Thalidomide and its analogues: comparative clinical efficacy and safety, and cost-effectiveness

Paumgartten, Francisco José Roma

doi:10.1590/0102-311xpe010414

Cited by 7 publications

(4 citation statements)

References 5 publications

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“…Several randomised clinical trials showed that Thalidomide is effective, both as a single agent and in combination with other drugs in advanced multiple myeloma. Its toxic effect causes the degradation of two transcription regulators of B and T cell development, stopping the multiple myeloma growth and altering the immune cell function [15,16].…”

Section: Thalidomidementioning

confidence: 99%

Adjuvant role of anti-angiogenic drugs in the management of head and neck arteriovenous malformations

et al. 2015

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Section: Thalidomidementioning

confidence: 99%

Adjuvant role of anti-angiogenic drugs in the management of head and neck arteriovenous malformations

et al. 2015

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“…This therapeutic indication came after the international discovery that the drug was effective for the treatment of leprosy erythema. From 1964 to recent days, the drug has been largely studied and new indications have been evaluated 14,15 and approved 16 , along with the efforts to regulate its commercialization.…”

Section: Resultsmentioning

confidence: 99%

“…The Clinical use and control of the dispensing of thalidomide in Brasília, Federal District, Brazil, from 2001 to 2012 was described by Paumgartten 15 but not new studies showing such numbers were published since then.…”

Section: Thalidomide Pharmaceutical Assistance and Consumption How To...mentioning

confidence: 99%

Thalidomide surveillance and pharmacovigilance in Brazil – an overview

Leal

Mota²,

Sanitária³

2021

Visa em Debate

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Introduction:The thalidomide is probably the best-known teratogenic drug and still results in cases of severe physical deformities in children born in Brazil. Objective:To present the overall context of surveillance and pharmacovigilance of thalidomide in Brazil. Method:This article presents a narrative review of current literature concerning thalidomide regulation, policies, and pharmacovigilance in Brazil. Results:New cases of congenital abnormalities whose phenotype is compatible with thalidomide embryopathy were identified in the last ten years, while the approval of thalidomide for new indications was recently updated. The mechanisms of diagnosing thalidomide embryopathy are complex, remaining the challenge in distinguishing this condition from other congenital abnormalities. The increasing number of thalidomide users in Brazil is correlated with the occurrence of embryopathy and the real extension of the rationality of its use is largely unknown. Additionally, our pharmacovigilance and surveillance systems are predominantly based on voluntary reports, issues that remains over the years. Conclusions:The policies have improved over the years to prevent the fetus from being exposed to thalidomide, and current regulation establishes rules for controlling its distribution, prescription, dispensation, and use. Brazilian surveillance system is manual and pharmacovigilance is supported by voluntary reports. The failure of the system to properly control the thalidomide use and its effects might lead to serious consequences to the community; therefore, this subject deserves constant attention.

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“…Despite this, two randomized, phase III clinical trials failed to show the survival advantage of melphalan-prednisone-lenalidomide over melphalan-prednisone-thalidomide [ 99 , 100 ]. It is noteworthy that thalidomide is not widely used in the US, although lenalidomide costs about 43-fold more than thalidomide [ 101 , 102 ].…”

Section: Barriers To Be Overcome In Drug Cancer Repurposingmentioning

confidence: 99%

Does Therapeutic Repurposing in Cancer Meet the Expectations of Having Drugs at a Lower Price?

et al. 2023

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Therapeutic repurposing emerged as an alternative to the traditional drug discovery and development model (DDD) of new molecular entities (NMEs). It was anticipated that by being faster, safer, and cheaper, the development would result in lower-cost drugs. As defined in this work, a repurposed cancer drug is one approved by a health regulatory authority against a non-cancer indication that then gains new approval for cancer. With this definition, only three drugs are repurposed for cancer: Bacillus Calmette–Guerin (BCG) vaccine (superficial bladder cancer, thalidomide [multiple myeloma], and propranolol [infantile hemangioma]). Each of these has a different history regarding price and affordability, and it is not yet possible to generalize the impact of drug repurposing on the final price to the patient. However, the development, including the price, does not differ significantly from an NME. For the end consumer, the product’s price is unrelated to whether it followed the classical development or repurposing. Economic constraints for clinical development, and drug prescription biases for repurposing drugs, are barriers yet to be overcome. The affordability of cancer drugs is a complex issue that varies from country to country. Many alternatives for having affordable drugs have been put forward, however these measures have thus far failed and are, at best, palliative. There are no immediate solutions to the problem of access to cancer drugs. It is necessary to critically analyze the impact of the current drug development model and be creative in implementing new models that genuinely benefit society.

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Thalidomide and its analogues: comparative clinical efficacy and safety, and cost-effectiveness

Abstract: Thalidomide and its analogues: comparative clinical efficacy and safety, and cost-effectiveness Talidomida e seus análogos: eficácia e segurança clínica comparativa e custo-efetividade Talidomida y sus análogos: eficacia y seguridad clínica y coste-efectividad

Cited by 7 publications

References 5 publications

Adjuvant role of anti-angiogenic drugs in the management of head and neck arteriovenous malformations

Adjuvant role of anti-angiogenic drugs in the management of head and neck arteriovenous malformations

Thalidomide surveillance and pharmacovigilance in Brazil – an overview

Does Therapeutic Repurposing in Cancer Meet the Expectations of Having Drugs at a Lower Price?

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