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Therapeutic class-specific signal detection of bradycardia associated with propranolol hydrochloride.

Gavali DK, Kulkarni KS, Kumar A, Chakraborty BS - Indian J Pharmacol (2009)

Bottom Line: Calculated statistics by different methods were compared with the regulatory criteria of a statistic value >/=4.0 for chi(2), and >/=3.0 for the rest for SD to be declared significant.The therapeutic class specific signal of bradycardia associated with propranolol hydrochloride was not found potent enough to cause bradycardia.However, since the calculated statistics were very high albeit not significant, the possibility of bradycardia-propranolol pairing should still be analyzed from larger databases.

View Article: PubMed Central - PubMed

Affiliation: Department of Pharmacology, SPTM Shirpur Campus SVKM's NMIMS University, Mumbai, India.

ABSTRACT

Background: Propranolol hydrochloride, one of the most widely used beta-blocker in the treatment of hypertension since 1960s, shows a number of serious and non-serious adverse events.

Objective: Major objectives of this study were to extract the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) database for possible toxic signal detection (SD) of propranolol hydrochloride, evaluate the frequency of the bradycardia associated with it in different stratified groups for a putative signal, and generate awareness in healthcare professionals regarding usefulness of SD.

Materials and methods: Appropriate statistical methods were used for adverse drug reaction (ADR) signal detection such as, proportional reporting ratio (PRR); reporting odds ratio (ROR); the Chi-square (chi(2)) statistic method; the 95% confidence interval (CI); the observed to expected ratio (O/E); and Du Mouchel method were used to calculate the possible signals. Significance of chi(2) and other calculated statistics, e.g., PRR and ROR, was based on a composite criterion of regulatory guidelines and not on any particular statistical level of significance.

Results: Calculated statistics by different methods were compared with the regulatory criteria of a statistic value >/=4.0 for chi(2), and >/=3.0 for the rest for SD to be declared significant. The PRR statistic was found to be 2.5054; by the ROR method it was 2.5820; the chi(2) statistic was 3.2598, whereas the lower and upper limits of 95% CI of PRR were found to be 0.0778 and 1.9104, respectively, by the O/E ratio was found to be 2.3978, and PRR with the help of Du Mouchel was found to be 2.3979. Thus, the bradycardia-propranolol signals calculated in this study were not significant.

Conclusions: The therapeutic class specific signal of bradycardia associated with propranolol hydrochloride was not found potent enough to cause bradycardia. However, since the calculated statistics were very high albeit not significant, the possibility of bradycardia-propranolol pairing should still be analyzed from larger databases.

No MeSH data available.


Related in: MedlinePlus

Procedure followed for Signal Detection by statistical and quantitative methods. The sub-database created here for computing a signal consists of only Iindividual case safety Reports reported for particular therapeutic class of anti-hypertensive drugs. While calculating an actual signal, duplicate reports were eliminated
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Figure 0001: Procedure followed for Signal Detection by statistical and quantitative methods. The sub-database created here for computing a signal consists of only Iindividual case safety Reports reported for particular therapeutic class of anti-hypertensive drugs. While calculating an actual signal, duplicate reports were eliminated

Mentions: The CADRMP is the vigilance program database of Health Canada. The Individual Case Safety Reports (ICSRs) in this database were collected by forwarding a request to health Canada, and the remaining ICSRs were collected from the official website of health Canada. The free text collected from the CADRMP was converted into a structured format, and finally statistical methods were applied to calculate an actual measure of signals. Therapeutic class-specific SD calculations were then carried out as shown in Figure 1.


Therapeutic class-specific signal detection of bradycardia associated with propranolol hydrochloride.

Gavali DK, Kulkarni KS, Kumar A, Chakraborty BS - Indian J Pharmacol (2009)

Procedure followed for Signal Detection by statistical and quantitative methods. The sub-database created here for computing a signal consists of only Iindividual case safety Reports reported for particular therapeutic class of anti-hypertensive drugs. While calculating an actual signal, duplicate reports were eliminated
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2875734&req=5

Figure 0001: Procedure followed for Signal Detection by statistical and quantitative methods. The sub-database created here for computing a signal consists of only Iindividual case safety Reports reported for particular therapeutic class of anti-hypertensive drugs. While calculating an actual signal, duplicate reports were eliminated
Mentions: The CADRMP is the vigilance program database of Health Canada. The Individual Case Safety Reports (ICSRs) in this database were collected by forwarding a request to health Canada, and the remaining ICSRs were collected from the official website of health Canada. The free text collected from the CADRMP was converted into a structured format, and finally statistical methods were applied to calculate an actual measure of signals. Therapeutic class-specific SD calculations were then carried out as shown in Figure 1.

Bottom Line: Calculated statistics by different methods were compared with the regulatory criteria of a statistic value >/=4.0 for chi(2), and >/=3.0 for the rest for SD to be declared significant.The therapeutic class specific signal of bradycardia associated with propranolol hydrochloride was not found potent enough to cause bradycardia.However, since the calculated statistics were very high albeit not significant, the possibility of bradycardia-propranolol pairing should still be analyzed from larger databases.

View Article: PubMed Central - PubMed

Affiliation: Department of Pharmacology, SPTM Shirpur Campus SVKM's NMIMS University, Mumbai, India.

ABSTRACT

Background: Propranolol hydrochloride, one of the most widely used beta-blocker in the treatment of hypertension since 1960s, shows a number of serious and non-serious adverse events.

Objective: Major objectives of this study were to extract the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) database for possible toxic signal detection (SD) of propranolol hydrochloride, evaluate the frequency of the bradycardia associated with it in different stratified groups for a putative signal, and generate awareness in healthcare professionals regarding usefulness of SD.

Materials and methods: Appropriate statistical methods were used for adverse drug reaction (ADR) signal detection such as, proportional reporting ratio (PRR); reporting odds ratio (ROR); the Chi-square (chi(2)) statistic method; the 95% confidence interval (CI); the observed to expected ratio (O/E); and Du Mouchel method were used to calculate the possible signals. Significance of chi(2) and other calculated statistics, e.g., PRR and ROR, was based on a composite criterion of regulatory guidelines and not on any particular statistical level of significance.

Results: Calculated statistics by different methods were compared with the regulatory criteria of a statistic value >/=4.0 for chi(2), and >/=3.0 for the rest for SD to be declared significant. The PRR statistic was found to be 2.5054; by the ROR method it was 2.5820; the chi(2) statistic was 3.2598, whereas the lower and upper limits of 95% CI of PRR were found to be 0.0778 and 1.9104, respectively, by the O/E ratio was found to be 2.3978, and PRR with the help of Du Mouchel was found to be 2.3979. Thus, the bradycardia-propranolol signals calculated in this study were not significant.

Conclusions: The therapeutic class specific signal of bradycardia associated with propranolol hydrochloride was not found potent enough to cause bradycardia. However, since the calculated statistics were very high albeit not significant, the possibility of bradycardia-propranolol pairing should still be analyzed from larger databases.

No MeSH data available.


Related in: MedlinePlus