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STERLING BEGAN SHIPPING BAYER "CALENDER PAKS"

Executive Summary

STERLING BEGAN SHIPPING BAYER "CALENDER PAKS" to pharmacies on Jan. 25. The company timed the launch of the new one-a-day packaging with the publication of a study in the New England Journal of Medicine showing regular aspirin use by healthy patients reduced the risk of heart attack. Taking one 325 mg aspirin tablet every other day for almost five years, the study showed, reduced the risk of heart attack by 47% in 11,037 male physicians. Sterling is promoting the Bayer "Calendar Pak" to the trade as "an easier way to work a wonder a day," and "an easier way to a healthy profit." Sterling's trade ads note that "nearly 3 mil. Calendar Pak 7-day samples have already been distributed to physicians as part of an extensive program promoting the benefits of Bayer aspirin for MI prophylaxis. Millions more will be distributed in 1988. "Sterling also is promoting ad support on television, radio, and in major magazines." A key hurdle for the new packaging may be acceptance by supermarkets and drugstores due to limited shelfspace for the crowded analgesic market. Winthrop, which is pricing the Bayer calendar paks of 28 aspirin tablets at $ 22.50 for cartons of 12, has been the industry leader in promoting aspirin for prevention uses. Sterling has effectively grown its mature Bayer aspirin franchise in the face of ibuprofen and acetaminophen brand competition with its "wonder drug" ad campaign, touting aspirin's wide range of uses. The company also has an ongoing TV ad campaign supporting aspirin use in preventing a second heart attack. The New England Journal study looked at 22,071 white male physicians aged 40 to 84, with approximately half receiving buffered aspirin and half placebo. After 4.8 years, there were 104 total heart attacks in the aspirin group compared to 189 in the placebo group. The findings are part of the Physician's Health Study, which is investigating whether aspirin reduces cardiovascular disease mortality and whether beta carotene taken on alternate days decreases the incidence of cancer. The latter part of the study is scheduled to end in 1990. Bristol-Myers, which is reportedly going to file an NDA for the heart attack indication, supplied its aspirin product Bufferin for the study. Both Bufferin and placebo were administered via calendar pack. BASF is supplying its beta carotene product, Lurotin, for the other study portion. A total of 88 cardiovascular deaths occurred during the study period, divided equally among the aspirin and placebo groups. The investigators stated that 733 cardiovascular deaths would have been expected based on the U.S. death rates for white males in the same age range as the study participants. The study found a "non-significant 15% increase" in the incidence of stroke among those receiving aspirin, 80 versus 70 in the placebo group. "The only significant result was an increased risk of moderate to severe or fatal hemorrhagic strokes among those in the aspirin group," the report states, "but the very wide 95% confidence interval reflects the fact that this finding was based on relatively small numbers of events (10 in the aspirin group and two in the placebo group)." Six fatal strokes occurred in the aspirin group compared to two with placebo. With regard to adverse events, gastrointestinal discomfort was reported by 24.2% of the aspirin group and 23.6% of the placebo group. The study notes that "not a single case of fatal gastrointestinal hemorrhage has been confirmed, and only one has been reported." An editorial published in the same issue of the New England Journal notes that a study appearing in the most recent issue of the British Medical Journal "found no significant effect on the incidence of first myocardial infarction" in 5,000 British doctors taking a daily dose of aspirin. However, the editorial states, "the confidence limits were wide, and smaller number of subjects, as well as the larger dosage in the British trial, may well account for the difference between its results" and those in the U.S. study.
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