A comparative study of lappaconitine hydrobromide extended release and propafenone in patients with paroxysmal atrial fibrillation

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Abstract

A new dosage form of lappaconitine hydrobromide has been created – the long-acting drug Allaforte®, which has fewer side effects compared to the traditional dosage form (Allapinin®).

Objective. To evaluate the effectiveness, safety and tolerability of Allaforte® therapy in comparison with the drug Rytmonorm® in patients with paroxysmal atrial fibrillation (AF).

Material and methods. Patients who met the inclusion criteria and those who did not meet the non-inclusion criteria were randomized into 2 groups: 1st (n=50) – patients received Allaforte® 25 mg 3 times a day with an increase in dose to 50 mg 2 times a day when detected attack of AF; 2nd (n=50) – patients received Rytmonorm® 150 mg 3 times a day with an increase in dose to 300 mg 2 times a day if an attack of AF was detected.

Results. The average time from the first dose of the drug to the development of AF paroxysm in the 1st group (Allaforte®) was 98.877±6.022 days, in the 2nd group (Rytmonorm®) – 98.808±5.876 days, the average time from the first dose of the drug to the completion of the study – 105.740±5.032 and 103.732±5.353 days, respectively. The drugs Allaforte® and Rytmonorm® equally improved the quality of life of patients. A comparative analysis in groups according to the severity of adverse events and their cause-and-effect relationship with the drug did not show significant differences.

Conclusion. The study drugs showed comparable effectiveness in preventing attacks of AF with similar safety and tolerability.

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About the authors

A. Revishvili

National Medical Research Center of Surgery named after A.Vishnevsky, Ministry of Health of Russia

Author for correspondence.
Email: kanorskysg@mail.ru

Professor, Academician of the Russian Academy of Sciences, MD

Russian Federation, Moscow

S. Golitsyn

National Medical Research Centre of cardiology named after Academician E.I. Chazov, Ministry of Health of Russia

Email: kanorskysg@mail.ru

Professor, MD

Russian Federation, Moscow

S. Aksentiev

Regional Clinical Hospital

Email: kanorskysg@mail.ru

Candidate of Medical Sciences

Russian Federation, Ryazan

A. Amiraslanov

National Medical Research Center of Surgery named after A.Vishnevsky, Ministry of Health of Russia

Email: kanorskysg@mail.ru
Russian Federation, Moscow

E. Artyukhina

National Medical Research Center of Surgery named after A.Vishnevsky, Ministry of Health of Russia

Email: kanorskysg@mail.ru

MD

Russian Federation, Moscow

D. Duplyakov

V.P. Polyakov Samara Region Clinical Cardiological Dispensary

Email: kanorskysg@mail.ru

Professor, MD

Russian Federation

E. Zubov

LLC «Professor's Clinic»

Email: kanorskysg@mail.ru

Candidate of Medical Sciences

Russian Federation, Perm

E. Isaeva

Interregional Clinical Diagnostic Center

Email: kanorskysg@mail.ru

Candidate of Medical Sciences

Russian Federation, Kazan

A. Loginova

National Medical Research Centre of cardiology named after Academician E.I. Chazov, Ministry of Health of Russia

Email: kanorskysg@mail.ru
Russian Federation, Moscow

T. Malkina

National Medical Research Centre of cardiology named after Academician E.I. Chazov, Ministry of Health of Russia

Email: kanorskysg@mail.ru

Candidate of Medical Sciences

Russian Federation, Moscow

G. Miloserdov

Regional Clinical Hospital

Email: kanorskysg@mail.ru
Russian Federation, Ryazan

A. Rivin

AntMed LLC

Email: kanorskysg@mail.ru
Russian Federation, Saint Petersburg

S. Teplykh

LLC «Center for Professional Medicine»

Email: kanorskysg@mail.ru
Russian Federation, Perm

I. Tsygankova

Regional Clinical Hospital

Email: kanorskysg@mail.ru
Russian Federation, Ryazan

Yu. Shvarts

Saratov State Medical University named after V.I. Razumovsky

Email: kanorskysg@mail.ru

Professor, MD

Russian Federation

Yu. Yuricheva

National Medical Research Centre of cardiology named after Academician E.I. Chazov, Ministry of Health of Russia

Email: kanorskysg@mail.ru

Candidate of Medical Sciences

Russian Federation, Moscow

S. Kanorsky

Kuban State Medical University, Ministry of Health of Russia

Email: kanorskysg@mail.ru

Professor, MD

Russian Federation, Krasnodar

S. Sokolov

National Medical Research Centre of cardiology named after Academician E.I. Chazov, Ministry of Health of Russia

Email: kanorskysg@mail.ru

Candidate of Medical Sciences

Russian Federation, Moscow

References

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2. Fig 1. Stages of a clinical study. Note. * – single dose of 50 mg of Allaforte® or 300 mg of Rytmonorm® (1/2 of the average daily therapeutic dose); ** – dose increases of the study drug after atrial fibrillation attack; *** – reason for unscheduled visit to the research center: occurrence of adverse drug effects; patient's condition control 7 days after dose increase of Allaforte® or Rytmonorm®.

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3. Fig. 2. Efficacy assessment by time interval from the first drug taking to the development of the first paroxysm of atrial fibrillation

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4. Fig. 3. Efficacy assessment by time interval from the first drug taking to the end of the study

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