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Journal Club

Journal Club. Bunck MC, Cornér A, Eliasson B, Heine RJ, Shaginian RM, Taskinen MR, Smith U, Yki-Järvinen H, Diamant M . Effects of exenatide on measures of β- cell function after 3 years in metformin-treated patients with type 2 diabetes. Diabetes Care. 2011 Sep;34(9):2041-7 .

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Journal Club

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  1. Journal Club BunckMC, Cornér A, Eliasson B, Heine RJ, Shaginian RM, Taskinen MR, Smith U, Yki-Järvinen H, Diamant M. Effects of exenatide on measures of β-cell function after 3 years in metformin-treated patients with type 2 diabetes. Diabetes Care. 2011 Sep;34(9):2041-7. Jolly K, Lewis A, Beach J, Denley J, Adab P, Deeks JJ, Daley A, Aveyard P. Comparison of range of commercial or primary care led weight reduction programmes with minimal intervention control for weight loss in obesity: Lighten Up randomised controlled trial. BMJ. 2011 Nov 3;343:d6500. doi: 10.1136/bmj.d6500. 埼玉医科大学　総合医療センター　内分泌・糖尿病内科 Department of Endocrinology and Diabetes, Saitama Medical Center, Saitama Medical University 松田　昌文 Matsuda, Masafumi 2011年11月17日8:30-8:55 ８階　医局

  2. His Ala O HN N Gila Monster OH NC インクレチン関連薬におけるGLP-1の位置づけ DPP-4 Glu Thr Phe Thr Ser Gly Asp Val インクレチンに基づく糖尿病治療薬 Ser Ala Ala Gln Gly Glu Leu Tyr Ser Lys Glu Phe 36 O NH2 F Trp Ile Ala Leu Lys Arg Gly Val Gly ヒトGLP-1 F N N N GLP-1受容体作動薬 DPP-4阻害薬 N CF3 F ビルダグリプチン シタグリプチン ヒトGLP-1アナログ GLP-1受容体アゴニスト アログリプチン (例)リラグルチド (例)エキセナチド

  3. GLP-1受容体作動薬リラグルチドの臨床使用　2型糖尿病治療の有用性の最大化に向けてGLP-1受容体作動薬リラグルチドの臨床使用　2型糖尿病治療の有用性の最大化に向けて 松田昌文(埼玉医科大学総合医療センター 内分泌・糖尿病内科) Progress in Medicine31巻7号 Page1753-1760, 2011

  4. ビクトーザのHbA1c，体重への効果 HbA1c(JDS)% kg BOT，強化インスリン治療からの切替例では治療前のインスリン合計量はそれぞれ１日10±7単位（4-20単位）と30±29単位（12-120単位）であった。 インスリン導入例では２例、76日、84日後にHbA1cが上昇した為インスリン治療に戻した。 押谷奈都子ら：第48回 日本糖尿病学会関東甲信越地方会

  5. Byetta(Exenatide) HbA1c(JDS) % BW (kg) 埼玉医科大学総合医療センター　内分泌・糖尿病内科　2011年3月～5月 (2011/3/31までに開始した例。７例ともビクトーザ0.9mg/日からの切替)

  6. LEAD-5 Liraglutide Effect and Action in Diabetes 18～80歳の2型糖尿病患者 3ヵ月以上のOAD療法 HbA1c (NGSP値) 7.0–10.0％ (OAD2剤) 7.5–10.0％ (OAD1剤) FPG 135–230mg/dl BMI ≦45kg/m2 リラグルチド1.8mg 1日1回（n=232）† プラセボ 1日1回（n=115）† インスリングラルギン 1日1回（n=234） –6 –4 –2 0 2 4 6 8 10 12 14 16 18 20 22 24 26 投与期間（週） リラグルチドの用量漸増 グラルギンの用量漸増 17ヵ国の107施設において 実施された試験 †二重盲検試験 無作為化時に前治療のOADsを中止 メトホルミン/グリメピリドの用量漸増 Diabetologia (2009) 52:2046–2055　に結果掲載

  7. 被験者背景 他に記述がない限り、データは平均値（SD）である Data on file, Novo Nordisk Pharma Ltd. (LEAD-5)

  8. HbA1c(NGSP値)の推移（26週間） * インスリン グラルギン ~24U リラグルチド 1.8mg プラセボ 9 8.5 8 *** 7.5 HbA1c（％）　NGSP値 7 6.5 0 0 4 8 12 16 20 24 投与期間（週） p値は変化量を投与群間で比較 *p=0.0015、***p<0.0001 Mean±2SE Russell-Jones et al. Diabetologia 2009;52(10);2046-55より作図 (LEAD-5)

  9. 体重の推移（26週間） インスリングラルギン　~24U リラグルチド 1.8mg プラセボ 90 89 88 87 86 p<0.0001 85 体重（kg） p=0.0001 84 83 82 81 0 0 4 8 12 16 20 24 投与期間（週） p値は変化量を投与群間で比較 **p<0.01***p<0.0001 Mean±SE Russell-Jones et al. Diabetologia 2009;52(10);2046-55より作図 (LEAD-5)

  10. プロインスリン/C-ペプチド比の変化量 ベースライン 0.026 ベースライン0.026 ベースライン0.024 0.008 0.006 0.004 0.002 0 プロインスリン/C-ペプチド比の変化量 -0.002 -0.004 -0.006 p<0.0001 -0.008 p=0.0019 リラグルチド 1.8mg プラセボ インスリングラルギン24U Mean±2SE Data on file, Novo Nordisk Pharma Ltd. (LEAD-5)

  11. 重大でない低血糖（血糖値＜56mg/dl）と症状のみ[淡色で表示]の低血糖重大でない低血糖（血糖値＜56mg/dl）と症状のみ[淡色で表示]の低血糖 被験者1例あたりの年間発現件数（件/人･年） 1.4 1.2 1 0.8 0.6 0.4 0.2 0 リラグルチド 1.8mg プラセボ インスリン グラルギン Rates of hypoglycaemicepisodes (major, minor and symptoms only, respectively) were 0.06,1.2 and 1.0 events/patient/year, respectively, in the liraglutidegroup (vs 0, 1.3, 1.8 and 0, 1.0, 0.5 with glargine and placebo, respectively). • 5例6件の「重大な低血糖」が発現した • 昏睡及び発作は生じなかった 全ての投与群間比較についてp=NS 申請資料より作図 (LEAD-5)

  12. エキセナチド/インスリングラルギン対照試験：試験デザインエキセナチド/インスリングラルギン対照試験：試験デザイン • 26週試験、1日2回（BID）用量固定エキセナチド vs 1日1回（QD）インスリングラルギン漸増 • 主要エンドポイント: HbA1c値の変化 • 対象患者：N=549　無作為割り付けされた患者で、ベースライン後１回以上の測定を行った患者 スクリーニング (HbA1c 値7.0％以上から10.0％未満) 無作為化 エキセナチド 5μg + MET/SU エキセナチド 10μg + MET/SU 既存の MET/SU 療法 インスリングラルギン + MET/SU （連日の血糖値モニタリングに基づく空腹時血漿血糖値が目標の100mg/dL未満となるようインスリンを漸増） -4 -2 0 2 4 8 12 18 26 時間 (週) HbA1c値はNGSP値で記載 ※「効能・効果」、「用法・用量」については、添付文書をご参照ください。 Heine RJ, et al. Ann Intern Med. 2005;143:559-569.

  13. エキセナチド/インスリングラルギン対照試験：患者のベースライン時の特性エキセナチド/インスリングラルギン対照試験：患者のベースライン時の特性 HbA1c値はNGSP値で記載 ※「効能・効果」、「用法・用量」については、添付文書をご参照ください。 Heine RJ, et al. Ann Intern Med. 2005;143:559-569.

  14. エキセナチド/インスリングラルギン対照治験：両群でHbA1c 値の低下が認められた 26Ｗ後 エキセナチド インスリングラルギン インスリン グラルギン （％） （％） エキセナチド 0.0 60 ＨｂＡ１ｃ値７％未満の 目標値を達成した患者の割合 48% 46% 50 ＨｂＡ１ｃ値の変化量 -0.5 40 30 -1.0 20 -1.1% -1.1% 10 -1.5 0 エキセナチド インスリン グラルギン ITT population; Mean ± S.E. HbA1c値はNGSP値で記載 ※「効能・効果」、「用法・用量」については、添付文書をご参照ください。 Heine RJ, et al. Ann Intern Med. 2005;143:559-569.

  15. エキセナチド/インスリングラルギン対照試験：エキセナチドでは体重の減少が認められたエキセナチド/インスリングラルギン対照試験：エキセナチドでは体重の減少が認められた エキセナチド インスリングラルギン （ｋｇ） 3 2 1 平均体重減少量 0 * * -1 * * -2 * * -3 （週） 0 2 4 8 12 18 26 時間 ITT population; Mean ± S.E. *p<0.0001, エキセナチド vs. インスリングラルギン ※「効能・効果」、「用法・用量」については、添付文書をご参照ください。 Heine RJ, et al. Ann Intern Med. 2005;143:559-569. Reprinted with permission from The American College of Physicians.

  16. エキセナチド/インスリングラルギン　クロスオーバー非劣性試験：試験デザインエキセナチド/インスリングラルギン　クロスオーバー非劣性試験：試験デザイン クロスオーバー 無作為化 スクリーニング 第1期 第2期 エキセナチド 10 μｇ (１日２回)† エキセナチド 10 μｇ (１日２回)† 患者: MET or SU HbA1c 値7.1%以上 11.0%未満 MET or SU SU or MET SU or MET インスリングラルギン(１日１回)‡ インスリングラルギン(１日１回)‡ 治療期間　± 1週 -2 0 16 32 † エキセナチドは、1日2回皮下注射し、最初の4週間は5 µg、その後は10 µgの用量で投与を行った。 ‡ インスリングラルギンは、空腹時血糖値が 99 mg/dLになるように増量した。 インスリングラルギンの平均投与量は第1期が28.6 ± 16.8 IU/day (n=69)、第2期が25.7 ± 17.6 IU/day。 HbA1c値はNGSP値で記載 ※「効能・効果」、「用法・用量」については、添付文書をご参照ください。 Barnett AH, et al. Clin Ther. 2007;29:2333-2348.

  17. エキセナチド/インスリングラルギンクロスオーバー非劣性試験：患者背景エキセナチド/インスリングラルギンクロスオーバー非劣性試験：患者背景 Intent-to-treat, N=138; mean ± S.E. or % HbA1c値はNGSP値で記載 ※「効能・効果」、「用法・用量」については、添付文書をご参照ください。 Barnett AH, et al. Clin Ther. 2007;29:2333-2348.

  18. エキセナチド/インスリングラルギンのクロスオーバー非劣性試験：エンドポイントにおける目標のHbA1c値が達成された患者の割合エキセナチド/インスリングラルギンのクロスオーバー非劣性試験：エンドポイントにおける目標のHbA1c値が達成された患者の割合 インスリングラルギン (n=127) （％） エキセナチド (n=136) 45 40 40 38 35 30 目標のHbA1c 値が達成された患者の割合 25 22 20 15 14 10 5 0 7.0%未満 HbA1c 6.5%未満 HbA1c Intent-to-treat sample, N=138 HbA1c値はNGSP値で記載 ※「効能・効果」、「用法・用量」については、添付文書をご参照ください。 Barnett AH, et al. Clin Ther. 2007;29:2333-2348.

  19. エキセナチド/インスリングラルギンクロスオーバー非劣性試験：体重変化の推移エキセナチド/インスリングラルギンクロスオーバー非劣性試験：体重変化の推移 インスリングラルギン （kg） エキセナチド 2 1 n=68 0 体重の変化量 - 1 n=70 - 2 - 3 （週） 0 2 4 6 8 12 16 18 20 22 24 28 32 時間 ITT, N=138;, 最小二乗平均 ± S.E. ※「効能・効果」、「用法・用量」については、添付文書をご参照ください。 Barnett AH, et al. Clin Ther. 2007;29:2333-2348.

  20. エキセナチド/インスリングラルギンのクロスオーバー非劣性試験：低血糖症の発現率エキセナチド/インスリングラルギンのクロスオーバー非劣性試験：低血糖症の発現率 インスリングラルギン (n=127) エキセナチド (n=136) （％） 40 35 34.5 低血糖症の発現率 30 30.0 25 25.2 20 15 17.4 14.7 10 * 5 2.6 0 全体 MET併用 SU併用 直接比較試験, N=138; 最小二乗平均差 ±S.E. *p=0.010 ※「効能・効果」、「用法・用量」については、添付文書をご参照ください。 Barnett AH, et al. Clin Ther. 2007;29:2333-2348.

  21. Figure 3—C-peptide concentrations during hyperglycemic clamp and ratio to pretreatment in the exenatide (A and C)- and insulin glargine (B and D)-treated group. Data represent mean ± SEM in A and B and geometric mean ±SEM in C and D. AIRarg, C-peptide response to arginine at 15 mmol/l glucose concentration; 1st phase, first-phase C-peptide response to glucose; 2nd phase, second-phase C-peptide response to glucose. Bunck MC, Diamant M, Cornér A, et al. One-year treatment with exenatide improves beta-cell function, compared with insulin glargine, in metformin-treated type 2 diabetic patients: a randomized, controlled trial. Diabetes Care 2009;32:762– 768

  22. From the 1Diabetes Center, Department of Internal Medicine, VU University Medical Center, Amsterdam, the Netherlands; the 2Department of Medicine, Helsinki University Central Hospital, Helsinki, Finland; the 3Minerva Medical Research Institute, Helsinki, Finland; the 4Lundberg Laboratory for Diabetes Research, Sahlgrenska University Hospital, Goteborg, Sweden; 5Eli Lilly and Company, Indianapolis, Indiana; and 6Eli Lilly and Company, Houten, the Netherlands. Diabetes Care 34:2041–2047, 2011

  23. OBJECTIVE—We previously showed that exenatide (EXE) enhanced insulin secretion after 1 year of treatment, relative to insulin glargine (GLAR), with a similar glucose-lowering action. These effects were not sustained after a 4-week off-drug period. This article reports the results after additional 2 years of exposure.

  24. RESEARCH DESIGN AND METHODS—Sixty-ninemetformin-treated patients with type 2 diabetes were randomized to EXE or GLAR. Forty-six patients entered the 2-year extension study in which they continued their allocated therapy. Thirty-six completed (EXE: n = 16; GLAR: n = 20) the 3-year exposure period. Insulin sensitivity (Mvalue) and b-cell function were measured by euglycemichyperinsulinemic clamp followed by hyperglycemic clamp with arginine stimulation at pretreatment (week 52) and 4weeks after discontinuation of study medication (week 56 and week 172). First-phase glucose stimulated C-peptide secretion was adjusted for M value and calculated as the disposition index (DI).

  25. Figure 1—Protocol flowchart and baseline characteristics of the study population. Data are mean ± SD.

  26. Figure 1—Protocol flowchart and baseline characteristics of the study population. Data are mean ± SD.

  27. Figure 2—Time course for HbA1c (A), fasting plasma glucose (B), and change in body weight (C). Data are mean (SEM).○= EXE;●= GLAR. Vertical hatched lines at weeks 52, 64, and 168 represent cessation and restart of study medication

  28. Combined euglycemichyperinsulinemic and hyperglycemic clamp with arginine stimulation Insulin sensitivity and C-peptide secretion measures were measured during a combined euglycemichyperinsulinemic and hyperglycemic clamp procedure as previously described (Supplementary Fig. 2) (9,10). Clamps were performed prior to randomization, following 52 weeks of treatment, after a 4-week off-drug period (week 56), and finally after a 4-week off-drug period following the total 3 years of treatment (week 172) as previously described (7). During the clamp at week 52, patients randomized to EXE were given the study drug 15 min prior to the onset of the hyperglycemic clamp, and patients randomized to GLAR received their last insulin dose the night before at bedtime. During the clamp at week 56 and week 172, patients did not receive either EXE or GLAR. Arginine was administered at t = 260 min during the hyperglycemic clamp to estimate maximum insulin secretory capacity at a steady-state glucose concentration of 15 mmol/L (11). Wholebody insulin–mediated glucose uptake (M value) was calculated as the mean glucose infusion rate during the last 30 min of the euglycemichyperinsulinemic clamp between 90–120 min (9). First- and secondphase C-peptide secretion was calculated as area under the curve (AUC) 180–190 min and AUC 190–260 min, respectively. Arginine-stimulated C-peptide secretion (AIRarg) was calculated as the incremental AUC 260–270 min above the C-peptide concentration prior to the start of the hyperglycemic clamp (t = 175 min). The disposition index (DI), a measure of b-cell function and adjusted for insulin sensitivity, was calculated by multiplying the firstphase incremental C-peptide secretion with the M value (AIRgluc*M) (12).

  29. Figure 3—b-Cell function parameters during 3 years of EXE (n = 16) and GLAR (n = 20) treatment. Serum C-peptide concentrations during hyperglycemic clampare shown at week 0 (A), week 52 (B), week 56 (C), and week 172 (D). ○ = EXE; ● = GLAR.

  30. Figure 3—b-Cell function parameters during 3 years of EXE (n = 16) and GLAR (n = 20) treatment. . b-Cell secretory capacity ratio-to-pretreatment is shown in the EXE- (E) and GLAR-treated (F) groups. ■ = week 0 (pretreatment);▦= week 52 (on-drug);▤= week 56 (off-drug); □ = week 172 (off-drug). Mean DI the EXE- and GLAR-treated group (G).■= EXE week 0 (pretreatment);□= EXE week 172 (off-drug); ● = GLAR week 0 (pretreatment); ○ = GLAR week 172 (off-drug). DI change from pretreatment (H).□= EXE;■= GLAR. Data are mean (SEM) in A–D and G–H; geometric mean (SEM) in E–F. AIRarg, C-peptide response to arginine at 15 mmol/L glucose concentration; AIRgluc and 1st phase, first-phase C-peptide response to glucose; 2nd phase, second-phase C-peptide response to glucose.

  31. Scatter plot showing the relation between treatment induced change in body weight and change in disposition index, calculated for the week 172 hyperglycemic clamp test. White circles = GLAR; black circles = EXE.

  32. RESULTS—At 3 years, EXE and GLAR resulted in similar levels of glycemic control: 6.6 ± 0.2% and 6.9 ±0.2%, respectively (P = 0.186). EXE compared with GLAR significantly reduced body weight (27.9 ±1.8 kg; P , 0.001). After the 4-week off-drug period, EXE increased the Mvalue by 39% (P = 0.006) while GLAR had no effect (P = 0.647). Following the 4-week off-drug period, the DI, compared with pretreatment, increased with EXE, but decreased with GLAR (1.43 ±0.78 and 20.99 ±0.65, respectively; P = 0.028).

  33. CONCLUSIONS—EXE and GLAR sustained HbA1c over the 3-year treatment period, while EXE reduced body weight and GLAR increased body weight. Following the 3-year treatment with EXE, the DI was sustained after a 4-week off-drug period. These findings suggest a beneficial effect on b-cell health.

  34. Message/Comments Exenatideのβ細胞保護効果があるというデータ！ Disposition indexで見るとExenatideを３年くらい使うと止めても１ヵ月くらいはβ細胞が頑張ってくれるようである。 （１年ではダメ） と言っても、血糖は３年使っても止めるとすぐに上昇してくるので止められるということにはならないようである。

  35. http://information.konamisportsclub.jp/004447.html

  36. a population of 2,284,093 (2001 census).[

  37. Objective To assess the effectiveness of a range of weight management programmes in terms of weight loss.

  38. Design Eight arm randomised controlled trial. Setting Primary care trust in Birmingham, England. Participants740 obese or overweight men and women with a comorbid disorder identified from general practice records. Interventions Weight loss programmes of 12 weeks’ duration: Weight Watchers; Slimming World; Rosemary Conley; group based, dietetics led programme; general practice one to one counselling; pharmacy led one to one counselling; choice of any of the six programmes. The comparator group was provided with 12 vouchers enabling free entrance to a local leisure (fitness) centre. Main outcome measures The primary outcome was weight loss at programme end (12 weeks). Secondary outcomes were weight loss at one year, self reported physical activity, and percentage weight loss at programme end and one year.

  39. Box 2: Brief description of interventions Weight Watchers is group based, and the participant was able to join at any time. One to one support is available for new members and during weighing. This is followed by a group talk from the leader, with discussion. Meetings took place in community venues and lasted one hour. Core programme material delivered over five weeks included a food points system (based on age, sex, height, weight, and activity), beating hunger, taking more physical activity, eating out, and keeping motivated. Other sessions delivered to the whole group covered recipes, health and nutrition, and keeping active. The plan aims for 500 kcal (2.09 MJ) deficit/day, leading to 0.5-1.0 kg weight loss a week. Physical activity is encouraged; the objective is to gradually build up to 10 000 steps daily. Predominant strategies used to change behaviour included stages of change, food and activity diaries, goal setting, and evaluation of progress. Rewards are given for every 3.2 kg (7 lb) lost and for loss of 5% and 10% of body weight. Slimming World is group based, and the participant was able to join at any time. Meetings took place in community venues and lasted 90 minutes. Also included is access to a website, magazines, and one to one telephone support from a consultant or other members. Members are encouraged to eat mainly foods with low energy density to achieve satiety, plus some extras rich in calcium and fibre, with controlled amounts of high energy dense foods. Weight loss goals are set by the individual. Physical activity is encouraged, with gradual build up to 30 minutes of moderately intense activity five days a week. The theoretical background is based on transactional analysis and motivational interviewing. Predominant behaviour change strategies used included weekly weighing; group support; and group praise for weight loss, new decisions, and continued commitment even in the absence of weight loss. Awards are given for 3.2 kg (7 lbs) lost and loss of 10% of body weight. Individual support, if needed, uses self monitoring of food and emotions, for and against evaluations, visualisation techniques, and personal eating plans. .

  40. Box 2: Brief description of interventions Rosemary Conley is group based, and the participant was able to join at any time. Meetings took place in community venues and lasted 90 minutes. One to one support is offered during weighing and to establish a calorie allowance. Additional support is available by email and telephone. Goals are staged: either 1-1.5 kg/week with a goal of 6.35 kg (1 stone) loss or 0.5-1 kg/week with an initial goal of 3.2 kg (7 lb). Sessions include a 45 minute optional exercise class. Extra exercise sessions may be offered for an additional fee. The theoretical background is based on role modelling and group support and uses visualisation and reframing to support behavioural change. Predominant behaviour change strategies used include rewards for slimmers who maintain or lose weight, slimmer of the week, and certificates for 3.2 kg and 6.35 kg milestones. The Size Down Programmewas an NHS group based programme run in community venues by support workers trained by the dietetics service. This provided six weekly two hour sessions, with follow-up sessions at nine and 12 weeks. All participants joined together in week one of the programme. Its particular focus was on long term changes in patterns of eating behaviour, achieving a balanced diet, and increasing physical activity in daily life, and it used an interactive style. Topics covered included managing behaviour around food and prevention of relapse, the eatwell plate, nutritional information, planning strategies to deal with lapses into previous dietary behaviours, interactive visual aids to show the fat and sugar content of foods, and adaptation of recipes. The theoretical background was based on the cycle of change (Prochaska and Di Clemente). The benefits of physical activity, setting goals, and finding activities to fit into life were discussed. Predominant behaviour change strategies used included goal setting, stages of change, and self monitoring with a food diary.

  41. Box 2: Brief description of interventions The general practice and pharmacy programmescomprised 12 one to one sessions in the general practice or pharmacy. The first session was planned to last 30 minutes, with follow-up sessions of 15-20 minutes. Sessions were client led and based around a problem solving approach. Sessions included weight and dieting history, exploration of goals and expectations of patients, the eat well plate, setting goals to reduce calorie intake and increase physical activity, planning strategies to deal with challenging situations, use of food diaries, and maintaining weight loss. Weight loss goals were 5-10% of starting body weight, at a rate of 0.5-1 kg/week over three to six months, followed by maintenance. Physical activity goals were to aim to slowly increase activity levels to achieve 30 minutes of moderate activity on five days each week. The theoretical basis used stages of change and motivational interviewing. Predominant behaviour change strategies included goal setting, self monitoring with food diaries, hunger scale, waist measurements, and physical activity. Resources were provided as homework for discussion in the next session or for personal reflection. Participants were encouraged to reward themselves for success.

  42. Commercially provided primary care based Recruitment took place from January to May 2009.

  43. In the choice arm, 71 (71%) participants chose one of the commercial providers (Weight Watchers 29 (29%), Slimming World 14 (14%), Rosemary Conley 28 (28%)), 16 (16%) chose the Size Down programme, 3 (3%) chose general practice, and 10 (10%) chose pharmacy provision. Women were more likely than men to choose one of the commercial providers (57 (81%) v 14 (47%)).

  44. The baseline-observation-carried-forward (BOCF) approach is one method to handle missing data from early treatment discontinuation. In the last-observation-carried-forward (LOCF) approach, the last observed nonmissing value is used in place of the missing endpoint.

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