Abstract
Pravastatin was a serendipitous discovery by Sankyo; its discovery occurred while the company was in the process of investigating compactin metabolism during its development process. Pravastatin became the second statin in the world in terms of commercialization (1989). Although the launch of pravastatin was delayed, it demonstrated hydrophilicity and organ selectivity unlike lovastatin and simvastatin, which enabled its global success. Indeed, in 2010, pravastatin was used clinically in 115 countries. However, there were a number of challenges in the commercialization process of pravastatin. In particular, it required the establishment of a new two-step fermentation production process. Pravastatin also promoted cooperative research between industry and academia, which played an important role in the elucidation of the action mechanism of statin, including the effect of the hydrophilic nature of pravastatin, as well as its therapeutic value. Despite the pioneer status of Sankyo, lovastatin by Merck became the first statin in the world (1987). Although Merck also suspended the clinical development of lovastatin following the Sankyo decision to discontinue the compactin project, it resumed the development sooner because of the higher willingness of the US market to try new innovative drugs. The resumption of the suspended clinical trial of lovastatin in the USA occurred at the request of clinical researchers. An educational program by the NIH pointing out the importance of lowering cholesterol to prevent heart disease began in 1985.
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- 1.
See Table 4.1
- 2.
Data source: Web of Science, Query: TS (topic name) = “WHHL rabbit.”
- 3.
A clinical trial in which the patient’s test group is known by the doctor, subject, and staff.
- 4.
A clinical trial in which the patient is randomly assigned to the treatment or placebo group. In a double-blinded study, neither the patient nor the physician is aware of the patient’s group.
- 5.
Source: Drug Interview Form: Pravastatin Sodium tablets Mevalotin tablets, a drug for treatment of hyperlipidemia, HMG-CoA reductase inhibitor.
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Hara, Y., Nagaoka, S. (2019). Pravastatin (Pravachol, Mevalotin). In: Nagaoka, S. (eds) Drug Discovery in Japan. Springer, Singapore. https://doi.org/10.1007/978-981-13-8906-1_3
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