Schram 2005.
Methods | Allocation: randomized Blinding: double‐blinded Duration: 12 months Funding: "AstraZeneca provided funding for this clinical trial (to CDAS), but had no influence on the data analyses or manuscript preparation." |
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Participants | Diagnosis: not reported N = 60 Age: Lisinopril group 62 ± 8 years; Candesartan group 60 ± 7 years; HCTZ group 63 ± 6 years Sex: 45% women; 55% men History: not reported Inclusion criteria: for the run‐in period were: T2DM ≥ 6 months (WHO criteria 1985); age 35‐70 years; "Caucasian ethnicity"; and urinary albumin excretion < 100 mg/24 hours. Patients with a sitting BP > 140/90 mmHg and < 190/120 mmHg after the run‐in period had an ECG. Participants were included if LVMI 490 g/m² in men or 470 g/m² in women Exclusion criteria: pregnancy or planning a pregnancy; a history of MI, angina pectoris, coronary artery bypass surgery, angioplasty, stroke, CHF, malignancy or other serious illnesses; serum creatinine > 140 mmol/L; body mass index 435 kg/m²; alcohol or drug abuse, or both; or participation in other clinical trials |
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Interventions | RAS inhibitor: lisinopril, candesartan; thiazide: HCTZ HCTZ 12.5 mg daily Candesartan 8 mg daily Lisinopril 10 mg daily Add‐on: consecutively, 12.5 mg HCTZ, doubling study medication; 5 mg felodipine, 50 mg metoprolol, 2 mg doxazosin, 5mg felodipine; 50 mg metoprolol, 2 mg doxazosin, 5 mg felodipine, 100 mg metoprolol, and 4 mg doxazosin |
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Outcomes | BP after 5 min of seated rest (mean of 3 consecutive measurements) | |
Notes | Participants were limited to people of "Caucasian ethnicity". The reason was not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of sequence generation was not described |
Allocation concealment (selection bias) | Unclear risk | Method of concealment was not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blinded |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Method of blinding was not described |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing data were unlikely to have an impact on the results of the trial |
Selective reporting (reporting bias) | Low risk | Outcomes listed in the methods were all reported |
Other bias | Unclear risk | Although the role of company was unlikely to have an impact on the study, no other information was found to evaluate the risk as either high or low |