Background
Methods
Trial design
Selection of randomized controlled trials indexed in PubMed
Abstract construction
Abstract with no mention of funding source and CoI | Abstract reporting funding source only | Abstract reporting funding source and CoI |
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Efficacy and safety of experimental treatment A in combination with treatment B and treatment c in patients with mixed dyslipidemia. | Efficacy and safety of experimental treatment A in combination with treatment B and treatment c in patients with mixed dyslipidemia. | Efficacy and safety of experimental treatment A in combination with treatment B and treatment c in patients with mixed dyslipidemia. |
AUTHORS: Thomson MR; Cook A; Pettigrew GE; Bower G; Bishop D; Potter LM; Alyn JC |
AUTHORS: Thomson MR; Cook A; Pettigrew GE; Bower G; Bishop D; Potter LM; Alyn JC |
AUTHORS: Thomson MR; Cook A; Pettigrew GE; Bower G; Bishop D; Potter LM; Alyn JC |
BACKGROUND: Treatment B and treatment C combination therapy may be insufficient to improve lipid and nonlipid parameters beyond low-density lipoprotein cholesterol (LDL-C) in patients with mixed dyslipidemia. |
BACKGROUND: Treatment B and treatment C combination therapy may be insufficient to improve lipid and nonlipid parameters beyond low-density lipoprotein cholesterol (LDL-C) in patients with mixed dyslipidemia. |
BACKGROUND: Treatment B and treatment C combination therapy may be insufficient to improve lipid and nonlipid parameters beyond low-density lipoprotein cholesterol (LDL-C) in patients with mixed dyslipidemia. |
METHODS: In this phase 3, multicenter, double-blind study, a total of 543 patients with triglycerides >/=150 mg/dL and <400 mg/dL, high-density lipoprotein cholesterol (HDL-C) <40 mg/dL (<50 mg/dL for women), and LDL-C >/=130 mg/dL were randomized to 12 weeks of treatment with experimental treatment A 135 mg or placebo, each coadministered with treatment B 40 mg + treatment C 10 mg (treatment BC). |
METHODS: In this phase 3, multicenter, double-blind study, a total of 543 patients with triglycerides >/=150 mg/dL and <400 mg/dL, high-density lipoprotein cholesterol (HDL-C) <40 mg/dL (<50 mg/dL for women), and LDL-C >/=130 mg/dL were randomized to 12 weeks of treatment with experimental treatment A 135 mg or placebo, each coadministered with treatment B 40 mg + treatment C 10 mg (treatment BC). |
METHODS: In this phase 3, multicenter, double-blind study, a total of 543 patients with triglycerides >/=150 mg/dL and <400 mg/dL, high-density lipoprotein cholesterol (HDL-C) <40 mg/dL (<50 mg/dL for women), and LDL-C >/=130 mg/dL were randomized to 12 weeks of treatment with experimental treatment A 135 mg or placebo, each coadministered with treatment B 40 mg + treatment C 10 mg (treatment BC). |
RESULTS: Both treatment regimens lowered LDL-C by >50%; however, experimental treatment A and treatment BC resulted in significantly (P < .001) greater improvements in HDL-C (13.0% vs 4.2%), triglycerides (-57.3% vs -39.7%), non-HDL-C (-55.6% vs -51.0%), and apoprotein B (-49.1% vs -44.7%) compared with treatment BC. Overall, adverse events were similar in the 2 treatment groups. No unexpected muscle, hepatic, or renal safety signals were identified with either treatment combination. |
RESULTS: Both treatment regimens lowered LDL-C by >50%; however, experimental treatment A and treatment BC resulted in significantly (P < .001) greater improvements in HDL-C (13.0% vs 4.2%), triglycerides (-57.3% vs -39.7%), non-HDL-C (-55.6% vs -51.0%), and apoprotein B (-49.1% vs -44.7%) compared with treatment BC. Overall, adverse events were similar in the 2 treatment groups. No unexpected muscle, hepatic, or renal safety signals were identified with either treatment combination. |
RESULTS: Both treatment regimens lowered LDL-C by >50%; however, experimental treatment A and treatment BC resulted in significantly (P < .001) greater improvements in HDL-C (13.0% vs 4.2%), triglycerides (-57.3% vs -39.7%), non-HDL-C (-55.6% vs -51.0%), and apoprotein B (-49.1% vs -44.7%) compared with treatment BC. Overall, adverse events were similar in the 2 treatment groups. No unexpected muscle, hepatic, or renal safety signals were identified with either treatment combination. |
CONCLUSIONS: In patients with mixed dyslipidemia, the combination of experimental treatment A + treatment BC significantly improved lipid and nonlipid parameters compared with treatment BC and was generally well tolerated. |
CONCLUSIONS: In patients with mixed dyslipidemia, the combination of experimental treatment A + treatment BC significantly improved lipid and nonlipid parameters compared with treatment BC and was generally well tolerated. |
CONCLUSIONS: In patients with mixed dyslipidemia, the combination of experimental treatment A + treatment BC significantly improved lipid and nonlipid parameters compared with treatment BC and was generally well tolerated. |
FUNDING: Abbott. |
FUNDING: Abbott. | |
CONFLICTS OF INTEREST: MRT, AC and GEP declared financial interest and/or other relationships with Abbott. GB, DB, LMP and JCA are employees of Abbott. |
Selection of general practitioners and recruitment procedures
Randomization and blinding of general practitioners
Outcomes
Sample size
Statistical analysis
Results
General practitioner characteristics
GP characteristics | All GPs number = 354 | Abstracts with no mention of funding source or CoI number = 118 | Abstracts reporting funding source only number = 118 | Abstracts reporting funding source and CoI number = 118 |
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Gender (male) - number (%) | 227 (64.9) | 78 (66.7) | 76 (65.5) | 73 (62.4) |
Age, years - median (Q1 to Q3) | 51.4 (36.4; 57.3) | 48.7 (37.1; 56.3) | 51.8 (36.2; 57.6) | 52.7 (37.4; 57.2) |
Receive fees from pharmaceutical industry - number (%) | 75 (21.6) | 30 (26.3) | 20 (17.1) | 25 (21.6) |
For performing a presentation | 22 (6.3) | 8 (7.0) | 7 (6.0) | 7 (6.0) |
For consulting | 16 (4.6) | 4 (3.5) | 6 (5.1) | 6 (5.2) |
For enrolling patients in a trial | 60 (17.3) | 26 (22.8) | 18 (15.4) | 16 (13.8) |
Participate (current or past) in a trial funded by pharmaceutical industry – number (%) | 151 (43.5) | 54 (47.4) | 47 (40.2) | 50 (43.1) |
Receive visits from medical representatives of pharmaceutical industry - number (%) | ||||
None | 174 (50.1) | 56 (49.1) | 59 (50.4) | 59 (50.9) |
1 to 5 per month | 84 (24.2) | 30 (26.3) | 25 (21.4) | 29 (25.0) |
6 to 10 per month | 54 (15.6) | 17 (14.9) | 21 (17.9) | 16 (13.8) |
>10 per month | 35 (10.1) | 11 (9.6) | 12 (10.3) | 12 (10.3) |
General practitioners’ confidence in abstract conclusions
Abstracts with no mention of funding source or CoI number = 118 | Abstracts reporting funding source only number = 118 | Abstracts reporting funding source and CoI number = 118 | Abstracts reporting funding source only versus no mention of funding source or CoI | Abstracts reporting funding source and CoI versus no mention of funding source or CoI | Abstracts reporting funding source and CoI versus funding source only | |
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Outcomes | Mean (SD) | Mean (SD) | Mean (SD) | Mean difference (95%CI) | Mean difference (95%CI) | Mean difference (95%CI) |
Confidence in the abstract conclusions (scale 0 to 10) | 3.6 (2.6) | 3.8 (2.6) | 3.2 (2.7) | 0.2 (-0.6; 1.0), P = 0.84 | -0.4 (-1.3; 0.4), P = 0.39 | -0.6 (-1.5; 0.2), P = 0.15 |
Methodological quality of the study (scale 0 to 10) | 4.5 (2.7) | 4.6 (2.5) | 4.1 (2.6) | 0.1 (-0.7; 0.9), P = 0.97 | -0.4 (-1.2; 0.4), P = 0.41 | -0.5 (-1.3; 0.3), P = 0.30 |
Treatment benefit in terms of efficacy and safety (scale 0 to 10) | 5.0 (2.8) | 4.8 (2.7) | 4.1 (2.8) | -0.1 (-1.0; 0.7), P = 0.93 | -0.8 (-1.7; 0.02), P = 0.06 | -0.7 (-1.5; 0.1), P = 0.13 |