6/28/23, 12:07 AM ALTITUDE Pathway Feedback Search Clinical Topics Home Studies ALTITUDE ALTITUDE Disease Diabetes mellitus type 2 Trial question What is the role of aliskiren in patients with T2DM and CKD and/or CVD? Study design Multi-center Double blinded RCT Population Characteristics of study participants 32.0% female N = 8561 68.0% male 8561 patients (2735 female, 5826 male) Inclusion criteria: patients with T2DM and CKD and/or CVD Key exclusion criteria: type 1 DM, unstable serum creatinine, congestive HF NYHA class III or IV, renal artery stenosis, malignancy within the past 5 years, renal artery stenosis, under immunosuppressive therapy, or pregnancy Interventions N=4274 aliskiren (at a dose of 300 mg daily plus angiotensin-converting-enzyme inhibitor or an angiotensin-receptor blocker) N=4287 placebo (matching placebo plus angiotensin-converting-enzyme inhibitor or an angiotensin-receptor blocker) https://web.pathway.md/studies/recM9S0zgMcD2pnHp 1/2 6/28/23, 12:07 AM ALTITUDE Pathway Primary outcome Cardiovascular death, cardiac arrest, nonfatal myocardial infarction, nonfatal stroke, unplanned hospitalization for heart failure, end-stage renal disease, renal death, renal replacement therapy, or doubling of baseline serum creatinine 18.3 % 18.3 17.1 13.7 % 9.2 % No significant difference 4.6 % 0.0 % Aliskiren Placebo No significant difference in cardiovascular death, cardiac arrest, nonfatal myocardial infarction, nonfatal stroke, unplanned hospitalization for HF, end-stage renal disease, renal death, RRT, or doubling of the baseline serum creatinine (18.3% vs. 17.1%; HR 1.08, 95% CI 0.98 to 1.2) Secondary outcomes No significant difference in cardiovascular events (13.8% vs. 12.6%; HR 1.11, 95% CI 0.99 to 1.25) No significant difference in renal events (6% vs. 5.9%; HR 1.03, 95% CI 0.87 to 1.23) Safety outcomes Significant differences in discontinuation of study drug (33.8% vs. 28.4%, p = 0.001) and discontinuation due to an adverse event (13.2% vs. 10.2%, p < 0.001); hyperkalemia (11.2% vs. 7.2%, p < 0.001), and hypotension (12.1% vs. 8.3%, p < 0.001). Conclusion In patients with T2DM and CKD and/or CVD, aliskiren was not superior to placebo with respect to cardiovascular death, cardiac arrest, nonfatal myocardial infarction, nonfatal stroke, unplanned hospitalization for HF, end-stage renal disease, renal death, RRT, or doubling of the baseline serum creatinine. Reference Parving HH, Brenner BM, McMurray JJ et al. Cardiorenal end points in a trial of aliskiren for type 2 diabetes. N Engl J Med. 2012 Dec 6;367(23):2204-13. Open reference URL https://web.pathway.md/studies/recM9S0zgMcD2pnHp 2/2