Breast Cancer ICYMI

Key clinical point: In estrogen receptor-positive/human epidermal growth factor receptor-positive (ER+/HER2+) breast cancer (BC), HER2-enriched (HER2-E) tumors were more likely to respond poorly to aromatase inhibitor (AI) therapy and pose an increased risk for disease recurrence.

Major finding: AI-treated HER2-E tumors were associated with poorer Ki67 response and higher Ki67 expression level at 2-weeks timepoint compared with luminal A and B tumors (odds ratio 1.52-12.31; false discovery rate < 0.0001). HER2-E subtype was an independent predictor of shorter time to recurrence (hazard ratio 2.55; P   =   .022).

Study details: Findings are from the phase 3 POETIC trial including 342 patients with early ER+/HER2+ BC who were assigned to 2 weeks of perisurgical AI (n = 237) or no AI (n = 105).

Disclosures: This study was funded by Cancer Research UK. Some authors declared holding or filing patents or receiving grants, nonfinancial support, consulting fees, honoraria, or research funding from several sources.

Source: Bergamino MA et al. HER2-enriched subtype and novel molecular subgroups drive aromatase inhibitor resistance and an increased risk of relapse in early ER+/HER2+ breast cancer. EBioMedicine. 2022;83:104205 (Aug 16). Doi: 10.1016/j.ebiom.2022.104205

Key clinical point: In estrogen receptor-positive/human epidermal growth factor receptor-positive (ER+/HER2+) breast cancer (BC), HER2-enriched (HER2-E) tumors were more likely to respond poorly to aromatase inhibitor (AI) therapy and pose an increased risk for disease recurrence.

Major finding: AI-treated HER2-E tumors were associated with poorer Ki67 response and higher Ki67 expression level at 2-weeks timepoint compared with luminal A and B tumors (odds ratio 1.52-12.31; false discovery rate < 0.0001). HER2-E subtype was an independent predictor of shorter time to recurrence (hazard ratio 2.55; P   =   .022).

Study details: Findings are from the phase 3 POETIC trial including 342 patients with early ER+/HER2+ BC who were assigned to 2 weeks of perisurgical AI (n = 237) or no AI (n = 105).

Disclosures: This study was funded by Cancer Research UK. Some authors declared holding or filing patents or receiving grants, nonfinancial support, consulting fees, honoraria, or research funding from several sources.

Source: Bergamino MA et al. HER2-enriched subtype and novel molecular subgroups drive aromatase inhibitor resistance and an increased risk of relapse in early ER+/HER2+ breast cancer. EBioMedicine. 2022;83:104205 (Aug 16). Doi: 10.1016/j.ebiom.2022.104205

Key clinical point: In estrogen receptor-positive/human epidermal growth factor receptor-positive (ER+/HER2+) breast cancer (BC), HER2-enriched (HER2-E) tumors were more likely to respond poorly to aromatase inhibitor (AI) therapy and pose an increased risk for disease recurrence.

Major finding: AI-treated HER2-E tumors were associated with poorer Ki67 response and higher Ki67 expression level at 2-weeks timepoint compared with luminal A and B tumors (odds ratio 1.52-12.31; false discovery rate < 0.0001). HER2-E subtype was an independent predictor of shorter time to recurrence (hazard ratio 2.55; P   =   .022).

Study details: Findings are from the phase 3 POETIC trial including 342 patients with early ER+/HER2+ BC who were assigned to 2 weeks of perisurgical AI (n = 237) or no AI (n = 105).

Disclosures: This study was funded by Cancer Research UK. Some authors declared holding or filing patents or receiving grants, nonfinancial support, consulting fees, honoraria, or research funding from several sources.

Source: Bergamino MA et al. HER2-enriched subtype and novel molecular subgroups drive aromatase inhibitor resistance and an increased risk of relapse in early ER+/HER2+ breast cancer. EBioMedicine. 2022;83:104205 (Aug 16). Doi: 10.1016/j.ebiom.2022.104205

Key clinical point: Patients with human epidermal growth factor receptor 2-positive (ERBB2+) and triple-negative breast cancer (TNBC) are more likely to need radiation for brain metastasis (BRM) than those with other BC subtypes.

Major finding: At the 3-year timepoint, the cumulative incidences of BRM was highest in patients with ERBB2+/hormone receptor-negative (HR−) BC (25.3%). TNBC (hazard ratio 4.25), ERBB2+/HR+ BC (hazard ratio 1.94), and ERBB2+/HR− BC (hazard ratio 2.81; all P < .001) were associated with a shorter time from BC diagnosis to brain radiotherapy than HR+/ERBB2− BC. Patients who received radiotherapy for BRM were more likely to have TNBC or ERBB2+ BC than HR+/ERBB2− BC (P < .001).

Study details: Findings are from a retrospective, observational population-based cohort study including 3916 patients with metastatic BC, of which 31.0% had HR+/ERBB2− BC, 7.9% had ERBB2+/HR+ BC, 5.1% had ERBB2+/HR− BC, and 6.6% had TNBC.

Disclosures: This research was supported by Eli Lilly. Some authors declared serving as consultants, board members, or speakers or receiving grants or personal fees from several sources, including Eli Lilly.

Source: Wang XY et al. Analysis of rates of brain metastases and association with breast cancer subtypes in Ontario, Canada. JAMA Netw Open. 2022;5(8):e2225424 (Aug 12). Doi: 10.1001/jamanetworkopen.2022.25424

Key clinical point: Patients with human epidermal growth factor receptor 2-positive (ERBB2+) and triple-negative breast cancer (TNBC) are more likely to need radiation for brain metastasis (BRM) than those with other BC subtypes.

Major finding: At the 3-year timepoint, the cumulative incidences of BRM was highest in patients with ERBB2+/hormone receptor-negative (HR−) BC (25.3%). TNBC (hazard ratio 4.25), ERBB2+/HR+ BC (hazard ratio 1.94), and ERBB2+/HR− BC (hazard ratio 2.81; all P < .001) were associated with a shorter time from BC diagnosis to brain radiotherapy than HR+/ERBB2− BC. Patients who received radiotherapy for BRM were more likely to have TNBC or ERBB2+ BC than HR+/ERBB2− BC (P < .001).

Study details: Findings are from a retrospective, observational population-based cohort study including 3916 patients with metastatic BC, of which 31.0% had HR+/ERBB2− BC, 7.9% had ERBB2+/HR+ BC, 5.1% had ERBB2+/HR− BC, and 6.6% had TNBC.

Disclosures: This research was supported by Eli Lilly. Some authors declared serving as consultants, board members, or speakers or receiving grants or personal fees from several sources, including Eli Lilly.

Source: Wang XY et al. Analysis of rates of brain metastases and association with breast cancer subtypes in Ontario, Canada. JAMA Netw Open. 2022;5(8):e2225424 (Aug 12). Doi: 10.1001/jamanetworkopen.2022.25424

Key clinical point: Patients with human epidermal growth factor receptor 2-positive (ERBB2+) and triple-negative breast cancer (TNBC) are more likely to need radiation for brain metastasis (BRM) than those with other BC subtypes.

Major finding: At the 3-year timepoint, the cumulative incidences of BRM was highest in patients with ERBB2+/hormone receptor-negative (HR−) BC (25.3%). TNBC (hazard ratio 4.25), ERBB2+/HR+ BC (hazard ratio 1.94), and ERBB2+/HR− BC (hazard ratio 2.81; all P < .001) were associated with a shorter time from BC diagnosis to brain radiotherapy than HR+/ERBB2− BC. Patients who received radiotherapy for BRM were more likely to have TNBC or ERBB2+ BC than HR+/ERBB2− BC (P < .001).

Study details: Findings are from a retrospective, observational population-based cohort study including 3916 patients with metastatic BC, of which 31.0% had HR+/ERBB2− BC, 7.9% had ERBB2+/HR+ BC, 5.1% had ERBB2+/HR− BC, and 6.6% had TNBC.

Disclosures: This research was supported by Eli Lilly. Some authors declared serving as consultants, board members, or speakers or receiving grants or personal fees from several sources, including Eli Lilly.

Source: Wang XY et al. Analysis of rates of brain metastases and association with breast cancer subtypes in Ontario, Canada. JAMA Netw Open. 2022;5(8):e2225424 (Aug 12). Doi: 10.1001/jamanetworkopen.2022.25424

Key clinical point: Lapatinib demonstrated excellent survival outcomes in patients with small, node-negative, human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC), when used in combination with trastuzumab, but not when used as a substitute for trastuzumab.

Major finding: The 7-year disease-free survival (DFS) rate in the overall cohort was excellent (88.1%), with improved DFS outcomes observed in the trastuzumab (89.6%), trastuzumab followed by lapatinib (89.0%), and trastuzumab+lapatinib (89.1%) arms, but not as much in the lapatinib-only arm (84.3%; stratified log-rank P   =   .031).

Study details: Findings are from a subanalysis of the phase 3 ALTTO trial including 2821 patients with small (pathological tumor size ≤ 3 cm), lymph node-negative, early HER2+ BC who were randomly assigned to receive adjuvant therapy with trastuzumab, lapatinib, trastuzumab followed by lapatinib, or trastuzumab+lapatinib.

Disclosures: The ALTTO trial received funding from GlaxoSmithKline, Novartis Pharma AG, and other sources. Two authors declared being employees of and owning stocks in Novartis. The other authors reported ties with several sources, including Novartis.

Source: Nader-Marta G et al. Outcomes of patients with small and node-negative HER2-positive early breast cancer treated with adjuvant chemotherapy and anti-HER2 therapy-a sub-analysis of the ALTTO study. Br J Cancer. 2022 (Sep 1). Doi: 10.1038/s41416-022-01963-8

Key clinical point: Lapatinib demonstrated excellent survival outcomes in patients with small, node-negative, human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC), when used in combination with trastuzumab, but not when used as a substitute for trastuzumab.

Major finding: The 7-year disease-free survival (DFS) rate in the overall cohort was excellent (88.1%), with improved DFS outcomes observed in the trastuzumab (89.6%), trastuzumab followed by lapatinib (89.0%), and trastuzumab+lapatinib (89.1%) arms, but not as much in the lapatinib-only arm (84.3%; stratified log-rank P   =   .031).

Study details: Findings are from a subanalysis of the phase 3 ALTTO trial including 2821 patients with small (pathological tumor size ≤ 3 cm), lymph node-negative, early HER2+ BC who were randomly assigned to receive adjuvant therapy with trastuzumab, lapatinib, trastuzumab followed by lapatinib, or trastuzumab+lapatinib.

Disclosures: The ALTTO trial received funding from GlaxoSmithKline, Novartis Pharma AG, and other sources. Two authors declared being employees of and owning stocks in Novartis. The other authors reported ties with several sources, including Novartis.

Source: Nader-Marta G et al. Outcomes of patients with small and node-negative HER2-positive early breast cancer treated with adjuvant chemotherapy and anti-HER2 therapy-a sub-analysis of the ALTTO study. Br J Cancer. 2022 (Sep 1). Doi: 10.1038/s41416-022-01963-8

Key clinical point: Lapatinib demonstrated excellent survival outcomes in patients with small, node-negative, human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC), when used in combination with trastuzumab, but not when used as a substitute for trastuzumab.

Major finding: The 7-year disease-free survival (DFS) rate in the overall cohort was excellent (88.1%), with improved DFS outcomes observed in the trastuzumab (89.6%), trastuzumab followed by lapatinib (89.0%), and trastuzumab+lapatinib (89.1%) arms, but not as much in the lapatinib-only arm (84.3%; stratified log-rank P   =   .031).

Study details: Findings are from a subanalysis of the phase 3 ALTTO trial including 2821 patients with small (pathological tumor size ≤ 3 cm), lymph node-negative, early HER2+ BC who were randomly assigned to receive adjuvant therapy with trastuzumab, lapatinib, trastuzumab followed by lapatinib, or trastuzumab+lapatinib.

Disclosures: The ALTTO trial received funding from GlaxoSmithKline, Novartis Pharma AG, and other sources. Two authors declared being employees of and owning stocks in Novartis. The other authors reported ties with several sources, including Novartis.

Source: Nader-Marta G et al. Outcomes of patients with small and node-negative HER2-positive early breast cancer treated with adjuvant chemotherapy and anti-HER2 therapy-a sub-analysis of the ALTTO study. Br J Cancer. 2022 (Sep 1). Doi: 10.1038/s41416-022-01963-8

Key clinical point: Neratinib as monotherapy or in combination with capecitabine showed good survival outcomes and was well tolerated in a real-world setting of patients with advanced human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC) with or without brain metastases (BM).

Major finding: The median progression-free survival (PFS) and overall survival (OS) for all patients were 5.9 months (95% CI 4.9-7.4) and 15.0 months (95% CI 10.4-22.2), respectively, with survival outcomes being similar in patients with vs without BM. PFS and OS were significantly longer with neratinib+capecitabine vs neratinib (P ≤ .001). Diarrhea was the major adverse event (64%) with 10% being grade 3.

Study details: Findings are from a single-center retrospective study including 72 patients with advanced HER2+ BC who received neratinib (n = 27) or neratinib+capecitabine (n = 45). Thirty-eight patients had BM.

Disclosures: This study was supported by the Royal Marsden National Institute for Health and Care Research Biomedical Research Centre for Cancer, UK. The authors declared receiving research funding, speaker’s fees, honoraria, or travel support from several sources.

Source: Cunningham N et al. Neratinib in advanced HER2-positive breast cancer: Experience from the Royal Marsden Hospital. Breast Cancer Res Treat. 2022;195(3):333-340 (Aug 17). Doi: 10.1007/s10549-022-06703-3

Key clinical point: Neratinib as monotherapy or in combination with capecitabine showed good survival outcomes and was well tolerated in a real-world setting of patients with advanced human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC) with or without brain metastases (BM).

Major finding: The median progression-free survival (PFS) and overall survival (OS) for all patients were 5.9 months (95% CI 4.9-7.4) and 15.0 months (95% CI 10.4-22.2), respectively, with survival outcomes being similar in patients with vs without BM. PFS and OS were significantly longer with neratinib+capecitabine vs neratinib (P ≤ .001). Diarrhea was the major adverse event (64%) with 10% being grade 3.

Study details: Findings are from a single-center retrospective study including 72 patients with advanced HER2+ BC who received neratinib (n = 27) or neratinib+capecitabine (n = 45). Thirty-eight patients had BM.

Disclosures: This study was supported by the Royal Marsden National Institute for Health and Care Research Biomedical Research Centre for Cancer, UK. The authors declared receiving research funding, speaker’s fees, honoraria, or travel support from several sources.

Source: Cunningham N et al. Neratinib in advanced HER2-positive breast cancer: Experience from the Royal Marsden Hospital. Breast Cancer Res Treat. 2022;195(3):333-340 (Aug 17). Doi: 10.1007/s10549-022-06703-3

Key clinical point: Neratinib as monotherapy or in combination with capecitabine showed good survival outcomes and was well tolerated in a real-world setting of patients with advanced human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC) with or without brain metastases (BM).

Major finding: The median progression-free survival (PFS) and overall survival (OS) for all patients were 5.9 months (95% CI 4.9-7.4) and 15.0 months (95% CI 10.4-22.2), respectively, with survival outcomes being similar in patients with vs without BM. PFS and OS were significantly longer with neratinib+capecitabine vs neratinib (P ≤ .001). Diarrhea was the major adverse event (64%) with 10% being grade 3.

Study details: Findings are from a single-center retrospective study including 72 patients with advanced HER2+ BC who received neratinib (n = 27) or neratinib+capecitabine (n = 45). Thirty-eight patients had BM.

Disclosures: This study was supported by the Royal Marsden National Institute for Health and Care Research Biomedical Research Centre for Cancer, UK. The authors declared receiving research funding, speaker’s fees, honoraria, or travel support from several sources.

Source: Cunningham N et al. Neratinib in advanced HER2-positive breast cancer: Experience from the Royal Marsden Hospital. Breast Cancer Res Treat. 2022;195(3):333-340 (Aug 17). Doi: 10.1007/s10549-022-06703-3

Key clinical point: Addition of durvalumab to neoadjuvant chemotherapy (NACT) improved survival in women with early triple-negative breast cancer (TNBC) although improvement in the pathological complete response (pCR) rate was nonsignificant.

Major finding: In the overall cohort, durvalumab vs placebo improved 3-year invasive disease-free survival (hazard ratio [HR] 0.48; log-rank P   =   .036), distant disease-free survival (HR 0.31; log-rank P   =   .005), and overall survival (HR 0.24; log-rank P   =   .006) rates, despite no adjuvant component of durvalumab.

Study details: Findings are from the phase 2 GeparNuevo study including 174 patients with primary nonmetastatic TNBC who were randomly assigned to receive NACT with durvalumab or placebo.

Disclosures: This study was funded by AstraZeneca and Celgene. The authors declared receiving grants, personal fees, nonfinancial support, or other support from several sources.

Source: Loibl S et al. Neoadjuvant durvalumab improves survival in early triple-negative breast cancer independent of pathological complete response. Ann Oncol. 2022 (Aug 9). Doi: 10.1016/j.annonc.2022.07.1940

Key clinical point: Addition of durvalumab to neoadjuvant chemotherapy (NACT) improved survival in women with early triple-negative breast cancer (TNBC) although improvement in the pathological complete response (pCR) rate was nonsignificant.

Major finding: In the overall cohort, durvalumab vs placebo improved 3-year invasive disease-free survival (hazard ratio [HR] 0.48; log-rank P   =   .036), distant disease-free survival (HR 0.31; log-rank P   =   .005), and overall survival (HR 0.24; log-rank P   =   .006) rates, despite no adjuvant component of durvalumab.

Study details: Findings are from the phase 2 GeparNuevo study including 174 patients with primary nonmetastatic TNBC who were randomly assigned to receive NACT with durvalumab or placebo.

Disclosures: This study was funded by AstraZeneca and Celgene. The authors declared receiving grants, personal fees, nonfinancial support, or other support from several sources.

Source: Loibl S et al. Neoadjuvant durvalumab improves survival in early triple-negative breast cancer independent of pathological complete response. Ann Oncol. 2022 (Aug 9). Doi: 10.1016/j.annonc.2022.07.1940

Key clinical point: Addition of durvalumab to neoadjuvant chemotherapy (NACT) improved survival in women with early triple-negative breast cancer (TNBC) although improvement in the pathological complete response (pCR) rate was nonsignificant.

Major finding: In the overall cohort, durvalumab vs placebo improved 3-year invasive disease-free survival (hazard ratio [HR] 0.48; log-rank P   =   .036), distant disease-free survival (HR 0.31; log-rank P   =   .005), and overall survival (HR 0.24; log-rank P   =   .006) rates, despite no adjuvant component of durvalumab.

Study details: Findings are from the phase 2 GeparNuevo study including 174 patients with primary nonmetastatic TNBC who were randomly assigned to receive NACT with durvalumab or placebo.

Disclosures: This study was funded by AstraZeneca and Celgene. The authors declared receiving grants, personal fees, nonfinancial support, or other support from several sources.

Source: Loibl S et al. Neoadjuvant durvalumab improves survival in early triple-negative breast cancer independent of pathological complete response. Ann Oncol. 2022 (Aug 9). Doi: 10.1016/j.annonc.2022.07.1940

Key clinical point: Sacituzumab govitecan (SG) was more effective than chemotherapy in improving progression-free survival (PFS) and showed a manageable safety profile in patients with heavily pretreated, endocrine-resistant, hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC).

Major finding: SG vs chemotherapy significantly improved PFS (hazard ratio [HR] 0.66; P   =   .0003), with PFS rates being 46% vs 30% at 6 months and 21% vs 7% at 12 months, respectively. The most common grade ≥3 treatment-related adverse events with SG vs chemotherapy were neutropenia (51% vs 38%) and diarrhea (9% vs 1%).

Study details: Findings are the primary results of the phase 3 TROPiCS-02 trial including 543 patients with HR+/HER2− locally recurrent inoperable/metastatic BC who had received prior cyclin-dependent kinase 4/6 inhibitor with 2-4 lines of chemotherapy and were randomly assigned to receive SG or chemotherapy.

Disclosures: This study was supported by Gilead Sciences Inc. Four authors declared being employees of or stockowners in Gilead Sciences. The other authors reported ties with several sources, including Gilead.

Source: Rugo HS et al. Sacituzumab govitecan in hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol. 2022 (Aug 26). Doi: 10.1200/JCO.22.01002

Key clinical point: Sacituzumab govitecan (SG) was more effective than chemotherapy in improving progression-free survival (PFS) and showed a manageable safety profile in patients with heavily pretreated, endocrine-resistant, hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC).

Major finding: SG vs chemotherapy significantly improved PFS (hazard ratio [HR] 0.66; P   =   .0003), with PFS rates being 46% vs 30% at 6 months and 21% vs 7% at 12 months, respectively. The most common grade ≥3 treatment-related adverse events with SG vs chemotherapy were neutropenia (51% vs 38%) and diarrhea (9% vs 1%).

Study details: Findings are the primary results of the phase 3 TROPiCS-02 trial including 543 patients with HR+/HER2− locally recurrent inoperable/metastatic BC who had received prior cyclin-dependent kinase 4/6 inhibitor with 2-4 lines of chemotherapy and were randomly assigned to receive SG or chemotherapy.

Disclosures: This study was supported by Gilead Sciences Inc. Four authors declared being employees of or stockowners in Gilead Sciences. The other authors reported ties with several sources, including Gilead.

Source: Rugo HS et al. Sacituzumab govitecan in hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol. 2022 (Aug 26). Doi: 10.1200/JCO.22.01002

Key clinical point: Sacituzumab govitecan (SG) was more effective than chemotherapy in improving progression-free survival (PFS) and showed a manageable safety profile in patients with heavily pretreated, endocrine-resistant, hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC).

Major finding: SG vs chemotherapy significantly improved PFS (hazard ratio [HR] 0.66; P   =   .0003), with PFS rates being 46% vs 30% at 6 months and 21% vs 7% at 12 months, respectively. The most common grade ≥3 treatment-related adverse events with SG vs chemotherapy were neutropenia (51% vs 38%) and diarrhea (9% vs 1%).

Study details: Findings are the primary results of the phase 3 TROPiCS-02 trial including 543 patients with HR+/HER2− locally recurrent inoperable/metastatic BC who had received prior cyclin-dependent kinase 4/6 inhibitor with 2-4 lines of chemotherapy and were randomly assigned to receive SG or chemotherapy.

Disclosures: This study was supported by Gilead Sciences Inc. Four authors declared being employees of or stockowners in Gilead Sciences. The other authors reported ties with several sources, including Gilead.

Source: Rugo HS et al. Sacituzumab govitecan in hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol. 2022 (Aug 26). Doi: 10.1200/JCO.22.01002

Key clinical point: De-escalation of locoregional radiotherapy, according to a predefined consensus-based study guideline, was oncologically safe in women with cT1-2N1 breast cancer (BC) who received primary chemotherapy.

Major finding: The 5-year locoregional recurrence rate was 2.2% (95% CI 1.4%-3.4%) in the overall cohort, with the rates being similar in the low- vs intermediate-risk group (P   =   .89), low- vs high-risk group (P   =   .75), and intermediate- vs high-risk group (P   =   .83) and the 5-year locoregional recurrence rate remaining < 4% as per the study guideline.

Study details: Findings are from a prospective registry study including 838 patients with cT1-2N1 invasive BC who were treated with ≥3 cycles of primary chemotherapy and surgery of the breast and axillary and were categorized into three predefined risk categorized based on axillary lymph node status.

Disclosures: This study was funded by the Dutch Cancer Society. Some authors declared holding patents, serving as the chair of a committee, or receiving grants, consulting fees, or financial and nonfinancial support from several sources.

Source: de Wild SR et al. De-escalation of radiotherapy after primary chemotherapy in cT1-2N1 breast cancer (RAPCHEM; BOOG 2010-03): 5-year follow-up results of a Dutch, prospective, registry study. Lancet Oncol. 2022;23(9):1201-1210 (Aug 8). Doi: 10.1016/S1470-2045(22)00482-X

Key clinical point: De-escalation of locoregional radiotherapy, according to a predefined consensus-based study guideline, was oncologically safe in women with cT1-2N1 breast cancer (BC) who received primary chemotherapy.

Major finding: The 5-year locoregional recurrence rate was 2.2% (95% CI 1.4%-3.4%) in the overall cohort, with the rates being similar in the low- vs intermediate-risk group (P   =   .89), low- vs high-risk group (P   =   .75), and intermediate- vs high-risk group (P   =   .83) and the 5-year locoregional recurrence rate remaining < 4% as per the study guideline.

Study details: Findings are from a prospective registry study including 838 patients with cT1-2N1 invasive BC who were treated with ≥3 cycles of primary chemotherapy and surgery of the breast and axillary and were categorized into three predefined risk categorized based on axillary lymph node status.

Disclosures: This study was funded by the Dutch Cancer Society. Some authors declared holding patents, serving as the chair of a committee, or receiving grants, consulting fees, or financial and nonfinancial support from several sources.

Source: de Wild SR et al. De-escalation of radiotherapy after primary chemotherapy in cT1-2N1 breast cancer (RAPCHEM; BOOG 2010-03): 5-year follow-up results of a Dutch, prospective, registry study. Lancet Oncol. 2022;23(9):1201-1210 (Aug 8). Doi: 10.1016/S1470-2045(22)00482-X

Key clinical point: De-escalation of locoregional radiotherapy, according to a predefined consensus-based study guideline, was oncologically safe in women with cT1-2N1 breast cancer (BC) who received primary chemotherapy.

Major finding: The 5-year locoregional recurrence rate was 2.2% (95% CI 1.4%-3.4%) in the overall cohort, with the rates being similar in the low- vs intermediate-risk group (P   =   .89), low- vs high-risk group (P   =   .75), and intermediate- vs high-risk group (P   =   .83) and the 5-year locoregional recurrence rate remaining < 4% as per the study guideline.

Study details: Findings are from a prospective registry study including 838 patients with cT1-2N1 invasive BC who were treated with ≥3 cycles of primary chemotherapy and surgery of the breast and axillary and were categorized into three predefined risk categorized based on axillary lymph node status.

Disclosures: This study was funded by the Dutch Cancer Society. Some authors declared holding patents, serving as the chair of a committee, or receiving grants, consulting fees, or financial and nonfinancial support from several sources.

Source: de Wild SR et al. De-escalation of radiotherapy after primary chemotherapy in cT1-2N1 breast cancer (RAPCHEM; BOOG 2010-03): 5-year follow-up results of a Dutch, prospective, registry study. Lancet Oncol. 2022;23(9):1201-1210 (Aug 8). Doi: 10.1016/S1470-2045(22)00482-X

A claim that drinking tea might protect people against developing type 2 diabetes has been met with caution from multiple experts ahead of the annual meeting of the European Association for the Study of Diabetes.

The claim is that people who drink four or more cups of tea every day – specifically green, Oolong, or black tea – are 17% less likely to develop type 2 diabetes than those who do not drink tea. Drinking fewer cups of tea per day was not found to confer any benefit.

“Our results are exciting because they suggest that people can do something as simple as drinking four cups of tea a day to potentially lessen their risk of developing type 2 diabetes,” Xiaying Li of Wuhan (China) University of Science and Technology is quoted as saying in an official EASD press release.

NataliTerr/Fotolia.com

“It is possible that particular components in tea, such as polyphenols, may reduce blood glucose levels, but a sufficient amount of these bioactive compounds may be needed to be effective,” Dr. Li added.

“The words ‘suggest’ and ‘potentially’ are crucial here,” said Kevin McConway, PhD, MSc, MBA, emeritus professor of applied statistics at The Open University, said in a separate statement to the press that reeled in Dr. Li’s enthusiasm.

“Tea drinking would only be useful for reducing diabetes risk if the tea drinking causes reductions in risk, that is, if the risk is reduced if you drink the tea and not if you don’t – and this study simply can’t show whether it does this or not,” Dr. Conway stressed.

Naveed Sattar, FMedSci FRCPath FRCPGlas FRSE, professor of metabolic medicine at the University of Glasgow, was also cautiously critical. “There is no good trial evidence whatsoever that the chemicals in tea prevent diabetes,” he observed separately.

“So, I suspect its more about tea being healthier (less calorific) than many alternative drinks or tea drinkers leading healthier lives more generally.”

Dr. Sattar added that it could be that people who drink tea might also be avoiding drinking more harmful sugary drinks and have other health behaviors that might lead them to have a lower risk for type 2 diabetes.

Time for tea?

Dr. Li will present the findings of two analyses on Sept. 21 at the EASD meeting: the first a large observational cohort study and the second an updated systematic review and meta-analysis.

For the cohort study, Dr. Li and her coauthors took data on more than 5,100 adults who had participated in the long-running and ongoing China Health and Nutrition Survey (CHNS). Information on tea drinking behavior was extracted from questionnaires that had been filled out at two time points – 1997 and 2009 – and they determined whether people had developed type 2 diabetes according to American Diabetes Association criteria.

Nearly half, 45.8%, were found to be tea drinkers, and 10% of the population they sampled had developed type 2 diabetes. No association between tea drinking and type 2 diabetes development was found, however, with the hazard ratio comparing tea drinkers and non–tea drinkers sitting firmly at 1.02. Moreover, a sensitivity analysis that excluded participants who had developed type 2 diabetes in the first 3 years of follow-up did not change the result.

Things were slightly different when Dr. Li and associates performed their meta-analysis that involved analyzing data on more than 1 million participants in 19 studies conducted in eight countries that had been published up to September 2021.

Here, they found there was a significant (P < .003) linear association between tea consumption and having type 2 diabetes, with the relative risk of developing type 2 diabetes decreasing by 0.986 for every additional cup of tea that was drunk.

HRs for the development of type 2 diabetes in tea drinkers versus non–tea drinkers were 1.00 for those who drank less than one cup per day, 0.96 for those who had one to two cups, and 0.84 for those who drank four or more cups.

“While more research needs to be done to determine the exact dosage and mechanisms behind these observations, our findings suggest that drinking tea is beneficial in reducing the risk of type 2 diabetes, but only at high doses (at least 4 cups a day)”, said Dr. Li.

Perhaps, “we did not find an association between tea drinking and type 2 diabetes in our cohort study because we did not look at higher tea consumption,” she added.

Tempest in a teacup

“This is large, observational data. It’s not a randomized controlled trial so there’s plenty of room for data to be misunderstood,” warned Matt Sydes, MSc, professor of clinical trials & methodology at the MRC Clinical Trials Unit, University College London.

“Everyone drinks fluids. If there is an effect here (and that’s a big if), it might be not about the tea they drink, but about what they don’t drink. One can’t tell at the moment. It seems unlikely that a large randomized controlled trial could be done to disambiguate” added Dr. Sydes

“Being only a conference abstract, it is difficult to assess the quality of this research,” Baptiste Leurent, PhD, a medical statistician also working at University College London, said. Not only was the cohort study observational, so were all the other studies included in the meta-analysis, he pointed out.

“Therefore, no cause-effect conclusions can be drawn. The association could simply be due to other factors, such as those drinking more tea having a healthier lifestyle. It does not seem that the authors tried to control for confounders, which is usually difficult in meta-analysis,” Dr. Leurent said.

“There is reason to be a bit skeptical at this point; we really need to have the full details to assess it properly,” said Jonathan Cook of the Centre for Statistics in Medicine at the University of Oxford (England). “It’s a fair attempt to look at this, but not cutting edge, [using] fairly standard approaches.”

Similar studies have shown a reduced risk associated with coffee drinking, noted Duane Mellor, PhD, a registered dietitian and senior teaching fellow at Aston University in Birmingham.

“The important take-home message is that lifestyle is important in managing risk of developing type 2 diabetes,” Dr. Mellor said.

“That includes choosing low-calorie drinks including mainly water as well as unsweetened tea and coffee as your drinks of choice as part of a healthy lifestyle.”

The study was funded by the Young Talents Project of Hubei Provincial Health Commission, the Science and Technology Research Key Project of Education Department of Hubei Province, the Sanuo Diabetes Charity Foundation, and the Xiangyang Science and Technology Plan Project, all based in China. Dr. Li had no conflicts of interest to disclose. Dr. McConway is a Trustee and on the advisory committee of The Science Media Centre.  Dr. Sattar has consulted for many companies that make diabetes and cardiovascular drugs and has been involved in multiple trials of lifestyle approaches for the prevention and remission of diabetes. Dr. Sydes, Dr. Leurent, Dr. Cook, and Dr. Mellor had no conflicts of interest to report.

A claim that drinking tea might protect people against developing type 2 diabetes has been met with caution from multiple experts ahead of the annual meeting of the European Association for the Study of Diabetes.

The claim is that people who drink four or more cups of tea every day – specifically green, Oolong, or black tea – are 17% less likely to develop type 2 diabetes than those who do not drink tea. Drinking fewer cups of tea per day was not found to confer any benefit.

“Our results are exciting because they suggest that people can do something as simple as drinking four cups of tea a day to potentially lessen their risk of developing type 2 diabetes,” Xiaying Li of Wuhan (China) University of Science and Technology is quoted as saying in an official EASD press release.

NataliTerr/Fotolia.com

“It is possible that particular components in tea, such as polyphenols, may reduce blood glucose levels, but a sufficient amount of these bioactive compounds may be needed to be effective,” Dr. Li added.

“The words ‘suggest’ and ‘potentially’ are crucial here,” said Kevin McConway, PhD, MSc, MBA, emeritus professor of applied statistics at The Open University, said in a separate statement to the press that reeled in Dr. Li’s enthusiasm.

“Tea drinking would only be useful for reducing diabetes risk if the tea drinking causes reductions in risk, that is, if the risk is reduced if you drink the tea and not if you don’t – and this study simply can’t show whether it does this or not,” Dr. Conway stressed.

Naveed Sattar, FMedSci FRCPath FRCPGlas FRSE, professor of metabolic medicine at the University of Glasgow, was also cautiously critical. “There is no good trial evidence whatsoever that the chemicals in tea prevent diabetes,” he observed separately.

“So, I suspect its more about tea being healthier (less calorific) than many alternative drinks or tea drinkers leading healthier lives more generally.”

Dr. Sattar added that it could be that people who drink tea might also be avoiding drinking more harmful sugary drinks and have other health behaviors that might lead them to have a lower risk for type 2 diabetes.

Time for tea?

Dr. Li will present the findings of two analyses on Sept. 21 at the EASD meeting: the first a large observational cohort study and the second an updated systematic review and meta-analysis.

For the cohort study, Dr. Li and her coauthors took data on more than 5,100 adults who had participated in the long-running and ongoing China Health and Nutrition Survey (CHNS). Information on tea drinking behavior was extracted from questionnaires that had been filled out at two time points – 1997 and 2009 – and they determined whether people had developed type 2 diabetes according to American Diabetes Association criteria.

Nearly half, 45.8%, were found to be tea drinkers, and 10% of the population they sampled had developed type 2 diabetes. No association between tea drinking and type 2 diabetes development was found, however, with the hazard ratio comparing tea drinkers and non–tea drinkers sitting firmly at 1.02. Moreover, a sensitivity analysis that excluded participants who had developed type 2 diabetes in the first 3 years of follow-up did not change the result.

Things were slightly different when Dr. Li and associates performed their meta-analysis that involved analyzing data on more than 1 million participants in 19 studies conducted in eight countries that had been published up to September 2021.

Here, they found there was a significant (P < .003) linear association between tea consumption and having type 2 diabetes, with the relative risk of developing type 2 diabetes decreasing by 0.986 for every additional cup of tea that was drunk.

HRs for the development of type 2 diabetes in tea drinkers versus non–tea drinkers were 1.00 for those who drank less than one cup per day, 0.96 for those who had one to two cups, and 0.84 for those who drank four or more cups.

“While more research needs to be done to determine the exact dosage and mechanisms behind these observations, our findings suggest that drinking tea is beneficial in reducing the risk of type 2 diabetes, but only at high doses (at least 4 cups a day)”, said Dr. Li.

Perhaps, “we did not find an association between tea drinking and type 2 diabetes in our cohort study because we did not look at higher tea consumption,” she added.

Tempest in a teacup

“This is large, observational data. It’s not a randomized controlled trial so there’s plenty of room for data to be misunderstood,” warned Matt Sydes, MSc, professor of clinical trials & methodology at the MRC Clinical Trials Unit, University College London.

“Everyone drinks fluids. If there is an effect here (and that’s a big if), it might be not about the tea they drink, but about what they don’t drink. One can’t tell at the moment. It seems unlikely that a large randomized controlled trial could be done to disambiguate” added Dr. Sydes

“Being only a conference abstract, it is difficult to assess the quality of this research,” Baptiste Leurent, PhD, a medical statistician also working at University College London, said. Not only was the cohort study observational, so were all the other studies included in the meta-analysis, he pointed out.

“Therefore, no cause-effect conclusions can be drawn. The association could simply be due to other factors, such as those drinking more tea having a healthier lifestyle. It does not seem that the authors tried to control for confounders, which is usually difficult in meta-analysis,” Dr. Leurent said.

“There is reason to be a bit skeptical at this point; we really need to have the full details to assess it properly,” said Jonathan Cook of the Centre for Statistics in Medicine at the University of Oxford (England). “It’s a fair attempt to look at this, but not cutting edge, [using] fairly standard approaches.”

Similar studies have shown a reduced risk associated with coffee drinking, noted Duane Mellor, PhD, a registered dietitian and senior teaching fellow at Aston University in Birmingham.

“The important take-home message is that lifestyle is important in managing risk of developing type 2 diabetes,” Dr. Mellor said.

“That includes choosing low-calorie drinks including mainly water as well as unsweetened tea and coffee as your drinks of choice as part of a healthy lifestyle.”

The study was funded by the Young Talents Project of Hubei Provincial Health Commission, the Science and Technology Research Key Project of Education Department of Hubei Province, the Sanuo Diabetes Charity Foundation, and the Xiangyang Science and Technology Plan Project, all based in China. Dr. Li had no conflicts of interest to disclose. Dr. McConway is a Trustee and on the advisory committee of The Science Media Centre.  Dr. Sattar has consulted for many companies that make diabetes and cardiovascular drugs and has been involved in multiple trials of lifestyle approaches for the prevention and remission of diabetes. Dr. Sydes, Dr. Leurent, Dr. Cook, and Dr. Mellor had no conflicts of interest to report.

A claim that drinking tea might protect people against developing type 2 diabetes has been met with caution from multiple experts ahead of the annual meeting of the European Association for the Study of Diabetes.

The claim is that people who drink four or more cups of tea every day – specifically green, Oolong, or black tea – are 17% less likely to develop type 2 diabetes than those who do not drink tea. Drinking fewer cups of tea per day was not found to confer any benefit.

“Our results are exciting because they suggest that people can do something as simple as drinking four cups of tea a day to potentially lessen their risk of developing type 2 diabetes,” Xiaying Li of Wuhan (China) University of Science and Technology is quoted as saying in an official EASD press release.

NataliTerr/Fotolia.com

“It is possible that particular components in tea, such as polyphenols, may reduce blood glucose levels, but a sufficient amount of these bioactive compounds may be needed to be effective,” Dr. Li added.

“The words ‘suggest’ and ‘potentially’ are crucial here,” said Kevin McConway, PhD, MSc, MBA, emeritus professor of applied statistics at The Open University, said in a separate statement to the press that reeled in Dr. Li’s enthusiasm.

“Tea drinking would only be useful for reducing diabetes risk if the tea drinking causes reductions in risk, that is, if the risk is reduced if you drink the tea and not if you don’t – and this study simply can’t show whether it does this or not,” Dr. Conway stressed.

Naveed Sattar, FMedSci FRCPath FRCPGlas FRSE, professor of metabolic medicine at the University of Glasgow, was also cautiously critical. “There is no good trial evidence whatsoever that the chemicals in tea prevent diabetes,” he observed separately.

“So, I suspect its more about tea being healthier (less calorific) than many alternative drinks or tea drinkers leading healthier lives more generally.”

Dr. Sattar added that it could be that people who drink tea might also be avoiding drinking more harmful sugary drinks and have other health behaviors that might lead them to have a lower risk for type 2 diabetes.

Time for tea?

Dr. Li will present the findings of two analyses on Sept. 21 at the EASD meeting: the first a large observational cohort study and the second an updated systematic review and meta-analysis.

For the cohort study, Dr. Li and her coauthors took data on more than 5,100 adults who had participated in the long-running and ongoing China Health and Nutrition Survey (CHNS). Information on tea drinking behavior was extracted from questionnaires that had been filled out at two time points – 1997 and 2009 – and they determined whether people had developed type 2 diabetes according to American Diabetes Association criteria.

Nearly half, 45.8%, were found to be tea drinkers, and 10% of the population they sampled had developed type 2 diabetes. No association between tea drinking and type 2 diabetes development was found, however, with the hazard ratio comparing tea drinkers and non–tea drinkers sitting firmly at 1.02. Moreover, a sensitivity analysis that excluded participants who had developed type 2 diabetes in the first 3 years of follow-up did not change the result.

Things were slightly different when Dr. Li and associates performed their meta-analysis that involved analyzing data on more than 1 million participants in 19 studies conducted in eight countries that had been published up to September 2021.

Here, they found there was a significant (P < .003) linear association between tea consumption and having type 2 diabetes, with the relative risk of developing type 2 diabetes decreasing by 0.986 for every additional cup of tea that was drunk.

HRs for the development of type 2 diabetes in tea drinkers versus non–tea drinkers were 1.00 for those who drank less than one cup per day, 0.96 for those who had one to two cups, and 0.84 for those who drank four or more cups.

“While more research needs to be done to determine the exact dosage and mechanisms behind these observations, our findings suggest that drinking tea is beneficial in reducing the risk of type 2 diabetes, but only at high doses (at least 4 cups a day)”, said Dr. Li.

Perhaps, “we did not find an association between tea drinking and type 2 diabetes in our cohort study because we did not look at higher tea consumption,” she added.

Tempest in a teacup

“This is large, observational data. It’s not a randomized controlled trial so there’s plenty of room for data to be misunderstood,” warned Matt Sydes, MSc, professor of clinical trials & methodology at the MRC Clinical Trials Unit, University College London.

“Everyone drinks fluids. If there is an effect here (and that’s a big if), it might be not about the tea they drink, but about what they don’t drink. One can’t tell at the moment. It seems unlikely that a large randomized controlled trial could be done to disambiguate” added Dr. Sydes

“Being only a conference abstract, it is difficult to assess the quality of this research,” Baptiste Leurent, PhD, a medical statistician also working at University College London, said. Not only was the cohort study observational, so were all the other studies included in the meta-analysis, he pointed out.

“Therefore, no cause-effect conclusions can be drawn. The association could simply be due to other factors, such as those drinking more tea having a healthier lifestyle. It does not seem that the authors tried to control for confounders, which is usually difficult in meta-analysis,” Dr. Leurent said.

“There is reason to be a bit skeptical at this point; we really need to have the full details to assess it properly,” said Jonathan Cook of the Centre for Statistics in Medicine at the University of Oxford (England). “It’s a fair attempt to look at this, but not cutting edge, [using] fairly standard approaches.”

Similar studies have shown a reduced risk associated with coffee drinking, noted Duane Mellor, PhD, a registered dietitian and senior teaching fellow at Aston University in Birmingham.

“The important take-home message is that lifestyle is important in managing risk of developing type 2 diabetes,” Dr. Mellor said.

“That includes choosing low-calorie drinks including mainly water as well as unsweetened tea and coffee as your drinks of choice as part of a healthy lifestyle.”

The study was funded by the Young Talents Project of Hubei Provincial Health Commission, the Science and Technology Research Key Project of Education Department of Hubei Province, the Sanuo Diabetes Charity Foundation, and the Xiangyang Science and Technology Plan Project, all based in China. Dr. Li had no conflicts of interest to disclose. Dr. McConway is a Trustee and on the advisory committee of The Science Media Centre.  Dr. Sattar has consulted for many companies that make diabetes and cardiovascular drugs and has been involved in multiple trials of lifestyle approaches for the prevention and remission of diabetes. Dr. Sydes, Dr. Leurent, Dr. Cook, and Dr. Mellor had no conflicts of interest to report.

Highlights of the European Association for the Study of Diabetes 2022 annual meeting include new data on weight loss with the blockbuster twincretin tirzepatide and on the effects of dapagliflozin on heart failure in people with diabetes, as well as updated guidelines for type 2 diabetes management.

The EASD meeting will take place Sept. 19-23 in Stockholm. It will be the first in-person meeting since 2019 but will also feature live-streamed content for participants around the world.

“The EASD congress will cover all the different areas and aspects of diabetes research – clinical, basic, epidemiologic, and psychological,” EASD President Stefano Del Prato, MD, told this news organization.

What attendees should expect, said Del Prato of the University of Pisa (Italy), “is the pleasure to be able to participate in person at a meeting and get useful information, not only in terms of the knowledge and intellectual aspects of diabetes, but also something that can be implemented the following day in their daily clinical activities.”  

EASD Honorary Secretary Mikael Rydén, MD, added: “I think meeting attendees will really be able to get the absolutely latest developments in all the areas that are relevant to diabetes treatments. It’s the best way to keep yourself up to date.”

This year, in particular, there’s a focus on past, present, and future trends in type 2 diabetes management, along with the co-occurring conditions of obesity, heart failure, and metabolic fatty liver disease.  
 

DELIVER: The diabetes side

On Sept. 22, new data will be presented from the DELIVER trial on the sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin (Farxiga) in patients with heart failure with preserved ejection fraction, comparing data for participants with diabetes, prediabetes, and normoglycemia.

Primary results from DELIVER were presented Aug. 26 at the European Society of Cardiology Congress 2022 in Barcelona and simultaneously published in the New England Journal of Medicine. The results showed that dapagliflozin benefits patients with heart failure with preserved ejection fraction, as previously demonstrated in those with reduced ejection fraction in the DAPA-HF trial.

“This information is quite important and is becoming of major interest in the field of diabetes,” Dr. Del Prato said, adding that a related joint EASD/ESC symposium will take place the next morning, on Sept. 23, entitled, “New perspectives on heart function and failure in diabetes.”

“So, within the congress, you get the background, pathophysiology, the diagnostic aspects, and the results of the effect of dapagliflozin on those individuals.”

Dr. Rydén commented, “I think this underlines how important it is for diabetologists to screen our patients better for heart failure because we can actually treat them now.”

However, Dr. Rydén of the Karolinska Institute, Stockholm, also cautioned about use of SGLT2 inhibitors in people with diabetes who use insulin, given the risk of euglycemic diabetic ketoacidosis. “These drugs have side effects and you have to be wary who you prescribe them to. For those on multiple daily [insulin] injections, the side effects probably outweigh the benefits.”
 

Tirzepatide, weight loss, and type 2 diabetes remission

On Sept. 21, a symposium will provide new data for the dual glucagonlike peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) agonist tirzepatide, approved for the treatment of type 2 diabetes in the United States in May with the brand name Mounjaro. The agent is now being studied as an obesity treatment.

Data from the SURMOUNT-1 trial presented at the ADA meeting in June showed the drug produced “unprecedented” weight loss of up to 22.5%.

At EASD, those findings will be reviewed and new data presented on morbidity and mortality, along with a new commentary. The degree of weight loss seen with this new twincretin has furthered discussion about the concept of remission in type 2 diabetes, Dr. Rydén noted. That will also be the subject of the Diabetologia symposium on Sept. 21, entitled, “Remission of type 2 diabetes – fact or fiction?”

Regarding tirzepatide, Dr. Rydén said: “It’s amazing, the most powerful antiobesity drug we have at our disposal. These drugs slow gastric emptying and have other beneficial effects. … We’re now closing in on drugs that produce more than 15% weight loss. That appears to be the ‘magic bullet’ where you can achieve type 2 diabetes remission.” He pointed to a symposium sponsored by The Lancet on this topic at last year’s EASD meeting.

“I think what we want with our drugs is not to treat but actually to combat type 2 diabetes and really to achieve remission. Of course, if you’ve had it for many decades that might be impossible, but we know that particularly in the first 5-10 years it’s very important to have good glucose control and we know we can also achieve remission.”

Dr. Del Prato noted the importance of weight reduction at the time of type 2 diabetes diagnosis will be emphasized in the ADA/EASD consensus document on the management of hyperglycemia in type 2 diabetes, to be presented in its final form on Sept. 23.

“I think we’ll be learning more about potential remission in the future, both because of metabolic surgery and agents like tirzepatide. The reduction in body weight that can be achieved [with these newer drugs], or that has been reported so far, is the closest to what can be obtained with metabolic surgery. I think there will be more and more information and a lot of discussion about this, and of course about the definition of remission and what to do after remission has occurred,” Dr. Del Prato said.  

The revised ADA/EASD consensus document is expected to endorse weight loss as a “co-primary goal” of care for those without cardiorenal disease, along with early initiation of combination therapies – for example, taking two drugs immediately upon diagnosis, rather than just metformin – as opposed to the prior stepwise approach. The document will also cover use of newer glucose-lowering therapies, surgery, and behavioral interventions.  

The key is a holistic approach, Dr. Del Prato said. “Of course, glucose control is important, but it’s not the only thing. The heterogeneity of the population with diabetes is also important. Some may already have microvascular complications, kidney dysfunction, are more or less obese, and older or younger. We need to keep these differences in mind to provide more and more individualized treatment.”

Related to that, he noted, will be a joint EASD/ADA symposium on Sept. 19, entitled, “Precision medicine in type 2 diabetes: How far can we get?”
 

COVID-19 and diabetes, UKPDS, type 1 diabetes, and much more

As always, there’s a whole lot more. On Sept. 21, there will be a symposium on COVID-19 and diabetes.

Another, on diabetes technology, has a somewhat cautionary theme: “A new hope (Star Wars) or strange new worlds (Star Trek): Submerging diabetes into emerging technologies.” One of the speakers will address the question: “Are we becoming robots? Automated insulin delivery (AID) systems for everyone with type 1 diabetes: Strengths and limitations.” And this year’s EASD/JDRF symposium topic will be prevention of type 1 diabetes.

Yet another symposium on Sept. 21 will present 44-year follow-up data from the landmark United Kingdom Prospective Diabetes Study (UKPDS), including an economic analysis and a look at dementia outcomes. “It’s a historical thing. This big trial represents a gold mine of information,” Dr. Del Prato commented.

On Sept. 22, new data will be presented for the investigational once-weekly insulins during a symposium entitled, “Re-inventing the insulin experience: Exploring the prospects of once-weekly insulins.”

And lest anyone was thinking of leaving the conference early, there’s a full agenda on Sept. 23, including symposia on diabetic nephropathy, type 1 diabetes, diabetes in old age, dietary management, and the role of primary care, among others. There will also be 12 separate oral presentation sessions that day.

Overall, the meeting will reflect the multidisciplinary direction the field is headed, Dr. Rydén said.

“We’re still in an era of medicine where a lot of things happen every year. Now we have the next generation of drugs that are coming that combine many areas of treatment – obesity, cardiology, and nephrology. So, we’re integrating. The future is integrating the diabetes world with our friends in other areas of clinical medicine.”

Dr. Del Prato has reported being a consultant, advisory board member, and/or lecturer for AstraZeneca, Boehringer Ingelheim, Novo Nordisk, Sanofi, Takeda, Eli Lilly, Abbott, and Applied Therapeutics. Dr. Rydén has reported receiving lecture fees from the Novo Nordisk Foundation and serving on advisory boards for MSD, Lilly, Boehringer Ingelheim, and AstraZeneca.

A version of this article first appeared on Medscape.com.  
 

Highlights of the European Association for the Study of Diabetes 2022 annual meeting include new data on weight loss with the blockbuster twincretin tirzepatide and on the effects of dapagliflozin on heart failure in people with diabetes, as well as updated guidelines for type 2 diabetes management.

The EASD meeting will take place Sept. 19-23 in Stockholm. It will be the first in-person meeting since 2019 but will also feature live-streamed content for participants around the world.

“The EASD congress will cover all the different areas and aspects of diabetes research – clinical, basic, epidemiologic, and psychological,” EASD President Stefano Del Prato, MD, told this news organization.

What attendees should expect, said Del Prato of the University of Pisa (Italy), “is the pleasure to be able to participate in person at a meeting and get useful information, not only in terms of the knowledge and intellectual aspects of diabetes, but also something that can be implemented the following day in their daily clinical activities.”  

EASD Honorary Secretary Mikael Rydén, MD, added: “I think meeting attendees will really be able to get the absolutely latest developments in all the areas that are relevant to diabetes treatments. It’s the best way to keep yourself up to date.”

This year, in particular, there’s a focus on past, present, and future trends in type 2 diabetes management, along with the co-occurring conditions of obesity, heart failure, and metabolic fatty liver disease.  
 

DELIVER: The diabetes side

On Sept. 22, new data will be presented from the DELIVER trial on the sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin (Farxiga) in patients with heart failure with preserved ejection fraction, comparing data for participants with diabetes, prediabetes, and normoglycemia.

Primary results from DELIVER were presented Aug. 26 at the European Society of Cardiology Congress 2022 in Barcelona and simultaneously published in the New England Journal of Medicine. The results showed that dapagliflozin benefits patients with heart failure with preserved ejection fraction, as previously demonstrated in those with reduced ejection fraction in the DAPA-HF trial.

“This information is quite important and is becoming of major interest in the field of diabetes,” Dr. Del Prato said, adding that a related joint EASD/ESC symposium will take place the next morning, on Sept. 23, entitled, “New perspectives on heart function and failure in diabetes.”

“So, within the congress, you get the background, pathophysiology, the diagnostic aspects, and the results of the effect of dapagliflozin on those individuals.”

Dr. Rydén commented, “I think this underlines how important it is for diabetologists to screen our patients better for heart failure because we can actually treat them now.”

However, Dr. Rydén of the Karolinska Institute, Stockholm, also cautioned about use of SGLT2 inhibitors in people with diabetes who use insulin, given the risk of euglycemic diabetic ketoacidosis. “These drugs have side effects and you have to be wary who you prescribe them to. For those on multiple daily [insulin] injections, the side effects probably outweigh the benefits.”
 

Tirzepatide, weight loss, and type 2 diabetes remission

On Sept. 21, a symposium will provide new data for the dual glucagonlike peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) agonist tirzepatide, approved for the treatment of type 2 diabetes in the United States in May with the brand name Mounjaro. The agent is now being studied as an obesity treatment.

Data from the SURMOUNT-1 trial presented at the ADA meeting in June showed the drug produced “unprecedented” weight loss of up to 22.5%.

At EASD, those findings will be reviewed and new data presented on morbidity and mortality, along with a new commentary. The degree of weight loss seen with this new twincretin has furthered discussion about the concept of remission in type 2 diabetes, Dr. Rydén noted. That will also be the subject of the Diabetologia symposium on Sept. 21, entitled, “Remission of type 2 diabetes – fact or fiction?”

Regarding tirzepatide, Dr. Rydén said: “It’s amazing, the most powerful antiobesity drug we have at our disposal. These drugs slow gastric emptying and have other beneficial effects. … We’re now closing in on drugs that produce more than 15% weight loss. That appears to be the ‘magic bullet’ where you can achieve type 2 diabetes remission.” He pointed to a symposium sponsored by The Lancet on this topic at last year’s EASD meeting.

“I think what we want with our drugs is not to treat but actually to combat type 2 diabetes and really to achieve remission. Of course, if you’ve had it for many decades that might be impossible, but we know that particularly in the first 5-10 years it’s very important to have good glucose control and we know we can also achieve remission.”

Dr. Del Prato noted the importance of weight reduction at the time of type 2 diabetes diagnosis will be emphasized in the ADA/EASD consensus document on the management of hyperglycemia in type 2 diabetes, to be presented in its final form on Sept. 23.

“I think we’ll be learning more about potential remission in the future, both because of metabolic surgery and agents like tirzepatide. The reduction in body weight that can be achieved [with these newer drugs], or that has been reported so far, is the closest to what can be obtained with metabolic surgery. I think there will be more and more information and a lot of discussion about this, and of course about the definition of remission and what to do after remission has occurred,” Dr. Del Prato said.  

The revised ADA/EASD consensus document is expected to endorse weight loss as a “co-primary goal” of care for those without cardiorenal disease, along with early initiation of combination therapies – for example, taking two drugs immediately upon diagnosis, rather than just metformin – as opposed to the prior stepwise approach. The document will also cover use of newer glucose-lowering therapies, surgery, and behavioral interventions.  

The key is a holistic approach, Dr. Del Prato said. “Of course, glucose control is important, but it’s not the only thing. The heterogeneity of the population with diabetes is also important. Some may already have microvascular complications, kidney dysfunction, are more or less obese, and older or younger. We need to keep these differences in mind to provide more and more individualized treatment.”

Related to that, he noted, will be a joint EASD/ADA symposium on Sept. 19, entitled, “Precision medicine in type 2 diabetes: How far can we get?”
 

COVID-19 and diabetes, UKPDS, type 1 diabetes, and much more

As always, there’s a whole lot more. On Sept. 21, there will be a symposium on COVID-19 and diabetes.

Another, on diabetes technology, has a somewhat cautionary theme: “A new hope (Star Wars) or strange new worlds (Star Trek): Submerging diabetes into emerging technologies.” One of the speakers will address the question: “Are we becoming robots? Automated insulin delivery (AID) systems for everyone with type 1 diabetes: Strengths and limitations.” And this year’s EASD/JDRF symposium topic will be prevention of type 1 diabetes.

Yet another symposium on Sept. 21 will present 44-year follow-up data from the landmark United Kingdom Prospective Diabetes Study (UKPDS), including an economic analysis and a look at dementia outcomes. “It’s a historical thing. This big trial represents a gold mine of information,” Dr. Del Prato commented.

On Sept. 22, new data will be presented for the investigational once-weekly insulins during a symposium entitled, “Re-inventing the insulin experience: Exploring the prospects of once-weekly insulins.”

And lest anyone was thinking of leaving the conference early, there’s a full agenda on Sept. 23, including symposia on diabetic nephropathy, type 1 diabetes, diabetes in old age, dietary management, and the role of primary care, among others. There will also be 12 separate oral presentation sessions that day.

Overall, the meeting will reflect the multidisciplinary direction the field is headed, Dr. Rydén said.

“We’re still in an era of medicine where a lot of things happen every year. Now we have the next generation of drugs that are coming that combine many areas of treatment – obesity, cardiology, and nephrology. So, we’re integrating. The future is integrating the diabetes world with our friends in other areas of clinical medicine.”

Dr. Del Prato has reported being a consultant, advisory board member, and/or lecturer for AstraZeneca, Boehringer Ingelheim, Novo Nordisk, Sanofi, Takeda, Eli Lilly, Abbott, and Applied Therapeutics. Dr. Rydén has reported receiving lecture fees from the Novo Nordisk Foundation and serving on advisory boards for MSD, Lilly, Boehringer Ingelheim, and AstraZeneca.

A version of this article first appeared on Medscape.com.  
 

Highlights of the European Association for the Study of Diabetes 2022 annual meeting include new data on weight loss with the blockbuster twincretin tirzepatide and on the effects of dapagliflozin on heart failure in people with diabetes, as well as updated guidelines for type 2 diabetes management.

The EASD meeting will take place Sept. 19-23 in Stockholm. It will be the first in-person meeting since 2019 but will also feature live-streamed content for participants around the world.

“The EASD congress will cover all the different areas and aspects of diabetes research – clinical, basic, epidemiologic, and psychological,” EASD President Stefano Del Prato, MD, told this news organization.

What attendees should expect, said Del Prato of the University of Pisa (Italy), “is the pleasure to be able to participate in person at a meeting and get useful information, not only in terms of the knowledge and intellectual aspects of diabetes, but also something that can be implemented the following day in their daily clinical activities.”  

EASD Honorary Secretary Mikael Rydén, MD, added: “I think meeting attendees will really be able to get the absolutely latest developments in all the areas that are relevant to diabetes treatments. It’s the best way to keep yourself up to date.”

This year, in particular, there’s a focus on past, present, and future trends in type 2 diabetes management, along with the co-occurring conditions of obesity, heart failure, and metabolic fatty liver disease.  
 

DELIVER: The diabetes side

On Sept. 22, new data will be presented from the DELIVER trial on the sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin (Farxiga) in patients with heart failure with preserved ejection fraction, comparing data for participants with diabetes, prediabetes, and normoglycemia.

Primary results from DELIVER were presented Aug. 26 at the European Society of Cardiology Congress 2022 in Barcelona and simultaneously published in the New England Journal of Medicine. The results showed that dapagliflozin benefits patients with heart failure with preserved ejection fraction, as previously demonstrated in those with reduced ejection fraction in the DAPA-HF trial.

“This information is quite important and is becoming of major interest in the field of diabetes,” Dr. Del Prato said, adding that a related joint EASD/ESC symposium will take place the next morning, on Sept. 23, entitled, “New perspectives on heart function and failure in diabetes.”

“So, within the congress, you get the background, pathophysiology, the diagnostic aspects, and the results of the effect of dapagliflozin on those individuals.”

Dr. Rydén commented, “I think this underlines how important it is for diabetologists to screen our patients better for heart failure because we can actually treat them now.”

However, Dr. Rydén of the Karolinska Institute, Stockholm, also cautioned about use of SGLT2 inhibitors in people with diabetes who use insulin, given the risk of euglycemic diabetic ketoacidosis. “These drugs have side effects and you have to be wary who you prescribe them to. For those on multiple daily [insulin] injections, the side effects probably outweigh the benefits.”
 

Tirzepatide, weight loss, and type 2 diabetes remission

On Sept. 21, a symposium will provide new data for the dual glucagonlike peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) agonist tirzepatide, approved for the treatment of type 2 diabetes in the United States in May with the brand name Mounjaro. The agent is now being studied as an obesity treatment.

Data from the SURMOUNT-1 trial presented at the ADA meeting in June showed the drug produced “unprecedented” weight loss of up to 22.5%.

At EASD, those findings will be reviewed and new data presented on morbidity and mortality, along with a new commentary. The degree of weight loss seen with this new twincretin has furthered discussion about the concept of remission in type 2 diabetes, Dr. Rydén noted. That will also be the subject of the Diabetologia symposium on Sept. 21, entitled, “Remission of type 2 diabetes – fact or fiction?”

Regarding tirzepatide, Dr. Rydén said: “It’s amazing, the most powerful antiobesity drug we have at our disposal. These drugs slow gastric emptying and have other beneficial effects. … We’re now closing in on drugs that produce more than 15% weight loss. That appears to be the ‘magic bullet’ where you can achieve type 2 diabetes remission.” He pointed to a symposium sponsored by The Lancet on this topic at last year’s EASD meeting.

“I think what we want with our drugs is not to treat but actually to combat type 2 diabetes and really to achieve remission. Of course, if you’ve had it for many decades that might be impossible, but we know that particularly in the first 5-10 years it’s very important to have good glucose control and we know we can also achieve remission.”

Dr. Del Prato noted the importance of weight reduction at the time of type 2 diabetes diagnosis will be emphasized in the ADA/EASD consensus document on the management of hyperglycemia in type 2 diabetes, to be presented in its final form on Sept. 23.

“I think we’ll be learning more about potential remission in the future, both because of metabolic surgery and agents like tirzepatide. The reduction in body weight that can be achieved [with these newer drugs], or that has been reported so far, is the closest to what can be obtained with metabolic surgery. I think there will be more and more information and a lot of discussion about this, and of course about the definition of remission and what to do after remission has occurred,” Dr. Del Prato said.  

The revised ADA/EASD consensus document is expected to endorse weight loss as a “co-primary goal” of care for those without cardiorenal disease, along with early initiation of combination therapies – for example, taking two drugs immediately upon diagnosis, rather than just metformin – as opposed to the prior stepwise approach. The document will also cover use of newer glucose-lowering therapies, surgery, and behavioral interventions.  

The key is a holistic approach, Dr. Del Prato said. “Of course, glucose control is important, but it’s not the only thing. The heterogeneity of the population with diabetes is also important. Some may already have microvascular complications, kidney dysfunction, are more or less obese, and older or younger. We need to keep these differences in mind to provide more and more individualized treatment.”

Related to that, he noted, will be a joint EASD/ADA symposium on Sept. 19, entitled, “Precision medicine in type 2 diabetes: How far can we get?”
 

COVID-19 and diabetes, UKPDS, type 1 diabetes, and much more

As always, there’s a whole lot more. On Sept. 21, there will be a symposium on COVID-19 and diabetes.

Another, on diabetes technology, has a somewhat cautionary theme: “A new hope (Star Wars) or strange new worlds (Star Trek): Submerging diabetes into emerging technologies.” One of the speakers will address the question: “Are we becoming robots? Automated insulin delivery (AID) systems for everyone with type 1 diabetes: Strengths and limitations.” And this year’s EASD/JDRF symposium topic will be prevention of type 1 diabetes.

Yet another symposium on Sept. 21 will present 44-year follow-up data from the landmark United Kingdom Prospective Diabetes Study (UKPDS), including an economic analysis and a look at dementia outcomes. “It’s a historical thing. This big trial represents a gold mine of information,” Dr. Del Prato commented.

On Sept. 22, new data will be presented for the investigational once-weekly insulins during a symposium entitled, “Re-inventing the insulin experience: Exploring the prospects of once-weekly insulins.”

And lest anyone was thinking of leaving the conference early, there’s a full agenda on Sept. 23, including symposia on diabetic nephropathy, type 1 diabetes, diabetes in old age, dietary management, and the role of primary care, among others. There will also be 12 separate oral presentation sessions that day.

Overall, the meeting will reflect the multidisciplinary direction the field is headed, Dr. Rydén said.

“We’re still in an era of medicine where a lot of things happen every year. Now we have the next generation of drugs that are coming that combine many areas of treatment – obesity, cardiology, and nephrology. So, we’re integrating. The future is integrating the diabetes world with our friends in other areas of clinical medicine.”

Dr. Del Prato has reported being a consultant, advisory board member, and/or lecturer for AstraZeneca, Boehringer Ingelheim, Novo Nordisk, Sanofi, Takeda, Eli Lilly, Abbott, and Applied Therapeutics. Dr. Rydén has reported receiving lecture fees from the Novo Nordisk Foundation and serving on advisory boards for MSD, Lilly, Boehringer Ingelheim, and AstraZeneca.

A version of this article first appeared on Medscape.com.  
 

COVID-19 has been linked to a significantly increased risk for new-onset Alzheimer’s disease (AD), a new study suggests.

The study of more than 6 million people aged 65 years or older found a 50%-80% increased risk for AD in the year after COVID-19; the risk was especially high for women older than 85 years.

However, the investigators were quick to point out that the observational retrospective study offers no evidence that COVID-19 causes AD. There could be a viral etiology at play, or the connection could be related to inflammation in neural tissue from the SARS-CoV-2 infection. Or it could simply be that exposure to the health care system for COVID-19 increased the odds of detection of existing undiagnosed AD cases.

Whatever the case, these findings point to a potential spike in AD cases, which is a cause for concern, study investigator Pamela Davis, MD, PhD, a professor in the Center for Community Health Integration at Case Western Reserve University, Cleveland, said in an interview.

“COVID may be giving us a legacy of ongoing medical difficulties,” Dr. Davis said. “We were already concerned about having a very large care burden and cost burden from Alzheimer’s disease. If this is another burden that’s increased by COVID, this is something we’re really going to have to prepare for.”

The findings were published online in Journal of Alzheimer’s Disease.
 

Increased risk

Earlier research points to a potential link between COVID-19 and increased risk for AD and Parkinson’s disease.

For the current study, researchers analyzed anonymous electronic health records of 6.2 million adults aged 65 years or older who received medical treatment between February 2020 and May 2021 and had no prior diagnosis of AD. The database includes information on almost 30% of the entire U.S. population.

Overall, there were 410,748 cases of COVID-19 during the study period.

The overall risk for new diagnosis of AD in the COVID-19 cohort was close to double that of those who did not have COVID-19 (0.68% vs. 0.35%, respectively).

After propensity-score matching, those who have had COVID-19 had a significantly higher risk for an AD diagnosis compared with those who were not infected (hazard ratio [HR], 1.69; 95% confidence interval [CI],1.53-1.72).

Risk for AD was elevated in all age groups, regardless of gender or ethnicity. Researchers did not collect data on COVID-19 severity, and the medical codes for long COVID were not published until after the study had ended.

Those with the highest risk were individuals older than 85 years (HR, 1.89; 95% CI, 1.73-2.07) and women (HR, 1.82; 95% CI, 1.69-1.97).

“We expected to see some impact, but I was surprised that it was as potent as it was,” Dr. Davis said.
 

Association, not causation

Heather Snyder, PhD, Alzheimer’s Association vice president of medical and scientific relations, who commented on the findings for this article, called the study interesting but emphasized caution in interpreting the results.

“Because this study only showed an association through medical records, we cannot know what the underlying mechanisms driving this association are without more research,” Dr. Snyder said. “If you have had COVID-19, it doesn’t mean you’re going to get dementia. But if you have had COVID-19 and are experiencing long-term symptoms including cognitive difficulties, talk to your doctor.”

Dr. Davis agreed, noting that this type of study offers information on association, but not causation. “I do think that this makes it imperative that we continue to follow the population for what’s going on in various neurodegenerative diseases,” Dr. Davis said.

The study was funded by the National Institute of Aging, National Institute on Alcohol Abuse and Alcoholism, the Clinical and Translational Science Collaborative of Cleveland, and the National Cancer Institute. Dr. Synder reports no relevant financial conflicts.

A version of this article first appeared on Medscape.com.

COVID-19 has been linked to a significantly increased risk for new-onset Alzheimer’s disease (AD), a new study suggests.

The study of more than 6 million people aged 65 years or older found a 50%-80% increased risk for AD in the year after COVID-19; the risk was especially high for women older than 85 years.

However, the investigators were quick to point out that the observational retrospective study offers no evidence that COVID-19 causes AD. There could be a viral etiology at play, or the connection could be related to inflammation in neural tissue from the SARS-CoV-2 infection. Or it could simply be that exposure to the health care system for COVID-19 increased the odds of detection of existing undiagnosed AD cases.

Whatever the case, these findings point to a potential spike in AD cases, which is a cause for concern, study investigator Pamela Davis, MD, PhD, a professor in the Center for Community Health Integration at Case Western Reserve University, Cleveland, said in an interview.

“COVID may be giving us a legacy of ongoing medical difficulties,” Dr. Davis said. “We were already concerned about having a very large care burden and cost burden from Alzheimer’s disease. If this is another burden that’s increased by COVID, this is something we’re really going to have to prepare for.”

The findings were published online in Journal of Alzheimer’s Disease.
 

Increased risk

Earlier research points to a potential link between COVID-19 and increased risk for AD and Parkinson’s disease.

For the current study, researchers analyzed anonymous electronic health records of 6.2 million adults aged 65 years or older who received medical treatment between February 2020 and May 2021 and had no prior diagnosis of AD. The database includes information on almost 30% of the entire U.S. population.

Overall, there were 410,748 cases of COVID-19 during the study period.

The overall risk for new diagnosis of AD in the COVID-19 cohort was close to double that of those who did not have COVID-19 (0.68% vs. 0.35%, respectively).

After propensity-score matching, those who have had COVID-19 had a significantly higher risk for an AD diagnosis compared with those who were not infected (hazard ratio [HR], 1.69; 95% confidence interval [CI],1.53-1.72).

Risk for AD was elevated in all age groups, regardless of gender or ethnicity. Researchers did not collect data on COVID-19 severity, and the medical codes for long COVID were not published until after the study had ended.

Those with the highest risk were individuals older than 85 years (HR, 1.89; 95% CI, 1.73-2.07) and women (HR, 1.82; 95% CI, 1.69-1.97).

“We expected to see some impact, but I was surprised that it was as potent as it was,” Dr. Davis said.
 

Association, not causation

Heather Snyder, PhD, Alzheimer’s Association vice president of medical and scientific relations, who commented on the findings for this article, called the study interesting but emphasized caution in interpreting the results.

“Because this study only showed an association through medical records, we cannot know what the underlying mechanisms driving this association are without more research,” Dr. Snyder said. “If you have had COVID-19, it doesn’t mean you’re going to get dementia. But if you have had COVID-19 and are experiencing long-term symptoms including cognitive difficulties, talk to your doctor.”

Dr. Davis agreed, noting that this type of study offers information on association, but not causation. “I do think that this makes it imperative that we continue to follow the population for what’s going on in various neurodegenerative diseases,” Dr. Davis said.

The study was funded by the National Institute of Aging, National Institute on Alcohol Abuse and Alcoholism, the Clinical and Translational Science Collaborative of Cleveland, and the National Cancer Institute. Dr. Synder reports no relevant financial conflicts.

A version of this article first appeared on Medscape.com.

COVID-19 has been linked to a significantly increased risk for new-onset Alzheimer’s disease (AD), a new study suggests.

The study of more than 6 million people aged 65 years or older found a 50%-80% increased risk for AD in the year after COVID-19; the risk was especially high for women older than 85 years.

However, the investigators were quick to point out that the observational retrospective study offers no evidence that COVID-19 causes AD. There could be a viral etiology at play, or the connection could be related to inflammation in neural tissue from the SARS-CoV-2 infection. Or it could simply be that exposure to the health care system for COVID-19 increased the odds of detection of existing undiagnosed AD cases.

Whatever the case, these findings point to a potential spike in AD cases, which is a cause for concern, study investigator Pamela Davis, MD, PhD, a professor in the Center for Community Health Integration at Case Western Reserve University, Cleveland, said in an interview.

“COVID may be giving us a legacy of ongoing medical difficulties,” Dr. Davis said. “We were already concerned about having a very large care burden and cost burden from Alzheimer’s disease. If this is another burden that’s increased by COVID, this is something we’re really going to have to prepare for.”

The findings were published online in Journal of Alzheimer’s Disease.
 

Increased risk

Earlier research points to a potential link between COVID-19 and increased risk for AD and Parkinson’s disease.

For the current study, researchers analyzed anonymous electronic health records of 6.2 million adults aged 65 years or older who received medical treatment between February 2020 and May 2021 and had no prior diagnosis of AD. The database includes information on almost 30% of the entire U.S. population.

Overall, there were 410,748 cases of COVID-19 during the study period.

The overall risk for new diagnosis of AD in the COVID-19 cohort was close to double that of those who did not have COVID-19 (0.68% vs. 0.35%, respectively).

After propensity-score matching, those who have had COVID-19 had a significantly higher risk for an AD diagnosis compared with those who were not infected (hazard ratio [HR], 1.69; 95% confidence interval [CI],1.53-1.72).

Risk for AD was elevated in all age groups, regardless of gender or ethnicity. Researchers did not collect data on COVID-19 severity, and the medical codes for long COVID were not published until after the study had ended.

Those with the highest risk were individuals older than 85 years (HR, 1.89; 95% CI, 1.73-2.07) and women (HR, 1.82; 95% CI, 1.69-1.97).

“We expected to see some impact, but I was surprised that it was as potent as it was,” Dr. Davis said.
 

Association, not causation

Heather Snyder, PhD, Alzheimer’s Association vice president of medical and scientific relations, who commented on the findings for this article, called the study interesting but emphasized caution in interpreting the results.

“Because this study only showed an association through medical records, we cannot know what the underlying mechanisms driving this association are without more research,” Dr. Snyder said. “If you have had COVID-19, it doesn’t mean you’re going to get dementia. But if you have had COVID-19 and are experiencing long-term symptoms including cognitive difficulties, talk to your doctor.”

Dr. Davis agreed, noting that this type of study offers information on association, but not causation. “I do think that this makes it imperative that we continue to follow the population for what’s going on in various neurodegenerative diseases,” Dr. Davis said.

The study was funded by the National Institute of Aging, National Institute on Alcohol Abuse and Alcoholism, the Clinical and Translational Science Collaborative of Cleveland, and the National Cancer Institute. Dr. Synder reports no relevant financial conflicts.

A version of this article first appeared on Medscape.com.