Research ArticleClinical Studies
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Anamorelin and Conduction Defects: A Literature Review and Analysis of the Japanese Pharmacovigilance Database

NAOHIRO YABUKI, KEN-ICHI SAKO, TOMOJI MAEDA and NAOHITO IDE
In Vivo January 2025, 39 (1) 404-410; DOI: https://doi.org/10.21873/invivo.13842

Abstract

Background/Aim: Cancer cachexia is characterized by weight loss with a specific decrease in skeletal muscle and adipose tissue. In Japan, anamorelin, which has a novel mechanism of action, was approved in 2021 for the treatment of cancer cachexia. However, little information is available on its safety in routine clinical care, in particular the occurrence of conduction defects as adverse reactions. Therefore, this study evaluated the risk and time to onset of anamorelin-related conduction defects by performing a literature review and evaluating the Japanese pharmacovigilance database. Patients and Methods: We reviewed the literature from April 2000 to June 2024 to identify reports of anamorelin-related conduction defects and analyzed data from April 2004 to December 2023 in the Japanese Adverse Drug Event Report (JADER) database. Using the database, we calculated reporting odds ratios (RORs) with 95% confidence intervals (CIs) and adjusted RORs (95%CIs) by considering whether patients were taking concomitant medications that can cause QT prolongation. In addition, we investigated outcomes and time to onset. Results: The literature review identified seven cases of conduction defects. All cases occurred within approximately three weeks after starting treatment, and all patients recovered. The JADER database contained 537 cases of adverse reactions to anamorelin. The adjusted ROR (95%CI) of conduction defects was 20.00 (14.86-26.91), and the median time to onset was 13 days. Poor clinical outcomes occurred in only a few cases. Conclusion: Performing frequent cardiac electrograms for two to three weeks after starting anamorelin may help to quickly identify anamorelin-related conduction defects.

Key Words:

Cancer cachexia is characterized by weight loss with a specific decrease in skeletal muscle and adipose tissue, which adversely affects patients’ quality of life. It is caused by various combinations of reduced food intake, increased energy expenditure, excessive catabolism, and inflammation (1). Treatment involves a combination of nutrition, exercise, and pharmacotherapy (2). As part of pharmacotherapy, progesterone analogs and short-term administration of corticosteroids (i.e., for up to a couple of months) have been recommended (3).

In Japan, anamorelin was approved in 2021 for the treatment of cancer cachexia (4, 5). Anamorelin has a novel mechanism of action: as a strong and highly specific ghrelin receptor agonist, it induces the secretion of growth hormone and thereby stimulates appetite, leading to weight gain (6). Some information is available on its efficacy and safety from phase II and III studies (7, 8). However, it has not been approved in Europe and the United States because insufficient safety data are available (9). To obtain additional information on the safety of anamorelin in real-world clinical settings, Takayama et al. analyzed data from approximately 6,000 patients and found conduction defects in 1.1% of them (10). Furthermore, Ohta et al. used a Japanese claims database to evaluate adverse effects of anamorelin and found elevation of blood glucose with anamorelin (11). However, although clinical studies have indicated that anamorelin may cause conduction defects, detailed information on these adverse reactions is lacking.

In recent years, various studies have used pharmacovigilance databases to analyze the risk and time to onset of adverse reactions to various drugs (12-14). Therefore, we performed a literature review and used data from the Japanese Adverse Drug Event Report (JADER) database, a database of spontaneous adverse event reports, to evaluate the risk and time to onset of conduction defects induced by anamorelin.

Patients and Methods

Literature review. We used the search term “anamorelin AND arrhythmia” to search for reports on conduction defects caused by anamorelin in PubMed and Google scholar published from April 2000 to June 2024.

Database analysis. We used data from JADER, a spontaneous reporting system published by the Pharmaceuticals and Medical Devices Agency (PMDA) that contains completely anonymized data submitted by healthcare professionals and pharmaceutical companies. The JADER database comprises the following four types of tables: case tables with patient information, such as age, sex, and reporting year; drug information tables with drug names, route of administration, start and end dates of administration, and dosages; adverse event tables with adverse events, clinical outcomes, and onset dates; and patient medical history tables. The drug information tables also rate drug involvement in adverse reactions as suspected, concomitant, or interaction. JADER adverse events are categorized by using the preferred terms (PT) from the Medical Dictionary for Regulatory Activities/Japanese version (MedDRA/J). In this study, we downloaded JADER data from April 2004 to December 2023 (the latest data available at the time of the study) from the PMDA website.

Survey content. In the present study, we included only cases of anamorelin-related conduction defects classified as suspected. Cases of conduction defects were defined by using the narrow Standardized MedDRA Query (SMQ) conduction defects (SMQ code: 20000056, which contains 37 PTs) in MedDRA/J version 27.0. We analyzed patient age and sex, reporting year, drug name, start dates of administration, clinical outcomes, onset dates, and patient medical history.

Disproportionality analysis of JADER data on conduction defects as adverse reactions to anamorelin. The PMDA and the Netherlands Pharmacovigilance Center use the reported odds ratio (ROR) and 95% confidence intervals (CIs) to detect adverse event signals in spontaneous reporting systems and to express disproportionality in adverse event reporting between groups (15). The ROR is a concept similar to the odds ratio in case-control studies and corresponds to the odds of exposure being greater among reported cases than among reported non-cases. We calculated the crude ROR and 95%CI for conduction defects in patients receiving anamorelin and considered a signal of an adverse reaction as positive if the lower limit of the 95%CI was greater than 1. In addition, we calculated the adjusted ROR and 95%CI in a multivariate logistic regression analysis that considered whether or not patients were receiving concomitant medications that can cause QT prolongation (Table I).

View this table:
Table I.

List of QT prolongation drugs.

JADER-based analysis of time to onset of conduction defects. When analyzing the time to onset of conduction defects in the JADER data, we excluded cases in which the start date of anamorelin administration or the onset date of the adverse event was unknown. The time to onset of adverse events for conduction defects was defined as the onset date of the adverse event minus the start date of anamorelin administration, plus 1.

In addition, to evaluate the pattern of adverse event onset we used the Weibull distribution, i.e., Weibull shape parameters (WSPs). WSPs represent the distribution of failure rates with respect to time, with failure rates corresponding to the onset of adverse reactions: WSP α represents the distribution, with larger values of WSP α indicating a wider distribution, and WSP β represents the hazard in the absence of a reference population. If WSP β is greater than 1 and its 95%CI does not include 1, the frequency of adverse events is considered to increase over time; if WSP β is less than 1 and its 95%CI does not include 1, the frequency of adverse events is considered to decrease over time; and if WSP β is equal to 1, the onset of an adverse effect is presumed to be constant over time.

Statistical analyses. All statistical analyses were performed with JMP pro 17.2 (SAS Institute Inc., Cary, NC, USA).

Results

Literature review. Table II shows the cases of conduction defects reported in PubMed or Google scholar from April 2000 to June 2024 identified with the search term “anamorelin AND arrhythmia”. Seven cases were reported, all in women in their 50s to 80s. The time to onset of conduction defects was short, i.e., approximately three weeks or less, except in two cases in which it was longer than two months. All patients recovered.

View this table:
Table II.

Summary of reports of conduction defects suspected to be caused by anamorelin.

Database analysis. In the period from April 2004 to December 2023, JADER contained a total of 903,522 cases of suspected adverse reactions to drugs. Of these, 537 were cases of suspected adverse reactions to anamorelin, and 51 of these adverse reactions were conduction defects (Table III). The characteristics and clinical outcomes of patients with conduction defects as suspected adverse reactions to anamorelin are shown in Table IV. The most common age group (approximately half of the cases) was the 70s, and the most common primary cancer was lung cancer. Clinical outcomes were poor in a comparatively low percentage of cases. Analysis of the reporting years revealed that the number of reports of conduction defects related to anamorelin was highest in the third quarter of 2021 (October-December) and declined thereafter (Figure 1).

View this table:
Table III.

Conduction defects as suspected adverse reactions to anamorelin listed in the Japanese Adverse Drug Event Report database.

View this table:
Table IV.

Characteristics and clinical outcomes of patients with conduction defects as suspected adverse reactions to anamorelin included in the Japanese Adverse Drug Event Report database.

Figure 1.
Figure 1.

Number of cases of conduction defects per quarter reported after approval of anamorelin.

Analysis of disproportionality and time to onset of conduction defects as adverse reactions to anamorelin. The crude ROR (95%CI) of conduction defects related to anamorelin was 16.14 (12.08-21.56), and a positive signal was detected (Figure 2). In the multivariate analysis that considered whether or not patients were taking concomitant medications that can cause QT prolongation, the adjusted ROR (95%CI) was 20.00 (14.86-26.91), which was also a significant signal. The time-to-onset analysis included 48 cases with complete records of the anamorelin start date and the onset date of conduction defects. The median time to onset of suspected anamorelin-associated conduction defects was 13 days (interquartile range=7.3-53.3), and the onset pattern was early failure type (Figure 3).

Figure 2.
Figure 2.

Reporting odds ratios of conduction defects for anamorelin in the Japanese Adverse Drug Event Report pharmacovigilance database. The adjusted reporting odds ratio was calculated by a multivariate logistic regression adjusted for whether or not patients were taking concomitant medications that can cause QT prolongation. CI: Confidence interval; ROR: reporting odds ratio.

Figure 3.
Figure 3.

Histogram (A) and median and Weibull parameters (B) of suspected anamorelin-related conduction defects. CI: Confidence interval; IQR: interquartile range.

Discussion

To our knowledge, this is the first study to use both a literature review and a spontaneous reporting database of adverse events to investigate the risk, time to onset, and outcome of suspected anamorelin-induced conduction defects as adverse reactions.

Leese et al. found no adverse events related to electrocardiogram parameters in a study with a small number of patients (16), but Takayama et al. observed conduction defects in 1.1% of approximately 6,000 anamorelin-treated patients (10). Furthermore, Katakami et al. reported that the more than 5% incidence of first-degree atrioventricular block in the anamorelin-treated group in their study was probably due to frequent electrocardiographic measurements (17). However, the present study detected a risk of anamorelin-induced conduction defects by analyzing data from a spontaneous reporting database of adverse events. A signal was detected for anamorelin-induced conduction defects, even when the adjusted ROR was calculated by considering whether or not patients were taking concomitant medications that can cause QT prolongation. Inoue discusses that Asian populations, particularly those from Japan, have a risk of anamorelin-induced conduction defects due to genetic differences in myocardial sodium channels (18). Thus, genes may influence the risk of anamorelin-induced conduction defects.

In the JADER analyses, QT prolongation accounted for the highest number of cases of anamorelin-associated conduction defects, but there were also three cases of atrioventricular block. The literature review identified no cases of atrioventricular block, but Kojima et al. reported that at their institution, two cases of atrioventricular block occurred in the 32 patients treated with anamorelin (19).

The mechanism of action of anamorelin-related conduction defects is not clear. However, anamorelin has been shown to bind weakly to the L-type calcium channel and sodium channel (6). Atrioventricular block may be related to its binding to L-type calcium channels, as is the case with benzothiazepine and phenylalkylamine. Also, conduction defects due to sodium channel blockade may cause re-entrant arrhythmias because of the expanded excitability gap (20). These effects may explain why anamorelin can cause conduction defects.

Concerning the timing of onset of conduction defects, most cases identified in the literature review occurred within three weeks of starting administration, and the analysis of JADER data also classified the conduction defects as early failure type, with a median value of approximately two weeks. One case showed QRS prolongation 3 h after the first oral administration of anamorelin (19). The median time to the maximum concentration of anamorelin is 0.5 to 1.75 h (16), and it has a relatively rapid onset of activity. Therefore, the pharmacokinetics of anamorelin may play a role in the early onset of conduction defects.

All patients with conduction defects identified in the literature review recovered, and the JADER analysis also showed relatively good outcomes. However, conduction defects such as QT prolongation may lead to fatal ventricular arrhythmias, such as torsade de pointes (21). In fact, two reports mention patients who developed ventricular tachycardia after QT prolongation (19, 22). Thus, physicians prescribing anamorelin should also pay attention to the occurrence of conduction defects such as QT prolongation.

The number of reports of conduction defects caused by anamorelin was highest in the third quarter of 2021 and declined thereafter. The reason for this trend is unknown, but it may be related to changes in the number of prescriptions of anamorelin in Japan; however, at the time of writing this manuscript, the Ministry of Health, Labour, and Welfare has only released data on pharmaceuticals prescribed in Japan through 2022, therefore, we cannot evaluate this issue in more detail.

Study limitations. First, we analyzed ROR and time to onset by using the JADER database, a spontaneous reporting database of adverse reactions. Therefore, as in other studies that used similar methods, it was not possible to calculate the incidence of adverse events or the inaccuracy of the registration data (23). Second, Takayama et al. reported a higher incidence of conduction defects in patients with a history of heart disorders than in those without such a history (10), but the present study did not investigate whether patients had a history of heart disorder. Last, blood levels of anamorelin have been reported to increase in patients with severe hepatic impairment and concomitant use of drugs that inhibit cytochrome P450 3A4 (24). However, the present study was unable to evaluate patients’ hepatic function or concomitant medications.

Conclusion

This study suggests that anamorelin carries a risk of inducing conduction disorders and that such adverse reactions usually occur early on after starting treatment. Performing frequent electrocardiograms for two to three weeks after administration of anamorelin may help to detect anamorelin-induced conduction defects early on.

Footnotes

  • Authors’ Contributions

    NY and NI conceived and designed the study. NY and NI wrote the manuscript. NY, NI, and KS analyzed the data. KS and TM interpreted the results and contributed to the discussion. All Authors read and approved the final manuscript.

  • Funding

    The Authors declare that no funds, grants, or other support were received for this study.

  • Conflicts of Interest

    The Authors have no conflicts of interest to disclose in relation to this study.

  • Received September 12, 2024.
  • Revision received September 25, 2024.
  • Accepted September 26, 2024.

This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY-NC-ND) 4.0 international license (https://creativecommons.org/licenses/by-nc-nd/4.0).

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Anamorelin and Conduction Defects: A Literature Review and Analysis of the Japanese Pharmacovigilance Database
NAOHIRO YABUKI, KEN-ICHI SAKO, TOMOJI MAEDA, NAOHITO IDE
In Vivo Jan 2025, 39 (1) 404-410; DOI: 10.21873/invivo.13842
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