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Since licensure, a number of clinical trials of pregabalin in different NeP conditions have been completed from which additional data on safety and tolerability can be drawn. In this analysis, patient\u2010level data from 31 randomized clinical trials of pregabalin in peripheral NeP sponsored by Pfizer were pooled and assessed for incidence of adverse events (<jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s). Incidence by age, disease condition, and race, together with risk differences and time to onset and resolution of <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s, was assessed. In total, 7,510 patients were included: 4,884 on pregabalin (representing 805 patient\u2010years treatment) and 2,626 on placebo. Pregabalin vs. placebo risk analysis identified 9 <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s with a risk difference, for which the lower limit of the 95% confidence interval (<jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>) was &gt;\u00a01%: dizziness (risk difference [95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>]: (17.0 [15.4 to 18.6]), somnolence (10.8 [9.5 to 12.1]), peripheral edema (5.4 [4.3 to 6.4]), weight increase (4.7 [3.9 to 5.5]), dry mouth (2.9 [2.1 to 3.8]), constipation (2.3 [1.5 to 3.2]), blurred vision (2.2 [1.6 to 2.9]), balance disorder (2.0 [1.5 to 2.5]), and euphoric mood (1.6 [1.2 to 2.0]). The most common <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s, dizziness and somnolence, typically emerged within the first 1 to 2\u00a0weeks of treatment and resolved 1 to 2\u00a0weeks later, without resulting in cessation of treatment. The data from this review provide information, indicating which <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s may be expected in patients treated with pregabalin, and suggest that careful dose titration to the highest tolerable dose is the most appropriate approach in clinical practice.<\/jats:p>","DOI":"10.1111\/papr.12146","type":"journal-article","created":{"date-parts":[[2013,11,27]],"date-time":"2013-11-27T07:07:30Z","timestamp":1385536050000},"page":"47-57","source":"Crossref","is-referenced-by-count":65,"title":["A Comprehensive Drug Safety Evaluation of Pregabalin in Peripheral Neuropathic Pain"],"prefix":"10.1111","volume":"15","author":[{"given":"Rainer","family":"Freynhagen","sequence":"first","affiliation":[{"name":"Zentrum f\u00fcr An\u00e4sthesiologie, Intensivmedizin, Schmerztherapie &amp; Palliativmedizin, Benedictus Krankenhaus Tutzing and Klinik f\u00fcr An\u00e4sthesiologie Technische Universit\u00e4t M\u00fcnchen M\u00fcnchen Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael","family":"Serpell","sequence":"additional","affiliation":[{"name":"Gartnavel General Hospital and Glasgow University Glasgow U.K"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Birol","family":"Emir","sequence":"additional","affiliation":[{"name":"Pfizer Inc New York City New York U.S.A"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ed","family":"Whalen","sequence":"additional","affiliation":[{"name":"Pfizer Inc New York City New York U.S.A"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bruce","family":"Parsons","sequence":"additional","affiliation":[{"name":"Pfizer Inc New York City New York U.S.A"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew","family":"Clair","sequence":"additional","affiliation":[{"name":"Pfizer Inc New York City New York U.S.A"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark","family":"Latymer","sequence":"additional","affiliation":[{"name":"Pfizer Ltd Tadworth Surrey U.K"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2013,11,27]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pain.2007.08.013"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.4065\/mcp.2009.0649"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1517\/14740338.2012.677026"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.b3002"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0b013e3182166ebe"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-1331.2010.02999.x"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1212\/01.WNL.0000140708.62856.72"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjmed.2009.04.007"},{"key":"e_1_2_6_10_1","unstructured":"Lyrica\u00ae Summary of Product Characteristics. 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