Assessment of Pregabalin Postapproval Trials and the Suggestion of Efficacy for New Indications: A Systematic Review

作者: Carole A. Federico , Taiji Wang , Adélaïde Doussau , Jeffrey S. Mogil , Dean Fergusson

DOI: 10.1001/JAMAINTERNMED.2018.5705

关键词:

摘要: Importance After a drug receives regulatory approval, researchers often pursue small, underpowered trials, called exploratory aimed at testing additional indications. If favorable early findings from trials are not promptly followed by confirmatory then physicians, patients, and payers can be left uncertain about drug’s clinical value (clinical agnosticism). Such may encourage the off-label use of ineffective drugs. Objective To characterize relationship between postapproval for blockbuster drug, pregabalin (Lyrica). Evidence Review Ovid MEDLINE Embase databases were used to identify published prior January 2018 that tested efficacy nonapproved Indications, trial outcomes, publication dates, design elements recorded. Time elapsed was calculated generation agnosticism (ie, publications reporting positive or inconclusive evidence on primary endpoint) it being addressed (publication least 1 in same indication, regardless outcome). Findings There 238 identified 33 indications; 5 indications eventually received European Medicines Agency and/or US Food Drug Administration marketing approval. Sixty-seven percent (22 33) first new have generated agnosticism. Of those with years follow-up, 63% (17 27) within years. As development expanded approval other indications, linkage diminished. Conclusions Relevance initial suggesting went unconfirmed extended periods time. Poor coordination represent an important vehicle through which prescription is recommended practice guidelines encouraged absence evidence.

参考文章(40)
, Pharmacological Management of Persistent Pain in Older Persons Journal of the American Geriatrics Society. ,vol. 57, pp. 1331- ,(2009) , 10.1111/J.1532-5415.2009.02376.X
B. Alberts, R. J. Cicerone, S. E. Fienberg, A. Kamb, M. McNutt, R. M. Nerem, R. Schekman, R. Shiffrin, V. Stodden, S. Suresh, M. T. Zuber, B. K. Pope, K. H. Jamieson, Self-correction in science at work Science. ,vol. 348, pp. 1420- 1422 ,(2015) , 10.1126/SCIENCE.AAB3847
Takahiro Ushida, Masahiko Ikeuchi, Maki Arakawa, Kikuyo Nishida, Young-Chang P Arai, Yoshihiro Yamamoto, Makota Nishihara, Combinations of low-dose antidepressants and low-dose pregabalin as useful adjuvants to opioids for intractable, painful bone metastases. Pain Physician. ,vol. 16, ,(2014) , 10.36076/PPJ.2013/16/E547
Hili Giladi, Manon Choinière, Mary-Ann Fitzcharles, Mark A. Ware, Xianming Tan, Yoram Shir, Pregabalin for chronic pain: does one medication fit all? Current Medical Research and Opinion. ,vol. 31, pp. 1403- 1411 ,(2015) , 10.1185/03007995.2015.1040750
Jonathan Kimmelman, Alex John London, The Structure of Clinical Translation:Efficiency, Information, and Ethics Hastings Center Report. ,vol. 45, pp. 27- 39 ,(2015) , 10.1002/HAST.433
John P A Ioannidis, Sander Greenland, Mark A Hlatky, Muin J Khoury, Malcolm R Macleod, David Moher, Kenneth F Schulz, Robert Tibshirani, Increasing value and reducing waste in research design, conduct, and analysis The Lancet. ,vol. 383, pp. 166- 175 ,(2014) , 10.1016/S0140-6736(13)62227-8
Karl-Fredrik Sjölund, Ruoyong Yang, Kyung-Hee Lee, Malca Resnick, Randomized study of pregabalin in patients with cancer-induced bone pain. Pain and Therapy. ,vol. 2, pp. 37- 48 ,(2013) , 10.1007/S40122-013-0009-8
Morten Andersen, Jakob Kragstrup, Jens Søndergaard, How Conducting a Clinical Trial Affects Physicians' Guideline Adherence and Drug Preferences JAMA. ,vol. 295, pp. 2759- 2764 ,(2006) , 10.1001/JAMA.295.23.2759
Mark Ratner, Pfizer settles largest ever fraud suit for off-label promotion. Nature Biotechnology. ,vol. 27, pp. 961- 962 ,(2009) , 10.1038/NBT1109-961
Scott D Halpern, Jason HT Karlawish, Jesse A Berlin, The continuing unethical conduct of underpowered clinical trials. JAMA. ,vol. 288, pp. 358- 362 ,(2002) , 10.1001/JAMA.288.3.358