Cohort maintenance and comparability in a pharmacoepidemiologic study using a commercial consumer panel to recruit comparators.

The Upjohn Consumer Health Survey (UCHS) was a prospective, observational study of users of ROGAINE (REGAINE in international markets) Topical Solution 2% (N=11,122) and a Comparator cohort (N=11,173) which was selected and group matched by stratified random sampling from among members of a commercial consumer panel. Study endpoints were confirmed cause-specific deaths and hospitalizations within 12 months of study entry. Data collection was accomplished by participant interviews and confirmation of participant-reported medical events. At least 94% of both cohorts completed 12 months of follow-up, with the completion rate highest in the Comparator cohort (96.8%). Although successful matching was achieved on the demographic variables used to select the Comparators, members of the two cohorts differed significantly in the presence of baseline chronic medical conditions and other risk factors for study endpoints. A commercial consumer panel is valuable for rapid selection of demographically-matched comparators for targeted cohorts which continue in the study through long-term follow-up. Multi-stage sampling may need to be employed when more specific characteristics must be identified.

Use of a commercial consumer panel to recruit a comparator cohort for a pharmacoepidemiologic study.

The Upjohn Consumer Health Survey (UCHS) was a prospective, observational study designed to comply with the US FDA's request that 10,000 users of ROGAINE (REGAINE in international markets) Topical Solution 2% (2% minoxidil solution) be systematically studied in the first year following the product's approval. Members of the Drug cohort were recruited at the time they filled prescriptions for 2% minoxidil solution at cooperating retail pharmacies in the United States. To meet the need for rapid identification of a cooperative comparison group, the Comparator cohort was selected by stratified random sampling from members of a commercial consumer panel. Group matching of Comparators to the Drug cohort on four variables--age, sex, race, and geography of residence--was accomplished prior to recruitment on the basis of information available from the consumer panel records; education was obtained via consent procedures and was also used as a group matching variable. Data collection was accomplished by participant interviews and confirmation of participant-reported medical events. Interviewing costs averaged 18.88 US dollars/completed interview. A commercial consumer panel offers a pool of rapidly identifiable subjects with known demographic characteristics and established willingness to participate in research for efficient cohort recruitment.

Androgenetic alopecia in the female. Treatment with 2% topical minoxidil solution.

BACKGROUND: Women generally regard their hair loss as socially unacceptable and go to great measures to conceal their problem. In some cases, the negative self-image brought about by hair loss may be the basis of psychiatric illness. The purpose of this study was to evaluate a 2% topical minoxidil solution (Rogaine/Regaine, The Upjohn Co, Kalamazoo, Mich) for the treatment of female androgenetic alopecia. A 32-week, double-blind, placebo-controlled trial was conducted in 11 US centers. Three hundred eight women with androgenetic alopecia were enrolled. Two hundred fifty-six of these women completed the trial. A refined photographic technique was used to objectively determine the number of nonvellus hairs regrown. RESULTS: After 32 weeks of treatment, the number of nonvellus hairs in a 1-cm2 evaluation site was increased by an average of 23 hairs in the 2% minoxidil group and by an average of 11 hairs in the placebo group. The 95% confidence interval for the difference in mean hair count change between the treatment groups was 5.9 to 17.5 hairs. The investigators determined that 13% in the minoxidil-treated group had moderate growth and 50% had minimal growth. This compared with 6% and 33%, respectively, in the placebo-treated group. Similarly, 60% of the patients in the 2% minoxidil group reported that they had new hair growth (20% moderate, 40% minimal) compared with 40% (7% moderate, 33% minimal) of the patients in the placebo group. No evaluations of dense hair growth were reported for either treatment group. No clinically significant changes in vital signs were observed and no serious or unexpected medical events were reported. CONCLUSIONS: Topical minoxidil was significantly more effective than placebo in the treatment of female androgenetic alopecia.

Use of topical minoxidil therapy for androgenetic alopecia in women.

BACKGROUND: Androgenetic alopecia is the most common cause of hair loss in men and women. Androgenetic alopecia in women begins as a diffuse and progressive thinning of the frontoparietal area of the scalp. In women, hair loss at any age is socially unacceptable and may be the basis of psychiatric illness. METHODS: A 32-week, double-blind, placebo-controlled trial was conducted in 10 European centers to assess the efficacy and safety of 2% topical minoxidil solution for the treatment of androgenetic alopecia in women. Two hundred ninety-four of the 346 women enrolled (85%) completed the 32-week trial. Photographic and computer imaging techniques were used at each visit to determine objectively the number of nonvellus hairs present in a 1-cm2 area selected as the target evaluation site. RESULTS: In the 2% minoxidil group, the mean increase in nonvellus hair count was 33 hairs, which was significantly greater than that of 19 hairs in the placebo group (P = 0.0001). The investigators observed that 44% of the patients in the 2% minoxidil group achieved new hair growth compared with 29% in the placebo group. When asked to evaluate their own hair growth, 55% of the women in the 2% minoxidil group compared to 41% of the women in the placebo group believed that they had achieved new hair growth. No clinically significant changes in vital signs were observed during the study and no serious or unexpected medical events were reported. CONCLUSION: Topical minoxidil solution was significantly more effective than placebo in the treatment of androgenetic alopecia in women.

Prevention of fatal hemorrhagic shock in dog by pretreatment with chronic high-salt diet.

The ability of a chronic high-salt diet to prevent fatal hemorrhagic shock was examined in 36 mongrel dogs. Twenty-one dogs received a dietary supplement of 9 g sodium chloride/day for 6 wk, and 15 dogs received the same basic diet for 6 wk but without the sodium chloride supplement. Hemorrhagic shock was induced in all dogs by bleeding into an overhanging sealed reservoir. After 3 h of shock, salt-pretreated dogs had a lower systemic vascular resistance of 0.70 +/- 0.02 versus 1.44 +/- 0.04 mmHg X ml-1 X min X kg (P less than 0.01) and a higher cardiac output of 53 +/- 3 versus 26 +/- 3 ml X min-1 X kg-1 (P less than 0.01) than was observed in controls. At 2.5 h of shock, the salt-pretreated dogs also experienced an increase in gastrointestinal (P less than 0.01), hepatic arterial, (P less than 0.05), kidney (P less than 0.05), brain (P less than 0.01), and heart blood flows (P less than 0.001) compared with 0.5 h of shock, whereas the control dogs experienced no increased flow during this same period. We also observed that after 3 h of hypotension there was a significantly smaller increase in plasma renin activity in the salt-pretreated dogs. Administration of 0.1 U X kg-1 X min-1 of hog renin eliminated the differences in systemic vascular resistance, cardiac output, and survival in five salt-pretreated dogs.

Dissociation between epicardial and transmural function during acute myocardial ischemia.

The relationship between epicardial and transmural function (measured with sonomicrometers) was examined in 13 anesthetized open-chest dogs. Systolic wall thickening was used as a standard of integrated transmural function to compare with epicardial function measured as segment shortening parallel to surface fibers. Three levels of coronary inflow restriction were produced by using decrements in systolic wall thickening as an index of changes in the transmural distribution of myocardial blood flow (microspheres) in myocardium perfused by the left anterior descending artery (anterior-apical group, n = 7) or circumflex artery (posterior-basal group, n = 6). Levels 1 and 2 were characterized by reductions in systolic wall thickening of 35% and 80%, respectively, and marked decreases in deep myocardial blood flow. In the subepicardium, myocardial blood flow was minimally affected at levels 1 and 2 and there was no change in posterior-basal epicardial segment shortening, but anterior segment shortening decreased significantly (by 21% and 37%, respectively). At level 3 myocardial blood flow was reduced transmurally, producing systolic wall thinning and marked epicardial dysfunction in both groups. Parallel epicardial segment shortening underestimated the extent of transmural dysfunction in both groups at levels 1 and 2 but the degree of underestimation was greatest in the posterior-basal group. Anterior-apical segment shortening was impaired at levels 1 and 2, whereas posterior-basal segment shortening was unaffected, suggesting that significant regional variability exists in the epicardial response to nontransmural ischemia.

Therapeutic effect of propranolol on paradoxical hypertension after repair of coarctation of the aorta.

Patients undergoing repair of coarctation of the aorta often have self-limited but severe hypertension in the first week after surgery (paradoxical hypertension). We conducted a controlled trial of treatment with propranolol before repair of coarctation of the aorta in 14 children to determine whether the drug would prevent paradoxical hypertension. Seven patients were randomly assigned to receive propranolol for two weeks before surgery and throughout the first postoperative week, and seven patients were assigned to receive standard postoperative care. Both groups had a similar significant (P less than 0.05) increase in the plasma norepinephrine level in response to surgery; however, when compared with no treatment, treatment with propranolol reduced not only the rise in systolic (P = 0.004) and diastolic (P = 0.003) blood pressure but also the postoperative increase in plasma renin activity (P less than 0.01). We conclude that prophylactic propranolol can prevent paradoxical hypertension and should therefore become a routine part of the operative care of patients with coarctation of the aorta.