Cholesterol Guidelines for Multi Ethnic CVD Prevention
Of the total 6,814 MESA participants, 5,437 were not taking statins during the baseline examination, had sufficient data to determine statin eligibility under both cholesterol guidelines (the 2013 ACC/AHA and the NCEP/ATP III guidelines), and were therefore included in this analysis. One thousand three hundred thirty-four (24.5%) participants were eligible under the 2001/2004 NCEP/ATP III guidelines (excluding the optional recommendation), whereas 1,624 (29.9%) were eligible when the optional criteria were considered for statin therapy. Three thousand fifteen (55.5%) were eligible under the 2013 ACC/AHA guidelines (excluding the optional recommendation), whereas 3,610 (66.4%) were eligible when the optional criteria were considered for statin therapy. Thus 1,742 (32.0%) were newly eligible without and 2,012 (37.0%) were newly eligible with the inclusion of both optional criteria for statin therapy during the MESA baseline examination. Sixty-one (4.6%) of participants who were eligible for statin therapy under the NCEP/ATP III cholesterol guidelines were no longer eligible for statin therapy under the 2013 ACC/AHA guidelines.
Table II and Table III show the demographic characteristics of the total MESA cohort, participants who were eligible for statin therapy under NCEP/ATP III guidelines, participants who are eligible for statin under the new ACC/AHA guidelines, and their corresponding net newly eligible participants.
Of 1,334 participants, 144 (10.7%) had an adjudicated ASCVD and 101 (7.7%) had T2DM during the follow-up. Assuming 10 years of moderate-intensity statin use and accounting for observed use of statins in this subcohort, 42.2 (29.3%; predicted interval 23.1–57.3) ASCVD events would have been prevented with an NNT of 31.7. 10 years of moderate-intensity statin use and it would have caused 7.8 (7.7%; predicted interval 1.0–14.2) T2DM with an NNH of 94.2.The corresponding NNT and NNH for high-intensity statins were 24.1 and 33.5, respectively, as shown in Table II. Online Supplementary Table I and Supplementary Table II show the extreme bounds of the NNT and the NNH, assuming all or none of these participants used statins during the 10-year follow-up period (Table IV).
Of 3,012 participants, 269 (8.9 %) had an adjudicated ASCVD and 285 (9.7%) had T2DM during the follow-up. Assuming 10 years of moderate-intensity statin use and accounting for observed use of statins in this subcohort, 77.2 (28.7%; predicted interval 42.7–104.2) ASCVD events would have been prevented with an NNT of 39.1. 10 years of moderate-intensity statin use and it would have caused 22.2 (7.8%; predicted interval: 2.8 to 40.6) T2DM with an NNH of 106.2. The corresponding NNT and NNH for high-intensity statin use were 29.9 and 37.4, respectively, as shown in Table IV. Online Supplementary Table I and Supplementary Table II show the extreme bounds of the NNT and the NNH, assuming all and none of these participants used statins during the 10-year follow-up period (Table IV).
Of 1,742 participants, 127 (7.3%) of the newly recommended MESA participants had an adjudicated ASCVD event and 194 (11.1%) had T2DM during 10 years of follow-up. Figure 1 is the Kaplan-Meier cumulative probability plot of ASCVD events during 10 years of follow-up time for the newly recommended MESA participants (estimated annual ASCVD event rate of 0.82 [0.69–0.97]/100 person-years). One hundred ninety-four (11.6%) of the newly recommended MESA subcohort developed diabetes mellitus after 10 years of follow-up. Figure 2 is the cumulative probability plot of diabetes mellitus events during 10 years of follow-up time for the newly recommended MESA participants. Assuming 10 years of moderate-intensity statin use and accounting for observed statin use during the follow-up period, 35.8 (28.2%; predicted interval 20.0–48.1) ASCVD events would have been prevented with an NNT of 48.7. 10 years of moderate-intensity statin use and it would have caused 15.2 (7.8%; predicted interval 1.9–27.9) T2DM with an NNH of 110.7. Ten years of high-intensity statin use would have prevented 46.5 (36.6%; predicted interval 31.4–59.4) ASCVD events with an NNT of 37.5 and caused 43.4 (22.4%; predicted interval 9.6–78.4) T2DM with an NNH of 38.6. Online Supplementary Table I and Supplementary Table II show the extreme bounds of the NNT and the NNH assuming all and none of these participants used statins during the10-year follow-up period. Table V and Table VI show the change in ASCVD prevented and T2DM caused with change in adherence rate for moderate-intensity statin therapy in the newly recommended MESA participants (Table IV).
(Enlarge Image)
Figure 1.
Kaplan-Meier cumulative probability plot of ASCVD event over 10 years of follow-up time for the 1,742 MESA subjects who are recommended statin therapy under the new AHA/ACC guidelines, but not the NCEP/ATP III guidelines (newly recommended), and were not taking statin during the baseline MESA.
(Enlarge Image)
Figure 2.
Kaplan-Meier cumulative probability plot of incident T2DM event over 10 years of follow-up time for the 1,679 MESA subjects who are recommended statin therapy under the new AHA/ACC guidelines but not the NCEP/ATP III guidelines (newly recommended), and were not taking statin during the baseline MESA.
Based on the estimates provided by Floyd et al on the incidence of statin-related rhabdomyolysis (5.2 events per 100,000 person-years), the 16,262.6-person-years exposure time in the current MESA subcohort (n = 1,742) yielded less than 1 case over the 10-year period of follow-up.
Results
Of the total 6,814 MESA participants, 5,437 were not taking statins during the baseline examination, had sufficient data to determine statin eligibility under both cholesterol guidelines (the 2013 ACC/AHA and the NCEP/ATP III guidelines), and were therefore included in this analysis. One thousand three hundred thirty-four (24.5%) participants were eligible under the 2001/2004 NCEP/ATP III guidelines (excluding the optional recommendation), whereas 1,624 (29.9%) were eligible when the optional criteria were considered for statin therapy. Three thousand fifteen (55.5%) were eligible under the 2013 ACC/AHA guidelines (excluding the optional recommendation), whereas 3,610 (66.4%) were eligible when the optional criteria were considered for statin therapy. Thus 1,742 (32.0%) were newly eligible without and 2,012 (37.0%) were newly eligible with the inclusion of both optional criteria for statin therapy during the MESA baseline examination. Sixty-one (4.6%) of participants who were eligible for statin therapy under the NCEP/ATP III cholesterol guidelines were no longer eligible for statin therapy under the 2013 ACC/AHA guidelines.
Table II and Table III show the demographic characteristics of the total MESA cohort, participants who were eligible for statin therapy under NCEP/ATP III guidelines, participants who are eligible for statin under the new ACC/AHA guidelines, and their corresponding net newly eligible participants.
Risk-benefit for Participants Eligible Under the NCEP/ATP III Guidelines
Of 1,334 participants, 144 (10.7%) had an adjudicated ASCVD and 101 (7.7%) had T2DM during the follow-up. Assuming 10 years of moderate-intensity statin use and accounting for observed use of statins in this subcohort, 42.2 (29.3%; predicted interval 23.1–57.3) ASCVD events would have been prevented with an NNT of 31.7. 10 years of moderate-intensity statin use and it would have caused 7.8 (7.7%; predicted interval 1.0–14.2) T2DM with an NNH of 94.2.The corresponding NNT and NNH for high-intensity statins were 24.1 and 33.5, respectively, as shown in Table II. Online Supplementary Table I and Supplementary Table II show the extreme bounds of the NNT and the NNH, assuming all or none of these participants used statins during the 10-year follow-up period (Table IV).
Risk-benefit for Participants Eligible Under the New ACC/AHA Guidelines
Of 3,012 participants, 269 (8.9 %) had an adjudicated ASCVD and 285 (9.7%) had T2DM during the follow-up. Assuming 10 years of moderate-intensity statin use and accounting for observed use of statins in this subcohort, 77.2 (28.7%; predicted interval 42.7–104.2) ASCVD events would have been prevented with an NNT of 39.1. 10 years of moderate-intensity statin use and it would have caused 22.2 (7.8%; predicted interval: 2.8 to 40.6) T2DM with an NNH of 106.2. The corresponding NNT and NNH for high-intensity statin use were 29.9 and 37.4, respectively, as shown in Table IV. Online Supplementary Table I and Supplementary Table II show the extreme bounds of the NNT and the NNH, assuming all and none of these participants used statins during the 10-year follow-up period (Table IV).
Risk-benefit for Participants in the Newly Recommended MESA Subcohort
Of 1,742 participants, 127 (7.3%) of the newly recommended MESA participants had an adjudicated ASCVD event and 194 (11.1%) had T2DM during 10 years of follow-up. Figure 1 is the Kaplan-Meier cumulative probability plot of ASCVD events during 10 years of follow-up time for the newly recommended MESA participants (estimated annual ASCVD event rate of 0.82 [0.69–0.97]/100 person-years). One hundred ninety-four (11.6%) of the newly recommended MESA subcohort developed diabetes mellitus after 10 years of follow-up. Figure 2 is the cumulative probability plot of diabetes mellitus events during 10 years of follow-up time for the newly recommended MESA participants. Assuming 10 years of moderate-intensity statin use and accounting for observed statin use during the follow-up period, 35.8 (28.2%; predicted interval 20.0–48.1) ASCVD events would have been prevented with an NNT of 48.7. 10 years of moderate-intensity statin use and it would have caused 15.2 (7.8%; predicted interval 1.9–27.9) T2DM with an NNH of 110.7. Ten years of high-intensity statin use would have prevented 46.5 (36.6%; predicted interval 31.4–59.4) ASCVD events with an NNT of 37.5 and caused 43.4 (22.4%; predicted interval 9.6–78.4) T2DM with an NNH of 38.6. Online Supplementary Table I and Supplementary Table II show the extreme bounds of the NNT and the NNH assuming all and none of these participants used statins during the10-year follow-up period. Table V and Table VI show the change in ASCVD prevented and T2DM caused with change in adherence rate for moderate-intensity statin therapy in the newly recommended MESA participants (Table IV).
(Enlarge Image)
Figure 1.
Kaplan-Meier cumulative probability plot of ASCVD event over 10 years of follow-up time for the 1,742 MESA subjects who are recommended statin therapy under the new AHA/ACC guidelines, but not the NCEP/ATP III guidelines (newly recommended), and were not taking statin during the baseline MESA.
(Enlarge Image)
Figure 2.
Kaplan-Meier cumulative probability plot of incident T2DM event over 10 years of follow-up time for the 1,679 MESA subjects who are recommended statin therapy under the new AHA/ACC guidelines but not the NCEP/ATP III guidelines (newly recommended), and were not taking statin during the baseline MESA.
Based on the estimates provided by Floyd et al on the incidence of statin-related rhabdomyolysis (5.2 events per 100,000 person-years), the 16,262.6-person-years exposure time in the current MESA subcohort (n = 1,742) yielded less than 1 case over the 10-year period of follow-up.
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