Sumar Sponsorii manifestării - Medicina Modernă

SIDE-EFFECTS OF SIMVASTATIN THERAPY IN THE ELDERLY.
ANALYTICAL APPROACHES AND CLINICAL CHALLENGES
Victor Dumitrascu 1,2 , Anca-Alexandra Matusz 3 , Adelina Chevereşan 1 ,
Daliborca Cristina Vlad 4 , Beatrice Giorgiana Barac 1
Rezumat.
Scop: Evaluarea profilului de siguranţă a
tratamentului cu simvastatină în doze reduse la pacienţii
geriatrici hipertensivi cu hipercolesterolemie, într-un
studiu prospectiv şi deschis.
Material şi metodă: Patienţii vârstnici (n = 65) au
fost randomizaţi în vederea tratamentului zilnic cu 10
mg simvastatină şi medicaţia antihipertensivă necesară,
pe o perioadă de monitorizare de 6 luni.
Rezultate şi discuţii: Comparativ cu valorile
bazale, valorile fracţiunii colesterolului cu densitate
joasă au scăzut semnificativ (33%), în timp ce
trigliceridele au scăzut uşor (7%). 27,27% dintre
pacienţi au semnalat reacţii adverse: sindrom digestiv
dispeptic (12,12%); citoliză reversibilă (7,58 %);
creşterea creatinfosfokinazei (4,55%); mialgii pasagere
(3,03%). Discontinuitatea tratamentului a fost necesară
în 4 cazuri (6,15%), în condiţţile interacţiunii
simvastatinei cu fibraţii, amiodarona şi macrolidele.
Concluzii: Rezultatele acestui studiu evidenţiază
eficienţa şi tolerabilitatea bună a dozei zilnice de 10 mg
simvastatină la pacienţii vârstnici cu tratamente asociate.
Cuvinte cheie: simvastatină, efecte secundare,
patienţi geriatrici..
Introduction
On the basis of clinical and experimental works it
is widely accepted that simvastatin, a 3-hydroxy-3methyl-glutaryl
coenzyme A (HMG-CoA)reductase
inhibitor has high efficacy and safety in
elderly patients (1). Age-related changes in
pharmacokinetics and pharmacodynamics require
reduced doses of simvastatin in elderly (2).
The purpose of our prospective and open-label
study was to evaluate the safety profile of lowdose
simvastatin therapy in hypertensive and
hypercholesterolemic elderly
Material and Methods
Elderly patients, (mean age 71 years) (n = 65)
Abstract. Objective: To evaluate the safety
profile of low-dose simvastatin therapy in hypertensive
and hypercholesterolemic elderly patients in a
prospective and open-label study.
Material and Methods: Elderly patients (n = 65)
were randomized to receive 10 mg simvastatin daily
with concurrent antihypertensive drug therapy during a 6
month follow-up period.
Results and Discussion: Comparing to baseline,
low-density lipoprotein levels decreased significantly
(33%), whereas triglyceride level decreased slightly
(7%). 27.27% of patients reported drug-related adverse
effects: gastrointestinal complaints (12.12%); reversible
cytolisis (7.58%); increase in creatinephosphokinase
(4.55%); transitory muscle pain (3.03%).
Discontinuation of therapy was necessary in 4 cases
(6.15%) when simvastatin therapy interracted with
fibrates, amiodarone or macrolides.
Conclusion: The results of this study reveal that a
low dose of 10 mg simvastatin daily is effective, safe
and well tolerated in elderly patients with concurrent
drug therapy.
Keywords: simvastatin, side-effects, elderly
patients.
were randomized to receive 10 mg simvastatin
daily with concurrent antihypertensive drug
therapy during a 6 month follow-up period.
Biochemical laboratory tests were comparatively
evaluated at baseline and at the end of the therapy:
low-density lipoprotein, triglycerides, aspartate
aminotransferase, alanine aminotransferase and
creatine phosphokinase. Possibly drug-related
adverse effects during the therapy period were
reported.
Results and Discussions
Baseline characteristics of study population are
presented in table 1:
Comparing to baseline, after 6 month of
1 Department of Pharmacology, “Victor Babes” University of Medicine and Pharmacy, Timisoara, Romania, 2
Emergency Clinical County Hospital, Timisoara, Romania, 3 Family Healthcare Unit, Timisoara, Romania, 4 ”Smart Lab
Diagnostics” Timisoara, Romania
17