@article {1418, title = {Temporal patterns of antihypertensive medication use among older adults, 1989 through 1992. An effect of the major clinical trials on clinical practice?}, journal = {JAMA}, volume = {273}, year = {1995}, month = {1995 May 10}, pages = {1436-8}, abstract = {

OBJECTIVE: To describe the changing patterns of antihypertensive medication use in the years immediately before and after the publication of the results of three major clinical trials of the treatment of hypertension in older adults.

DESIGN: In this cohort study, adults 65 years or older were examined annually on four occasions between June 1989 and May 1992, and the use of antihypertensive medications was assessed by inventory at each visit. The four visits defined the boundaries of three study periods. For each study period, participants receiving antihypertensive therapy were either continuous users (n = 1667, 1643, and 1605, respectively) or starters (n = 157, 142, 120) of hypertensive therapy. The large clinical trials that convincingly proved the efficacy and safety of low-dose diuretic therapy in older adults were published during the latter parts of period 2 and the early parts of period 3.

RESULTS: Among starters, the proportion initiating therapy on diuretics increased from 35.9\% in period 2 to 47.5\% in period 3, significantly so among women (P = .04). The proportions initiating other drugs displayed no significant trends. Among continuous users, the use of diuretics, beta-blockers, and vasodilators generally decreased over the 3-year period, while the use of calcium channel blockers and angiotensin-converting enzyme inhibitors increased significantly in each of the three periods (P < .05). The decline of 2.7\% in the prevalence of diuretic use in period 1 abated during period 2 (1.8\% decline), and it slowed significantly (P = .03) to almost a complete halt during period 3 (0.2\% decline). The rate of increase in the use of calcium channel blockers slowed significantly (P = .01) between period 1 (+6.7\%) and period 3 (+2.8\%).

CONCLUSIONS: Although other factors such as cost may have been important, the temporal trends in antihypertensive drug therapy coincided in time with and may have reflected in part the influence of the major clinical trials on the patterns of clinical practice.

}, keywords = {Aged, Antihypertensive Agents, Clinical Trials as Topic, Data Interpretation, Statistical, Drug Utilization Review, Female, Humans, Hypertension, Male, Practice Patterns, Physicians{\textquoteright}, United States}, issn = {0098-7484}, author = {Psaty, B M and Koepsell, T D and Yanez, N D and Smith, N L and Manolio, T A and Heckbert, S R and Borhani, N O and Gardin, J M and Gottdiener, J S and Rutan, G H} } @article {1468, title = {Hypertension and outcomes research. From clinical trials to clinical epidemiology.}, journal = {Am J Hypertens}, volume = {9}, year = {1996}, month = {1996 Feb}, pages = {178-83}, abstract = {

Outcomes research seeks to identify effective evidence-based methods of providing the best medical care. While randomized clinical trials (RCT) usually provide the clearest answers, they are often not done or not practicable. More than a decade after the introduction of calcium channel blockers and angiotensin converting enzyme (ACE) inhibitors, clinical trial data about their effect on major disease endpoints in patients with hypertension are still not available. The primary alternatives are the use of randomized trials that include surrogate endpoints, such as level of blood pressure or extent of carotid atherosclerosis, and the use of observational studies that include major disease endpoints. Both approaches, their strengths and limitations, are discussed in detail. The possibility of residual confounding limits the strength of inferences that can be drawn from observational studies. Similarly, the possibility of important drug effects, other than those involving the surrogate endpoint, limits the inferences that can be drawn from randomized trials that rely solely on surrogate outcomes as guides to therapy. In the absence of evidence from large clinical trials that include major disease endpoints, treatment decisions and guidelines need to synthesize the best available information from a variety of sources. Consistency of findings across various study designs, outcomes, and populations is critical to the practice of evidence-based medicine and the effort to maximize the health benefits of antihypertensive therapies.

}, keywords = {Clinical Trials as Topic, Epidemiologic Methods, Evidence-Based Medicine, Humans, Hypertension, Outcome Assessment (Health Care)}, issn = {0895-7061}, author = {Psaty, B M and Siscovick, D S and Weiss, N S and Koepsell, T D and Rosendaal, F R and Lin, D and Heckbert, S R and Wagner, E H and Furberg, C D} }