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Comparison of the efficacy and tolerability of ivabradine and ranolazine in patients of chronic stable angina pectoris.

Chaturvedi A, Singh Y, Chaturvedi H, Thawani V, Singla S, Parihar D - J Pharmacol Pharmacother (2013)

Bottom Line: The blood pressure, heart rate and routine hematological and biochemical evaluations did not show any significant difference in the pre-post values.IVA significantly decreased the resting heart rate after eight weeks of intervention.However, RAN had a better safety and tolerability profile than IVA.

View Article: PubMed Central - PubMed

Affiliation: Department of Pharmacology, Veer Chandra Singh Garhwali Government Medical Sciences and Research Institute, Srikot, Uttarakhand, India.

ABSTRACT

Introduction: To compare the efficacy and tolerability of Ivabradine (IVA) and Ranolazine (RAN) in chronic angina patients.

Materials and methods: This was a follow-on, open-label trial conducted in a tertiary care hospital of Uttarakhand. Thirty patients each taking IVA 5 mg twice daily or RAN 500 mg twice daily were distributed to the respective groups. Patients were asked to fill a pretested questionnaire on frequency of anginal attacks and adverse reactions before and 2, 4 and 8 weeks after taking the respective medicines. Their blood pressure, heart rate and routine hematological and biochemical estimations were performed at baseline and after intervention. Results were statistically analyzed using different statistical tests, with P < 0.05 considered as significant.

Results: There was no significant difference in the frequency of anginal attacks per week between the groups. The adverse drug reactions (ADRs) reported in the IVA group were dizziness (30%), headache (16.6%), backache (16.6%), vertigo (13.3%), blurred vision (13.3%), muscle cramps (10%), arthralgia (10%), cough and dyspnea (6.6%), hypersensitivity rash (6.6%), fever (3.3%) and nausea (3.3%). The ADRs in the RAN group were nausea (26.6%), dizziness (23.3%), vomiting (3.3%), constipation (3.3%) and vertigo (3.3%). The blood pressure, heart rate and routine hematological and biochemical evaluations did not show any significant difference in the pre-post values. IVA significantly decreased the resting heart rate after eight weeks of intervention.

Conclusions: Both antianginal agents appeared equiactive. However, RAN had a better safety and tolerability profile than IVA. Serum sickness-like reaction was an adverse event noticed with IVA, which needs causality establishment.

No MeSH data available.


Related in: MedlinePlus

Consort flow chart of the efficacy and tolerability of Ivabradine and Ranolazine in patients of chronic stable angina pectoris
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Figure 1: Consort flow chart of the efficacy and tolerability of Ivabradine and Ranolazine in patients of chronic stable angina pectoris

Mentions: This was a follow-on, open-label, non crossover trial conducted from May 2010 to July 2010 in a tertiary care hospital of Uttarakhand, with permission from the institutional ethics committee, as a project under short-term studentship (STS) from the Indian Council of Medical Research (ICMR). Patients of either gender, >18 years and < 60 years of age, diagnosed to be suffering from CSAP, attending the cardiology outpatient department of the hospital, taking IVA or RAN for at least 1 month prior to the enrolment in the trial, were approached and requested to participate in the trial. Those who showed interest in joining and fulfilled the inclusion criteria were supplied with a detailed information sheet and briefed about the possible ADRs with the trial medicines in vernacular language and all their questions concerning the trial were answered. Patients with BP > 170/100 mm, systolic BP < 100 mm, history of chronic diabetes mellitus, rheumatoid arthritis, renal or hepatic impairment, pregnancy, lactation, past history of myocardial infarction, cerebrovascular event, severe bradycardia, moderate to severe heart failure, severe hypotension, second- to third-degree heart block, arrhythmias or anemia (Hb < 7 g/dL) were excluded. From those who agreed to participate, informed, witnessed and written consent was taken. One hundred and twelve patients were assessed for eligibility, 45 were excluded, six refused to participate and one was lost to follow-up in the IVA group [Figure 1]. After seeking review and permission from the attending cardiologist, the 30 patients who were started on IVA 5 mg twice daily (M/s Lupin Laboratories Ltd., Mumbai, India) and an equal number taking RAN 500 mg (M/s Cipla Ltd., Mumbai, India) twice daily were included. Trial medicines of the same batch and date of manufacture from the same manufacturer were procured from the local market and supplied free of cost to the participants during the trial period. Patients were monitored on a weekly basis along with ECG recordings.


Comparison of the efficacy and tolerability of ivabradine and ranolazine in patients of chronic stable angina pectoris.

Chaturvedi A, Singh Y, Chaturvedi H, Thawani V, Singla S, Parihar D - J Pharmacol Pharmacother (2013)

Consort flow chart of the efficacy and tolerability of Ivabradine and Ranolazine in patients of chronic stable angina pectoris
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3643340&req=5

Figure 1: Consort flow chart of the efficacy and tolerability of Ivabradine and Ranolazine in patients of chronic stable angina pectoris
Mentions: This was a follow-on, open-label, non crossover trial conducted from May 2010 to July 2010 in a tertiary care hospital of Uttarakhand, with permission from the institutional ethics committee, as a project under short-term studentship (STS) from the Indian Council of Medical Research (ICMR). Patients of either gender, >18 years and < 60 years of age, diagnosed to be suffering from CSAP, attending the cardiology outpatient department of the hospital, taking IVA or RAN for at least 1 month prior to the enrolment in the trial, were approached and requested to participate in the trial. Those who showed interest in joining and fulfilled the inclusion criteria were supplied with a detailed information sheet and briefed about the possible ADRs with the trial medicines in vernacular language and all their questions concerning the trial were answered. Patients with BP > 170/100 mm, systolic BP < 100 mm, history of chronic diabetes mellitus, rheumatoid arthritis, renal or hepatic impairment, pregnancy, lactation, past history of myocardial infarction, cerebrovascular event, severe bradycardia, moderate to severe heart failure, severe hypotension, second- to third-degree heart block, arrhythmias or anemia (Hb < 7 g/dL) were excluded. From those who agreed to participate, informed, witnessed and written consent was taken. One hundred and twelve patients were assessed for eligibility, 45 were excluded, six refused to participate and one was lost to follow-up in the IVA group [Figure 1]. After seeking review and permission from the attending cardiologist, the 30 patients who were started on IVA 5 mg twice daily (M/s Lupin Laboratories Ltd., Mumbai, India) and an equal number taking RAN 500 mg (M/s Cipla Ltd., Mumbai, India) twice daily were included. Trial medicines of the same batch and date of manufacture from the same manufacturer were procured from the local market and supplied free of cost to the participants during the trial period. Patients were monitored on a weekly basis along with ECG recordings.

Bottom Line: The blood pressure, heart rate and routine hematological and biochemical evaluations did not show any significant difference in the pre-post values.IVA significantly decreased the resting heart rate after eight weeks of intervention.However, RAN had a better safety and tolerability profile than IVA.

View Article: PubMed Central - PubMed

Affiliation: Department of Pharmacology, Veer Chandra Singh Garhwali Government Medical Sciences and Research Institute, Srikot, Uttarakhand, India.

ABSTRACT

Introduction: To compare the efficacy and tolerability of Ivabradine (IVA) and Ranolazine (RAN) in chronic angina patients.

Materials and methods: This was a follow-on, open-label trial conducted in a tertiary care hospital of Uttarakhand. Thirty patients each taking IVA 5 mg twice daily or RAN 500 mg twice daily were distributed to the respective groups. Patients were asked to fill a pretested questionnaire on frequency of anginal attacks and adverse reactions before and 2, 4 and 8 weeks after taking the respective medicines. Their blood pressure, heart rate and routine hematological and biochemical estimations were performed at baseline and after intervention. Results were statistically analyzed using different statistical tests, with P < 0.05 considered as significant.

Results: There was no significant difference in the frequency of anginal attacks per week between the groups. The adverse drug reactions (ADRs) reported in the IVA group were dizziness (30%), headache (16.6%), backache (16.6%), vertigo (13.3%), blurred vision (13.3%), muscle cramps (10%), arthralgia (10%), cough and dyspnea (6.6%), hypersensitivity rash (6.6%), fever (3.3%) and nausea (3.3%). The ADRs in the RAN group were nausea (26.6%), dizziness (23.3%), vomiting (3.3%), constipation (3.3%) and vertigo (3.3%). The blood pressure, heart rate and routine hematological and biochemical evaluations did not show any significant difference in the pre-post values. IVA significantly decreased the resting heart rate after eight weeks of intervention.

Conclusions: Both antianginal agents appeared equiactive. However, RAN had a better safety and tolerability profile than IVA. Serum sickness-like reaction was an adverse event noticed with IVA, which needs causality establishment.

No MeSH data available.


Related in: MedlinePlus