Change in Cardiovascular Risk Parameters Among Virally Suppressed Adults Randomized to Switch to Dolutegravir or Remain on Protease Inhibitor Over 48 wk of Follow up
| Parameter . | Dolutegravir N = 389 . | Ritonavir-boosted Protease Inhibitor N = 388 . | Total N = 777 . | P Value . |
|---|---|---|---|---|
| Blood pressure | ||||
| Incident hypertension | 48/292 (16.4%) | 46/295 (15.6%) | 94/587 (16.0%) | .868 |
| Change in systolic blood pressure, mm Hg | +3 (−6, 14) | +5 (−4, 13) | +4 (−4, 14) | .692 |
| Change in diastolic blood pressure, mm Hg | +5 (−2, 11) | +4 (−3, 10) | +4.0 (−2, 11) | .099 |
| Anthropometric measures | ||||
| Change in weight, kg | +1.5 (−1.0, 4.0) | +1.0 (−1.5, 3.0) | 1.0 (−1.0, 3.5) | .019 |
| ≥5% increase in weight | 123 (31.7%) | 80 (20.8%) | 203 (26.3%) | <.001 |
| Change in body mass index, kg/m2 | +0.6 (−0.4, 1.5) | 0.3 (−0.6, 1.1) | 0.4 (−0.4, 1.3) | .023 |
| Percentage change in waist-to-hip circumference ratio | +0.6 (−3.6, 4.5) | +0.2 (−3.5, 4.1) | +0.4 (−3.6, 4.4) | .436 |
| Metabolic assays | ||||
| Incident hyperglycemia | 18/363 (5%) | 13/370 (3.5%) | 31/733 (4.2%) | .430 |
| Incident dyslipidemia | 42/332 (12.7%) | 47/327 (14.4%) | 89/659 (13/5%) | .594 |
| Percentage change in low-density lipoprotein | +5.1 (−12.2, 27.6) | +11.8 (−6.3, 35.6) | +9.4 (−10.0, 32.4) | .005 |
| Percentage change in high-density lipoprotein | −18.3 (−37.9, 1.9) | −13.0 (−32.4, 7.3) | −16.4 (−35.2, 4.3) | .017 |
| Percentage change in total cholesterol | −7.0 (−18.5, 5.5) | −1.9 (−13.2, 12.7) | −4.1 (−16.3, 9.4) | <.001 |
| Percentage change in triglycerides | −25.5 (−44.4, 3.0) | −6.5 (−30.6, 22.7) | −16.2 (−39.7, 12.5) | <.001 |
| Percentage change in total cholesterol-to-high-density lipoprotein ratio | +14.0 (−4.8, 40.0) | +11.7 (−6.1, 40.7) | +12.7 (−5.2, 40.3) | .895 |
| ASCVD riska | ||||
| Change in ASCVD risk score | +0.4 (−0.1, 1.5) | +0.7 (0.0, 1.6) | +0.5 (−0.1, 1.6) | .187 |
| Worsening ASCVD risk categoryb | .298 | |||
| No change | 226 (76.4%) | 219 (77.7%) | 445 (77.0%) | |
| Improved risk category | 20 (6.8%) | 11 (3.9%) | 31 (5.4%) | |
| Worsened risk category | 50 (16.9% | 52 (18.4%) | 102 (17.6%) |
| Parameter . | Dolutegravir N = 389 . | Ritonavir-boosted Protease Inhibitor N = 388 . | Total N = 777 . | P Value . |
|---|---|---|---|---|
| Blood pressure | ||||
| Incident hypertension | 48/292 (16.4%) | 46/295 (15.6%) | 94/587 (16.0%) | .868 |
| Change in systolic blood pressure, mm Hg | +3 (−6, 14) | +5 (−4, 13) | +4 (−4, 14) | .692 |
| Change in diastolic blood pressure, mm Hg | +5 (−2, 11) | +4 (−3, 10) | +4.0 (−2, 11) | .099 |
| Anthropometric measures | ||||
| Change in weight, kg | +1.5 (−1.0, 4.0) | +1.0 (−1.5, 3.0) | 1.0 (−1.0, 3.5) | .019 |
| ≥5% increase in weight | 123 (31.7%) | 80 (20.8%) | 203 (26.3%) | <.001 |
| Change in body mass index, kg/m2 | +0.6 (−0.4, 1.5) | 0.3 (−0.6, 1.1) | 0.4 (−0.4, 1.3) | .023 |
| Percentage change in waist-to-hip circumference ratio | +0.6 (−3.6, 4.5) | +0.2 (−3.5, 4.1) | +0.4 (−3.6, 4.4) | .436 |
| Metabolic assays | ||||
| Incident hyperglycemia | 18/363 (5%) | 13/370 (3.5%) | 31/733 (4.2%) | .430 |
| Incident dyslipidemia | 42/332 (12.7%) | 47/327 (14.4%) | 89/659 (13/5%) | .594 |
| Percentage change in low-density lipoprotein | +5.1 (−12.2, 27.6) | +11.8 (−6.3, 35.6) | +9.4 (−10.0, 32.4) | .005 |
| Percentage change in high-density lipoprotein | −18.3 (−37.9, 1.9) | −13.0 (−32.4, 7.3) | −16.4 (−35.2, 4.3) | .017 |
| Percentage change in total cholesterol | −7.0 (−18.5, 5.5) | −1.9 (−13.2, 12.7) | −4.1 (−16.3, 9.4) | <.001 |
| Percentage change in triglycerides | −25.5 (−44.4, 3.0) | −6.5 (−30.6, 22.7) | −16.2 (−39.7, 12.5) | <.001 |
| Percentage change in total cholesterol-to-high-density lipoprotein ratio | +14.0 (−4.8, 40.0) | +11.7 (−6.1, 40.7) | +12.7 (−5.2, 40.3) | .895 |
| ASCVD riska | ||||
| Change in ASCVD risk score | +0.4 (−0.1, 1.5) | +0.7 (0.0, 1.6) | +0.5 (−0.1, 1.6) | .187 |
| Worsening ASCVD risk categoryb | .298 | |||
| No change | 226 (76.4%) | 219 (77.7%) | 445 (77.0%) | |
| Improved risk category | 20 (6.8%) | 11 (3.9%) | 31 (5.4%) | |
| Worsened risk category | 50 (16.9% | 52 (18.4%) | 102 (17.6%) |
Data are median (interquartile range) or n (%) unless otherwise stated.
The bolded values are those <.05 (level of significance).
Abbreviation: ASCVD, atherosclerotic cardiovascular disease; BP, blood pressure; HTN, hypertension.
aASCVD risk: prediction score of percentage risk of having a major cardiovascular event in 10 y, calculated for all participants aged 40–79 y using the American College of Cardiology equation with input of age, sex, race, systolic BP, diastolic BP, total cholesterol, high-density lipoprotein cholesterol, history of diabetes, smoking status, and HTN treatment status, available at https://tools.acc.org/ascvd-risk-estimator-plus/#!/calculate/estimate.
bASCVD risk category: 10-year categories are defined as: low (<5% risk), borderline (5%–7.4% risk), intermediate (7.5%–19.9% risk), or high (≥20% risk).
Change in Cardiovascular Risk Parameters Among Virally Suppressed Adults Randomized to Switch to Dolutegravir or Remain on Protease Inhibitor Over 48 wk of Follow up
| Parameter . | Dolutegravir N = 389 . | Ritonavir-boosted Protease Inhibitor N = 388 . | Total N = 777 . | P Value . |
|---|---|---|---|---|
| Blood pressure | ||||
| Incident hypertension | 48/292 (16.4%) | 46/295 (15.6%) | 94/587 (16.0%) | .868 |
| Change in systolic blood pressure, mm Hg | +3 (−6, 14) | +5 (−4, 13) | +4 (−4, 14) | .692 |
| Change in diastolic blood pressure, mm Hg | +5 (−2, 11) | +4 (−3, 10) | +4.0 (−2, 11) | .099 |
| Anthropometric measures | ||||
| Change in weight, kg | +1.5 (−1.0, 4.0) | +1.0 (−1.5, 3.0) | 1.0 (−1.0, 3.5) | .019 |
| ≥5% increase in weight | 123 (31.7%) | 80 (20.8%) | 203 (26.3%) | <.001 |
| Change in body mass index, kg/m2 | +0.6 (−0.4, 1.5) | 0.3 (−0.6, 1.1) | 0.4 (−0.4, 1.3) | .023 |
| Percentage change in waist-to-hip circumference ratio | +0.6 (−3.6, 4.5) | +0.2 (−3.5, 4.1) | +0.4 (−3.6, 4.4) | .436 |
| Metabolic assays | ||||
| Incident hyperglycemia | 18/363 (5%) | 13/370 (3.5%) | 31/733 (4.2%) | .430 |
| Incident dyslipidemia | 42/332 (12.7%) | 47/327 (14.4%) | 89/659 (13/5%) | .594 |
| Percentage change in low-density lipoprotein | +5.1 (−12.2, 27.6) | +11.8 (−6.3, 35.6) | +9.4 (−10.0, 32.4) | .005 |
| Percentage change in high-density lipoprotein | −18.3 (−37.9, 1.9) | −13.0 (−32.4, 7.3) | −16.4 (−35.2, 4.3) | .017 |
| Percentage change in total cholesterol | −7.0 (−18.5, 5.5) | −1.9 (−13.2, 12.7) | −4.1 (−16.3, 9.4) | <.001 |
| Percentage change in triglycerides | −25.5 (−44.4, 3.0) | −6.5 (−30.6, 22.7) | −16.2 (−39.7, 12.5) | <.001 |
| Percentage change in total cholesterol-to-high-density lipoprotein ratio | +14.0 (−4.8, 40.0) | +11.7 (−6.1, 40.7) | +12.7 (−5.2, 40.3) | .895 |
| ASCVD riska | ||||
| Change in ASCVD risk score | +0.4 (−0.1, 1.5) | +0.7 (0.0, 1.6) | +0.5 (−0.1, 1.6) | .187 |
| Worsening ASCVD risk categoryb | .298 | |||
| No change | 226 (76.4%) | 219 (77.7%) | 445 (77.0%) | |
| Improved risk category | 20 (6.8%) | 11 (3.9%) | 31 (5.4%) | |
| Worsened risk category | 50 (16.9% | 52 (18.4%) | 102 (17.6%) |
| Parameter . | Dolutegravir N = 389 . | Ritonavir-boosted Protease Inhibitor N = 388 . | Total N = 777 . | P Value . |
|---|---|---|---|---|
| Blood pressure | ||||
| Incident hypertension | 48/292 (16.4%) | 46/295 (15.6%) | 94/587 (16.0%) | .868 |
| Change in systolic blood pressure, mm Hg | +3 (−6, 14) | +5 (−4, 13) | +4 (−4, 14) | .692 |
| Change in diastolic blood pressure, mm Hg | +5 (−2, 11) | +4 (−3, 10) | +4.0 (−2, 11) | .099 |
| Anthropometric measures | ||||
| Change in weight, kg | +1.5 (−1.0, 4.0) | +1.0 (−1.5, 3.0) | 1.0 (−1.0, 3.5) | .019 |
| ≥5% increase in weight | 123 (31.7%) | 80 (20.8%) | 203 (26.3%) | <.001 |
| Change in body mass index, kg/m2 | +0.6 (−0.4, 1.5) | 0.3 (−0.6, 1.1) | 0.4 (−0.4, 1.3) | .023 |
| Percentage change in waist-to-hip circumference ratio | +0.6 (−3.6, 4.5) | +0.2 (−3.5, 4.1) | +0.4 (−3.6, 4.4) | .436 |
| Metabolic assays | ||||
| Incident hyperglycemia | 18/363 (5%) | 13/370 (3.5%) | 31/733 (4.2%) | .430 |
| Incident dyslipidemia | 42/332 (12.7%) | 47/327 (14.4%) | 89/659 (13/5%) | .594 |
| Percentage change in low-density lipoprotein | +5.1 (−12.2, 27.6) | +11.8 (−6.3, 35.6) | +9.4 (−10.0, 32.4) | .005 |
| Percentage change in high-density lipoprotein | −18.3 (−37.9, 1.9) | −13.0 (−32.4, 7.3) | −16.4 (−35.2, 4.3) | .017 |
| Percentage change in total cholesterol | −7.0 (−18.5, 5.5) | −1.9 (−13.2, 12.7) | −4.1 (−16.3, 9.4) | <.001 |
| Percentage change in triglycerides | −25.5 (−44.4, 3.0) | −6.5 (−30.6, 22.7) | −16.2 (−39.7, 12.5) | <.001 |
| Percentage change in total cholesterol-to-high-density lipoprotein ratio | +14.0 (−4.8, 40.0) | +11.7 (−6.1, 40.7) | +12.7 (−5.2, 40.3) | .895 |
| ASCVD riska | ||||
| Change in ASCVD risk score | +0.4 (−0.1, 1.5) | +0.7 (0.0, 1.6) | +0.5 (−0.1, 1.6) | .187 |
| Worsening ASCVD risk categoryb | .298 | |||
| No change | 226 (76.4%) | 219 (77.7%) | 445 (77.0%) | |
| Improved risk category | 20 (6.8%) | 11 (3.9%) | 31 (5.4%) | |
| Worsened risk category | 50 (16.9% | 52 (18.4%) | 102 (17.6%) |
Data are median (interquartile range) or n (%) unless otherwise stated.
The bolded values are those <.05 (level of significance).
Abbreviation: ASCVD, atherosclerotic cardiovascular disease; BP, blood pressure; HTN, hypertension.
aASCVD risk: prediction score of percentage risk of having a major cardiovascular event in 10 y, calculated for all participants aged 40–79 y using the American College of Cardiology equation with input of age, sex, race, systolic BP, diastolic BP, total cholesterol, high-density lipoprotein cholesterol, history of diabetes, smoking status, and HTN treatment status, available at https://tools.acc.org/ascvd-risk-estimator-plus/#!/calculate/estimate.
bASCVD risk category: 10-year categories are defined as: low (<5% risk), borderline (5%–7.4% risk), intermediate (7.5%–19.9% risk), or high (≥20% risk).
This PDF is available to Subscribers Only
View Article Abstract & Purchase OptionsFor full access to this pdf, sign in to an existing account, or purchase an annual subscription.
