Table 1
Summary of characteristics of participants enrolled in open-label extension.
| TREATMENT DURING RANDOMIZED PHASE | ||||
|---|---|---|---|---|
| PLACEBO | GMRx2 ¼ | GMRx2 ½ | OVERALL | |
| Participants | 8 (16%) | 21 (42%) | 21 (42%) | 50 (100%) |
| Age, years | 47 (15) | 48 (8) | 50 (7) | 49 (9) |
| Female | 7 (88%) | 13 (62%) | 10 (48%) | 30 (60%) |
| BMI, Kg/m2 | 25.2 (4.2) | 28.0 (3.6) | 24.8 (3.6) | 26.2 (3.9) |
| Race | ||||
| Black or African American | 3 (38%) | 2 (10%) | 4 (19%) | 9 (18%) |
| Asian | 5 (62%) | 19 (90%) | 17 (81%) | 41 (82%) |
| Country | ||||
| Sri Lanka | 5 (62%) | 19 (90%) | 17 (81%) | 41 (82%) |
| Nigeria | 3 (38%) | 2 (10%) | 4 (19%) | 9 (18%) |
| Health conditions | ||||
| Mild congestive heart failure (NYHA class I or II) | 0 (0%) | 1 (5%) | 0 (0%) | 1 (2%) |
| Diabetes mellitus type II | 0 (0%) | 4 (19%) | 0 (0%) | 4 (8%) |
| Dyslipidemia | 3 (38%) | 5 (24%) | 5 (24%) | 13 (26%) |
| Thyroid disease | 0 (0%) | 1 (5%) | 1 (5%) | 2 (4%) |
| Mean (SD) BP at Week 0 | ||||
| Clinic SBP/DBP | 140/84 (8/12) | 137/85 (9/9) | 135/85 (12/9) | 137/85 (10/10) |
| Home SBP/DBP | 137/88 (7/10) | 136/85 (6/8) | 136/84 (6/6) | 136/85 (6/7) |
| Mean BP (SD) at Week 4 | ||||
| Clinic SBP/DBP | 134/83 (11/7) | 130/81 (12/8) | 131/84 (12/9) | 131/83 (12/8) |
| Home SBP/DBP | 135/84 (13/7) | 124/79 (10/8) | 123/77 (11/7) | 126/79 (12/8) |
| Clinic BP ≥140/90 mmHg at Week 4 | 4 (50%) | 2 (10%) | 8 (38%) | 14 (28%) |
| Home BP ≥130/80 mmHg at Week 4 | 7 (88%) | 13 (62%) | 9 (43%) | 29 (58%) |
[i] All values are count (percentage) or mean (standard deviation).
BMI = body mass index; BP = blood pressure; DBP = diastolic blood pressure; NYHA = New York Heart Association.
OLE = Open-label extension; SBP = systolic blood pressure; SD = standard deviation.
Table 2
Blood pressure control rates throughout follow-up.
| N | HOME BP <130/80 mmHg | HOME BP <135/85 mmHg | N | CLINIC BP <140/90 mmHg | |
|---|---|---|---|---|---|
| Week 0 | 50 | 2 (4%) | 13 (26%) | 50 | 23 (46%) |
| Week 4 | 48 | 21 (44%) | 32 (67%) | 50 | 36 (72%) |
| Week 6 | 50 | 27 (54%) | 39 (78%) | 50 | 36 (72%) |
| Week 8 | 49 | 26 (53%) | 42 (86%) | 49 | 35 (71%) |
| Week 16 | 48 | 27 (56%) | 38 (79%) | 49 | 37 (76%) |
| Week 28 | 48 | 33 (69%) | 41 (85%) | 48 | 44 (92%) |
| Week 40 | 48 | 33 (73%) | 40 (83%) | 48 | 44 (92%) |
| Week 52 | 48 | 29 (60%) | 43 (90%) | 48 | 42 (88%) |
[i] All values are number of participants (percentage).
BP = blood pressure; N = number of participants analyzed.
Figure 1
Home systolic blood pressure over time.
Legend: This figure illustrates, during the randomized double-blind period, from week 0 to 4, participants received placebo, GMRx2 ¼, or GMRx2 ½. At week 4, participants entered the open-label extension phase and were switched to GMRx2 ¼ until week 6. From week 6 onward, at each follow-up visit, if home blood pressure was ≥130/80 mmHg, participants were up-titrated according to the following sequence (GMRx2 mixed): GMRx2 ½ → GMRx2 standard → addition of telmisartan 40 mg + amlodipine 5 mg → addition of spironolactone 25 mg.
Table 3
Blood pressure levels throughout follow-up.
| HOME BP MEAN (SD) | CLINIC BP MEAN (SD) | |||||
|---|---|---|---|---|---|---|
| N | SBP | DBP | N | SBP | DBP | |
| Week 0 | 50 | 136 (6) | 85 (7) | 50 | 137 (10) | 85 (10) |
| Week 4 | 48 | 126 (12) | 79 (8) | 50 | 131 (12) | 83 (8) |
| Week 6 | 50 | 123 (9) | 80 (7) | 50 | 127 (11) | 80 (10) |
| Week 8 | 49 | 121 (10) | 78 (6) | 49 | 126 (13) | 79 (10) |
| Week 16 | 48 | 121 (11) | 78 (7) | 49 | 127 (10) | 80 (10) |
| Week 28 | 48 | 120 (12) | 77 (7) | 48 | 122 (11) | 76 (10) |
| Week 40 | 48 | 121 (10) | 77 (7) | 48 | 121 (9) | 76 (9) |
| Week 52 | 48 | 120 (9) | 77 (6) | 48 | 122 (11) | 76 (9) |
[i] BP = blood pressure; DBP = diastolic blood pressure; N = participants; SBP = systolic blood pressure; SD = standard deviation.
Table 4
Safety Outcomes.
| OUTCOME | ALL (N = 50) |
|---|---|
| From Week 4 to Week 52 | |
| Trial treatment discontinuation due to an adverse event | 0 (0%) |
| Adverse events of special interest | 33 (66%) |
| Symptomatic hypotension | 2 (4%) |
| Abnormal laboratory finding | 31 (62%)1 |
| Headache | 1 (2%) |
| Peripheral oedema | 0 (0%) |
| Any other symptom or laboratory abnormality that led to permanent discontinuation of trial medication | 0 (0%) |
| Treatment-related adverse events2 | 2 (4%) |
| Serious adverse event | 2 (4%) |
| Unstable angina | 1 (2%) |
| Acute coronary syndrome | 1 (2%) |
| Acute gastroenteritis | 1 (2%) |
| At Week 52 | |
| Hyponatraemia (sodium <135 mmol/l) | 4 (8%) |
| Hypernatraemia (sodium >145 mmol/l) | 5 (10%) |
| Hypokalaemia (<3.5 mmol/l) | 1 (2%) |
| Hyperkalaemia (>5.5 mmol/l) | 0 (0%) |
[i] Values are number of participants with ≥1 event and are presented as number of participants (%).
1Abnormal lipids (30%), sodium (20%), glucose (18%), uric acid (14%), creatinine (8%), potassium (2%). Total of 11% were reported as clinically significant.
2Those reported by the site investigators as possibly, probably or definitely related.