Empagliflozin Does Not Cause Interstitial Lung Disease
Based on extensive cardiovascular outcomes trials and safety data, empagliflozin has not been associated with interstitial lung disease (ILD) in patients with type 2 diabetes. In fact, recent evidence suggests empagliflozin may actually reduce respiratory complications.
Evidence from Major Clinical Trials
The landmark EMPA-REG OUTCOME trial, which followed 7,020 patients with type 2 diabetes over a median of 3.1 years, did not report interstitial lung disease as an adverse event 1. This trial comprehensively evaluated safety outcomes and found empagliflozin reduced cardiovascular death by 38% and all-cause mortality by 32% compared to placebo 1.
The EMPEROR-Preserved trial, involving 5,988 patients followed for a median of 26.2 months, similarly showed no signal for ILD 2. Instead, this study demonstrated that empagliflozin reduced the composite outcome of cardiovascular death or heart failure hospitalization by 21% 2.
Protective Effects on Respiratory Outcomes
Contrary to causing lung disease, empagliflozin appears to have protective effects on the respiratory system:
In the EMPEROR-Preserved analysis, empagliflozin reduced the incidence of lower respiratory tract infections by 17% compared to placebo (5.2 vs 6.2 events per 100 person-years; HR 0.83,95% CI 0.71-0.96, p=0.014) 3
Preclinical studies demonstrate that empagliflozin protects against pulmonary ischemia/reperfusion injury through ERK1/2-mediated signaling pathways, reducing lung edema, structural damage, and inflammatory cytokine production 4
Established Safety Profile
Multiple guidelines and comprehensive reviews confirm empagliflozin's favorable safety profile 2, 5. The recognized adverse events include:
- Genital mycotic infections (most common, particularly in women) 6, 7, 1
- Euglycemic diabetic ketoacidosis (rare but serious; requires discontinuation 3-4 days before surgery) 8, 6
- Volume depletion (particularly in elderly patients, those on diuretics, or with renal impairment) 6
- Hypoglycemia (only when combined with insulin or insulin secretagogues) 6
Common Pitfalls to Avoid
Do not confuse empagliflozin's safety profile with other drug classes. Unlike saxagliptin (a DPP-4 inhibitor), which increased heart failure hospitalizations, empagliflozin reduces heart failure risk by 35% 2. Unlike canagliflozin (another SGLT2 inhibitor), empagliflozin has not been associated with increased amputation or bone fracture risk 5.
Interstitial lung disease is not a recognized adverse effect of empagliflozin and should not influence prescribing decisions in patients with type 2 diabetes who would otherwise benefit from this medication's proven cardiovascular and renal protective effects 2, 7, 5.