Weber 1991.
Methods | 4‐week placebo phase; inclusion criteria=supine DBP 100‐114 mm Hg; 14‐week double‐blind treatment consisting of 2‐week titration period followed by three 1‐month fixed‐dose treatment periods; after each 1‐month period, patients were advanced to next highest dosage level even if their BP had already responded well to treatment (i.e. forced titration design) | |
Participants | All patients: n=256 (179 males, 77 females); 102 white, 86 black, 65 hispanic, 3 other; mean age=58 (range 27‐83) years; baseline SBP/DBP not reported Group 1 (terazosin 1, 2, 5 mg): n=63; baseline SBP/DBP not reported Group 2 (terazosin 5, 10, 20 mg): n=64; baseline SBP/DBP not reported Group 3( terazosin 20, 40, 80 mg): n=66; baseline SBP/DBP not reported Placebo: n=63; baseline SBP/DBP not reported |
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Interventions | Terazosin 1 mg during first month, 2 mg during second month, 5 mg during third month Terazosin 5 mg during first month, 10 mg during second month, 20 mg during third month Terazosin 20 mg during first month, 40 mg during second month, 80 mg during third month Placebo during each of the three 1‐month segments Administered as single oral dose between 8 and 10 AM each morning |
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Outcomes | Mean change from baseline in trough standing SBP/DBP using mercury sphygmomanometer Mean change from baseline in trough supine SBP/DBP using mercury sphygmomanometer |
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Notes | Data for Group 1 after third month (terazosin 5mg) reported only; SBP change and SD not reported; DBP change reported; DBP SD of change not reported, endpoint BP and SD not reported; baseline BP and SD not reported; imputed overal trial mean SD of change for DBP; BP data from text, pp. 907‐8 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described. |
Allocation concealment (selection bias) | Unclear risk | Not described. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not described. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Method of analysis (intention‐to‐treat or per protocol) not reported. Losses to follow‐up and withdrawals from study not reported. Unclear how dropouts were dealt with. |
Selective reporting (reporting bias) | High risk | Quote: "This report provides only a preliminary analysis of the blood pressure data obtained in this study." BP data for Groups 1‐3 not extractable from Figure 2, p. 907. BP data for placebo group not provided in Figure 2. Only DBP data for Group 1 and placebo after third month reported in text; BP data for Groups 2 and 3 not reported in text. Safety/tolerability data not reported. |
Other bias | High risk | Funding source is manufacturer of terazosin (Abbott). |
BP = blood pressure; SBP = systolic blood pressure; DBP = diastolic blood pressure; PP = pulse pressure; HR = heart rate; bpm = beats per minute; WDAE = withdrawals due to adverse effects; SD = standard deviation; SE = standard error; 95% CI = 95% confidence interval