Systematic review of genuine versus spurious side-effects of beta-blockers in heart failure using placebo control: Recommendations for patient information

被引:78
作者
Barron, Anthony J. [1 ,2 ]
Zaman, Nabeela [2 ]
Cole, Graham D. [1 ,3 ]
Wensel, Roland [4 ]
Okonko, Darlington O. [1 ,2 ]
Francis, Darrel P. [1 ,2 ]
机构
[1] Univ London Imperial Coll Sci Technol & Med, Natl Heart & Lung Inst, London W2 1LA, England
[2] Imperial Coll Healthcare NHS Trust, St Marys Hosp, London, England
[3] Imperial Coll Healthcare NHS Trust, Hammersmith Hosp, London, England
[4] West Hertfordshire Hosp NHS Trust, Watford Gen Hosp, London, England
关键词
Beta-blockers; Heart failure; Side-effects; LEFT-VENTRICULAR DYSFUNCTION; RANDOMIZED-TRIAL; DOUBLE-BLIND; CARVEDILOL; NEBIVOLOL; SURVIVAL; THERAPY;
D O I
10.1016/j.ijcard.2013.05.068
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background: Patients trying life-preserving agents such as beta-blockers may be discouraged by listings of harmful effects provided in good faith by doctors, drug information sheets, and media. We systematically review the world experience of side-effect information in blinded, placebo-controlled beta-blockade in heart failure. We present information for a physician advising a patient experiencing an unwanted symptom and suspecting the drug. Methods: We searched Medline for double-blinded randomized trials of beta-blocker versus placebo in heart failure reporting side-effects. We calculated, per 100 patients reporting the symptom on beta-blockade, how many would have experienced it on placebo: the "proportion of symptoms non-pharmacological". Results: 28 of the 33 classically-described side-effects are not significantly more common on beta-blockers than placebo. Of the 100 patients developing dizziness on beta-blockers, 81 (95% CI 73-89) would have developed it on placebo. For diarrhoea this proportion is 82/100 (70-95), and hyperglycaemia 83/100 (68-98). For only two side-effects is this under half (i.e. predominantly due to beta-blocker): bradycardia (33/100, CI 21-44) and intermittent claudication (41/100, 2-81). At least 6 so-called side-effects are less common on beta-blocker than placebo, including depression (reduced by 35%, p < 0.01) and insomnia (by 27%, p - 0.01). Conclusions: Clinicians might reconsider whether it is scientifically and ethically correct to warn a patient that a drug might cause them a certain side-effect, when randomized controlled trials show no significant increase, or indeed a significant reduction. A better informed consultation could, in patients taking beta-blockers, alleviate suffering. In patients who might otherwise not take the drug, it might prevent deaths. (C) 2013 The Authors. Published by Elsevier Ireland Ltd. All rights reserved.
引用
收藏
页码:3572 / 3579
页数:8
相关论文
共 25 条
  • [1] Lack of Improvement in Outpatient Management of Congestive Heart Failure in the United States
    Banerjee, Dipanjan
    Stafford, Randall S.
    [J]. ARCHIVES OF INTERNAL MEDICINE, 2010, 170 (15) : 1399 - 1400
  • [2] Nonspecific medication side effects and the nocebo phenomenon
    Barsky, AJ
    Saintfort, R
    Rogers, MP
    Borus, JF
    [J]. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2002, 287 (05): : 622 - 627
  • [3] Carvedilol produces dose-related improvements in left ventricular function and survival in subjects with chronic heart failure
    Bristow, MR
    Gilbert, EM
    Abraham, WT
    Adams, KF
    Fowler, MB
    Hershberger, RE
    Kubo, SH
    Narahara, KA
    Ingersoll, H
    Krueger, S
    Young, S
    Shusterman, N
    [J]. CIRCULATION, 1996, 94 (11) : 2807 - 2816
  • [4] The national heart failure audit for England and Wales 2008-2009
    Cleland, John G. F.
    McDonagh, Theresa
    Rigby, Alan S.
    Yassin, Ashraf
    Whittaker, Tracy
    Dargie, Henry J.
    [J]. HEART, 2011, 97 (11) : 876 - 886
  • [5] Carvedilol inhibits clinical progression in patients with mild symptoms of heart failure
    Colucci, WS
    Packer, M
    Bristow, MR
    Gilbert, EM
    Cohn, JN
    Fowler, MB
    Krueger, SK
    Hershberger, R
    Uretsky, BF
    Bowers, JA
    SacknerBernstein, JD
    Young, ST
    Holcslaw, TL
    Lukas, MA
    [J]. CIRCULATION, 1996, 94 (11) : 2800 - 2806
  • [6] Effect of carvedilol on outcome after myocardial infarction in patients with left-ventricular dysfunction: the CAPRICORN randomised trial
    Dargie, HJ
    Colucci, Y
    Ford, I
    Sendon, JLL
    Remme, W
    Sharpe, N
    Blank, A
    Holcslaw, TL
    [J]. LANCET, 2001, 357 (9266) : 1385 - 1390
  • [7] Doyal L, 2001, QUAL HEALTH CARE, V10, pI29
  • [8] Eichhorn E, 2001, NEW ENGL J MED, V344, P1659
  • [9] Trading on illusions: Unrealistic perceptions of control and trading performance
    Fenton-O'Creevy, M
    Nicholson, N
    Soane, E
    Willman, P
    [J]. JOURNAL OF OCCUPATIONAL AND ORGANIZATIONAL PSYCHOLOGY, 2003, 76 : 53 - 68
  • [10] FASTTRACK Randomized trial to determine the effect of nebivolol on mortality and cardiovascular hospital admission in elderly patients with heart failure (SENIORS)
    Flather, MD
    Shibata, MC
    Coats, AJS
    Van Veldhuisen, DJ
    Parkhomenko, A
    Borbola, J
    Cohen-Solal, A
    Dumitrascu, D
    Ferrari, R
    Lechat, P
    Soler-Soler, J
    Tavazzi, L
    Spinarova, L
    Toman, J
    Böhm, M
    Anker, SD
    Thompson, SG
    Poole-Wilson, PA
    [J]. EUROPEAN HEART JOURNAL, 2005, 26 (03) : 215 - 225