Table 3.

Persons eligible for each randomised clinical trial with their corresponding event rates, and American College of Cardiology/American Heart Association (ACC/AHA) 2013 and European Society of Cardiology (ESC) 2016 definite treatment recommendations.

Event rates per 1000 person-years
ACC/AHA 2013ESC 2016
Randomised clinical trialTotal out of 7279 participants (%)Atherosclerotic CVD incidence rate (95% CI)CVD mortality rate (95% CI)Proportion of adults with definite treatment recommendations (95% CI)Proportion of adults with definite treatment recommendations (95% CI)
Positive trials
 WOSCOPS659 (9.1)15.7 (12.0–20.0)1.7 (0.8–3.4)86.3 (83.5–88.9)35.4 (31.7–39.1)
 AFCAPS/TexCAPS635 (8.7)13.5 (10.3–17.4)3.8 (2.3–6.0)77.6 (74.2–80.8)38.1 (34.3–42.0)
 PROSPER448 (6.2)23.6 (18.8–29.2)8.8 (6.1–12.3)99.6 (98.4–99.9)89.5 (86.3–92.2)
 ASCOT-LLA358 (4.9)22.1 (16.6–29.0)4.8 (2.5–8.1)95.3 (92.5–97.2)72.3 (67.4–76.9)
 MRC/BHF HPS145 (2.0)17.6 (10.4–27.8)7.2 (3.1–14.2)96.6 (92.1–98.9)87.6 (81.1–92.5)
 CARDS407 (5.6)21.4 (16.2–27.7)7.3 (4.6–11.1)92.4 (89.4–94.8)76.2 (71.7–80.2)
 MEGA2240 (30.8)10.3 (8.8–12.0)2.3 (1.6–3.1)55.5 (53.4–57.6)26.3 (24.5–28.2)
 JUPITER332 (4.6)10.6 (6.8–15.8)2.8 (1.1–5.8)68.1 (62.8–73.1)26.8 (22.1–31.9)
 HOPE-3a1215 (16.7)7.8 (6.1–9.9)1.9 (1.2–3.0)66.0 (63.3–68.7)b10.7 (9.0–12.6)c
Neutral trialsc
 ALLHAT-LLT31 (0.4)17.7 (4.8–45.4)0.0d100 (88.8–100)67.7 (48.6–83.3)
 ASPEN185 (2.5)15.1 (9.2–23.3)4.1 (1.5–8.9)95.1 (91.0–97.8)82.2 (75.9–87.4)
Event rates per 1000 person-years
ACC/AHA 2013ESC 2016
Randomised clinical trialTotal out of 7279 participants (%)Atherosclerotic CVD incidence rate (95% CI)CVD mortality rate (95% CI)Proportion of adults with definite treatment recommendations (95% CI)Proportion of adults with definite treatment recommendations (95% CI)
Positive trials
 WOSCOPS659 (9.1)15.7 (12.0–20.0)1.7 (0.8–3.4)86.3 (83.5–88.9)35.4 (31.7–39.1)
 AFCAPS/TexCAPS635 (8.7)13.5 (10.3–17.4)3.8 (2.3–6.0)77.6 (74.2–80.8)38.1 (34.3–42.0)
 PROSPER448 (6.2)23.6 (18.8–29.2)8.8 (6.1–12.3)99.6 (98.4–99.9)89.5 (86.3–92.2)
 ASCOT-LLA358 (4.9)22.1 (16.6–29.0)4.8 (2.5–8.1)95.3 (92.5–97.2)72.3 (67.4–76.9)
 MRC/BHF HPS145 (2.0)17.6 (10.4–27.8)7.2 (3.1–14.2)96.6 (92.1–98.9)87.6 (81.1–92.5)
 CARDS407 (5.6)21.4 (16.2–27.7)7.3 (4.6–11.1)92.4 (89.4–94.8)76.2 (71.7–80.2)
 MEGA2240 (30.8)10.3 (8.8–12.0)2.3 (1.6–3.1)55.5 (53.4–57.6)26.3 (24.5–28.2)
 JUPITER332 (4.6)10.6 (6.8–15.8)2.8 (1.1–5.8)68.1 (62.8–73.1)26.8 (22.1–31.9)
 HOPE-3a1215 (16.7)7.8 (6.1–9.9)1.9 (1.2–3.0)66.0 (63.3–68.7)b10.7 (9.0–12.6)c
Neutral trialsc
 ALLHAT-LLT31 (0.4)17.7 (4.8–45.4)0.0d100 (88.8–100)67.7 (48.6–83.3)
 ASPEN185 (2.5)15.1 (9.2–23.3)4.1 (1.5–8.9)95.1 (91.0–97.8)82.2 (75.9–87.4)

AFCAPS/TexCAPS: Air Force/Texas Coronary Atherosclerosis Prevention Study; ALLHAT-LLT: Lipid-Lowering Trial component of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial; ASCOT-LLA: Prevention of Coronary and Stroke Events with Atorvastatin in Hypertensive Patients in the Anglo-Scandinavian Cardiac Outcomes Trial: The Lipid Lowering Arm; ASPEN: Atorvastatin Study for Prevention of Coronary Heart Disease Endpoints in Non-Insulin-Dependent Diabetes Mellitus; CARDS: Collaborative Atorvastatin Diabetes Study; CI: confidence interval; CVD: cardiovascular disease; HOPE-3: Heart Outcomes Prevention Evaluation 3; JUPITER: Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin; MEGA: Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese Study Group; MRC/BHF HPS: Heart Protection Study of Cholesterol Lowering with Simvastatin; PROSPER: Prospective Study of Pravastatin in the Elderly at Risk; WOSCOPS: West of Scotland Coronary Prevention Study.

a

HOPE-3 published their results in April 2016, therefore results of this randomised clinical trial were not taken into account in ACC/AHA 2013 and ESC 2016 guidelines.

b

Due to major exclusion criteria for HOPE-3 (indication for statin therapy), all individuals qualifying for statin therapy by guidelines valid at the time of recruitment (ESC 2007 and Adult Treatment Panel III guidelines) are considered ineligible for HOPE-3.

c

Neutral trials: 14 out of 31 persons eligible for ALLHAT-LLT, and 161 out of 185 persons eligible for ASPEN would qualify for at the least one out of nine randomised clinical trials reporting positive findings on clinical cardiovascular end points.

d

Among ALLHAT-LLT eligible individuals, no cardiovascular death cases were observed in our study population.

Table 3.

Persons eligible for each randomised clinical trial with their corresponding event rates, and American College of Cardiology/American Heart Association (ACC/AHA) 2013 and European Society of Cardiology (ESC) 2016 definite treatment recommendations.

Event rates per 1000 person-years
ACC/AHA 2013ESC 2016
Randomised clinical trialTotal out of 7279 participants (%)Atherosclerotic CVD incidence rate (95% CI)CVD mortality rate (95% CI)Proportion of adults with definite treatment recommendations (95% CI)Proportion of adults with definite treatment recommendations (95% CI)
Positive trials
 WOSCOPS659 (9.1)15.7 (12.0–20.0)1.7 (0.8–3.4)86.3 (83.5–88.9)35.4 (31.7–39.1)
 AFCAPS/TexCAPS635 (8.7)13.5 (10.3–17.4)3.8 (2.3–6.0)77.6 (74.2–80.8)38.1 (34.3–42.0)
 PROSPER448 (6.2)23.6 (18.8–29.2)8.8 (6.1–12.3)99.6 (98.4–99.9)89.5 (86.3–92.2)
 ASCOT-LLA358 (4.9)22.1 (16.6–29.0)4.8 (2.5–8.1)95.3 (92.5–97.2)72.3 (67.4–76.9)
 MRC/BHF HPS145 (2.0)17.6 (10.4–27.8)7.2 (3.1–14.2)96.6 (92.1–98.9)87.6 (81.1–92.5)
 CARDS407 (5.6)21.4 (16.2–27.7)7.3 (4.6–11.1)92.4 (89.4–94.8)76.2 (71.7–80.2)
 MEGA2240 (30.8)10.3 (8.8–12.0)2.3 (1.6–3.1)55.5 (53.4–57.6)26.3 (24.5–28.2)
 JUPITER332 (4.6)10.6 (6.8–15.8)2.8 (1.1–5.8)68.1 (62.8–73.1)26.8 (22.1–31.9)
 HOPE-3a1215 (16.7)7.8 (6.1–9.9)1.9 (1.2–3.0)66.0 (63.3–68.7)b10.7 (9.0–12.6)c
Neutral trialsc
 ALLHAT-LLT31 (0.4)17.7 (4.8–45.4)0.0d100 (88.8–100)67.7 (48.6–83.3)
 ASPEN185 (2.5)15.1 (9.2–23.3)4.1 (1.5–8.9)95.1 (91.0–97.8)82.2 (75.9–87.4)
Event rates per 1000 person-years
ACC/AHA 2013ESC 2016
Randomised clinical trialTotal out of 7279 participants (%)Atherosclerotic CVD incidence rate (95% CI)CVD mortality rate (95% CI)Proportion of adults with definite treatment recommendations (95% CI)Proportion of adults with definite treatment recommendations (95% CI)
Positive trials
 WOSCOPS659 (9.1)15.7 (12.0–20.0)1.7 (0.8–3.4)86.3 (83.5–88.9)35.4 (31.7–39.1)
 AFCAPS/TexCAPS635 (8.7)13.5 (10.3–17.4)3.8 (2.3–6.0)77.6 (74.2–80.8)38.1 (34.3–42.0)
 PROSPER448 (6.2)23.6 (18.8–29.2)8.8 (6.1–12.3)99.6 (98.4–99.9)89.5 (86.3–92.2)
 ASCOT-LLA358 (4.9)22.1 (16.6–29.0)4.8 (2.5–8.1)95.3 (92.5–97.2)72.3 (67.4–76.9)
 MRC/BHF HPS145 (2.0)17.6 (10.4–27.8)7.2 (3.1–14.2)96.6 (92.1–98.9)87.6 (81.1–92.5)
 CARDS407 (5.6)21.4 (16.2–27.7)7.3 (4.6–11.1)92.4 (89.4–94.8)76.2 (71.7–80.2)
 MEGA2240 (30.8)10.3 (8.8–12.0)2.3 (1.6–3.1)55.5 (53.4–57.6)26.3 (24.5–28.2)
 JUPITER332 (4.6)10.6 (6.8–15.8)2.8 (1.1–5.8)68.1 (62.8–73.1)26.8 (22.1–31.9)
 HOPE-3a1215 (16.7)7.8 (6.1–9.9)1.9 (1.2–3.0)66.0 (63.3–68.7)b10.7 (9.0–12.6)c
Neutral trialsc
 ALLHAT-LLT31 (0.4)17.7 (4.8–45.4)0.0d100 (88.8–100)67.7 (48.6–83.3)
 ASPEN185 (2.5)15.1 (9.2–23.3)4.1 (1.5–8.9)95.1 (91.0–97.8)82.2 (75.9–87.4)

AFCAPS/TexCAPS: Air Force/Texas Coronary Atherosclerosis Prevention Study; ALLHAT-LLT: Lipid-Lowering Trial component of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial; ASCOT-LLA: Prevention of Coronary and Stroke Events with Atorvastatin in Hypertensive Patients in the Anglo-Scandinavian Cardiac Outcomes Trial: The Lipid Lowering Arm; ASPEN: Atorvastatin Study for Prevention of Coronary Heart Disease Endpoints in Non-Insulin-Dependent Diabetes Mellitus; CARDS: Collaborative Atorvastatin Diabetes Study; CI: confidence interval; CVD: cardiovascular disease; HOPE-3: Heart Outcomes Prevention Evaluation 3; JUPITER: Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin; MEGA: Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese Study Group; MRC/BHF HPS: Heart Protection Study of Cholesterol Lowering with Simvastatin; PROSPER: Prospective Study of Pravastatin in the Elderly at Risk; WOSCOPS: West of Scotland Coronary Prevention Study.

a

HOPE-3 published their results in April 2016, therefore results of this randomised clinical trial were not taken into account in ACC/AHA 2013 and ESC 2016 guidelines.

b

Due to major exclusion criteria for HOPE-3 (indication for statin therapy), all individuals qualifying for statin therapy by guidelines valid at the time of recruitment (ESC 2007 and Adult Treatment Panel III guidelines) are considered ineligible for HOPE-3.

c

Neutral trials: 14 out of 31 persons eligible for ALLHAT-LLT, and 161 out of 185 persons eligible for ASPEN would qualify for at the least one out of nine randomised clinical trials reporting positive findings on clinical cardiovascular end points.

d

Among ALLHAT-LLT eligible individuals, no cardiovascular death cases were observed in our study population.

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