Low-dose ASA for primary prevention of CV events in elderly w/ multiple atherosclerotic risk factors

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Surprisingly, ASA shows no significant long-term primary preventive benefit (CV death, MI, stroke, non-fatal stroke or MI) in this subset of patents

PREVENTION OF atherosclerotic cardiovascular diseases (ASCVD) has been an important public health priority due to the aging of the population and changes of lifestyle. The authors of this study aimed to examine the efficacy of low-dose aspirin for primary prevention of cardiovascular events in Japanese elderly patients with multiple atherosclerotic risk factors who have no previous history of ASCVD.

The authors are: Yasuo Ikeda, Waseda Univ, Tokyo, Japan; Tamio Teramoto, Teikyo Univ, Tokyo, Japan; Kazuyuki Shimada, Shin-Oyama City Hosp, Tochigi, Japan; Shinichiro Uchiyama, Intl Univ of Health and Welfare, Tokyo, Japan; Tsutomu Yamazaki, Univ of Tokyo Hosp, Tokyo, Japan; Shinichi Oikawa, Fukujuji Hosp, Tokyo, Japan; Masahiro Sugawara, Sugawara Medical Clinic, Tokyo, Japan; Katsuyuki Ando, Kitamura Memorial Clinic, Tokyo, Japan; Mitsuru Murata, Sch of Med, Keio Univ, Tokyo, Japan; Kenji Yokoyama, Tokai Univ Hachioji Hosp, Tokyo, Japan; Takuro Shimbo, Ohta Nishinouchi Hosp, Fukushima, Japan; Naoki Ishizuka, Cancer Inst Hosp, Tokyo, Japan.

The Japanese Primary Prevention Projects (JPPP) is a multicenter, open-labelled, randomized, parallel-group trial which evaluates primary prevention with low-dose aspirin in Japanese patients aged 60 to 85 years with hypertension, dyslipidemia, or diabetes mellitus. Enrollment began in March 2005 and was completed in June 2007. A total of 14,466 individuals were randomly allocated to receive enteric-coated aspirin, 100mg/day or no aspirin.

At randomization, study cohort had a mean age of 70.6 years. 57.8 percent of the patients were women, 85.0 percent had hypertension, 71.7 percent had dyslipidemia, and 33.9 percent had diabetes. 80.4 percent of enrolled patients had = 3 conventional risk factors.

The primary endpoints were atherosclerotic events including fatal or nonfatal myocardial infarction, fatal or nonfatal stroke and other cardiovascular death. Secondary endpoints included each and combinations of primary and other cardiovascular endpoints as well as death from any cause. Endpoint assessment was done by a central adjudication committee blinded to treatment assignments.

The final analysis was done at a median follow-up time of 5.02 years (Quartiles: 4.55- 5.33) according to the recommendation in Data Safety Monitoring Board. The number of eligible patients in aspirin and non-aspirin group was 7,220 and 7,244, respectively. There was no significant difference between two groups (P=0.544) while the researchers observed 193 and 207 primary events in each group and the estimated hazard ratio was 0.941 (95 percent CI 0.774-1.145).

The five year cumulative event rates were also 2.772 percent (95 percent CI 2.400-3.201 ) and 2.960 percent (95 percent CI 2.575-3.402), respectively, although the assumed annual event rate would be 1.5 percent or 2.0 percent in the non-aspirin group.

Aspirin was not associated with significant reduction in total cardiovascular events in elderly patients with multiple cardiovascular risk factors.

The paper was presented by Prof. Yasuo Ikeda, during the AHA Scientific Sessions 2014, in Chicago.

Vital Signs Issue 69 Vol. 3, November 1-30 2014

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