Efficacy and safety outcomes of one generic nifedipine versus ADALAT long-acting nifedipine for hypertension management.
efficacy
generic drugs
hypertension
nifedipine
safety
Journal
Journal of clinical hypertension (Greenwich, Conn.)
ISSN: 1751-7176
Titre abrégé: J Clin Hypertens (Greenwich)
Pays: United States
ID NLM: 100888554
Informations de publication
Date de publication:
12 2020
12 2020
Historique:
received:
08
06
2020
revised:
14
09
2020
accepted:
15
09
2020
pubmed:
10
10
2020
medline:
29
5
2021
entrez:
9
10
2020
Statut:
ppublish
Résumé
Data regarding the long-term outcomes of generic antihypertensive drugs are limited. This nationwide retrospective database analysis aimed to evaluate the efficacy and safety of a generic versus brand-name nifedipine for hypertension treatment. Patients who were prescribed generic or brand-name nifedipine between January 1, 2008, and December 31, 2013, were identified from the National Health Insurance Research Database of Taiwan. The efficacy outcomes included all-cause mortality and the composite cardiovascular (CV) outcome, including CV death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization, and hospitalization for heart failure. Safety outcomes included headache, peripheral edema, constipation, acute kidney injury, hypotension, syncope, new diagnosis of cancer, and cancer death. Among the 98 335 patients who were eligible for analysis, 21 087 (21.4%) were prescribed generic nifedipine. Both the generic and the brand-name groups included 21 087 patients after propensity score matching. At a mean follow-up of 4.1 years, the generic nifedipine was comparable to the brand-name drug with regard to all-cause mortality (7.2% vs. 7.1%; hazard ratio [HR] 1.02, 95% confidence interval [CI] 0.95-1.09) and the composite CV outcomes (11.6% vs. 11.9%; HR 0.97; 95% CI 0.92-1.03). The generic nifedipine was associated with higher rates of headache, peripheral edema, and constipation but a modest reduction in the risk of newly diagnosed cancer (7.1% vs. 7.8%; subdistribution HR 0.90, 95% CI 0.84-0.97). The risks of acute kidney injury, hypotension, syncope, and cancer death were not significantly different between the two groups. In conclusion, the generic nifedipine was comparable to the brand-name drug with regard to the risks of all-cause mortality and the composite CV outcome. The finding of cancer risk could be chance and should be interpreted with caution.
Identifiants
pubmed: 33035392
doi: 10.1111/jch.14070
pmc: PMC8029800
doi:
Substances chimiques
Drugs, Generic
0
Nifedipine
I9ZF7L6G2L
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
2296-2305Informations de copyright
© 2020 Wiley Periodicals LLC.
Références
Pharmacoepidemiol Drug Saf. 2011 Mar;20(3):236-42
pubmed: 21351304
Cardiovasc Drugs Ther. 2006 Feb;20(1):45-54
pubmed: 16552473
Clin Epidemiol. 2019 May 03;11:349-358
pubmed: 31118821
JAMA. 2008 Dec 3;300(21):2514-26
pubmed: 19050195
Int J Cardiol. 2015 Dec 15;201:96-101
pubmed: 26292275
PLoS One. 2014 Dec 02;9(12):e112257
pubmed: 25464005
Lancet Oncol. 2010 Jul;11(7):627-36
pubmed: 20542468
Lancet. 2015 Feb 28;385(9970):825-7
pubmed: 25752181
Lancet. 2012 Dec 15;380(9859):2224-60
pubmed: 23245609
Eur J Pharm Biopharm. 2009 Nov;73(3):311-23
pubmed: 19602438
Eur J Epidemiol. 2016 Apr;31(4):351-68
pubmed: 26620809
J Am Soc Hypertens. 2010 Mar-Apr;4(2):90-8
pubmed: 20400053
J Formos Med Assoc. 2015 Mar;114(3):254-9
pubmed: 24140108
Cancer. 1999 Mar 15;85(6):1369-74
pubmed: 10189144
Obstet Gynecol. 2010 Nov;116(5):1018-9
pubmed: 20966682
Lancet Oncol. 2011 Jan;12(1):65-82
pubmed: 21123111
PLoS Med. 2019 Mar 13;16(3):e1002763
pubmed: 30865626
Lancet. 1996 Aug 24;348(9026):493-7
pubmed: 8757150
Stat Med. 2019 Feb 28;38(5):751-777
pubmed: 30347461
PLoS One. 2014 Dec 01;9(12):e113649
pubmed: 25436889
Lancet. 2005 Jan 15-21;365(9455):217-23
pubmed: 15652604
J Am Coll Cardiol. 2018 Mar 6;71(9):1021-1034
pubmed: 29495982
Lancet. 2015 Dec 5;386(10010):2287-323
pubmed: 26364544
BMJ. 2018 Oct 24;363:k4209
pubmed: 30355745
Am J Med. 2000 Feb 15;108(3):210-5
pubmed: 10723975
JAMA. 2012 Nov 14;308(18):1906-14
pubmed: 23162861
BMJ. 2009 May 19;338:b1665
pubmed: 19454737
Curr Med Res Opin. 2006 Oct;22(10):1879-92
pubmed: 17022845
J Clin Hypertens (Greenwich). 2020 Dec;22(12):2296-2305
pubmed: 33035392
Am Health Drug Benefits. 2012 Nov;5(7):423
pubmed: 24991338
Lancet. 2014 Aug 16;384(9943):591-598
pubmed: 25131978
Lancet. 2000 Jul 29;356(9227):366-72
pubmed: 10972368
Eur J Clin Invest. 2014 Oct;44(10):933-9
pubmed: 25132063
Hypertension. 2003 Mar;41(3):431-6
pubmed: 12623939
Lancet. 2008 May 3;371(9623):1513-8
pubmed: 18456100
Circ Cardiovasc Qual Outcomes. 2017 Oct;10(10):
pubmed: 28974512