Detail
Článek
Článek online
FT
Medvik - BMČ
  • Je něco špatně v tomto záznamu ?

Drug tolerability: How much ambiguity can be tolerated? A systematic review of the assessment of tolerability in clinical studies

V. Stanulović, M. Hodolic, DD. Mitsikostas, D. Papadopoulos

. 2022 ; 88 (2) : 551-565. [pub] 20210831

Jazyk angličtina Země Velká Británie

Typ dokumentu časopisecké články, systematický přehled

Perzistentní odkaz   https://www.medvik.cz/link/bmc22019402

AIMS: Drug tolerability refers to the degree to which drugs' overt adverse effects can be tolerated by patients. The tolerability profile is of comparative importance to its efficacy and safety, as it largely determines adherence to treatment and ultimately treatment success or failure. However, the term is frequently used imprecisely, and it is unclear if tolerability is limited to subjective patient-reported symptoms or also covers certain objective signs and findings. The aim of this systematic review was to assess how clinical studies define, evaluate and present drug tolerability. METHODS: The study consisted of a systematic review of clinical studies in PubMed® reporting the term "tolerability". RESULTS: Eighty clinical studies were screened and 56 studies reporting drug tolerability were retained. None of the retained studies defined events encompassed by the term tolerability by making a distinction between safety and tolerability. Twenty-five studies claimed to evaluate tolerability, but none of them described how to evaluate tolerability from the patient perspective. Most studies (54 out of 56) concluded that the treatment was well tolerated, apparently implying favourable safety. However, none of them actually presented tolerability in terms of a contrast between safety and tolerability. CONCLUSIONS: Tolerability is used frequently, albeit incorrectly, to refer to a drug's favourable safety profile. Focused evaluation of drug tolerability (i.e., the patient perspective of adverse drug reactions) should become routine. Presentation in regulatory documents, such as risk management plan summaries, product information and patient leaflets should be a continuation of the process of patient-centred healthcare.

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc22019402
003      
CZ-PrNML
005      
20220804135624.0
007      
ta
008      
220720s2022 xxk f 000 0|eng||
009      
AR
024    7_
$a 10.1111/bcp.15016 $2 doi
035    __
$a (PubMed)34342031
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a xxk
100    1_
$a Stanulović, Vid $u Global Pharmacovigilance, R&D Sanofi, Chilly-Mazarin, France $1 https://orcid.org/0000000170854632
245    10
$a Drug tolerability: How much ambiguity can be tolerated? A systematic review of the assessment of tolerability in clinical studies / $c V. Stanulović, M. Hodolic, DD. Mitsikostas, D. Papadopoulos
520    9_
$a AIMS: Drug tolerability refers to the degree to which drugs' overt adverse effects can be tolerated by patients. The tolerability profile is of comparative importance to its efficacy and safety, as it largely determines adherence to treatment and ultimately treatment success or failure. However, the term is frequently used imprecisely, and it is unclear if tolerability is limited to subjective patient-reported symptoms or also covers certain objective signs and findings. The aim of this systematic review was to assess how clinical studies define, evaluate and present drug tolerability. METHODS: The study consisted of a systematic review of clinical studies in PubMed® reporting the term "tolerability". RESULTS: Eighty clinical studies were screened and 56 studies reporting drug tolerability were retained. None of the retained studies defined events encompassed by the term tolerability by making a distinction between safety and tolerability. Twenty-five studies claimed to evaluate tolerability, but none of them described how to evaluate tolerability from the patient perspective. Most studies (54 out of 56) concluded that the treatment was well tolerated, apparently implying favourable safety. However, none of them actually presented tolerability in terms of a contrast between safety and tolerability. CONCLUSIONS: Tolerability is used frequently, albeit incorrectly, to refer to a drug's favourable safety profile. Focused evaluation of drug tolerability (i.e., the patient perspective of adverse drug reactions) should become routine. Presentation in regulatory documents, such as risk management plan summaries, product information and patient leaflets should be a continuation of the process of patient-centred healthcare.
650    12
$a nežádoucí účinky léčiv $x epidemiologie $7 D064420
650    _2
$a lidé $7 D006801
650    _2
$a výsledek terapie $7 D016896
655    _2
$a časopisecké články $7 D016428
655    _2
$a systematický přehled $7 D000078182
700    1_
$a Hodolic, Marina $u Nuclear Medicine Research Department, IASON, Graz, Austria $u Department of Nuclear Medicine, Faculty of Medicine and Dentistry, Palacký University, Olomouc, Czech Republic
700    1_
$a Mitsikostas, Dimos D $u 1st Neurology Department, Aeginition Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece
700    1_
$a Papadopoulos, Dimitrios $u School of Medicine, European University Cyprus, Athens, Greece
773    0_
$w MED00000858 $t British journal of clinical pharmacology $x 1365-2125 $g Roč. 88, č. 2 (2022), s. 551-565
856    41
$u https://pubmed.ncbi.nlm.nih.gov/34342031 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y p $z 0
990    __
$a 20220720 $b ABA008
991    __
$a 20220804135618 $b ABA008
999    __
$a ok $b bmc $g 1822830 $s 1170645
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2022 $b 88 $c 2 $d 551-565 $e 20210831 $i 1365-2125 $m British journal of clinical pharmacology $n Br J Clin Pharmacol $x MED00000858
LZP    __
$a Pubmed-20220720

Najít záznam

Citační ukazatele

Možnosti archivace