Kanyini Guidelines Adherence with the Polypill (Kanyini GAP)

Transcription

1 Kanyini Guidelines Adherence with the Polypill (Kanyini GAP)

2 Disclosures Funded by the National Health and Medical Research Council of Australia. Dr Reddy s Laboratories Ltd manufactured and supplied polypills for this trial free of charge. The George Institute for Global Health has secured an exclusive global license for the polypills used in this trial following a commercial decision by Dr Reddy s Laboratories Ltd not to proceed with taking the products to market.

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4 Primary Hypotheses Among individuals at high risk of a cardiovascular event, a polypill-based strategy compared with usual care will result in: Greater use of indicated combination treatment (use of antiplatelet, statin and at least two blood pressure lowering medications) Lower systolic blood pressure Lower total cholesterol

5 Study design Patients with established cardiovascular disease Patients without CVD who are at high risk and indicated antiplatelet, statin and 2 BP lowering drugs (N=1000 Indigenous and non-indigenous) Randomisation Treatment strategy based on the polypill (n=500) Continued usual care (n=500) Scheduled end of follow-up (average 18 months)

6 Polypill formulations Version 1 (post MI) aspirin 75mg simvastatin 40mg lisinopril 10mg atenolol 50mg Version 2 (post stroke) aspirin 75mg simvastatin 40mg lisinopril 10mg hydrochlorothiazide 12.5mg

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8 Follow up 623 participants randomised Median 18 months follow-up Completeness: Adherence: 98% Blood pressure: 91% Total cholesterol: 83%

9 Baseline characteristics Polypill strategy n=311 Age (years) 63.4 (12.5) 63.7 (12.7) Usual care n=312 Male 197 (63.3%) 195 (62.7%) Indigenous identification 153 (49.2%) 162 (52.1%) Established CVD 183 (58.8%) 198 (63.4%) SBP (mmhg) (18.5) (20.5) Total cholesterol (mmol/l) 4.4 (1.1) 4.5 (1.2) Combination treatment* 151 (48.6%) 160 (51.3%) * Self-reported use of aspirin + a statin + at least 2 BP lowering medications

10 Primary outcomes Outcome Polypill n=311 Usual n=312 Treatment effect (95% CI) P-value Use of combination treatment* Systolic blood pressure (mmhg) Total cholesterol (mmol/l) 70.1% 46.9% 1.49 (1.30, 1.72) < (-4.0, 1.0) (-0.06, 0.22) 0.26 * Self-reported use of aspirin + a statin + at least 2 BP lowering medications

11 Secondary outcomes Outcome Polypill n=311 Usual n=312 Treatment effect (95% CI) P- value Prescription at study 79.3% 51.5% 1.54 (1.36, 1.74) <0.001 end* (%) All CVD events 26 (8.4%) 22 (7.1%) 1.15 (0.65, 2.03) 0.62 All renal events 56 (18.0%) 46 (14.7%) 1.17 (0.80, 1.74) 0.42 * Combination treatment: aspirin + a statin + at least 2 BP lowering medications

12 Self-reported combination medication use

13 Polypill discontinuations 90 (28.9%) discontinued polypill; of these, 5% recommenced polypill and 28% reported use of (separate) combination treatment at the final visit Main reasons for permanent withdrawal: Choice of treating GP (34%) Choice of participant (17%) Stopped by specialist or in hospital (13%) Cough (12%) Dizziness / hypotension (5%)

14 Statin use Polypill-based strategy associated with ~10% relative greater use of statins At final visit, 17% of polypill group participants on a statin were taking atorvastatin or rosuvastatin At final visit, 67% of usual care group participants on a statin were taking atorvastatin or rosuvastatin

15 Conclusions Polypill-based strategy significantly improves self-reported medication use Trial under-powered for BP and cholesterol, but use of more potent statins in the usual care group may have influenced the results for cholesterol

16 Conclusions Greater benefits on medication use in primary prevention group and those not taking combination treatment at baseline Economic analysis and process evaluation will be important in determining the potential role of polypill-based strategies