Consumul de statine și reducerea mortalității legate de cancer

aug.28

Abstract

Context: O reducere a disponibilității colesterolului poate limita proliferarea celulară necesară pentru creșterea cancerului și metastaze. Am testat ipoteza că utilizarea statinelor a început înainte de diagnosticarea cancerului este asociată cu o mortalitate redusă legată de cancer.

Metode: Am evaluat mortalitatea în rândul pacienților din întreaga populație daneză care au primit un diagnostic de cancer între 1995 și 2007, cu urmărire până la 31 decembrie 2009. În rândul pacienților cu vârsta de 40 de ani sau peste, 18.721 folosiseră statine în mod regulat înainte de diagnosticul de cancer și 277.204 nu au folosit niciodată statine.

Rezultate: Raporturile de pericol ajustate multivariabil pentru utilizatorii de statine, comparativ cu pacienții care nu au folosit niciodată statine, au fost de 0,85 (interval de încredere 95% [IC], 0,83-0,87) pentru deces din orice cauză și 0,85 (IC 95%, 0,82-0,87) pentru moartea de cancer. Raporturile de pericol ajustate pentru deces din orice cauză în funcție de doza zilnică definită de statină (doza medie de întreținere presupusă pe zi) au fost de 0,82 (IÎ 95%, 0,81 până la 0,85) pentru o doză de 0,01 până la 0,75 doză zilnică definită pe zi, 0,87 ( IÎ 95%, 0,83 – 0,89) pentru doza zilnică definită de 0,76 până la 1,50 pe zi și 0,87 (IÎ 95%, 0,81 până la 0,91) pentru doza zilnică mai mare de 1,50 definită pe zi; raporturile de pericol corespunzătoare pentru deces prin cancer au fost 0,83 (95% CI, 0,81-0,86), 0,87 (95% CI, 0,83-0,91) și 0,87 (95% CI, 0,81-0,92).Reducerea mortalității legate de cancer în rândul consumatorilor de statine în comparație cu cei care nu au folosit niciodată statine a fost observată pentru fiecare dintre cele 13 tipuri de cancer.

Concluzii: utilizarea statinei la pacienții cu cancer este asociată cu o mortalitate redusă prin cancer. Acest lucru sugerează necesitatea studiilor de statine la pacienții cu cancer.

N Engl J Med

 . 8 noiembrie 2012; 367 (19): 1792-802. doi: 10.1056 / NEJMoa1201735.

Consumul de statine și reducerea mortalității legate de cancer

Sune F Nielsen 1,  Børge G Nordestgaard ,  Stig E BojesenAfilieri extinde

Colesterolul este o componentă structurală fundamentală a membranelor celulare ale mamiferelor și este esențial pentru proliferarea celulară. 1,2  Statinele inhibă producția de colesterol endogen 3  și blochează prenilarea proteinelor și, prin urmare, utilizarea statinelor poate influența proliferarea și migrația celulară. 4,5

Proliferarea celulelor canceroase este văzută clinic ca o creștere a cancerului și metastază și, în cele din urmă, duce la moartea pacientului. O reducere a disponibilității colesterolului ar putea duce la scăderea proliferării și migrării celulelor canceroase. 6,7 De  asemenea, o reducere a produselor din aval în calea mevalonate datorită utilizării statina a fost asociat cu mai multe potentiale proprietati anticancerigene 8-12  si un risc redus de recurenta a cancerului. 13,14  La nivel celular, statinele au fost legate de oprirea progresiei ciclului celular și de creșterea radiosensibilizării în celulele canceroase. 10,15,16 Astfel, utilizarea regulată a statinelor înainte și după un diagnostic de cancer ar putea reduce teoretic mortalitatea legată de cancer. În studiile la scară largă cu statine pentru a reduce riscul bolilor cardiovasculare în rândul persoanelor fără cancer, utilizarea statinelor nu a influențat incidența cancerului sau a mortalității asociate. 17,18

Am emis ipoteza că utilizarea statinelor începută înainte de diagnosticarea cancerului ar fi asociată cu o mortalitate redusă legată de cancer. Pentru a testa această ipoteză, am analizat datele privind pacienții cu cancer din întreaga populație daneză pentru perioada 1995 până în 2009, comparând mortalitatea în rândul pacienților care au utilizat statine înainte de diagnostic cu mortalitatea în rândul celor care nu au folosit niciodată statine.

Metode

POPULAȚIA DE STUDIU ȘI COLECTAREA DE DATE

Sistemul danez de înregistrare civilă înregistrează toate nașterile, imigrațiile, emigrațiile și decesele din Danemarca prin intermediul numerelor de înregistrare civilă, care identifică în mod unic toți locuitorii Danemarcei și includ informații cu privire la vârstă și sex. Sistemul danez de înregistrare civilă este 100% complet, astfel încât, în scopuri practice, nu se pierd persoane în urma monitorizării. 19

Persoanele cu cancer diagnosticate între 1 ianuarie 1995 și 31 decembrie 2007 au fost identificate cu utilizarea Registrului danez al cancerului, care urmărește datele privind 98% din toate cazurile de cancer incident din Danemarca 20,21  și este orbit de înregistrarea statinei utilizare. Prin includerea numai a pacienților care au primit un diagnostic de cancer până în 2007, am permis cel puțin 2 ani de urmărire pentru toți pacienții. Toate diagnosticele din registru sunt atribuite pe baza examenului histologic de către un patolog complet instruit. Diagnosticarea cancerului a fost clasificată în conformitate cu   codurile C00.0 – C43.0, C45.0 – C96.0, D00.0 – D03.0 și D05.0 – D09 din clasificarea internațională a bolilor, a 10-a revizuire (ICD-10). .0. 22,23

Sistemul de stadializare tumora-nod-metastază (TNM) 24 a  fost adoptat de Registrul danez al cancerului la 1 ianuarie 2004, astfel încât informațiile referitoare la dimensiunea tumorii primare, răspândite în sistemul limfatic și metastazele la distanță în momentul diagnosticului au fost disponibil în perioada 2004-2007. Dimensiunea tumorii a fost clasificată ca fiind mică (T0, T1 sau T2) sau mare (T3 sau T4), cancerul răspândindu-se în sistemul limfatic ca fiind nici unul (N0) sau oricare (N1, N2 sau N3) și metastaze îndepărtate ca niciuna (M0) sau oricare (M1).

Din 1995 până în 2003, Registrul danez al cancerului a înregistrat informațiile de tratament în mod dihotomic (niciunul vs. niciunul), atât pentru radioterapie, cât și pentru chimioterapie, începute în decurs de 4 luni după un diagnostic de cancer. Cu toate acestea, nu au fost disponibile detalii cu privire la tipul specific de tratament administrat.

UTILIZARE STATINELOR

Registrul statistic al produselor medicamentoase din Danemarca a înregistrat informații despre toate medicamentele prescrise eliberate în farmaciile daneze începând cu 1995 și este orbit de înregistrarea diagnosticelor de cancer. Statinele au fost clasificate drept cod chimic terapeutic anatomic C10AA; codurile pentru alte medicamente care scad colesterolul au fost C10AB, C10AC, C10AD, C10AX și C10BA (Tabelul S1 din  apendicele suplimentar , disponibil împreună cu textul integral al acestui articol la NEJM.org). Pentru fiecare rețetă completată pentru fiecare participant la studiu, am înregistrat numele medicamentului, data eliberării și cantitatea totală a dozei zilnice recomandate definite (adică, doza medie de întreținere presupusă pe zi). Tabelul S1 din  apendicele suplimentar enumeră distribuțiile diferitelor tipuri de medicamente cu statine și alte medicamente care scad colesterolul prescrise.

Doza zilnică pentru utilizatorii de statine a fost estimată ca doză 2  împărțită la | t 1 − t 2 |, unde doza 2  este penultima prescripție a unei statine înainte de diagnosticul de cancer, măsurată în doze zilnice definite totale (adică, totalul de miligrame eliberate, împărțit la doza zilnică definită pentru statina specifică) (Tabelul S1 din  apendicele suplimentar ). Valoarea | t 1 −t 2 | este intervalul dintre datele ultimei prescripții a statinei (t 1 ) și penultima prescripție a statinei (t 2 ) înainte de diagnosticarea cancerului (Fig. S4 din  apendicele suplimentar). Dozele de statine au fost analizate în următoarele categorii de doze zilnice definite pe zi: 0,00 (referință), 0,01 până la 0,75, 0,76 până la 1,50 și mai mult de 1,50.

Pentru a exclude cauzalitatea inversă, utilizarea statinelor a fost măsurată numai înainte de data diagnosticării cancerului și a fost utilizată pentru a indica utilizarea statinelor înainte și după diagnosticul cancerului. Am analizat, de asemenea, dacă pacienții au folosit vreodată statine, într-o analiză în care toți pacienții cu cancer care au primit vreodată o statină înainte de diagnosticul de cancer au fost comparați cu cei care nu au folosit niciodată statine.

Pacienții cărora li s-au completat prescripțiile cu statine în termen de 6 luni înainte de data diagnosticului de cancer și în termen de 2 ani înainte de data diagnosticului au fost clasificați drept consumatori obișnuiți de statine (a se vedea figurile S1 și S4 din  apendicele suplimentar ). Fig. S2 din  apendicele suplimentar  arată că modelul prescripțiilor completate pentru statine a fost aproximativ simetric înainte și după diagnosticul de cancer. Toți pacienții care au folosit statine înainte de diagnosticul de cancer, dar a căror utilizare a fost în afara intervalelor de timp specificate, au fost clasificați drept utilizatori neregulați de statine.

Deoarece utilizarea statinelor a crescut și informațiile privind clasificarea și tratamentul TNM pentru fiecare pacient cu cancer s-au modificat în timpul perioadei de observație, am efectuat, de asemenea, un studiu cuibărit 1: 3 (adică, un studiu care a adaptat fiecare utilizator de statine cu trei pacienți care nu folosiseră niciodată statine), cu potrivire pentru sex, vârstă la diagnosticarea cancerului, anul diagnosticului și tipul de cancer (Fig. S3, S11 și S14 în  anexa suplimentară ). 23  Pentru a aborda tiparele necunoscute și alte potențiale prejudecăți între utilizatorii de statine și pacienții care nu folosiseră niciodată statine, s-a efectuat o analiză a scorului de înclinație și ajustarea pentru codul de zonă în care a fost localizat furnizorul (a se vedea  apendicele suplimentar ).

BOALĂ CARDIOVASCULARĂ ȘI DIABET MELLITUS

Diagnosticele bolilor cardiovasculare și ale diabetului zaharat înainte de diagnosticul de cancer au fost identificate cu utilizarea Registrului național al pacienților, 20  care înregistrează toate internările spitalicești din Danemarca. Diagnosticele pentru bolile cardiovasculare și diabetul zaharat au fost clasificate în conformitate cu codurile ICD-10 I00 – I99 și, respectiv, E10 – E14.

CAUZELE MORȚII

Sistemul danez de înregistrare civilă înregistrează data decesului pentru toate persoanele din Danemarca. Pentru toate decesele din Danemarca, Registrul danez al cauzelor de deces 25  înregistrează până la trei cauze de deces clasificate, după cum a raportat medicul curant în practica generală sau la un spital sau de către un medic dintr-un departament de criminalistică sau patologie. Diagnosticele enumerate drept cauze de deces sunt clasificate cu utilizarea ICD-10. Pentru acest studiu, cauza decesului a fost definită ca fiind prima dintre cele trei cauze de deces clasificate, astfel cum a fost evaluată de oricare dintre medicii enumerați mai sus ca fiind cauza principală a decesului. În analizele de sensibilitate, au fost examinate și alte categorizări ale morții cauzale specifice.

ALTE COVARIATE

Din 1980, Statistics Danemarca a adunat informații referitoare la toate persoanele care locuiesc în Danemarca. Pentru acest studiu, am obținut date despre rasă și descendență etnică, cel mai înalt nivel de educație și dimensiunea zonei rezidențiale.

ANALIZE STATISTICE

Am exclus din analize pacienții cu cancer care aveau vârsta mai mică de 40 de ani, deoarece este puțin probabil ca acești pacienți să primească statine. Metoda indicatorului lipsă a fost utilizată pentru a ține cont de informațiile lipsă. 26

Curbele de incidență cumulative au fost estimate prin metoda Fine și Grey 27  și au fost comparate cu utilizarea testelor log-rank. Modele de regresie Cox cu timpul (în ani) după un diagnostic de cancer, ca scară de timp, au fost utilizate pentru a calcula rapoartele de pericol cu ​​intervale de încredere de 95%. Modelele Cox multivariabile au fost ajustate în funcție de vârstă la diagnostic; stadiul cancerului (dimensiunea tumorii, prezența sau absența răspândirii în sistemul limfatic și prezența sau absența metastazelor la distanță); starea în ceea ce privește chimioterapia, radioterapia, diagnosticul bolilor cardiovasculare înainte de cancer și diagnosticul diabetului zaharat înainte de cancer; anul nașterii; sex; rasă și origine etnică (97% dintre pacienți erau persoane albe de origine daneză); cel mai înalt nivel de educație; și dimensiunea zonei rezidențiale.

Toți 295.925 de pacienți au fost urmăriți de la data diagnosticării cancerului; datele au fost cenzurate la data decesului (195.594 pacienți) sau emigrare (635) sau la 31 decembrie 2009 (99.696), oricare ar fi fost primul. Astfel, riscul concurent de deces a fost luat în considerare în analiză prin intermediul cenzurii la data decesului (informații care sunt 100% complete în registrele daneze). Efectul evenimentelor concurente a fost, de asemenea, modelat prin calcularea raporturilor de pericol, ca o măsură a riscului relativ, luând în considerare moartea, cu utilizarea metodei Fine și Grey. 27 Pentru analizele de regresie a riscurilor proporționale Cox, nu am detectat nicio încălcare majoră a presupunerii riscurilor proporționale grafic după trasarea jurnalului pericolului cumulativ pentru diferite categorii de doze de statine, în funcție de jurnalul duratei de urmărire după cancer diagnostic.

Subgrupurile au fost pre-specificate și au cuprins 27 de tipuri de cancer (fig. S14 în  apendicele suplimentar ) și nouă caracteristici ale pacienților. Am efectuat toate calculele cu ajutorul software-ului Stata, versiunea 12.0MP (StataCorp).

Rezultate

PACIENTI DE STUDIU

Tabelul 1. Caracteristicile de bază ale pacienților, în funcție de utilizarea statinei, în studiile la nivel național și corelate.

Am inclus pacienți din întreaga populație daneză care au primit un diagnostic de cancer între 1995 și 2007 și i-au urmat până la 31 decembrie 2009 (mediană, 2,6 ani; interval, 0-15). Dintre pacienții cu vârsta de 40 de ani sau peste, 18.721 au folosit statine în mod regulat până la diagnosticul de cancer, în timp ce 277.204 nu au folosit niciodată statine sau alte medicamente care scad colesterolul înainte de diagnosticul de cancer (Fig. S1 în  apendicele suplimentar ). Caracteristicile inițiale ale pacienților sunt prezentate în  Tabelul 1 . Pe parcursul a 1.072.503 ani-persoană de urmărire, 195.594 de pacienți au murit: 162.067 din cauza cancerului, 14.489 din cauze cardiovasculare și 19.038 din alte cauze.

UTILIZARE ȘI MORTALITATE A STATINULUI

Figura 1. Utilizarea regulată a statinelor și incidența cumulativă a decesului din orice cauză și decesul cauzat de cancer, în funcție de timpul de după diagnosticarea cancerului.

Incidența cumulativă a decesului din orice cauză în funcție de timpul de urmărire de la data diagnosticului de cancer a fost mai mică în rândul consumatorilor de statine decât în ​​rândul pacienților care nu au folosit niciodată statine (P <0,001 prin testul log-rank) ( Figura 1A ). Cele două curbe de incidență cumulative converg după 5 ani de urmărire, probabil din cauza mortalității cardiovasculare crescute în rândul consumatorilor de statine, în comparație cu pacienții care nu au folosit niciodată statine (Fig. S5 în  Anexa suplimentară ). Raportul de risc ajustat multivariabil pentru deces din orice cauză în rândul consumatorilor de statine, comparativ cu pacienții care nu au folosit niciodată statine, a fost de 0,85 (interval de încredere 95% [IC], 0,83-0,87). Rezultatele studiului asociat 1: 3 au fost similare ( Figura 1B ).

Incidența cumulativă a morții cauzate de cancer în funcție de timpul de urmărire de la data diagnosticului de cancer a fost, de asemenea, mai mică în rândul consumatorilor de statine decât în ​​rândul pacienților care nu au folosit niciodată statine (P <0,001 prin testul log-rank) ( Figura 1A ). Raportul de risc ajustat multivariabil pentru decesul cauzat de cancer în rândul consumatorilor de statine, comparativ cu pacienții care nu au folosit niciodată statine, a fost de 0,85 (IÎ 95%, 0,82 – 0,87), cu rezultate similare în studiul asociat 1: 3 ( Figura 1B ).

DOZA STATINĂ ȘI MORTALITATEA

Figura 2. Riscul de deces din diverse cauze, în conformitate cu doza zilnică definită de statină.

Raporturile de pericol ajustate multivariabil pentru deces din orice cauză în funcție de doza zilnică de statină definită, comparativ cu utilizarea fără statine, au fost de 0,82 (IÎ 95%, 0,81 până la 0,85) pentru o doză de 0,01 până la 0,75 doză zilnică definită, 0,87 ( IC 95%, 0,83-0,89) pentru doza zilnică definită de 0,76 până la 1,50 și 0,87 (IC 95%, 0,81-0,91) pentru doza zilnică mai mare de 1,50 ( Figura 2A). Raporturile de risc corespunzătoare pentru decesul cauzat de cancer au fost de 0,83 (95% CI, 0,81-0,86), 0,87 (95% CI, 0,83-0,91) și 0,87 (95% CI, 0,81-0,92). Raporturile de risc corespunzătoare pentru deces din cauze cardiovasculare au fost 1,08 (95% CI, 0,99 la 1,19), 1,25 (95% CI, 1,12 la 1,41) și 1,24 (95% CI, 1,03 la 1,48). În cele din urmă, raporturile de risc corespunzătoare pentru deces din alte cauze au fost de 0,70 (95% CI, 0,64-0,77), 0,76 (95% CI, 0,68-0,86) și 0,77 (95% CI, 0,66-0,92). Studiul imbricat 1: 3 a avut rezultate similare ( Figura 2B ).

ANALIZE DE SENSIBILITATE

Rezultatele pentru mortalitatea cauzată de cancer au rămas similare atunci când am luat în considerare riscul concurent de deces din alte cauze cu utilizarea regresiei subhazardului fin și gri (Fig. S6 în  apendicele suplimentar ). O analiză care a fost limitată la pacienții care au avut cancer mic fără metastaze și o analiză care a inclus pacienți care au folosit vreodată statine au avut rezultate similare. În plus, rezultatele au fost similare atunci când am clasificat decesul în funcție de toate cauzele clasificate de deces din Registrul danez de cauze ale decesului, mortalitatea legată de cancer limitată la același cancer ca și cancerul incident, a exclus ajustarea pentru covariabile cu informații lipsă pentru mai multe mai mult de 0,1% din toți pacienții și ajustat pentru codul de zonă al furnizorului (fig. S7 până la S13 în  apendicele suplimentar).

Reducerea mortalității legate de cancer în rândul consumatorilor de statine în comparație cu pacienții care nu au folosit niciodată statine a fost observată pentru 13 tipuri de cancer: raporturile de risc ajustate multivariabil pentru decesul cauzate de cancer în rândul consumatorilor de statine au fost cuprinse între 0,64 (IC 95%, 0,46 până la 0,88) pentru cancerul de col uterin până la 0,89 (IC 95%, 0,81 până la 0,98) pentru cancerul pancreatic (Fig. S14 în  anexa suplimentară ). Pentru cele 14 tipuri de cancer rămase, raporturile de risc ajustate multivariabil au fost în mare măsură similare, dar cu intervale de încredere care s-au suprapus peste 1,0. Rezultatele studiului imbricat 1: 3 au fost, de asemenea, în mare măsură similare (Fig. S14, panoul din dreapta, în  apendicele suplimentar ). Figura 3. Orice utilizare a statinelor și riscul de deces cauzat de cancer.

În analize stratificate în funcție de caracteristicile asociate cu un risc crescut de deces din orice cauză sau din cauza cancerului (de exemplu, sex, vârstă, tratament cu chimioterapie, tratament cu radioterapie, dimensiune mai mare a tumorii, prezența metastazelor la diagnostic, diagnosticarea bolilor cardiovasculare înainte de cancer și diagnosticul de diabet zaharat înainte de cancer), mortalitatea legată de cancer a fost redusă în rândul consumatorilor de statine, comparativ cu pacienții care nu au folosit niciodată statine, în toate straturile, cu excepția pacienților cu cancer care primeau chimioterapie ( Figura 3 ). Un istoric de diabet sau boli cardiovasculare înainte sau după diagnosticul de cancer nu a influențat în mod substanțial rezultatele (fig. S15 și S16 și tabelul S2 din  apendicele suplimentar ).

Încercând să ne adaptăm pentru diferențele din istoricul medical al pacienților cu cancer, pentru a evita o „părtinire a utilizatorului sănătos”, am repetat studiul asociat 1: 3 cu potrivirea scorului de înclinație (Fig. S17 în  anexa suplimentară ). Rezultatele au fost similare cu cele prezentate în  Figura 2 , cu excepția faptului că utilizarea statinelor nu mai este asociată cu creșterea mortalității cardiovasculare.

Discuţie

În acest studiu la nivel național, am observat că utilizarea statinelor la pacienții cu cancer a fost asociată cu o mortalitate redusă legată de cancer. Descoperirile noastre sunt plauzibile, deoarece statinele inhibă sinteza colesterolului în celule prin inhibarea 3-hidroxi-3-metilglutaril coenzimei A (HMG-CoA) reductază, enzima care limitează rata în calea mevalonatului și a sintezei colesterolului. 28  Multe dintre aceste produse în aval sunt utilizate în proliferarea celulară , deoarece acestea sunt necesare pentru funcțiile celulare esențiale , cum ar fi menținerea integrității membranei, semnalizare, sinteza proteinelor si progresia ciclului celular. 15,28  Întreruperile acestor procese în celulele maligne duc la inhibarea creșterii cancerului și a metastazei. 15,29-31 În special, calea mevalonatului este reglată în sus de p53 (proteina supresoare tumorale) mutantă 32 ,  care este frecventă în cancer. 33 În  consecință, inhibarea acestei căi cu statine întoarce fenotipul malign al celulelor canceroase mutate p53. 32  Scăderea produselor din aval ale căii mevalonate a fost legată de apoptoză și de producția redusă de matrice-metaloproteinază și angiogeneză, precum și de o reducere a invazivității cancerelor in situ. 8-12  statine au fost legate de oprirea progresiei ciclului celular în celulele canceroase cu efecte antiproliferative rezultate, de inhibarea funcțiilor celulare cheie în celulele canceroase și de radiosensibilizarea crescută. 10,15,16

Deoarece statinele sunt localizate selectiv la ficat, mai puțin de 5% dintr-o doză dată ajunge în sistemul circulator. 6,34  Pentru tipurile de cancer, altele decât cancerul hepatic și biliar, 35  un mecanism plauzibil din spatele riscului redus de deces observat de cancer ar putea fi reducerea nivelurilor plasmatice de colesterol. Într-adevăr, cancerele cu creștere rapidă necesită o absorbție ridicată a colesterolului extracelular, iar pacienții cu cancer au niveluri reduse de colesterol în plasmă. 36,37  Prin urmare, o reducere indusă de statină a nivelurilor de colesterol sintetizat sau circulant local ar putea inhiba creșterea cancerului și metastazele și reduce mortalitatea.

Descoperirile noastre sunt, de asemenea, susținute de observarea mortalității reduse legate de cancer la pacienții cu cancer de prostată avansat care iau statine 38  și o recurență redusă corespunzător în rândul pacienților cu cancer de prostată 39  sau de sân 13,14  . Cu toate acestea, utilizarea statinelor la persoanele fără cancer, cu scopul de a reduce riscul bolilor cardiovasculare, nu influențează incidența cancerului sau mortalitatea cauzată de cancer. 17,18  Cu toate acestea, observația noastră că mortalitatea prin toate cauzele la pacienții cu cancer care luau statine a fost redusă cu 15% (IC 95%, 13-17) este similară cu reducerea observată a mortalității prin toate cauzele de 10% (95 % CI, 7-13) la pacienții cu risc de deces din cauze cardiovasculare. 40 Absența unei relații doză-răspuns pentru statine și mortalitatea legată de cancer sugerează că orice doză de statină va fi suficientă pentru reducerea mortalității la pacienții cu cancer.

Teoretic posibilele limitări ale acestui studiu includ părtinirea selecției; cu toate acestea, aceasta nu este o problemă, deoarece am urmărit toți pacienții cu cancer din întreaga populație daneză care au avut vârsta de 40 de ani sau mai mult și au fost eligibili pentru consumul de statine, fără pierderi de urmărire. O limitare potențială aferentă se referă la disponibilitatea și completitudinea informațiilor de diagnostic; cu toate acestea, Registrul danez al cancerului captează date privind 98% din toate diagnosticele de cancer din Danemarca, Registrul național al prescripțiilor daneze înregistrează 100% din toate prescripțiile eliberate de statine, precum și sistemul danez de înregistrare civilă și Registrul danez al datelor de captură a cauzelor morții 100% din toate decesele. Datele privind caracteristicile cancerelor (dimensiunea și prezența sau absența metastazelor în momentul diagnosticului) lipseau pentru mulți pacienți care nu folosiseră niciodată statine;cu toate acestea, această limitare nu pare să fi denaturat constatările noastre, deoarece rezultatele studiului la nivel național au fost similare cu cele ale studiului cuibărit 1: 3, în care informațiile lipsă erau echilibrate între utilizatorii de statine și pacienții care nu folosiseră niciodată statine.

O altă limitare este posibilitatea ca utilizarea statinelor să fie un marker al creșterii gradului de conștientizare a sănătății, afectând teoretic rezultatele noastre. Așa cum ne-am așteptat, utilizatorii de statine au fost mai predispuși să fie bărbați și să aibă boli cardiovasculare sau diabet, astfel încât datele ar putea fi predispuse la o părtinire sănătoasă a utilizatorului, ceea ce ar putea indica prezența unei părtiniri prin indicație (de exemplu, pacienții din acest studiu pot avea a avut mai multe motive pentru a primi medicamentul de către medic). Cu toate acestea, atât studiul imbricat 1: 3, care a avut un număr egal de bărbați și femei și a exclus pacienții cu boli cardiovasculare sau diabet, cât și analiza scorului de înclinație, care s-a potrivit pentru probabilitatea ca pacientul să primească statine pe baza modelelor în istoria medicală, au avut rezultate similare cu cele ale studiului la nivel național.Similitudinea rezultatelor dintre aceste trei analize argumentează împotriva unei influențe a sexului masculin, a bolilor cardiovasculare sau a diabetului zaharat sau a unei conștientizări sporite a sănătății în rândul consumatorilor de statine.

În cele din urmă, deoarece 97% dintre pacienți erau persoane albe de origine daneză, rezultatele noastre s-ar putea să nu se aplice neapărat altor grupuri etnice.

În concluzie, în rândul pacienților cu cancer, am observat o asociere între utilizarea statinelor în momentul diagnosticului și un risc redus de mortalitate legată de cancer, cu o reducere de până la 15%. Este necesară evaluarea prospectivă a ipotezei că utilizarea statinelor prelungește supraviețuirea pacienților cu cancer.

Formularele de divulgare  furnizate de autori sunt disponibile împreună cu textul integral al acestui articol la NEJM.org.

Mulțumim personalului din Registrul danez al cancerului pentru că a oferit acces la înregistrările sale de date.

Afilierile Autorului

De la Departamentul de Biochimie Clinică, Spitalul Herlev, Spitalul Universitar din Copenhaga, Herlev și Facultatea de Științe ale Sănătății, Universitatea din Copenhaga, Copenhaga – ambele în Danemarca.

Adresați solicitări de reimprimare către Dr. Bojesen la Departamentul de Biochimie Clinică, 54M1, Spitalul Herlev, Spitalul Universitar din Copenhaga, Herlev Ringvej 75, DK-2730 Herlev, Danemarca sau la adresa  stig.egil.bojesen@regionh.dk .

Material suplimentar

Anexă suplimentarăPDF375 KB
Formulare de divulgarePDF103KB
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                Un gând despre „Consumul de statine și reducerea mortalității legate de cancer”

                1. Nielsen și colegii (ediția din 8 noiembrie) 1 raportează că utilizarea statinelor la pacienții danezi cu cancer corelată cu mortalitatea redusă legată de cancer într-un studiu observațional. Cu toate acestea, o meta-analiză recentă a 22 de studii randomizate, controlate bine efectuate, cu date de la 66.582 de pacienți care au primit statine și 66.604 care au primit placebo, a arătat că 5 ani de terapie cu statine nu au avut niciun efect asupra riscului de deces legat de cancer (risc relativ , 1,00; interval de încredere 95%, 0,93-0,08) .2 Studiile observaționale arată efectele benefice ale statinelor asupra diferitelor rezultate asupra sănătății, surprinzător de des, în timp ce studiile randomizate și controlate nu. Astfel de discrepanțe între studiile observaționale și studiile randomizate, controlate, au fost observate și pentru studiile privind fracturile3 și pneumonia.4. Un sondaj efectuat în rândul medicilor generaliști britanici a arătat că aceștia sub-prescriu în mod selectiv statine fumătorilor, din cauza stilului lor de viață nesănătos.5 Fumatul este un factor de risc puternic pentru fracturi, pneumonie și deces cauzat de cancer. Acest lucru ar fi putut duce la o asociere inversă între utilizarea statinelor și riscul de deces legat de cancer în studiul observațional realizat de Nielsen și colegii săi. Lipsa unui efect doză-răspuns în studiul lor susține în continuare această ipoteză.

                  Corinne Klop, Pharm.D.
                  Institutul de Științe Farmaceutice din Utrecht, Utrecht, Olanda

                  Johanna H.M. Driessen, M.Sc.
                  Școala CAPHRI pentru sănătate publică și asistență primară, Maastricht, Olanda

                  Frank de Vries, Ph.D., Pharm.D.
                  Institutul de Științe Farmaceutice din Utrecht, Utrecht, Olanda
                  f.devries@uu.nl

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