Andrade S E, Walker A M, Gottlieb L K, Hollenberg N K, Testa M A, Saperia G M, Platt R
Department of Epidemiology, Harvard School of Public Health, Boston, MA 02115, USA.
N Engl J Med. 1995 Apr 27;332(17):1125-31. doi: 10.1056/NEJM199504273321703.
Discontinuation rates for drugs used to treat chronic conditions may affect the success of therapy. However, the discontinuation rates reported in clinical trials may not reflect those in primary care settings.
We conducted a cohort study using computerized research files and medical records on 2369 new users of antihyperlipidemic therapy at two health maintenance organizations (HMOs) from 1988 through 1990. The rates of drug discontinuation in these primary care settings were compared with the rates reported in clinical trials published from 1975 through 1993, located with the Medline data base.
In the HMOs, the one-year probability of drug discontinuation was 41 percent for bile acid sequestrants (95 percent confidence interval, 38 to 44 percent), 46 percent for niacin (95 percent confidence interval, 42 to 51 percent), 15 percent for lovastatin (95 percent confidence interval, 11 to 19 percent), and 37 percent for gemfibrozil (95 percent confidence interval, 31 to 43 percent). For the bile acid sequestrants, niacin, and gemfibrozil, the risks of discontinuation were substantially higher in the HMOs than in randomized clinical trials, in which the summary estimates of this risk were 31 percent, 4 percent, and 15 percent, respectively, for trials of one year or longer. The rates of discontinuation in open-label studies were similar to those in the HMOs.
The discontinuation rates reported in randomized clinical trials may not reflect the rates actually observed in primary care settings. The effectiveness and tolerability of antihyperlipidemic medications should be studied further in populations that typically use the agents.
用于治疗慢性病的药物停药率可能会影响治疗效果。然而，临床试验中报告的停药率可能无法反映初级保健机构中的停药率。
我们利用计算机化研究档案和病历，对1988年至1990年期间两个健康维护组织（HMO）中2369名新使用抗血脂药物的患者进行了队列研究。将这些初级保健机构中的药物停药率与1975年至1993年发表在Medline数据库中的临床试验报告率进行比较。
在HMO中，胆汁酸螯合剂的一年停药概率为41%（95%置信区间，38%至44%），烟酸为46%（95%置信区间，42%至51%），洛伐他汀为15%（95%置信区间，11%至19%），吉非贝齐为37%（95%置信区间，31%至43%）。对于胆汁酸螯合剂、烟酸和吉非贝齐，HMO中的停药风险显著高于随机临床试验，在这些试验中，一年或更长时间试验的该风险汇总估计分别为31%、4%和15%。开放标签研究中的停药率与HMO中的相似。
随机临床试验中报告的停药率可能无法反映初级保健机构中实际观察到的停药率。应在通常使用这些药物的人群中进一步研究抗血脂药物的有效性和耐受性。
