PMID- 19132804
OWN - NLM
STAT- MEDLINE
DCOM- 20090407
LR  - 20211020
IS  - 0114-5916 (Print)
IS  - 0114-5916 (Linking)
VI  - 32
IP  - 1
DP  - 2009
TI  - Use and risk management of carvedilol for the treatment of heart failure in the 
      community in England: results from a modified prescription-event monitoring 
      study.
PG  - 43-54
LID - 10.2165/00002018-200932010-00004 [doi]
AB  - BACKGROUND: In the UK, the licence for carvedilol was extended in 1998 to include 
      symptomatic heart failure (New York Heart Association [NYHA] class II and III 
      heart failure) with the recommendation that initiation and up-titration should be 
      under the supervision of a hospital physician. A post-marketing surveillance 
      study was conducted to address the UK regulatory authority's request for 
      monitoring the use and safety of carvedilol prescribed for heart failure in 
      clinical practice. AIM: To investigate adherence to risk management 
      recommendations for the use of carvedilol for heart failure, monitor how 
      patients' subsequent care was managed and collect event data to evaluate the 
      safety profile of carvedilol used for the treatment of heart failure. METHODS: An 
      observational cohort study using a modified prescription-event monitoring 
      technique identified patients from dispensed primary care prescriptions in 
      England (August 1999 to June 2001). An eligibility questionnaire was used to 
      identify patients who had been prescribed carvedilol for heart failure for the 
      first time after 31 July 1999. Up to three follow-up questionnaires were sent to 
      the prescribers of eligible patients, requesting demographic information, dosage, 
      supervision of treatment, status of cardiac failure and event information. 
      RESULTS: 2311 patients met the eligibility criteria. For 1666 patients, one or 
      more valid follow-up questionnaires were returned: 68.5% were male; male median 
      age 66 years; female median age 72 years; the observation period was up to 3 
      years. Hospital physicians supervised initiation of treatment and first 
      up-titration in 85.6% and 61.4% of patients, respectively. 49.2% of patients were 
      prescribed the recommended starting dosage of carvedilol (6.25 mg/day). 
      Approximately 25% of patients started on a lower dose than recommended, and the 
      same proportion were prescribed a higher dose. NYHA status of cardiac failure 
      between starting treatment and the third questionnaire improved for 39.5% of 
      patients, deteriorated for 10.9%, and 11.7% of those for whom NYHA status was 
      given died. Adverse drug reactions (ADRs) were reported for 2.4% of patients; the 
      most commonly reported ADR was malaise/lassitude. Overall, 27.1% of patients 
      stopped taking carvedilol. None of the 163 deaths were attributed to carvedilol. 
      CONCLUSIONS: Regulatory guidelines for the use and risk management of carvedilol 
      in heart failure were mostly followed, and most patients appeared to benefit from 
      treatment with carvedilol for heart failure. Malaise/lassitude was the main 
      reason for discontinuing treatment. Further investigations may be warranted to 
      examine the prescribing of carvedilol at lower than recommended doses.
FAU - Aurich-Barrera, Beate
AU  - Aurich-Barrera B
AD  - Drug Safety Research Unit, Bursledon Hall, Southampton, UK.
FAU - Wilton, Lynda V
AU  - Wilton LV
FAU - Shakir, Saad A W
AU  - Shakir SA
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - New Zealand
TA  - Drug Saf
JT  - Drug safety
JID - 9002928
RN  - 0 (Adrenergic beta-Antagonists)
RN  - 0 (Carbazoles)
RN  - 0 (Propanolamines)
RN  - 0K47UL67F2 (Carvedilol)
SB  - IM
MH  - Adrenergic beta-Antagonists/administration & dosage/*adverse effects/therapeutic 
      use
MH  - Aged
MH  - Aged, 80 and over
MH  - Carbazoles/administration & dosage/*adverse effects/therapeutic use
MH  - Carvedilol
MH  - Cohort Studies
MH  - Dose-Response Relationship, Drug
MH  - England/epidemiology
MH  - Fatigue/chemically induced
MH  - Female
MH  - Follow-Up Studies
MH  - Guideline Adherence
MH  - Heart Failure/*drug therapy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - *Practice Guidelines as Topic
MH  - Practice Patterns, Physicians'/standards
MH  - Product Surveillance, Postmarketing
MH  - Propanolamines/administration & dosage/*adverse effects/therapeutic use
MH  - Risk Management/methods
MH  - Surveys and Questionnaires
EDAT- 2009/01/10 09:00
MHDA- 2009/04/08 09:00
CRDT- 2009/01/10 09:00
PHST- 2009/01/10 09:00 [entrez]
PHST- 2009/01/10 09:00 [pubmed]
PHST- 2009/04/08 09:00 [medline]
AID - 4 [pii]
AID - 10.2165/00002018-200932010-00004 [doi]
PST - ppublish
SO  - Drug Saf. 2009;32(1):43-54. doi: 10.2165/00002018-200932010-00004.