used with caution in patients who consume substantial quantities of alcohol and/ or have a history of liver disease.
20mg
Skeletal muscle effects
Filmsko obložena tableta
Atorvastatin, like other HMG-CoA reductase inhibitors, may in rare occasions affect the skeletal muscle and cause myalgia, myositis, and myopathy that may progress to rhabdomyolysis, a potentially life-threatening condition characterised by markedly elevated CPK levels (> 10 times ULN), myoglobinaemia and myoglobinuria which may lead to renal failure.
Peroralna uporaba
Before the treatment Atorvastatin should be prescribed with caution in patients with pre-disposing factors for rhabdomyolysis.
Nizozemska
In such situations, the risk of treatment should be considered in relation to possible benefit, and clinical monitoring is recommended.
Pfizer bv
Creatine phosphokinase measurement Creatine phosphokinase (CPK) should not be measured following strenuous exercise or in the presence of any plausible alternative cause of CPK increase as this makes value interpretation difficult.
Lipitor
Whilst on treatment − Patients must be asked to promptly report muscle pain, cramps, or weakness especially if accompanied by malaise or fever.
40mg
15 − If such symptoms occur whilst a patient is receiving treatment with atorvastatin, their CPK levels should be measured.
Filmsko obložena tableta
Risk of rhabdomyolysis is increased when atorvastatin is administered concomitantly with certain medicaments such as: ciclosporin, erythromycin, clarithromycin, itraconazole, ketoconazole, nefazodone, niacin, gemfibrozil, other fibric acid derivates or HIV-protease inhibitors (see section 4.5 and section 4.8).
Peroralna uporaba
Patients with rare hereditary problems of galactose intolerance, Lapp lactose deficiency or glucose- galactose malabsorption should not take this medicine.
Nizozemska
4.5 Interaction with other medicinal products and other forms of interaction
Pfizer bv
The risk of myopathy during treatment with HMG-CoA reductase inhibitors is increased with concurrent administration of ciclosporin, fibric acid derivatives, macrolide antibiotics including erythromycin, azole antifungals, or niacin and on rare occasions has resulted in rhabdomyolysis with renal dysfunction secondary to myoglobinuria.
Lipitor
Inhibitors of cytochrome P450 3A4
80mg
Atorvastatin is metabolized by cytochrome P450 3A4.
Filmsko obložena tableta
Inhibitors of P-glycoprotein
Peroralna uporaba
Atorvastatin and atorvastatin-metabolites are substrates of P-glycoprotein.
Portugalska
Coadministration of atorvastatin 10 mg OD and erythromycin (500 mg QID), or atorvastatin 10 mg OD and clarithromycin (500 mg BID), known inhibitors of cytochrome P450 3A4, were associated with higher plasma concentrations of atorvastatin.
Zarator
Itraconazole
10mg
Concomitant administration of atorvastatin 40 mg and itraconazole 200 mg daily resulted in a 3-fold increase in atorvastatin AUC.
Filmsko obložena tableta
Protease inhibitors
Peroralna uporaba
Coadministration of atorvastatin and protease inhibitors, known inhibitors of cytochrome P450 3A4, was associated with increased plasma concentrations of atorvastatin.
Portugalska
16 Grapefruit juice
Laboratórios Pfizer, Lda
Contains one or more components that inhibit CYP3A4 and can increase plasma concentrations of medicinal products metabolized by CYP3A4.
Zarator
Inducers of cytochrome P450 3A4
20mg
The effect of inducers of cytochrome P450 3A4 (e. g. rifampicin or phenytoin) on {PRODUCT NAME} is unknown.
Filmsko obložena tableta
Other concomitant therapy
Peroralna uporaba
Gemfibrozil / fibric acid derivatives The risk of atorvastatin-induced myopathy may be increased with the concomitant use of fibric acid derivatives.
Portugalska
17 Colestipol Plasma concentrations of atorvastatin and its active metabolites were lower (by approx.
40mg
35%; however, LDL-C reduction was not altered.
Filmsko obložena tableta
Warfarin Coadministration of {PRODUCT NAME} and warfarin caused a small decrease in prothrombin time during the first days of dosing which returned to normal within 15 days of {PRODUCT NAME} treatment.
Peroralna uporaba
Phenazone Coadministration of multiple doses of {PRODUCT NAME} and phenazone showed little or no detectable effect in the clearance of phenazone.
Portugalska
Cimetidine An interaction study with cimetidine and {PRODUCT NAME} was conducted, and no interaction was seen.
Laboratórios Pfizer, Lda
Amlodipine Atorvastatin pharmacokinetics were not altered by the coadministration of atorvastatin 80 mg and amlodipine 10 mg at steady state.
Zarator
Other In clinical studies in which {PRODUCT NAME} was administered with antihypertensives or hypoglycaemic agents no clinically significant interactions were seen.
80mg
4.6 Pregnancy and lactation
Filmsko obložena tableta
{PRODUCT NAME} is contraindicated in pregnancy and while breast feeding.
Peroralna uporaba
There is evidence from animal studies that HMG-CoA reductase inhibitors may influence the development of embryos or foetuses.
Španija
In rats, plasma concentrations of atorvastatin and its active metabolites are similar to those in milk.
PARKE- DAVIS, S. L.
It is not known whether this medicinal product or its metabolites are excreted in human milk.
Zarator
4.7 Effects on ability to drive and use machines
10mg
{PRODUCT NAME} has negligible influence on the ability to drive and use machines.
Filmsko obložena tableta
18 4.8 Undesirable effects
Peroralna uporaba
The most commonly expected adverse events are mainly gastrointestinal, including constipation, flatulence, dyspepsia, abdominal pain and usually ameliorate on continued treatment.
Španija
Less than 2% of patients were discontinued from clinical trials due to side effects attributed to {PRODUCT NAME}.
PARKE- DAVIS, S. L.
Based on data from clinical studies and extensive post-marketing experience, the following table presents the adverse event profile for {PRODUCT NAME}.
Zarator
Estimated frequencies of events are ranked according to the following convention: common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (≤ 1/ 10,000).
20mg
Gastrointestinal disorders
Filmsko obložena tableta
Uncommon: anorexia, vomiting.
Peroralna uporaba
Blood and lymphatic system disorders
Španija
Common: allergic reactions.
Filmsko obložena tableta
Very rare: anaphylaxis.
Peroralna uporaba
Endocrine disorders
Španija
Uncommon: alopecia, hyperglycaemia, hypoglycaemia, pancreatitis.
PARKE- DAVIS, S. L.
Psychiatric
Zarator
Common: insomnia.
Filmsko obložena tableta
Uncommon: amnesia.
Peroralna uporaba
Nervous system disorders
3 Država članica Švedska
Common: headache, dizziness, paraesthaesia, hypoesthesia.
Imetnik dovoljenja za promet z zdravilom Pfizer AB
Uncommon: peripheral neuropathy.
Izmišljeno ime Lipitor
Hepato-biliary disorders
Farmacevtska oblika Filmsko obložena tableta
Rare: hepatitis, cholestatic jaundice.
Pot uporabe zdravila Peroralna uporaba
Skin/ Appendages
Švedska
Uncommon: urticaria.
Filmsko obložena tableta
Ear and Labyrinth Disorders
Peroralna uporaba
19 Musculoskeletal disorders
Filmsko obložena tableta
Common: myalgia, arthralgia.
Peroralna uporaba
Uncommon: myopathy.
Švedska
Reproductive system disorders
Filmsko obložena tableta
Uncommon: impotence.
Peroralna uporaba
General disorders
4 DODATEK II
Uncommon: malaise, weight gain.
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNITEV POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, PREDSTAVLJENI S STRANI EVROPSKE AGENCIJE ZA ZDRAVILA
Investigations
5 ZNANSTVENI ZAKLJUČKI
As with other HMG-CoA reductase inhibitors elevated serum transaminases have been reported in patients receiving {PRODUCT NAME}.
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ATORVASTATINA (zdravilo Sortis in povezana imena - glejte Dodatek I)
These changes were usually mild, transient, and did not require interruption of treatment.
- kot dopolnilo k dieti za znižanje zvišanih vrednosti skupnega holesterola, LDL- holesterola,
Clinically important (> 3 times upper normal limit) elevations in serum transaminases occurred in 0.8% patients on {PRODUCT NAME}.
apoliproteina B in trigliceridov pri bolnikih s primarno hiperholesterolemijo, vključno s družinsko hiperholesterolemijo (heterozigotna varianta) ali kombinirano (mešano) hiperlipidemijo (ki ustreza tipoma IIa in IIb v Fredericksonovi klasifikaciji), kadar odziv na dieto in druge nefarmacevtske ukrepe ni zadosten.
These elevations were dose related and were reversible in all patients.
- za znižanje skupne ravni holesterola in LDL- holesterola pri bolnikih s homozigotno družinsko
Elevated serum creatine phosphokinase (CPK) levels greater than 3 times upper limit of normal occurred in 2.5% of patients on {PRODUCT NAME}, similar to other HMG-CoA reductase inhibitors in clinical trials.
hiperholesterolemijo kot dopolnilo k drugim vrstam zdravljenja za znižanje ravni lipidov v krvi (npr.
Levels above 10 times the normal upper range occurred in 0.4% {PRODUCT NAME}-treated patients (see section 4.4).
LDL- afereza), ali kadar druge vrste zdravljenja niso na voljo.
4.9 Overdose
„ Preprečevanje srčno- žilnih dogodkov pri bolnikih z več dejavniki tveganja (npr. bolnikih s sladkorno boleznijo tipa 2 in enim dejavnikom tveganja in bolnikih s hipertenzijo in 3 dejavniki tveganja) in normalnimi ali zvišanimi ravnmi holesterola brez klinično izražene koronarne srčne bolezni (CHD) “.
Specific treatment is not available for {PRODUCT NAME} overdosage.
Atorvastatin je statistično značilno znižal pogostnost koronarnih in srčno- žilnih dogodkov, infarktov in revaskularizacijskih posegov v celotni preiskani kohorti.
Should an overdose occur, the patient should be treated symptomatically and supportive measures instituted, as required.
Vendar se je v analizah podskupin, razdeljenih po spolu (81% moških, 19% žensk), pokazal koristen učinek atorvastatina le pri moških, medtem ko ga pri ženskam niso mogli dokazati.
Liver function tests should be performed and serum CPK levels should be monitored.
Ravno tako sta bili pri bolnicah skupna smrtnost in smrtnost zaradi srčno- žilnih bolezni številčno višji (statistično neznačilno).
Due to extensive atorvastatin binding to plasma proteins, haemodialysis is not expected to significantly enhance atorvastatin clearance.
V končnem poročilu o oceni zdravila (1. november 2005) je referenčna država članica predlagala naslednjo indikacijo, s katero se je strinjal imetnik dovoljenja za promet z zdravilom:
PHARMACOLOGICAL PROPERTIES
pri čemer se je indikacija zožila na populacijo, ki je bila vključena v preskušanje CARDs, rezultati preskušanja ASCOT- LLA pa so bili zaradi nedokazane učinkovitosti pri ženskah uvrščeni v opis v poglavju 5. 1 Povzetka glavnih značilnosti zdravila (SPC).
5.1 Pharmacodynamic properties
Na decembrskem plenarnem zasedanju je Odbor za zdravila za
C10AA05
6 uporabo v humani medicini (CHMP) sprejel seznam vprašanj (LoQ), ki se osredotoča na naslednje točke:
Atorvastatin is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme responsible for the conversion of 3-hydroxy-3-methyl-glutaryl-coenzyme A to mevalonate, a precursor of sterols, including cholesterol.
Kako naj besedilo Povzetka glavnih značilnosti zdravila ustrezno odraža odsotnost statistično značilnega učinka atorvastatina v sestavljenem primarnem kazalcu izida in več sekundarnih kazalcih izida pri ženskah?
Triglycerides and cholesterol in the liver are incorporated into very low-density lipoproteins (VLDL) and released into the plasma for delivery to peripheral tissues.
Ali naj se iz predlagane indikacije izključi ciljna populacija preskušanja ASCOT- LLA in s tem onemogoči zdravljenje bolnikov brez sladkorne bolezni, ki imajo veliko tveganje za srčno- žilno bolezen?
Low- density lipoprotein (LDL) is formed from VLDL and is catabolized primarily through the receptor with high affinity to LDL (LDL receptor).
Ali je kardioprotektivni učinek atorvastatina večji, če se uporablja v kombinaciji s specifičnim( i) antihipertenzivnim( i) zdravljenjem( nji) in ali naj to odraža Povzetek glavnih značilnosti zdravila?